SAFETY DATA SHEET
SECTION 1: Identification of the substance/mixture and of the company/undertaking
1.1. Product identifier
Trade name or designation
of the mixture
Unleaded petrol (RON 95), (RON 98)
Registration number
-
Synonyms
None.
Issue date
17-April-2013
Version number
02
Revision date
30-August-2013
Supersedes date
17-April-2013
1.2. Relevant identified uses of the substance or mixture and uses advised against
Identified uses
Use as a Fuel.
Other registered uses for this product can be found in section 15 of this SDS.
Uses advised against
-
1.3. Details of the supplier of the safety data sheet
Supplier
Company name
Address
Telephone
Fax
e-mail
Contact person
Emergency number in the
EU
1.4. Emergency telephone
number
LUKOIL Neftohim Burgas AD
Burgas 8104, Bulgaria
+359 5511 5654
+359 5511 5555
SDS@neftochim.bg
REACH@neftochim.bg
112
+1-760-476-3961 (333368)
SECTION 2: Hazards identification
2.1. Classification of the substance or mixture
The mixture has been assessed and/or tested for its physical, health and environmental hazards and the following classification
applies.
Classification according to Directive 67/548/EEC or 1999/45/EC as amended
Classification
F+;R12, Carc. Cat. 2;R45, Muta. Cat. 2;R46, Repr. Cat. 3;R62-63, Xn;R65, Xi;R38, R67,
N;R51/53
The full text for all R-phrases is displayed in section 16.
Classification according to Regulation (EC) No 1272/2008 as amended
Physical hazards
Flammable liquids
Category 1
H224 - Extremely flammable liquid
and vapour.
Health hazards
Skin corrosion/irritation
Category 2
H315 - Causes skin irritation.
Germ cell mutagenicity
Category 1B
H340 - May cause genetic defects.
Carcinogenicity
Category 1B
H350 - May cause cancer.
Reproductive toxicity
Category 2
H361fd - Suspected of damaging
fertility. Suspected of damaging the
unborn child.
Specific target organ toxicity - single
exposure
Category 3 narcotic effects
H336 - May cause drowsiness or
dizziness.
Aspiration hazard
Category 1
H304 - May be fatal if swallowed
and enters airways.
Category 2
H411 - Toxic to aquatic life with
long lasting effects.
Environmental hazards
Hazardous to the aquatic environment,
long-term aquatic hazard
Unleaded petrol (RON 95), (RON 98)
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Hazard summary
Physical hazards
Extremely flammable.
Health hazards
May cause cancer. May cause heritable genetic damage. Irritating to skin. Possible risk of
impaired fertility. Possible risk of harm to the unborn child. Also harmful: may cause lung damage
if swallowed. Vapours may cause drowsiness and dizziness. Occupational exposure to the
substance or mixture may cause adverse health effects.
Environmental hazards
Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.
Specific hazards
Breathing of high vapour concentrations may cause dizziness, light-headedness, headache,
nausea and loss of co-ordination. Continued inhalation may result in unconsciousness. Prolonged
or repeated contact with skin may cause redness, itching, irritation, eczema/chapping and oil
acne. Prolonged and repeated contact with the product may cause skin cancer. Components of
the product may be absorbed into the body through the skin. Droplets of the product aspirated into
the lungs through ingestion or vomiting may cause a serious chemical pneumonia. Material will
float and can be re-ignited on surface of water.
Main symptoms
Irritation of eyes and mucous membranes. Skin irritation. Dermatitis. Ingestion may cause
irritation and malaise.
2.2. Label elements
Label according to Regulation (EC) No. 1272/2008 as amended
Gasoline, tert-Butyl methyl ether
Contains:
Hazard pictograms
Signal word
Danger
Hazard statements
H224 - Extremely flammable liquid and vapour.
H304 - May be fatal if swallowed and enters airways.
H315 - Causes skin irritation.
H336 - May cause drowsiness or dizziness.
H340 - May cause genetic defects.
H350 - May cause cancer.
H361fd - Suspected of damaging fertility. Suspected of damaging the unborn child.
H411 - Toxic to aquatic life with long lasting effects.
Precautionary statements
Prevention
P201 - Obtain special instructions before use.
P280 - Wear protective gloves/protective clothing/eye protection/face protection.
P210 - Keep away from heat/sparks/open flames/hot surfaces. - No smoking.
Response
P301 + P310 - IF SWALLOWED: Immediately call a POISON CENTRE or doctor/physician.
Storage
P403 + P235 - Store in a well-ventilated place. Keep cool.
Disposal
P501 - Dispose of contents/container in accordance with local/regional/national/international
regulations.
Supplemental label information
Not applicable.
2.3. Other hazards
Hydrogen sulfide (H2S) can accumulate in the headspace of storage tanks and reach potentially
hazardous concentrations. Not a PBT or vPvB substance or mixture.
SECTION 3: Composition/information on ingredients
3.2. Mixtures
General information
Chemical name
Gasoline
Classification:
%
CAS-No. / EC No. REACH Registration No.
INDEX No.
Notes
≥ 85
86290-81-5
01-2119471335-39-0034 649-378-00-4
289-220-8
DSD: F+;R12, Carc. Cat. 2;R45, Muta. Cat. 2;R46, Repr. Cat. 3;R62-63, Xn;R65, Xi;R38, R67,
N;R51-53
CLP:
Flam. Liq. 1;H224, Asp. Tox. 1;H304, Skin Irrit. 2;H315, STOT SE 3;H336, Muta. 1B;H340,
Carc. 1B;H350, Repr. 2;H361fd, Aquatic Chronic 2;H411
Unleaded petrol (RON 95), (RON 98)
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Issue date: 17-April-2013
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Chemical name
%
tert-Butyl methyl ether
Classification:
≤ 15
CAS-No. / EC No. REACH Registration No.
1634-04-4
216-653-1
INDEX No.
01-2119452786-27-0028 603-181-00-X
Notes
#
DSD: F;R11, Xi;R38
CLP:
Flam. Liq. 2;H225, Skin Irrit. 2;H315
DSD: Directive 67/548/EEC.
CLP: Regulation No. 1272/2008.
#: This substance has workplace exposure limit(s).
Composition comments
This product is registered under the REACH Regulation 1907/2006 as a UVCB. The full text for all
R-phrases is displayed in section 16 of the SDS. The full text for all R- and H-phrases is displayed
in section 16. All concentrations are in percent by weight unless ingredient is a gas. Gas
concentrations are in percent by volume. Hydrogen sulphide (H2S) can accumulate in the
headspace of storage tanks and reach potentially hazardous concentrations. For more detailed
chemical composition, refer to the certificate of analysis.
SECTION 4: First aid measures
General information
Get medical attention if any discomfort develops.
4.1. Description of first aid measures
Inhalation
Move to fresh air. If breathing is difficult, give oxygen. Get medical attention if discomfort develops
or persists.
If there is any suspicion of inhalation of H2S:
Rescuers must wear breathing apparatus, belt and safety rope, and follow rescue procedures.
Remove casualty to fresh air as quickly as possible.
Immediately begin artificial respiration if breathing has ceased.
Provision of oxygen may help.
Obtain medical advice for further treatment.
Skin contact
Immediately remove contaminated clothing. Wash with soap and water. Continue to rinse for at
least 15 minutes. In case of rashes, wounds or other skin disorders: Seek medical attention and
bring along these instructions. If product is injected into or under the skin, or into any part of the
body, regardless of the appearance of the wound or its size, the individual should be evaluated
immediately by a physician as a surgical emergency. Even though initial symptoms from high
pressure injection may be minimal or absent, early surgical treatment within the first few hours may
significantly reduce the ultimate extent of injury.
Eye contact
Immediately flush with plenty of water for up to 15 minutes. Remove any contact lenses and open
eyelids wide apart. Get medical attention if irritation develops or persists.
Ingestion
Immediately rinse mouth and drink plenty of water or milk. Keep person under observation. Do not
induce vomiting. If vomiting occurs, keep head low. Transport immediately to hospital and take
these instructions. Never give anything by mouth to an unconscious person.
4.2. Most important symptoms
and effects, both acute and
delayed
Irritation of eyes and mucous membranes. Skin irritation. Dermatitis. Ingestion may cause irritation
and malaise. Droplets of the product aspirated into the lungs through ingestion or vomiting may
cause a serious chemical pneumonia.
4.3. Indication of any
immediate medical attention
and special treatment needed
Treat symptomatically. The effects might be delayed.
SECTION 5: Firefighting measures
General fire hazards
5.1. Extinguishing media
Suitable extinguishing
media
Unsuitable extinguishing
media
5.2. Special hazards arising
from the substance or mixture
5.3. Advice for firefighters
Special protective
equipment for firefighters
Special fire fighting
procedures
The product is extremely flammable, and explosive vapour/air mixtures may be formed even at
normal room temperatures. Material will float and can be re-ignited on surface of water.
Dry chemical, CO2, sand, earth, water spray or regular foam.
Do not use water jet as an extinguisher, as this will spread the fire. Simultaneous use of foam and
water on the same surface is to be avoided as water destroys the foam.
Thermal decomposition may produce smoke, oxides of carbon and lower molecular weight organic
compounds whose composition have not been characterised. Sulfur Oxides (SOx). Nitrogen
Oxides (NOx).
Self-contained breathing apparatus and full protective clothing must be worn in case of fire.
Move containers from fire area if you can do it without risk. Use water spray to cool unopened
containers. Cool containers with flooding quantities of water until well after fire is out.
Unleaded petrol (RON 95), (RON 98)
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SECTION 6: Accidental release measures
6.1. Personal precautions, protective equipment and emergency procedures
For non-emergency
Stay upwind. Eliminate all ignition sources (no smoking, flares, sparks or flames in immediate
area). Avoid contact with skin. Use personal protection as recommended in section 8 of the SDS.
personnel
For emergency responders
Use personal protection as recommended in section 8 of the SDS.
6.2. Environmental precautions
Prevent spreading over a wide area (e.g. by containment or oil barriers). Do not contaminate
water. Contact local authorities in case of spillage to drain/aquatic environment.
6.3. Methods and material for
containment and cleaning up
Stop the flow of material, if this is without risk. Dike far ahead of spill for later disposal. Remove
sources of ignition. Beware of the explosion danger.
Small Spills: Absorb spillage with non-combustible, absorbent material.
Large Spills: Remove with vacuum trucks or pump to storage/salvage vessels. Use a
non-combustible material like vermiculite, sand or earth to soak up the product and place into a
container for later disposal. Ensure that waste and contaminated materials are collected and
removed from the work area as soon as possible in a suitably labelled container. Wash area with
soap and water. If necessary dike the product with dry earth, sand or similar non-combustible
materials.
6.4. Reference to other
sections
For personal protection, see section 8 of the SDS. For waste disposal, see section 13 of the SDS.
SECTION 7: Handling and storage
7.1. Precautions for safe
handling
Before entering storage tanks and commencing any operation in a confined area check the
atmosphere for oxygen content and flammability. (Subject to applicability) If sulfur compounds are
suspected to be present in the product, check the atmosphere for H2S content. Access to work
area should be restricted to people handling the product only. Should be handled in closed
systems, if possible. Avoid contact with eyes, skin, and clothing. Avoid inhalation of vapours. Wear
appropriate personal protective equipment. The product is extremely flammable, and explosive
vapour/air mixtures may be formed even at normal room temperatures. Ground container and
transfer equipment to eliminate static electric sparks. Vapours are heavier than air and may travel
along the floor and in the bottom of containers. Immediately change contaminated clothes. Do not
eat, drink or smoke when using the product. Observe good industrial hygiene practices.
7.2. Conditions for safe
storage, including any
incompatibilities
Follow rules for flammable liquids. Keep away from heat, sparks and open flame. Keep in a cool,
well-ventilated place. Keep away from food, drink and animal feeding stuffs. Store away from
incompatible materials.
7.3. Specific end use(s)
For detailed information, see section 15. Recommendations given in the exposure scenario for the
uses are distributed and annexed as separate documents to this eSDS.
SECTION 8: Exposure controls/personal protection
8.1. Control parameters
Occupational exposure limits
UK. EH40 Workplace Exposure Limits (WELs)
Components
Type
Value
tert-Butyl methyl ether (CAS
1634-04-4)
STEL
367 mg/m3
TWA
100 ppm
183.5 mg/m3
50 ppm
EU. Indicative Exposure Limit Values in Directives 91/322/EEC, 2000/39/EC, 2006/15/EC, 2009/161/EU
Components
Type
Value
tert-Butyl methyl ether (CAS
1634-04-4)
STEL
367 mg/m3
TWA
100 ppm
183.5 mg/m3
50 ppm
Biological limit values
No biological exposure limits noted for the ingredient(s).
Recommended monitoring
procedures
Follow standard monitoring procedures.
Derived no-effect level (DNEL)
Components
Gasoline (CAS 86290-81-5)
Type
Route
Value
Workers
Inhalation
1300 mg/m³/15min Acute exposure systemic
effect
Unleaded petrol (RON 95), (RON 98)
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Issue date: 17-April-2013
Form
SDS UK
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Components
Type
Route
Value
Inhalation
1100 mg/m³/15min Acute exposure local
effects
840 mg/m³/8h
Long term exposure local
effects
3570 mg/kg/day
Long term Systemic
effects
53.6 mg/m3
Long term Systemic
effects
214 mg/m3
Acute Local effects
7.1 mg/kg/day
Long term Systemic
effects
5100 mg/kg/day
Long term Systemic
effects
357 mg/m3
Acute exposure local
effects
178.5 mg/m3
Long term Systemic
effects
Inhalation
tert-Butyl methyl ether (CAS 1634-04-4)
Consumer
Dermal
Inhalation
Inhalation
Oral
Workers
Dermal
Inhalation
Inhalation
Predicted no effect concentrations (PNECs)
Components
tert-Butyl methyl ether (CAS 1634-04-4)
Type
Route
Aqua (freshwater)
Aqua (intermittent
releases)
Aqua (marine water)
Sediment
(freshwater)
Sediment (marine
water)
Sewage Treatment
Plant
Soil
Not applicable 5.1 mg/l
Not applicable 47.2 mg/l
Value
Form
Form
Not applicable 0.26 mg/l
Not applicable 25 mg/kg
Not applicable 1.17 mg/kg
Not applicable 71 mg/l
Not applicable 1.62 mg/kg
8.2. Exposure controls
Appropriate engineering
controls
In the absence of occupational exposure limits for this product it is recommended that the above
mentioned standards are followed. Provide adequate ventilation and minimise the risk of inhalation
of vapours and oil mist. Provide easy access to water supply and eye wash facilities. Use
explosion-proof equipment.
Individual protection measures, such as personal protective equipment
General information
Use personal protective equipment as required. Keep working clothes separately. Personal
protective equipment should be chosen according to the CEN standards and in discussion with the
supplier of the personal protective equipment.
Eye/face protection
Wear goggles/face shield.
Skin protection
- Hand protection
Wear protective gloves. Nitrile gloves are recommended, but be aware that the liquid may
penetrate the gloves. Frequent change is advisable. Suitable gloves can be recommended by the
glove supplier.
- Other
Protection suit must be worn. Anti-static and flame-retardant protective clothing is recommended.
Respiratory protection
In case of inadequate ventilation or when the product is heated, use suitable respiratory equipment
with gas filter (type A2). Wear air-supplied mask in confined areas. Seek advice from local
supervisor.
Thermal hazards
Wear appropriate thermal protective clothing, when necessary.
Hygiene measures
When using, do not eat, drink or smoke. Wash hands after handling. Launder contaminated
clothing before reuse. Private clothes and working clothes should be kept separately. Handle in
accordance with good industrial hygiene and safety practices. Observe any medical surveillance
requirements.
Environmental exposure
controls
Contain spills and prevent releases and observe national regulations on emissions.
SECTION 9: Physical and chemical properties
9.1. Information on basic physical and chemical properties
Appearance
Colourless liquid.
Physical state
Liquid.
Form
Liquid.
Colour
Colourless.
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Odour
Not available.
Odour threshold
Not available.
pH
Not applicable.
Melting point/freezing point
< -20 °C (< -4 °F) / Not available.
Initial boiling point and boiling
range
-88 - 260 °C (-126.4 - 500 °F)
Flash point
<0°C - <55°C (<32°F - <131°F)
Evaporation rate
Not available.
Flammability (solid, gas)
Not applicable.
Upper/lower flammability or explosive limits
1.4 %
Flammability limit - lower
(%)
Flammability limit - upper
(%)
7.6 %
Vapour pressure
4 - 240 kPa (37.8°C/100°F)
Vapour density
Not available.
Relative density
0.62 - 0.88
Relative density temperature
15 °C (59 °F)
Solubility(ies)
Insoluble.
Partition coefficient
(n-octanol/water)
Not available.
Auto-ignition temperature
280 - 470 °C (536 - 878 °F)
Decomposition temperature
Not available.
Viscosity
<= 1 mm²/s Typically
Viscosity temperature
37.8 °C (100.04 °F)
Explosive properties
Not explosive.
Oxidizing properties
Not oxidizing.
9.2. Other information
Bulk density
Not applicable.
Percent volatile
100 %
Pour point
Not available.
VOC (Weight %)
100 %
SECTION 10: Stability and reactivity
10.1. Reactivity
The product is non-reactive under normal conditions of use, storage and transport.
10.2. Chemical stability
Stable at normal conditions.
10.3. Possibility of hazardous
reactions
Hazardous polymerisation does not occur. Hazardous reactions do not occur.
10.4. Conditions to avoid
Heat, sparks, flames, elevated temperatures. Contact with incompatible materials.
10.5. Incompatible materials
Strong acids. Strong oxidising agents.
10.6. Hazardous
decomposition products
Thermal decomposition or combustion may liberate carbon oxides and other toxic gases or
vapours.
SECTION 11: Toxicological information
General information
Occupational exposure to the substance or mixture may cause adverse effects.
Information on likely routes of exposure
Ingestion may cause irritation and malaise.
Ingestion
Inhalation
Breathing of high concentrations may cause dizziness, light-headedness, headache, nausea and
loss of co-ordination. Continued inhalation may result in unconsciousness.
Skin contact
Causes skin irritation. Repeated exposure may cause skin dryness or cracking. May be absorbed
through the skin.
Eye contact
May cause eye irritation on direct contact.
Symptoms
Skin irritation. Dermatitis. Irritation of eyes and mucous membranes. Irritation of nose and throat.
11.1. Information on toxicological effects
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Acute toxicity
Components
Breathing of high concentrations may cause dizziness, light-headedness, headache, nausea and
loss of co-ordination. Continued inhalation may result in unconsciousness. Irritant effect on skin.
May irritate and cause stomach pain, vomiting, diarrhoea and nausea. Human evidence indicates
that the product has very low acute oral, dermal or inhalation toxicity. However, it can produce
severe injury if taken into the lung as a liquid, and there may be profound central nervous system
depression following prolonged exposure to high levels of vapour.
Species
Test results
Acute
Dermal
LD50
Rabbit
> 2000 mg/kg
Inhalation
LC50
Rat
> 5610 mg/m3
Oral
LD50
Rat
> 5000 mg/kg
Gasoline (CAS 86290-81-5)
tert-Butyl methyl ether (CAS 1634-04-4)
Acute
Dermal
LD50
Rat
> 2000 mg/kg
Oral
LD50
Rat
> 2000 mg/kg
Skin corrosion/irritation
Causes skin irritation. Pre-existing skin conditions including dermatitis might be aggravated by
exposure to this product.
Serious eye damage/eye
irritation
May cause eye irritation on direct contact.
Respiratory sensitisation
Not classified.
Skin sensitisation
Not a skin sensitiser.
Germ cell mutagenicity
May cause genetic defects.
Carcinogenicity
May cause cancer.
IARC Monographs. Overall Evaluation of Carcinogenicity
Gasoline (CAS 86290-81-5)
2B Possibly carcinogenic to humans.
tert-Butyl methyl ether (CAS 1634-04-4)
3 Not classifiable as to carcinogenicity to humans.
Reproductive toxicity
Suspected of damaging fertility or the unborn child.
Specific target organ toxicity single exposure
May cause drowsiness or dizziness.
Specific target organ toxicity repeated exposure
Test data conclusive but not sufficient for classification.
Aspiration hazard
Droplets of the product aspirated into the lungs through ingestion or vomiting may cause a serious
chemical pneumonia.
Mixture versus substance
information
Not available.
Other information
Components of the product may be absorbed into the body through the skin.
SECTION 12: Ecological information
12.1. Toxicity
Oil spills are generally hazardous to the environment.
Components
Species
Test results
Gasoline (CAS 86290-81-5)
Aquatic
Algae
EC50
Pseudokirchneriella subcapitata
3.1 mg/l, 72 Hours
Crustacea
EC50
Daphnia magna
4.5 mg/l, 48 Hours
Fish
LC50
Oncorhynchus mykiss
10 mg/l, 96 Hours
Pimephales promelas
8.2 mg/l, 96 Hours
Mysid shrimp
106 mg/l, 48 Hours
Pseudokirchneriella subcapitata
491 mg/l, 96 Hours
tert-Butyl methyl ether (CAS 1634-04-4)
EC50
Aquatic
Algae
EC50
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Components
Species
Test results
472 mg/l, 48 Hours
Crustacea
EC50
Daphnia magna
Fish
LC50
Fathead minnow (Pimephales promelas) 672 mg/l, 96 hours
Inland silverside (Menidia beryllina)
12.2. Persistence and
degradability
Expected to be inherently biodegradable.
12.3. Bioaccumulative potential
Has the potential to bioaccumulate.
Partition coefficient
n-octanol/water (log Kow)
tert-Butyl methyl ether (CAS 1634-04-4)
574 mg/l, 96 Hours
0.94
Bioconcentration factor (BCF)
Not available.
12.4. Mobility in soil
Based on the calculation model the product has a low potential of being absorbed in the soil.
Mobility in general
The product is insoluble in water. It will spread on the water surface while some of the components
will eventually sediment in water systems. The volatile components of the product will spread in the
atmosphere.
12.5. Results of PBT
and vPvB
assessment
Not a PBT or vPvB substance or mixture.
12.6. Other adverse effects
Toxic to aquatic life with long lasting effects. The product contains volatile organic compounds
which have a photochemical ozone creation potential. Oil spills are generally hazardous to the
environment.
SECTION 13: Disposal considerations
13.1. Waste treatment methods
Residual waste
Dispose of in accordance with local regulations.
Contaminated packaging
Since emptied containers may retain product residue, follow label warnings even after container is
emptied.
EU waste code
13 07 02*
13 07 03*
The Waste code should be assigned in discussion between the user, the producer and the waste
disposal company.
Disposal methods/information
Dispose in accordance with all applicable regulations. This material and/or its container must be
disposed of as hazardous waste.
SECTION 14: Transport information
ADR
14.1. UN number
14.2. UN proper shipping
name
14.3. Transport hazard
class(es)
Subsidiary class(es)
14.4. Packing group
14.5. Environmental hazards
Tunnel restriction code
Labels required
14.6. Special precautions
for user
RID
14.1. UN number
14.2. UN proper shipping
name
14.3. Transport hazard
class(es)
Subsidiary class(es)
14.4. Packing group
14.5. Environmental hazards
Labels required
14.6. Special precautions
for user
ADN
14.1. UN number
UN1203
GASOLINE
3
II
Yes
D/E
3
Read safety instructions, SDS and emergency procedures before handling.
UN1203
GASOLINE
3
II
Yes
3
Read safety instructions, SDS and emergency procedures before handling.
UN1203
Unleaded petrol (RON 95), (RON 98)
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14.2. UN proper shipping
name
14.3. Transport hazard
class(es)
Subsidiary class(es)
14.4. Packing group
14.5. Environmental hazards
Labels required
14.6. Special precautions
for user
IATA
14.1. UN number
14.2. UN proper shipping
name
14.3. Transport hazard
class(es)
Subsidiary class(es)
14.4. Packing group
14.5. Environmental hazards
Labels required
ERG code
14.6. Special precautions
for user
IMDG
14.1. UN number
14.2. UN proper shipping
name
14.3. Transport hazard
class(es)
Subsidiary class(es)
14.4. Packing group
14.5. Environmental hazards
Marine pollutant
Labels required
EmS
14.6. Special precautions
for user
14.7. Transport in bulk
according to Annex II of
MARPOL 73/78 and the IBC
Code
GASOLINE
3
II
Yes
3
Read safety instructions, SDS and emergency procedures before handling.
UN1203
GASOLINE
3
II
Yes
3
3H
Read safety instructions, SDS and emergency procedures before handling.
UN1203
GASOLINE
3
II
Yes
3
F-E, S-E
Read safety instructions, SDS and emergency procedures before handling.
Not applicable. However, this product is a liquid and if transported in bulk covered under
MARPOL 73/78, Annex I.
SECTION 15: Regulatory information
15.1. Safety, health and environmental regulations/legislation specific for the substance or mixture
EU regulations
Regulation (EC) No. 1005/2009 on substances that deplete the ozone layer, Annex I
Not listed.
Regulation (EC) No. 1005/2009 on substances that deplete the ozone layer, Annex II
Not listed.
Regulation (EC) No. 850/2004 On persistent organic pollutants, Annex I as amended
Not listed.
Regulation (EC) No. 689/2008 concerning the export and import of dangerous chemicals, Annex I, part 1 as amended
Not listed.
Regulation (EC) No. 689/2008 concerning the export and import of dangerous chemicals, Annex I, part 2 as amended
Not listed.
Regulation (EC) No. 689/2008 concerning the export and import of dangerous chemicals, Annex I, part 3 as amended
Not listed.
Regulation (EC) No. 689/2008 concerning the export and import of dangerous chemicals, Annex V as amended
Not listed.
Regulation (EC) No. 166/2006 Annex II Pollutant Release and Transfer Registry
Not listed.
Regulation (EC) No. 1907/2006, REACH Article 59(1) Candidate List as currently published by ECHA
Not listed.
Unleaded petrol (RON 95), (RON 98)
913668 Version No.: 02 Revision date: 30-August-2013
Issue date: 17-April-2013
SDS UK
9 / 11
Authorisations
Regulation (EC) No. 1907/2006, REACH Annex XIV Substances subject to authorisation, as amended
Not listed.
Restrictions on use
Regulation (EC) No. 1907/2006, REACH Annex XVII Substances subject to restriction on marketing and use as amended
tert-Butyl methyl ether (CAS 1634-04-4)
Directive 2004/37/EC: on the protection of workers from the risks related to exposure to carcinogens and mutagens at
work
Not regulated.
Directive 92/85/EEC: on the safety and health of pregnant workers and workers who have recently given birth or are
breastfeeding
Gasoline (CAS 86290-81-5)
Other EU regulations
Directive 96/82/EC (Seveso II) on the control of major-accident hazards involving dangerous substances
Not regulated.
Directive 98/24/EC on the protection of the health and safety of workers from the risks related to chemical agents at work
Gasoline (CAS 86290-81-5)
tert-Butyl methyl ether (CAS 1634-04-4)
Directive 94/33/EC on the protection of young people at work
Gasoline (CAS 86290-81-5)
Other regulations
The product is classified and labelled in accordance with Regulation (EC) 1272/2008 (CLP
Regulation) as amended and respective national laws implementing EC directives. 96/82/EC
(Seveso II) Directive; Part 2 (Classified Substances) - Extremely Flammable This Safety Data
Sheet complies with the requirements of Regulation (EC) No 1907/2006.
National regulations
Young people under 18 years old are not allow to work with this product according to the EU
Directive 94/33/EC on the protection of young people at work. Pregnant women should not work
with the product, if there is the least risk of exposure. Follow national regulation for work with
chemical agents.
15.2. Chemical safety
assessment
No Chemical safety assessment has been carried out for the mixture. The Chemical safety
assessment has been carried out for the components of the mixture listed in section 3 of the SDS.
Exposure scenarios relevant for these substances are annexed and distributed as separate
document to this eSDS.
Exposure scenarios relevant for this material are annexed and distributed as separate document to
this eSDS.
Other registered uses:
Gasoline:
Industrial uses:
Distribution of a substance.
Formulation & (re) packaging of substances and mixtures.
Use as a Fuel.
Professional uses:
Use as a Fuel.
Consumer uses:
Use as a Fuel.
MTBE:
Formulation.
Industrial distribution of MTBE and gasoline containing MTBE.
Use as a Fuel.
Unleaded petrol (RON 95), (RON 98)
913668 Version No.: 02 Revision date: 30-August-2013
Issue date: 17-April-2013
SDS UK
10 / 11
SECTION 16: Other information
List of abbreviations
UVCB: Substances of Unknown or Variable composition, Complex reaction products or Biological
materials.
DNEL: Derived No-Effect Level.
PNEC: Predicted No-Effect Concentration.
PBT: Persistent, bioaccumulative and toxic.
vPvB: Very Persistent and very Bioaccumulative.
DSD: Directive 67/548/EEC.
CLP: Regulation No. 1272/2008.
LD50: Lethal Dose, 50%.
LC50: Lethal Concentration, 50%.
EC50: Effective concentration, 50%.
N/A: Not applicable.
References
IARC Monographs. Overall Evaluation of Carcinogenicity
IUCLID
Chemical safety report.
CLP files – http://concawe.org/
CONCAWE compilation of selected physical-chemical properties of petroleum substances and
sulfur, Brussels, November 2010
ESIS (European chemical Substances Information System)
Information on evaluation
method leading to the
classification of mixture
The mixture is classified based on test data for physical hazards. The classification for health and
environmental hazards is derived by a combination of calculation methods and test data, if
available. For details, refer to Sections 9, 11 and 12.
Full text of any statements or
R-phrases and H-statements
under Sections 2 to 15
R11 Highly flammable.
R12 Extremely flammable.
R38 Irritating to skin.
R45 May cause cancer.
R46 May cause heritable genetic damage.
R51 Toxic to aquatic organisms.
R51/53 Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic
environment.
R53 May cause long-term adverse effects in the aquatic environment.
R62 Possible risk of impaired fertility.
R63 Possible risk of harm to the unborn child.
R65 Also harmful: may cause lung damage if swallowed.
R67 Vapours may cause drowsiness and dizziness.
H224 Extremely flammable liquid and vapour.
H225 Highly flammable liquid and vapour.
H304 May be fatal if swallowed and enters airways.
H315 Causes skin irritation.
H336 May cause drowsiness or dizziness.
H340 May cause genetic defects.
H350 May cause cancer.
H361fd Suspected of damaging fertility. Suspected of damaging the unborn child.
H411 Toxic to aquatic life with long lasting effects.
Training information
Follow training instructions when handling this material.
Disclaimer
The information in the sheet was written based on the best knowledge and experience currently
available at the date of revision and exclusively refer to the product in its as-delivered condition.
The information and recommendations are offered for the user’s consideration and examination.
The logo and the name “LUKOIL oil company” may include anyone or more of LUKOIL or any
affiliates in which they directly or indirectly hold any interest.
Unleaded petrol (RON 95), (RON 98)
913668 Version No.: 02 Revision date: 30-August-2013
Issue date: 17-April-2013
SDS UK
11 / 11
Annex to the extended Safety Data Sheet (eSDS)
Distribution of Low Boiling Point Naphthas (Gasoline) – Industrial
Exposure Scenario
Section 1 Exposure Scenario Title Low boiling point naphthas (Gasoline) that is classified as H340
and/or H350 and/or H361; (containing 0% to 1% benzene)
Title
Distribution of substance
Use Descriptor
Sector(s) of Use
3
1, 2, 3, 8a, 8b, 15
Process Categories
1, 2, 3, 4, 5, 6a, 6b, 6с, 6d, 7
Environmental Release Categories
ESVOC SpERC 1.1b.v1
Specific Environmental Release Category
Processes, tasks, activities covered
Bulk loading (including marine vessel/barge, rail/road car and IBC loading) of substance within closed or
contained systems, including incidental exposures during its sampling, storage, unloading, maintenance
and associated laboratory activities.
Assessment Method
See Section 3.
Section 2 Operational conditions and risk management measures
Section 2.1 Control of worker exposure
Product characteristics
Physical form of product
Liquid, vapour pressure > 10 kPa at STP OC5
Concentration of substance
Covers percentage substance in the product up to 100 % (unless
stated differently) G13
in product
Amount used
Not applicable
Frequency and duration of
Covers daily exposures up to 8 hours (unless stated differently) G2
use/exposure
Human factors not influenced by
Not applicable
risk management
Other Operational Conditions
Assumes use at not more than 20°C above ambient temperature,
affecting exposure
unless stated differently. G15. Assumes a good basic standard of
occupational hygiene is implemented G1.
Contributing Scenarios
Specific Risk Management Measures and Operating Conditions
General Measures (skin
Avoid direct skin contact with product. Identify potential areas for
indirect skin contact. Wear gloves (tested to EN374) if hand contact
irritants). G19.
with substance likely. Clean up contamination/spills as soon as they
occur. Wash off skin contamination immediately. Provide basic
employee training to prevent / minimise exposures and to report any
skin effects that may develop. E3
General Measures
Consider technical advances and process upgrades (including
automation) for the elimination of releases. Minimise exposure using
(carcinogens). G18.
measures such as closed systems, dedicated facilities and suitable
general / local exhaust ventilation. Drain down systems and clear
transfer lines prior to breaking containment. Clean / flush equipment,
where possible, prior to maintenance. Where there is potential for
exposure: Restrict access to authorised staff; provide specific activity
training to operators to minimise exposures; wear suitable gloves
(tested to EN374) and coveralls to prevent skin contamination; wear
respiratory protection when its use is identified for certain contributing
scenarios; clear up spills immediately and dispose of wastes safely.
Regularly inspect, test and maintain all control measures. Consider
the need for risk based health surveillance. G20.
CS15 General exposures (closed Handle substance within closed systems. E47.
systems). + CS56 With sample
Sample via a closed loop or other system intended to avoid exposure.
collection.
E8.
Wear suitable gloves tested to EN374. PPE15.
CS15 General exposures (closed
systems). OC9 Outdoor.
CS2 Process sampling
CS36 Laboratory activities.
Handle substance within closed systems. E47.
Sample via a closed loop or other system to avoid exposure. E8.
Handle within a fume cupboard or implement suitable equivalent
methods to minimise exposure. E12.
CS501 Bulk closed loading and
Ensure material transfers are under containment or extract ventilation.
unloading.
E66.
CS39 Equipment cleaning and
Drain down and flush system prior to equipment break-in or
maintenance
maintenance. E55.
Retain drain downs in sealed storage pending disposal or for
subsequent recycle. ENVT4.
Clear spills immediately. C&H13.
Wear chemically resistant gloves (tested to EN374) in combination
with 'basic' employee training. PPE16.
Ensure operation is undertaken outdoors. E69.
CS67 Storage.
Store substance within a closed system. E84.
Section 2.2 Control of environmental exposure
Product characteristics
Substance is complex UVCB [PrC3]. Predominantly hydrophobic [PrC4a].
Amounts used
Fraction of EU tonnage used in region
0.1
Regional use tonnage (tonnes/year)
1.87Е7
Fraction of Regional tonnage used locally
0.002
Annual site tonnage (tonnes/year)
3.75Е4
Maximum daily site tonnage (kg/day)
1.2Е5
Frequency and duration of use
Continuous release [FD2].
Emission days (days/year)
300
Environmental factors not influenced by risk management
Local freshwater dilution factor
10
Local marine water dilution factor
100
Other given operational conditions affecting environmental exposure
Release fraction to air from process (initial release prior to RMM)
0.001
Release fraction to wastewater from process (initial release prior to
0.00001
RMM)
Release fraction to soil from process (initial release prior to RMM)
0.00001
Technical conditions and measures at process level (source) to prevent release
Common practices vary across sites thus conservative process release estimates used [TCS1].
Technical onsite conditions and measures to reduce or limit discharges, air emissions and
releases to soil
Risk from environmental exposure is driven by humans via indirect exposure (primarily inhalation)
[TCR1k]. If discharging to domestic sewage treatment plant, no onsite wastewater treatment required
[TCR9].
Treat air emission to provide a typical removal efficiency of (%)
90
Treat onsite wastewater (prior to receiving water discharge) to provide
12
the required removal efficiency ≥(%)
If discharging to domestic sewage treatment plant, provide the required
0
onsite wastewater removal efficiency of ≥(%)
Organisation measures to prevent/limit release from site
Do not apply industrial sludge to natural soils [OMS2]. Sludge should be incinerated, contained or
reclaimed [OMS3].
Conditions and measures related to municipal sewage treatment plant
Estimated substance removal from wastewater via domestic sewage
treatment (%)
Total efficiency of removal from wastewater after onsite and offsite
(domestic treatment plant) RMMs (%)
Maximum allowable site tonnage (MSafe) (kg/d)
Assumed domestic sewage treatment plant flow (m 3/d)
95.5
95.5
1.1E6
2000
Conditions and measures related to external treatment of waste for disposal
External treatment and disposal of waste should comply with applicable local and/or national regulations
[ETW3].
Conditions and measures related to external recovery of waste
External recovery and recycling of waste should comply with applicable local and/or national regulations
[ERW1].
Section 3 Exposure Estimation
3.1. Health
The ECETOC TRA tool has been used to estimate workplace exposures unless otherwise indicated. G21.
3.2. Environment
The Hydrocarbon Block Method has been used to calculate environmental exposure with the Petrorisk
model [EE2].
Section 4 Guidance to check compliance with the Exposure Scenario
4.1. Health
Predicted exposures are not expected to exceed the DN(M)EL when the Risk Management
Measures/Operational Conditions outlined in Section 2 are implemented. G22.
Where other Risk Management Measures/Operational Conditions are adopted, then users should ensure
that risks are managed to at least equivalent levels. G23.
Available hazard data do not enable the derivation of a DNEL for dermal irritant effects. G32. Available
hazard data do not enable the derivation of a DNEL for carcinogenic effects. G33. Available hazard data
do not support the need for a DNEL to be established for other health effects. G36. Risk Management
Measures are based on qualitative risk characterisation. G37.
4.2. Environment
Guidance is based on assumed operating conditions which may not be applicable to all sites; thus, scaling
may be necessary to define appropriate site-specific risk management measures [DSU1]. Required
removal efficiency for wastewater can be achieved using onsite/offsite technologies, either alone or in
combination [DSU2]. Required removal efficiency for air can be achieved using onsite technologies, either
alone or in combination [DSU3]. Further details on scaling and control technologies are provided in
SpERC factsheet (http://cefic.org/en/reach-for-industries-libraries.html) [DSU4].
Annex to the extended Safety Data Sheet (eSDS)
Formulation & (re)packing of Low Boiling Point Naphthas (Gasoline) – Industrial
Exposure Scenario
Section 1 Exposure Scenario Title Low boiling point naphthas (Gasoline) that is classified
as H340 and/or H350 and/or H361; (containing 0% to 1% benzene)
Title
Formulation & (re)packing of substances and mixtures
Use Descriptor
Sector(s) of Use
3, 10
1, 2, 3, 8a, 8b, 15
Process Categories
2
Environmental Release Categories
ESVOC SpERC 2.2.v1
Specific Environmental Release Category
Processes, tasks, activities covered
Formulation of the substance and its mixtures in batch or continuous operations within closed or contained
systems, including incidental exposures during storage, materials transfers, mixing, maintenance, sampling
and associated laboratory activities.
Assessment Method
See Section 3.
Section 2 Operational conditions and risk management measures
Section 2.1 Control of worker exposure
Product characteristics
Physical form of product
Liquid, vapour pressure > 10 kPa at STP OC5.
Concentration of substance
Covers percentage substance in the product up to 100 % (unless stated
differently) G13
in product
Amounts used
Not applicable
Frequency and duration of
Covers daily exposures up to 8 hours (unless stated differently) G2
use/exposure
Human factors not influenced by
Not applicable
risk management
Other Operational Conditions
Assumes use at not more than 20°C above ambient temperature, unless
affecting exposure
stated differently. G15. Assumes a good basic standard of occupational
hygiene is implemented G1.
Contributing Scenarios
Specific Risk Management Measures and Operating Conditions
General Measures (skin
Avoid direct skin contact with product. Identify potential areas for indirect
irritants). G19.
skin contact. Wear gloves (tested to EN374) if hand contact with
substance likely. Clean up contamination/spills as soon as they occur.
Wash off skin contamination immediately. Provide basic employee
training to prevent / minimise exposures and to report any skin effects
that may develop. E3
General Measures
Consider technical advances and process upgrades (including
automation) for the elimination of releases. Minimise exposure using
(carcinogens). G18.
measures such as closed systems, dedicated facilities and suitable
general / local exhaust ventilation. Drain down systems and clear transfer
lines prior to breaking containment. Clean / flush equipment, where
possible, prior to maintenance.
Where there is potential for exposure: Restrict access to authorised staff;
provide specific activity training to operators to minimise exposures; wear
suitable gloves (tested to EN374) and coveralls to prevent skin
contamination; wear respiratory protection when its use is identified for
certain contributing scenarios; clear up spills immediately and dispose of
wastes safely.
Regularly inspect, test and maintain all control measures.
Consider the need for risk based health surveillance. G20.
CS15 General exposures (closed Handle substance within closed systems. E47.
systems). + CS56 With sample
Sample via a closed loop or other system intended to avoid exposure.
collection.
E8.
Wear suitable gloves tested to EN374. PPE15.
CS15 General exposures (closed
systems). OC9 Outdoor
CS2 Process sampling
Handle substance within a closed system. E47.
Sample via a closed loop or other system intended to avoid exposure.
E8.
Handle within a fume cupboard or implement suitable equivalent methods
CS36 Laboratory activities
to minimise exposure. E12.
Ensure material transfers are under containment or extract ventilation.
CS14 Bulk transfers
E66.
Ensure material transfers are under containment or extract ventilation.
CS8 Drum/batch transfers
E66.
CS39 Equipment cleaning and
Drain down and flush system prior to equipment break-in or maintenance.
maintenance
E55.
Retain drain downs in sealed storage pending disposal or for subsequent
recycle. ENVT4.
Clear spills immediately. C&H13.
Wear chemically resistant gloves (tested to EN374) in combination with
'basic' employee training. PPE16.
Store substance within a closed system. E84.
CS67 Storage.
Wear suitable gloves tested to EN374. PPE15.
Section 2.2 Control of environmental exposure
Product characteristics
Substance is complex UVCB [PrC3]. Predominantly hydrophobic [PrC4a].
Amounts used
Fraction of EU tonnage used in region
0.1
Regional use tonnage (tonnes/year)
1.65е7
Fraction of Regional tonnage used locally
0.0018
Annual site tonnage (tonnes/year)
3.0е4
Maximum daily site tonnage (kg/day)
1.0е5
Frequency and duration of use
Continuous release [FD2].
Emission days (days/year)
300
Environmental factors not influenced by risk management
Local freshwater dilution factor
10
Local marine water dilution factor
100
Other given operational conditions affecting environmental exposure
Release fraction to air from process (initial release prior to RMM)
0.025
Release fraction to wastewater from process (initial release prior to
0.002
RMM)
Release fraction to soil from process (initial release prior to RMM)
0.0001
Technical conditions and measures at process level (source) to prevent release
Common practices vary across sites thus conservative process release estimates used [TCS1].
Technical onsite conditions and measures to reduce or limit discharges, air emissions and releases
to soil
Prevent discharge of undissolved substance to or recover from wastewater [TCR14].Risk from environmental
exposure is driven by humans via indirect exposure (primarily inhalation) [TCR1k].
If discharging to domestic sewage treatment plant, no onsite wastewater treatment required [TCR9].
Treat air emission to provide a typical removal efficiency of (%)
56.5
Treat onsite wastewater (prior to receiving water discharge) to provide
94.7
the required removal efficiency ≥(%)
If discharging to domestic sewage treatment plant, provide the required
0
onsite wastewater removal efficiency of ≥(%)
Organisation measures to prevent/limit release from site
Do not apply industrial sludge to natural soils [OMS2]. Sludge should be incinerated, contained or reclaimed
[OMS3].
Conditions and measures related to municipal sewage treatment plant
Estimated substance removal from wastewater via domestic sewage
treatment (%)
Total efficiency of removal from wastewater after onsite and offsite
95.5
95.5
(domestic treatment plant) RMMs (%)
Maximum allowable site tonnage (MSafe) (kg/d)
1.0E5
Assumed domestic sewage treatment plant flow (m 3/d)
2000
Conditions and measures related to external treatment of waste for disposal
External treatment and disposal of waste should comply with applicable local and/or national regulations
[ETW3].
Conditions and measures related to external recovery of waste
External recovery and recycling of waste should comply with applicable local and/or national regulations
[ERW1].
Additional information on the basis for the allocation of the indentified OCs and RMMs is contained in
Petrorisk file
Section 3 Exposure Estimation
3.1. Health
The ECETOC TRA tool has been used to estimate workplace exposures unless otherwise indicated. G21.
3.2. Environment
The Hydrocarbon Block Method has been used to calculate environmental exposure with the Petrorisk model
[EE2].
Section 4 Guidance to check compliance with the Exposure Scenario
4.1. Health
Predicted exposures are not expected to exceed the DN(M)EL when the Risk Management
Measures/Operational Conditions outlined in Section 2 are implemented. G22.
Where other Risk Management Measures/Operational Conditions are adopted, then users should ensure that
risks are managed to at least equivalent levels. G23.
Available hazard data do not enable the derivation of a DNEL for dermal irritant effects. G32. Available
hazard data do not support the need for a DNEL to be established for other health effects. G36. Risk
Management Measures are based on qualitative risk characterisation. G37.
4.2. Environment
Guidance is based on assumed operating conditions which may not be applicable to all sites; thus, scaling
may be necessary to define appropriate site-specific risk management measures [DSU1].
Required removal efficiency for wastewater can be achieved using onsite/offsite technologies, either alone or
in combination [DSU2]. Required removal efficiency for air can be achieved using onsite technologies, either
alone or in combination [DSU3]. Further details on scaling and control technologies are provided in SpERC
factsheet (http://cefic.org/en/reach-for-industries-libraries.html) [DSU4].
Annex to the extended Safety Data Sheet (eSDS)
Use of Low Boiling Point Naphthas (Gasoline) as a fuel – Industrial
Exposure Scenario
Section 1 Exposure Scenario Title Low boiling point naphthas (Gasoline) that is classified as H340
and/or H350 and/or H361; (containing 0% to 1% benzene)
Title
Use as a fuel
Use Descriptor
Sector(s) of Use
3
1, 2, 3, 8a, 8b, 16
Process Categories
7
Environmental Release Categories
ESVOC SpERC 7.12а.v1
Specific Environmental Release Category
Processes, tasks, activities covered
Covers the use as a fuel (or fuel additives and additive components) within closed or contained systems,
including incidental exposures during activities associated with its transfer, use, equipment maintenance
and handling of waste.
Assessment Method
See Section 3.
Section 2 Operational conditions and risk management measures
Section 2.1 Control of worker exposure
Product characteristics
Physical form of product
Liquid, vapour pressure > 10 kPa at STP OC5
Concentration of substance in
Covers percentage substance in the product up to 100 % (unless
product
stated differently) G13
Amounts used
Not applicable
Frequency and duration of
Covers daily exposures up to 8 hours (unless stated differently) G2
use/exposure
Human factors not influenced by
Not applicable
risk management
Other Operational Conditions
Assumes use at not more than 20°C above ambient temperature,
affecting exposure
unless stated differently. G15. Assumes a good basic standard of
occupational hygiene is implemented G1.
Contributing Scenarios
Specific Risk Management Measures and Operating Conditions
General Measures (skin
Avoid direct skin contact with product. Identify potential areas for
irritants). G19.
indirect skin contact. Wear gloves (tested to EN374) if hand contact
with substance likely. Clean up contamination/spills as soon as they
occur.
Wash off skin contamination immediately. Provide basic employee
training to prevent / minimise exposures and to report any skin effects
that may develop. E3
General Measures
Consider technical advances and process upgrades (including
(carcinogens). G18.
automation) for the elimination of releases. Minimise exposure using
measures such as closed systems, dedicated facilities and suitable
general / local exhaust ventilation. Drain down systems and clear
transfer lines prior to breaking containment. Clean / flush equipment,
where possible, prior to maintenance.
Where there is potential for exposure: Restrict access to authorised
staff; provide specific activity training to operators to minimise
exposures; wear suitable gloves (tested to EN374) and coveralls to
prevent skin contamination; wear respiratory protection when its use
is identified for certain contributing scenarios; clear up spills
immediately and dispose of wastes safely.
Regularly inspect, test and maintain all control measures. Consider
the need for risk based health surveillance. G20.
CS502 Bulk closed unloading
Ensure material transfers are under containment or extract ventilation.
E66.
Ensure material transfers are under containment or extract ventilation.
CS8 Drum/batch transfers
E66.
CS507 Refuelling
CS508 Refuelling aircraft
CS15 General exposures (closed
systems)
GEST_12I Use as a fuel,
CS107 (closed systems)
CS39 Equipment cleaning and
maintenance.
Ensure material transfers are under containment or extract ventilation.
E66.
Ensure material transfers are under containment or extract ventilation.
E66.
Handle substance within a closed system. E47.
Provide a good standard of general ventilation. Natural ventilation is
from doors, windows etc. Controlled ventilation means air is supplied
or removed by a powered fan. E1.
Handle substance within closed systems. E47.
Drain down system prior to equipment break-in or maintenance. E65.
Retain drain downs in sealed storage pending disposal or for
subsequent recycle. ENVT4.
Clear spills immediately. C&H13.
Provide a good standard of general ventilation. Natural ventilation is
from doors, windows etc. Controlled ventilation means air is supplied
or removed by a powered fan. E1.
Wear chemically resistant gloves (tested to EN374) in combination
with 'basic' employee training. PPE16.
Store substance within a closed system. E84.
CS67 Storage
Provide a good standard of general ventilation. Natural ventilation is
from doors, windows etc. Controlled ventilation means air is supplied
or removed by a powered fan. E1.
Section 2.2 Control of environmental exposure
Product characteristics
Substance is complex UVCB [PrC3]. Predominantly hydrophobic [PrC4a].
Amounts used
Fraction of EU tonnage used in region
0.1
Regional use tonnage (tonnes/year)
1.4Е6
Fraction of Regional tonnage used locally
1
Annual site tonnage (tonnes/year)
1.4Е6
Maximum daily site tonnage (kg/day)
4.6Е6
Frequency and duration of use
Continuous release [FD2].
Emission days (days/year)
300
Environmental factors not influenced by risk management
Local freshwater dilution factor
10
Local marine water dilution factor
100
Other given operational conditions affecting environmental exposure
Release fraction to air from process (initial release prior to RMM)
0.0025
Release fraction to wastewater from process (initial release prior to
0.00001
RMM)
Release fraction to soil from process (initial release prior to RMM)
0
Technical conditions and measures at process level (source) to prevent release
Common practices vary across sites thus conservative process release estimates used [TCS1].
Technical onsite conditions and measures to reduce or limit discharges, air emissions and
releases to soil
Risk from environmental exposure is driven by humans via indirect exposure (primarily inhalation)
[TCR1k]. If discharging to domestic sewage treatment plant, no onsite wastewater treatment required
[TCR9].
Treat air emission to provide a typical removal efficiency of (%)
99.4
Treat onsite wastewater (prior to receiving water discharge) to provide
76.9
the required removal efficiency ≥(%)
If discharging to domestic sewage treatment plant, provide the required
0
onsite wastewater removal efficiency of ≥(%)
Organisation measures to prevent/limit release from site
Do not apply industrial sludge to natural soils [OMS2]. Sludge should be incinerated, contained or
reclaimed [OMS3].
Conditions and measures related to municipal sewage treatment plant
Estimated substance removal from wastewater via domestic sewage
95.5
treatment (%)
Total efficiency of removal from wastewater after onsite and offsite
95.5
(domestic treatment plant) RMMs (%)
Maximum allowable site tonnage (MSafe) (kg/d)
4.6E6
Assumed domestic sewage treatment plant flow (m3/d)
2000
Conditions and measures related to external treatment of waste for disposal
Combustion emissions limited by required exhaust emission controls [ETW1]. Combustion emissions
considered in regional exposure assessment [ETW2].
Conditions and measures related to external recovery of waste
This substance is consumed during use and no waste of the substance is generated [ERW3].
Section 3 Exposure Estimation
3.1. Health
The ECETOC TRA tool has been used to estimate workplace exposures unless otherwise indicated. G21.
3.2. Environment
The Hydrocarbon Block Method has been used to calculate environmental exposure with the Petrorisk
model [EE2].
Section 4 Guidance to check compliance with the Exposure Scenario
4.1. Health
Predicted exposures are not expected to exceed the DN(M)EL when the Risk Management Measures/
Operational Conditions outlined in Section 2 are implemented. G22.
Where other Risk Management Measures/Operational Conditions are adopted, then users should ensure
that risks are managed to at least equivalent levels. G23.
Available hazard data do not enable the derivation of a DNEL for dermal irritant effects. G32. Available
hazard data do not support the need for a DNEL to be established for other health effects. G36. Risk
Management Measures are based on qualitative risk characterisation. G37.
4.2. Environment
Guidance is based on assumed operating conditions which may not be applicable to all sites; thus, scaling
may be necessary to define appropriate site-specific risk management measures [DSU1].
Required removal efficiency for wastewater can be achieved using onsite/offsite technologies, either alone
or in combination [DSU2]. Required removal efficiency for air can be achieved using onsite technologies,
either alone or in combination [DSU3]. Further details on scaling and control technologies are provided in
SpERC factsheet (http://cefic.org/en/reach-for-industries-libraries.html) [DSU4].
Annex to the extended Safety Data Sheet (eSDS)
Use of Low Boiling Point Naphthas (Gasoline) as a fuel – Professional
Exposure Scenario
Section 1 Exposure Scenario Title Low boiling point naphthas (Gasoline) that is classified as as H340
and/or H350 and/or H361; (containing 0% to 1% benzene)
Title
Use as a fuel
Use Descriptor
Sector(s) of Use
22
1, 2, 3, 8a, 8b, 16
Process Categories
9а, 9b
Environmental Release Categories
ESVOC SpERC 9.12а.v1
Specific Environmental Release Category
Processes, tasks, activities covered
Covers the use as a fuel (or fuel additives and additive components) within closed or contained systems,
including incidental exposures during activities associated with its transfer, use, equipment maintenance and
handling of waste.
Assessment Method
See Section 3.
Section 2 Operational conditions and risk management measures
Section 2.1 Control of worker exposure
Product characteristics
Physical form of product
Liquid, vapour pressure > 10 kPa at STP OC5
Concentration of substance in
Covers percentage substance in the product up to 100 % (unless stated
product
differently) G13
Amounts used
Not applicable
Frequency and duration of
Covers daily exposures up to 8 hours (unless stated differently) G2
use/exposure
Human factors not influenced by
Not applicable
risk management
Other Operational Conditions
Assumes use at not more than 20°C above ambient temperature, unless
affecting exposure
stated differently. G15. Assumes a good basic standard of occupational
hygiene is implemented G1.
Contributing Scenarios
Specific Risk Management Measures and Operating Conditions
General Measures (skin
Avoid direct skin contact with product. Identify potential areas for indirect
irritants). G19.
skin contact. Wear gloves (tested to EN374) if hand contact with
substance likely. Clean up contamination/spills as soon as they occur.
Wash off skin contamination immediately. Provide basic employee
training to prevent / minimise exposures and to report any skin effects
that may develop. E3
General Measures
Consider technical advances and process upgrades (including
(carcinogens). G18.
automation) for the elimination of releases. Minimise exposure using
measures such as closed systems, dedicated facilities and suitable
general / local exhaust ventilation. Drain down systems and clear transfer
lines prior to breaking containment. Clean / flush equipment, where
possible, prior to maintenance.
Where there is potential for exposure: Restrict access to authorised staff;
provide specific activity training to operators to minimise exposures; wear
suitable gloves (tested to EN374) and coveralls to prevent skin
contamination; wear respiratory protection when its use is identified for
certain contributing scenarios; clear up spills immediately and dispose of
wastes safely.
Regularly inspect, test and maintain all control measures. Consider the
need for risk based health surveillance. G20.
CS15 General exposures (closed Handle substance within a closed system. E47.
systems), OC9 Outdoor.
CS502 Bulk closed unloading
Ensure material transfers are under containment or extract ventilation.
E66.
Ensure material transfers are under containment or extract ventilation.
CS8 Drum/batch transfers
CS507 Refuelling
GEST_12I Use as a fuel,
CS107 (closed systems)
CS5 Equipment maintenance
E66.
Ensure material transfers are under containment or extract ventilation.
E66.
Handle substance within closed systems. E47.
Drain down system prior to equipment break-in or maintenance. E65.
Retain drain downs in sealed storage pending disposal or for subsequent
recycle. ENVT4.
Clear spills immediately. C&H13.
Provide a good standard of general ventilation. Natural ventilation is from
doors, windows etc. Controlled ventilation means air is supplied or
removed by a powered fan. E1.
Ensure operatives are trained to minimise exposures. EI19.
Store substance within a closed system. E84.
CS67 Storage.
Provide a good standard of general ventilation. Natural ventilation is from
doors, windows etc. Controlled ventilation means air is supplied or
removed by a powered fan. E1.
Section 2.2 Control of environmental exposure
Product characteristics
Substance is complex UVCB [PrC3]. Predominantly hydrophobic [PrC4a].
Amounts used
Fraction of EU tonnage used in region
0.1
Regional use tonnage (tonnes/year)
1.19Е6
Fraction of Regional tonnage used locally
0.0005
Annual site tonnage (tonnes/year)
5.9Е2
Maximum daily site tonnage (kg/day)
1.6Е3
Frequency and duration of use
Continuous release [FD2].
Emission days (days/year)
365
Environmental factors not influenced by risk management
Local freshwater dilution factor
10
Local marine water dilution factor
100
Other given operational conditions affecting environmental exposure
Release fraction to air from process (initial release prior to RMM)
0.01
Release fraction to wastewater from process (initial release prior to RMM)
0.00001
Release fraction to soil from process (initial release prior to RMM)
0.00001
Technical conditions and measures at process level (source) to prevent release
Common practices vary across sites thus conservative process release estimates used [TCS1].
Technical onsite conditions and measures to reduce or limit discharges, air emissions and releases
to soil
Risk from environmental exposure is driven by humans via indirect exposure (primarily inhalation) [TCR1k]. If
discharging to domestic sewage treatment plant, no onsite wastewater treatment required [TCR9].
Treat air emission to provide a typical removal efficiency of (%)
N/A
Treat onsite wastewater (prior to receiving water discharge) to provide
3.4
the required removal efficiency ≥(%)
If discharging to domestic sewage treatment plant, provide the required
0
onsite wastewater removal efficiency of ≥(%)
Organisation measures to prevent/limit release from site
Do not apply industrial sludge to natural soils [OMS2]. Sludge should be incinerated, contained or reclaimed
[OMS3].
Conditions and measures related to municipal sewage treatment plant
Estimated substance removal from wastewater via domestic sewage
95.5
treatment (%)
Total efficiency of removal from wastewater after onsite and offsite
95.5
(domestic treatment plant) RMMs (%)
Maximum allowable site tonnage (MSafe) (kg/d)
1.5E4
Assumed domestic sewage treatment plant flow (m 3/d)
2000
Conditions and measures related to external treatment of waste for disposal
Combustion emissions limited by required exhaust emission controls [ETW1]. Combustion emissions
considered in regional exposure assessment [ETW2].
Conditions and measures related to external recovery of waste
This substance is consumed during use and no waste of the substance is generated [ERW3].
Section 3 Exposure Estimation
3.1. Health
The ECETOC TRA tool has been used to estimate workplace exposures unless otherwise indicated. G21.
3.2. Environment
The Hydrocarbon Block Method has been used to calculate environmental exposure with the Petrorisk model
[EE2].
Section 4 Guidance to check compliance with the Exposure Scenario
4.1. Health
Predicted exposures are not expected to exceed the DN(M)EL when the Risk Management
Measures/Operational Conditions outlined in Section 2 are implemented. G22.
Where other Risk Management Measures/Operational Conditions are adopted, then users should ensure that
risks are managed to at least equivalent levels. G23.
Available hazard data do not enable the derivation of a DNEL for dermal irritant effects. G32. Available
hazard data do not support the need for a DNEL to be established for other health effects. G36. Risk
Management Measures are based on qualitative risk characterisation. G37.
4.2. Environment
Guidance is based on assumed operating conditions which may not be applicable to all sites; thus, scaling
may be necessary to define appropriate site-specific risk management measures [DSU1].
Required removal efficiency for wastewater can be achieved using onsite/offsite technologies, either alone or
in combination [DSU2]. Required removal efficiency for air can be achieved using onsite technologies, either
alone or in combination [DSU3]. Further details on scaling and control technologies are provided in SpERC
factsheet (http://cefic.org/en/reach-for-industries-libraries.html) [DSU4].
Annex to the extended Safety Data Sheet (eSDS)
Use of Low Boiling Point Naphthas (Gasoline) as a fuel – Consumer
Exposure Scenario
Section 1 Exposure Scenario Title Low boiling point naphthas (Gasoline) that is classified as H340
and/or H350 and/or H361; (containing 0% to 1% benzene)
Title
Use as a fuel
Use Descriptor
Sector(s) of Use
21
13
Product Categories
9а, 9b
Environmental Release Categories
ESVOC SpERC 9.12с.v1
Specific Environmental Release Category
Processes, tasks, activities covered
Covers the consumer use of substance in liquid fuels
Assessment Method
See Section 3.
Section 2 Operational conditions and risk management measures
Section 2.1 Control of consumer exposure
Product characteristics
Physical form of product
Liquid
Vapour pressure (Pa)
Liquid, vapour pressure > 10 kPa at STP OC5
Concentration of substance in
Unless otherwise stated, cover concentrations up to 100% [ConsOC1]
product
Unless otherwise stated, covers use amounts up to37500g [ConsOC2];
Amounts used
covers skin contact area up to 420cm2 [ConsOC5]
Frequency and duration of
Unless otherwise stated, covers use frequency up to 0.143 times per
use/exposure
day [ConsOC4]; covers exposure up to 2 hours per event [ConsOC14]
Other Operational Conditions
Unless otherwise stated assumes use at ambient temperatures
affecting exposure
[ConsOC15]; assumes use in a 20 m 3 room [ConsOC11]; assumes use
with typical ventilation [ConsOC8].
Product Category
Specific Risk Management Measures and Operating Conditions
PC13:Fuels--Liquid Unless otherwise stated, covers concentrations up to 1%
OC
subcategories added: Automotive
[ConsOC1]; covers use up to 52 days/year[ConsOC3]; covers
Refuelling
use up to 1 time/on day of use[ConsOC4]; covers skin contact
area up to 210.00 cm2 [ConsOC5]; for each use event, covers
use amounts up to 37500g [ConsOC2]; covers outdoor use
[ConsOC12]; covers use in room size of 100m3[ConsOC11];
for each use event, covers exposure up to
0.05hr/event[ConsOC14];
RMM No specific RMMs developed beyond those OCs stated
PC13:Fuels--Liquid subcategories added: Scooter
Refuelling
OC
RMM
PC13:Fuels--Liquid subcategories added: Garden
Equipment - Use
OC
Unless otherwise stated, covers concentrations up to 1%
[ConsOC1]; covers use up to 52 days/year[ConsOC3]; covers
use up to 1 time/on day of use[ConsOC4]; covers skin contact
area up to 210.00 cm2 [ConsOC5]; for each use event, covers
use amounts up to 3750g [ConsOC2]; covers outdoor use
[ConsOC12]; covers use in room size of 100m3[ConsOC11];
for each use event, covers exposure up to
0.03hr/event[ConsOC14];
No specific RMMs developed beyond those OCs stated
Unless otherwise stated, covers concentrations up to 1%
[ConsOC1]; covers use up to 26 days/year[ConsOC3]; covers
use up to 1 time/on day of use[ConsOC4]; for each use event,
covers use amounts up to 750g [ConsOC2]; covers outdoor
use [ConsOC12]; covers use in room size of
100m3[ConsOC11]; for each use event, covers exposure up to
2.00hr/event[ConsOC14];
RMM
PC13:Fuels—Liquid
(subcategories added): Garden
Equipment - Refuelling
No specific RMMs developed beyond those OCs stated
Unless otherwise stated, covers concentrations up to 1%
[ConsOC1]; covers use up to 26 days/year[ConsOC3]; covers
use up to 1 time/on day of use[ConsOC4]; covers skin contact
area up to 420.00 cm2 [ConsOC5]; for each use event, covers
use amounts up to 750g [ConsOC2]; Covers use in a one car
garage (34m3) under typical ventilation [ConsOC10]; covers
use in room size of 34m3[ConsOC11]; for each use event,
covers exposure up to 0.03hr/event[ConsOC14];
RMM No specific RMMs developed beyond those OCs stated
Section 2.2 Control of environmental exposure
Product characteristics
Substance is complex UVCB [PrC3]. Predominantly hydrophobic [PrC4a].
Amounts used
Fraction of EU tonnage used in region
0.1
Regional use tonnage (tonnes/year)
1.39Е7
Fraction of Regional tonnage used locally
0.0005
Annual site tonnage (tonnes/year)
7.0Е3
Maximum daily site tonnage (kg/day)
1.9Е4
Frequency and duration of use
Continuous release [FD2].
Emission days (days/year)
365
Environmental factors not influenced by risk management
Local freshwater dilution factor
10
Local marine water dilution factor
100
Other given operational conditions affecting environmental exposure
Release fraction to air from process (initial release prior to RMM)
0.01
Release fraction to wastewater from process (initial release prior to RMM)
0.00001
Release fraction to soil from process (initial release prior to RMM)
0.00001
Conditions and measures related to municipal sewage treatment plant
Risk from environmental exposure is driven by humans via indirect exposure (primarily inhalation) [STP7k].
Estimated substance removal from wastewater via domestic sewage
95.5
treatment (%)
Maximum allowable site tonnage (MSafe) (kg/d)
1.8E5
Assumed domestic sewage treatment plant flow (m 3/d)
2000
Conditions and measures related to external treatment of waste for disposal
Combustion emissions limited by required exhaust emission controls [ETW1]. Combustion emissions
considered in regional exposure assessment [ETW2].
Conditions and measures related to external recovery of waste
This substance is consumed during use and no waste of the substance is generated [ERW3].
Section 3 Exposure Estimation
3.1. Health
The ECETOC TRA tool has been used to estimate consumer exposures, consistent with the content of
ECETOC Report #107 and the Chapter R15 of the IR&CSA TGD. Where exposure determinants differ to
these sources, then they are indicated.
3.2. Environment
The Hydrocarbon Block Method has been used to calculate environmental exposure with the Petrorisk
model [EE2].
Section 4 Guidance to check compliance with the Exposure Scenario
4.1. Health
Predicted exposures are not expected to exceed the applicable consumer reference values when the
operational conditions/risk management measures given in section 2 are implemented. G39.
Where other Risk Management Measures/Operational Conditions are adopted, then users should ensure
that risks are managed to at least equivalent levels. G23.
4.2. Environment
Guidance is based on assumed operating conditions which may not be applicable to all sites; thus, scaling
may be necessary to define appropriate site-specific risk management measures [DSU1].
Further details on scaling and control technologies are provided in SpERC factsheet
(http://cefic.org/en/reach-for-industries-libraries.html) [DSU4].
OC
Annex to the extended Safety Data Sheet (eSDS)
Exposure Scenario 2: Formulation - industrial
Formulation of MTBE covers the blending of petrol with MTBE, both on site and off site. The formulation of
MTBE into petrol is considered to be in an automated and principally closed outdoor system with a connection
to central waste gas system.
9.2.1. Exposure scenario
Section 1
Exposure Scenario Title
Title
Formulation of MTBE;CAS RN1634-04-4
Use Descriptor
Sector of Use: Industrial (SU3)
Process Categories: PROC1, PROC2, PROC3, PROC4,
PROC5, PROC8a, PROC8b, PROC9, PROC15
Environmental Release Categories: ERC2
Specific Environmental Release Categories: ESVOC4 SpERC
Processes, tasks, activities covered
Section 2
Formulation, packing and re-packing of the substance and its
mixtures in batch or continuous operations, including storage,
materials transfers, mixing, large and small scale packing,
maintenance and associated laboratory activities
Operational conditions and risk management measures
Section 2.1
Control of worker exposure
Product characteristics
Physical form of product
Liquid, vapour pressure > 10 kPa [OC5].
Concentration of substance in product
Amounts used
Frequency and duration of use
Human factors not influenced by risk
management
Other Operational Conditions affecting worker
exposure
Contributing Scenarios
General measures (skin irritants) [G19].
General exposures (closed systems) [CS15].
General exposures (closed systems) [CS15]. ;
With sample collection [CS56].
General exposures (closed systems) [CS15]. ;
Use in contained batch processes [CS37]. ;
With sample collection [CS56].
General exposures (open systems) [CS16].
Batch process [CS55]. With sample collection
[CS56]. ;
Filling / preparation of equipment from drums
or containers. [CS45].
Covers percentage substance in the product up to 100 % (unless
stated differently) [G13].
Not applicable
Covers daily exposures up to 8 hours (unless stated differently)
[G2]
Not applicable
Assumes use at not > 20 ˚C above ambient [G15];
Assumes a good basic standard of occupational hygiene is
implemented [G1].
Risk Management Measures
Avoid all skin contact with product, clean up contamination/
spills as soon as they occur. Wear gloves (tested to EN374) if
hand contamination likely, wash off any skin contamination
immediately. Provide basic employee training to prevent /
minimise exposures and to report any skin problems that may
develop [E3].
No specific measures identified [EI18].
Provide a good standard of general ventilation (3 to 5 air
changes per hour) [E40].
Provide extract ventilation to points where emissions occur
[E54].
Provide extract ventilation to points where emissions occur
[E54].
General exposures (closed systems) [CS15]. ;
Batch processes at elevated temperatures
[CS136].With sample collection [CS56].
Process sampling [CS2].
Formulate in enclosed or ventilated mixing vessels
[E46].Provide extract ventilation to points where emissions
occur [E54].
Provide extract ventilation to points where emissions occur
[E54].
Laboratory activities [CS36]. Cleaning [CS47]
[wiping, brushing, flushing]
Handle in a fume cupboard or under extract ventilation [E83].
bulk closed loading and unloading
[CS501]Dedicated facility [CS81]
Provide extract ventilation to material transfer points and other
openings [E82].
Mixing operations (open systems) [CS30].
Batch process [CS55].
Provide extract ventilation to points where emissions occur
[E54].
Manual [CS34]. ;
Transfer from/pouring from containers [CS22].
Non-dedicated facility [CS82]
Ensure material transfers are under containment or extract
ventilation [E66].
Drum/batch transfers [CS8]. Dedicated facility
[CS81]
Use drum pumps [E53].Minimise exposure by partial enclosure
of the operation or equipment and provide extract ventilation at
openings [E60].
Fill containers/cans at dedicated fill points supplied with local
extract ventilation [E51]
Drain down and flush system prior to equipment break-in or
maintenance [E55].Avoid carrying out activities involving
exposure for more than 4 hours [OC28], or: Wear a respirator
conforming to EN140 with Type A filter or better. [PPE22]
Drum and small package filling [CS6].
Dedicated facility [CS81]
Equipment cleaning and maintenance [CS39].
Non-dedicated facility [CS82]
Storage [CS67];
General exposures (closed systems) [CS15].
No specific measures identified [EI18].
Storage [CS67];
General exposures (closed systems) [CS15]. ;
With sample collection [CS56].
Avoid carrying out activities involving exposure for more than 4
hours [OC28], or: Wear a respirator conforming to EN140 with
Type A filter or better. [PPE22]
Section 2.2
Control of environmental exposure
Product characteristics
Substance is a unique structure [PrC1].
Predominantly hydrophobic [PrC4a].
Readily biodegradable [PrC5a].
Operational conditions
Outdoor use [OOC1].
Amounts used
Fraction of EU tonnage used in region [A1]:
0.15
Regional use tonnage (tonnes/year) [A2]:
Fraction of regional tonnage used locally [A3]:
100,376
0.05
Average local daily tonnage (kg/d) [A5]:
16,729
Annual site tonnage (tonnes/year) [A6]
5,019
Frequency and duration of use
Type of release
Continuous release [FD2].
Emission days (days/year) [FD4]:
300
Other Operational Conditions of use
affecting environmental exposure
Use in closed systems.
Release fraction to air from process:
0.025
Release fraction to wastewater from process:
Release fraction to soil from process (regional
only):
RMMs
Either wet or dry processes.
5.00E-03
1.00E-04
Technical conditions and measures at process
level (source) to prevent release
Common practices vary across sites thus conservative process
release estimates used [TCS 1].
Technical onsite conditions and measures to reduce or limit discharges, air emissions and releases to soil
Air:
Wastewater:
Soil:
No air emission controls required; required removal efficiency
is 0% [TCR5].
Treat onsite wastewater (prior to receiving water discharge) to
provide the required removal efficiency of >99% [TCR9].
Organisation measures to prevent/limit
release from site
No soil emission controls required; required removal efficiency
is 0% [TCR7].
Prevent discharge of undissolved substance to or recover from
wastewater [OMS1].
Conditions and measures related to
municipal sewage treatment plant
Assumed industrial sewage treatment plant effluent flow is 2000
m3/d.
Conditions and measures related to external
treatment of waste for disposal
Not applicable
Conditions and measures related to external
recovery of waste
Not applicable
Other environmental control measures
additional to above
None
9.2.2. Exposure estimation – Formulation - industrial
9.2.2.1. Worker exposure
The situations leading to exposure include formulation (blending and storing): petrol blending with MTBE. The
worker exposure estimates for the activities associated with formulation have been assessed using ECETOC
TRA version 2. (See Annex A2). In contrast to the default of the ECETOC TRA model, no influence of local
exhaust ventilation (LEV) was taken into account for assessment of dermal exposure. In Annex A2.1 general
information, including the DNELs, of the exposure scenario is presented. In Annex A2.2 the contributing
scenarios with typical mapped operational conditions and Risk Management Measures are presented. Annex
A2.3 is explained in the next section.
When modeling resulted in risk characterization ratios above 1, exposure data was used to estimate exposure
(tier-2). Only tier-2 data as presented in the EU RAR for MTBE (European Commission, 2002) was used (see
Annex B1.2, containing a summary of data from the EU RAR of MTBE).
The workers' exposure to MTBE may principally occur only during incidental leaks and spills from pipeline and
valve connections (fugitive emissions) and maintenance operations. In formulation (blending and storing)
operations, exposure might either concern neat MTBE or blended fuel.
Sampling and laboratory work, handling products containing MTBE for analyses, lead to exposure of laboratory
assistants.
The mechanics are daily exposed during removal of pumps and repairing repellers. They are also doing
maintenance on pipelines and vapour recovery equipment. The maintenance tasks are such that the workers are
exposed to MTBE vapours and their hands are in contact with petrol products.
Acute/Short term exposure
Table A.2-3 contain the two subtables (1&2) describing the mapping of uses in the supply chain (contributing
scenarios) (table 1) and the characterising of the risk, the Chemical Safety Assessment (table 2). This table, in
the CEFIC-GES format, contains all operating conditions and the efficiencies of the exposure modifiers
including RPE, PPE and LEV (efficiencies are from the ECETOC TRA model, version 2) choosen for
estimation of worker exposure (long term and short term). When deviating from the standard ecetoc values or
when tier 2 assessement (Annex B 1.2) is used, this is explained in the free text column of the table.
The RMMs associated with the estimated exposure for each contributing scenario are presented in chapter 9.2.1.
Operational conditions and worker exposure data (short term and long term) corresponding with the handling of
neat MTBE for inhalatory exposure as described in the EU RAR of MTBE (European Commission, 2002) are
summarized in annex B1.1 and B1.2.
Long-term exposure
See references provided in chapter 9.2.2.1.1
Justification for use of additional efficiency factors:
- Draining prior to maintenance (Drain down and flush system prior to equipment break-in or
maintenance [E55]) delivers a reduction of 90% of the exposure estimate. Reduction is based on
comparison of CONCAWE data on exposures resulting from spills and those arising from same/similar
task when SOP invoked (only applicable in industrial settings).
9.2.2.2. Consumer exposure
Not applicable
9.2.2.3. Indirect exposure of humans via the environment
The human intake of MTBE from indirect exposure from formulation is presented in Table 60. All food
products are considered to come from the vicinity of the point source. The estimations are results of EUSES
(2008) calculations.
Table 60: Local concentrations for indirect exposure of humans via the environment
Total
Local
Regional
Human intake media
concentration
concentration
concentration
Fish (mg/kg)
1.99E-03
6.70E-04
2.64E-03
Root crops (mg/kg)
3.80E-01
3.27E-04
3.80E-01
Leaf crops (mg/kg)
4.84E-02
1.00E-04
4.85E-02
Grass (mg/kg)
4.84E-02
1.00E-04
4.85E-02
Drinking water (mg/l)
3.54E-01
4.22E-04
3.54E-01
Meat (mg/kg)
7.90E-05
1.50E-07
7.92E-05
Milk (mg/l)
7.90E-04
1.50E-06
7.92E-04
Air (mg/m3)
6.28E-01
---
6.28E-01
9.2.2.4. Environmental exposure
9.2.2.4.1. Environmental releases
Formulation of MTBE covers the blending of petrol with MTBE. Emissions into environment are mainly
atmospheric.
There are two formulation techniques for blending petrol with MTBE, in-line blending and batch blending. In
in-line blending the petrol components (including MTBE) are pumped from their storage tanks to a common
line and pumped further through the common line to the product storage tank. The components are blended both
during the pumping through the common line and in the product tank. In batch blending the petrol components
are pumped through separate lines to the storage tank. The blending of the components hence takes place only in
the product tank.
When MTBE is blended in to petrol outside the refineries, e.g. in commercial terminals, both techniques can be
used for the blending. Batch blending is however usually more used. There are 4-8 commercial terminals within
the EU that do blending of petrol. Approximately 5% or less of the MTBE used in Europe are blended outside
the refineries (Fortum, 2000a). It is expected that the MTBE emissions in these terminals should not differ from
the emissions from blending activities in the refineries since the techniques used are similar.
The default emission factors from the Technical Guidance Document (2003) for mineral oil and fuel Industry;
fuel additives (IC9, UC28) are replaced by the emission factors from the ESVOC 4 SpERC. The release factor
for air is set at 0.025, the release factor for waste water at 0.005, and the factor to soil at 0.0001. The default
fraction of the main source is also replaced by specific data (fraction of the main source is 0.05.
For the regional assessment it is assumed that all waste water is collected by industrial sewage treatment plants.
The releases to the environment from formulation calculated with EUSES (2008) are listed in Table 61.
Table 61: Summary of the releases to the environment
Compartment
Local source release
Regional source release
Air (kg/d)
2.75E+03
7.14E+04
Waste water (kg/d)
5.49E+02
1.74E+04
Surface water (kg/d)
---
0
Industrial soil (kg/d)
---
1.02E+03
Agricultural soil (kg/d)
---
0
9.2.2.4.2. Exposure concentration in the aquatic pelagic compartment
The Predicted Exposure Concentrations (PEC) in the aquatic compartment for formulation calculated with
EUSES (2008) are given in Table 62.
For the determination of the PECSTP, homogeneous mixing in the aeration tank is assumed. The PECstp is
therefore equal to the dissolved concentration of the substance. The PEC in the sewage treatment plant for
formulation calculated with EUSES (2008) are listed in Table 62.
Table 62: Predicted Exposure Concentrations (PEC) in the aquatic compartment
Local
concentration
Regional
concentration
Total
concentration
Surface water (mg/l)
1.43E-03
4.22E-04
1.85E-03
Marine water (mg/l)
1.56E-04
5.47E-05
2.11E-04
Surface water – annual avg (mg/l)
1.25E-03
---
1.25E-03
Marine water – annual avg. (mg/l)
1.38E-04
---
1.38E-04
STP effluent (mg/l)
1.01E-02
---
1.01E-02
Compartment
9.2.2.4.3. Exposure concentration in soils and sediments
The exposure routes taken into account in PEClocal calculations are application of sewage sludge in agriculture
and dry and wet deposition from the atmosphere. Concentration in soil (Clocal soil) can be estimated using the
aerial deposition flux per kg of soil and the sludge concentration (see Table 63).
The concentration of MTBE in groundwater is calculated for indirect exposure of humans through drinking
water. As an indication for potential groundwater levels, the concentration in porewater of agricultural soil is
taken. This is a worst-case assumption, neglecting transformation and dilution in deeper soil layers.
The Predicted Exposure Concentrations (PEC) in soil and groundwater for formulation calculated with EUSES
(2008) are given in Table 63.
The Predicted Exposure Concentrations (PEC) in sediment calculated with EUSES (2008) are given in Table 63.
Table 63: Predicted Exposure Concentrations (PEC) in soils and sediments
Local
concentration
Regional
concentration
Total
concentration
Freshwater sediment (mg/kgwwt)
1.40E-03
3.69E-04
1.77E-03
Marine sediment (mg/kgwwt)
1.53E-04
4.84E-05
2.01E-04
Agricultural soil – 30 d (mg/kgwwt)
9.94E-02
8.53E-05
9.95E-02
Agricultural soil – 180 d (mg/kgwwt)
9.91E-02
3.41E-05
9.91E-02
Grassland – 180 d (mg/kgwwt)
1.06E-01
---
1.06E-01
Groundwater (mg/l)
3.54E-01
---
3.54E-01
Compartment
9.2.2.4.4. Atmospheric compartment
The concentration of the substance in air is estimated at a distance of 100 m from a point source (REACH
Guidance R.16, 2008). In the calculation of PEClocal for air, both emissions from a point source as well as the
emissions from a STP are taken into account. The Predicted Exposure Concentrations (PEC) in air for
formulation calculated with EUSES (2008) are given in Table 64.
Table 64: Predicted Exposure Concentration (PEC) in air
Local
Regional
Compartment
concentration
concentration
Air – episodic (mg/m3)
3
Air – annual avg (mg/m )
Total
concentration
7.64E-01
---
7.64E-01
6.28E-01
1.30E-03
6.29E-01
9.2.2.4.5. Exposure concentration relevant for the food chain (Secondary poisoning)
Exposure assessment through secondary poisoning has not been carried out for MTBE since it has low potential
to accumulate to living organisms, and it is not classified as very toxic (T+), toxic (T) or harmful (Xn) according
to mammalian toxicity data.
Annex to the extended Safety Data Sheet (eSDS)
Exposure Scenario 5: Transport and distribution – industrial
MTBE is used in transportation and distribution as fuel additive in fuels BY transfer of substance or preparation. Neat
MTBE and the blended petrol products are transported from the refinery to the depot-terminals and distributed from
the depot area (bulk station) to service stations. The products can be transported in an airplane, railcar, truck and ship.
9.5.1. Exposure scenario
Section 1
Title
Exposure Scenario Title
Distribution of MTBE;CAS RN1634-04-4
Use Descriptor
Sector of Use: Industrial (SU3)
Process Categories: PROC1, PROC2, PROC3, PROC4,
PROC8a, PROC8b, PROC9, PROC15
Environmental Release Categories: ERC1, ERC2
Specific Environmental Release Categories: ESVOC3
SpERC (distribution) and A&B Tables (storage)
Loading (including marine vessel/barge, rail/road car and
IBC loading) and repacking (including drums and small
packs) of substance, including its distribution and associated
laboratory activities
Processes, tasks, activities covered
Section 2
Operational conditions and risk management measures
Section 2.1
Product characteristics
Physical form of product
Concentration of substance in product
Control of worker exposure
Amounts used
Frequency and duration of use
Human factors not influenced by risk
management
Other Operational Conditions affecting worker
exposure
Contributing Scenarios
General measures (skin irritants) [G19].
General exposures (closed systems) [CS15].
Liquid, vapour pressure > 10 kPa [OC5].
Covers percentage substance in the product up to 100 %
(unless stated differently) [G13].
Not applicable
Covers daily exposures up to 8 hours (unless stated
differently) [G2]
Not applicable
Assumes use at not > 20 ˚C above ambient [G15];
Assumes a good basic standard of occupational hygiene is
implemented [G1].
Risk Management Measures
Avoid all skin contact with product, clean up
contamination/spills as soon as they occur. Wear gloves
(tested to EN374) if hand contamination likely, wash off any
skin contamination immediately. Provide basic employee
training to prevent / minimise exposures and to report any
skin problems that may develop [E3].
No specific measures identified [EI18].
General exposures (closed systems) [CS15]. ;
With sample collection [CS56].
Ensure operation is undertaken outdoors [E69].
General exposures (closed systems) [CS15]. ;
Use in contained batch processes [CS37]. ;
With sample collection [CS56].
Ensure operation is undertaken outdoors [E69]. Avoid
carrying out activities involving exposure for more than 4
hours [OC28], or: Wear a respirator conforming to EN140
with Type A filter or better. [PPE22]
General exposures (open systems) [CS16].
Batch process [CS55]. With sample collection
[CS56]. ;
Filling / preparation of equipment from drums
or containers. [CS45].
Process sampling [CS2].
Laboratory activities [CS36]. Cleaning [CS47]
[wiping, brushing, flushing]
Bulk closed loading and unloading [CS501].
Dedicated facility [CS81]
Bulk open loading and unloading [CS503].
Non-dedicated facility [CS82]
Drum and small package filling [CS6].
Dedicated facility [CS81]
Equipment cleaning and maintenance [CS39].
Non-dedicated facility [CS82]
Storage [CS67];
General exposures (closed systems) [CS15].
Storage [CS67];
General exposures (closed systems) [CS15]. ;
With sample collection [CS56].
Section 2.2
Product characteristics
Transport and distribution
Operational conditions
Amounts used
Fraction of EU tonnage used in region [A1]:
Regional use tonnage (tonnes/year) [A2]:
Fraction of regional tonnage used locally
[A3]:
Average local daily tonnage (kg/d) [A5]:
Annual site tonnage (tonnes/year) [A6]
Frequency and duration of use
Type of release
Emission days (days/year) [FD4]:
Other Operational Conditions of use
affecting environmental exposure
Release fraction to air from process:
Release fraction to wastewater from process:
Provide extract ventilation to points where emissions occur
[E54];
Ensure samples are obtained under containment or extract
ventilation [E76]
Avoid carrying out activities involving exposure for more
than 15 minutes [OC26], or: Wear a respirator conforming
to EN140 with Type A filter or better. [PPE22]
Handle in a fume cupboard or under extract ventilation
[E83].
Ensure operation is undertaken outdoors [E69]. Avoid
carrying out activities involving exposure for more than 1
hour [OC27], or: Wear a respirator conforming to EN140
with Type A filter or better. [PPE22]
Ensure material transfers are under containment or extract
ventilation [E66]. , or: Wear a respirator conforming to
EN140 with Type A filter or better. [PPE22]
Fill containers/cans at dedicated fill points supplied with
local extract ventilation [E51]
Drain down and flush system prior to equipment break-in or
maintenance [E55].
No specific measures identified [EI18].
Avoid carrying out activities involving exposure for more
than 1 hour [OC27], or: Wear a respirator conforming to
EN140 with Type A filter or better. [PPE22]
Control of environmental exposure
Substance is a unique structure [PrC1].
Predominantly hydrophobic [PrC4a].
Readily biodegradable [PrC5a].
Outdoor use [OOC1].
0.15
100,376
0.05
16,729
5,019
Continuous release [FD2].
300
Use in closed systems.
Either wet or dry processes.
1.00E-04
1.00E-05
Release fraction to soil from process (regional
0
only):
RMMs
Common practices vary across sites thus conservative
Technical conditions and measures at
process release estimates used [TCS 1].
process level (source) to prevent release
Technical onsite conditions and measures to reduce or limit discharges, air emissions and releases to
soil
Air:
No air emission controls required; required removal
efficiency is 0% [TCR5].
Wastewater:
Soil:
Organisation measures to prevent/limit
release from site
Conditions and measures related to
municipal sewage treatment plant
Conditions and measures related to
external treatment of waste for disposal
Conditions and measures related to
external recovery of waste
Other environmental control measures
additional to above
Storage
Operational conditions
Amounts used
Fraction of EU tonnage used in region [A1]:
Regional use tonnage (tonnes/year) [A2]:
Fraction of regional tonnage used locally
[A3]:
Average local daily tonnage (kg/d) [A5]:
Annual site tonnage (tonnes/year) [A6]
Frequency and duration of use
Type of release
Emission days (days/year)
Other Operational Conditions of use
affecting environmental exposure
Release fraction to air from process:
Release fraction to wastewater from process:
Treat onsite wastewater (prior to receiving water discharge)
to provide the required removal efficiency of >95% [TCR9].
No soil emission controls required; required removal
efficiency is 0% [TCR7].
Prevent discharge of undissolved substance to or recover
from wastewater [OMS1].
Assumed industrial sewage treatment plant effluent flow is
2000 m3/d.
-
Outdoor use [OOC1].
0.25
669,175
1
1,833,356
669,175
Continuous release [FD2].
365
Use in closed systems.
Either wet or dry processes.
0.1
1.00E-03
Release fraction to soil from process (regional
1.00E-05
only):
Release to wastewater from process (kg/d):
8.4
RMMs
Common practices vary across sites thus conservative
Technical conditions and measures at
process release estimates used [TCS 1].
process level (source) to prevent release
Technical onsite conditions and measures to reduce or limit discharges, air emissions and releases to
soil
Air:
Air emission controls are not appliable as there is no direct
release to air [TCR2].
Wastewater:
Treat onsite wastewater (prior to receiving water discharge)
to provide the required removal efficiency of >99% [TCR9].
Soil:
Soil emission controls are not applicable as there is no direct
release to soil [TCR4].
Prevent discharge of undissolved substance to or recover
Organisation measures to prevent/limit
from wastewater [OMS1].
release from site
Prevent leakages and spillages to soil.
Assumed industrial sewage treatment plant effluent flow is
Conditions and measures related to
2000 m3/d.
municipal sewage treatment plant
Not applicable
Conditions and measures related to
external treatment of waste for disposal
Not applicable
Conditions and measures related to
external recovery of waste
Other environmental control measures
additional to above
None
9.5.2. Exposure estimation – Transport and distribution – industrial
9.5.2.1. Workers exposure
The situations leading to exposure include loading and unloading railroad car, ship etc. and distribution of petrol
containing MTBE to service stations (loading and unloading tank trucks). The worker exposure estimates for the
activities associated with transport and distribution have been assessed using ECETOC TRA version 2. (See Annex
A5). In contrast to the default of the ECETOC TRA model, no influence of local exhaust ventilation (LEV) was taken
into account for assessment of dermal exposure. In Annex A5.1 general information, including the DNELs, of the
exposure scenario is presented. In Annex A5.2 the contributing scenarios with typical mapped operational conditions
and Risk Management Measures are presented. Annex A5.3 is explained in the next section.
When modeling resulted in risk characterization ratios above 1 exposure data was used to estimate exposure (tier-2).
Only tier-2 data as presented in the EU RAR for MTBE (European Commission, 2002) was used (see Annex B1.2,
containing a summary of data from the EU RAR of MTBE).
Transporting operations concerns both neat MTBE and mixed fuel. The exposed workers are bulk terminal, railcar,
truck and marine employees. Leaks from the fittings and dry break mating surfaces contribute to the operators‟
exposure during the loading/unloading operations. The severity of drivers' exposure to petrol vapours depends on the
method of loading (top loading or bottom loading), and how the vapours from the empty tanks are displaced,
recovered or vented.
Exposure can be the result of the following loading/unloading activities (as described in the RAR, European
Commission, 2002):
Unloading of a railroad car (disconnecting the bottom cap from the rail car, connecting a male unloading elbow, and
connecting a female unloading dry break to the male elbow for product transfer to a storage tank), Loading and
delivery operations (The major part of exposure of road tanker drivers takes place during loading and delivery
operations. The principal source for workers' exposure at depot area is created by the flow of petrol into the truck
tank. The petrol flow displaces petrol vapours from the truck tank into the atmosphere or into a vapour recovery
system. Leaking from the filling lines or spillage of petrol may also produce vapours through evaporation),
disconnecting the bottom cap from the truck (at service stations for product transfer to the storing tank), connecting a
male unloading elbow, and connecting a female unloading dry break to the male elbow. Spills and leaks from the
fittings and dry break mating surfaces contribute to the driver's exposure. The highest short-term exposures may occur
during the connecting and disconnecting the dry break valves. Saturated petrol vapours escaping from the tanks when
the tanks are filled with new liquid likely causes the main exposure.
Taking samples
During transportation, also samplings for laboratory analyses are required by removal an unloading valve cap located
underneath the car, installing a sample valve, and filling a glass bottle for sampling. The operators' exposures increase
especially while handling the wetted valves. After finishing the sampling, the valves become plugged and then
cleaned. The bucket used to drain the overflow of the sampling increases the exposure. Mechanics are daily exposed
during removal of pumps and repairing repellers, during replacement of railroad car dry break couplings, and while
repairing and calibrating fuel meters at transport loading racks and at service stations. They are also doing
maintenance on pipelines and vapour recovery equipment. The maintenance tasks are such that the workers are
exposed to MTBE vapours and their hands are in contact with petrol products.
Acute/Short term exposure
Table A.5-3 contain the two subtables (1&2) describing the mapping of uses in the supply chain (contributing
scenarios) (table 1) and the characterising of the risk, the Chemical Safety Assessment (table 2). This table, in the
CEFIC-GES format, contains all operating conditions and the efficiencies of the exposure modifiers including RPE,
PPE and LEV (efficiencies are from the ECETOC TRA model, version 2) choosen for estimation of worker exposure
(long term and short term). When deviating from the standard ecetoc values or when tier 2 assessement (Annex B 1.2)
is used, this is explained in the free text column of the table.
The RMMs associated with the estimated exposure in for each contributing scenario are presented in chapter 9.5.1.
Operational conditions and worker exposure data (short term and long term) corresponding with the handling of neat
MTBE for inhalatory exposure as described in the EU RAR of MTBE (European Commission, 2002) are summarized
in annex B1.1 and B.1.2. The exposure situation includes both handling of neat MTBE and blended fuels. An
overview of the data, which corresponds to handling neat MTBE, is given. If the situation is safe on this worst case
situation, the exposure is assumed to be safe if the concentration of MTBE in the formulation is lower. Exposure
during transporting and distributing occurs intermittently.
Long-term exposure
See references in chapter 9.5.2.1.1
Justification for use of additional efficiency factors:
- Draining prior to maintenance (Drain down and flush system prior to equipment break-in or maintenance
[E55]) delivers a reduction of 90% of the exposure estimate. Reduction is based on comparison of
CONCAWE data on exposures resulting from spills and those arising from same/similar task when SOP
invoked (only applicable in industrial settings).
9.5.2.2. Consumer exposure
Not applicable.
9.5.2.3. Indirect exposure of humans via the environment
The human intake of MTBE from indirect exposure from transport and distribution is presented in Tables 75 and 76.
All food products are considered to come from the vicinity of the point source. The estimations are results of EUSES
(2008) calculations.
Table 75: Local concentrations for indirect exposure of humans via the environment - distribution
Total
Local
Regional
Human intake media
concentration
concentration
concentration
Fish (mg/kg)
1.93E-03
6.70E-04
2.60E-03
Root crops (mg/kg)
2.91E-03
3.27E-04
3.24E-03
Leaf crops (mg/kg)
2.87E-04
1.00E-04
3.87E-04
Grass (mg/kg)
2.87E-04
1.00E-04
3.87E-04
Drinking water (mg/l)
2.71E-03
4.22E-04
3.13E-03
Meat (mg/kg)
4.95E-07
1.50E-07
6.45E-07
Milk (mg/l)
4.95E-06
1.50E-06
6.45E-06
3
2.43E-03
---
2.43E-03
Air (mg/m )
Table 76: Local concentrations for indirect exposure of humans via the environment – storage
Local
concentration
Regional
concentration
Total
concentration
Fish (mg/kg)
2.22E-03
6.70E-04
2.89E-03
Root crops (mg/kg)
1.04E-02
3.27E-04
1.07E-02
Leaf crops (mg/kg)
1.06E-04
1.00E-04
2.06E-04
Grass (mg/kg)
1.06E-04
1.00E-04
2.06E-04
Drinking water (mg/l)
9.66E-03
4.22E-04
1.01E-02
Meat (mg/kg)
5.61E-07
1.50E-07
7.11E-07
Milk (mg/l)
5.61E-06
1.50E-06
7.11E-06
3
7.07E-05
---
7.07E-05
Human intake media
Air (mg/m )
9.5.2.4. Environmental exposure
9.5.2.4.1. Environmental releases
Emissions during transport and distribution are mainly atmospheric, even if emission to all environmental
compartments are possible during storage, loading/reloading, transportation and delivery of petrol at service stations.
Release to the aquatic environment may occur during transportation of petrol/MTBE through waterways and
refuelling of watercrafts.
Transport and distribution
The default emission factor to waste water from the Technical Guidance Document (2003) for mineral oil and fuel
Industry; fuel additives (IC9, UC28) are replaced by the emission factors from the ESVOC 3 SpERC. The release
factor for air is set at 0.0001, the release factor for waste water at 0.00001, and the factor to soil at zero. For the
regional assessment it is assumed that all waste water is collected by industrial sewage treatment plants. The releases
to the environment from transport and distribution calculated with EUSES (2008) are listed in Table 77.
Table 77: Summary of the releases to the environment from distribution
Compartment
Local source release
Regional source release
Air (kg/d)
1.06E+01
7.14E+04
Waste water (kg/d)
1.06E+00
1.74E+04
Surface water (kg/d)
---
0
Industrial soil (kg/d)
---
1.02E+03
Agricultural soil (kg/d)
---
0
Storage
In refinery, marketing and border depots petrol is stored in tanks of different construction, i.e., fixed roof tanks, fixed
roof tank with internal floating covers or floating roof tanks as well as in some countries, also in underground
manmade caverns in basement rock. The size of marketing and border terminal storage tanks is highly variable and
typical size is 5,000-50,000 m3. In the current assessment the worst-case tank size of 100,000 m3 is assumed
In the EU RAR (2002) it was assumed that in Europe the MTBE is stored in pure form and in blended gasoline in
tanks which may be floating roof tanks with only one sealing. If the sealing is not upgraded to a recent technical
standard, in case of rainfall relevant amounts of water may penetrate into the tank. Phase separation will lead to a
water phase which is found at the bottom of the tank and has to be removed from time to time. Because of its water
solubility remarkable amounts of MTBE in water are contained at the bottom of tanks storing MTBE containing
gasoline.
On a delivery rate of 100,000 m3 of gasoline about 20 m3 of tank bottom water is set free. This tank bottom water is
corrosive and should be regularly discharged to prevent corrosion. The bottom of the gasoline tank is not fully
horizontal, but holds a cone-down device for the collection of tank bottom water. The level of tank bottom water can
be read off from a gauge outside the tank. Discharge of tank bottom water may be done fully automatically by
gauging equipment, which transfers the tank bottom water to a sewer system, connected to an industrial or a
municipal waste water treatment plant. It is never discharged directly to surface water. Where there is no automatic
control of the tank bottom water in a gasoline storage tank for instance in a regional gasoline tank park, operators
check daily the level and switch on manually the drain of tank bottom water to the municipal sewer system, mostly
every other day but at least once per week.
For a tank of 100,000 m3 a worst-case amount of 8.4 kg MTBE can be assumed in the tank bottom water (see Table
78). This is a worst-case scenario regarding tank volume, tank bottom water volume (20 m3), the ratio between
gasoline and water of 0.039 (v/w) and a weekly release of the tank bottom water. If gasoline contains 15% MTBE (a
worst-case assumption as the average level in Europe is about 5% MTBE in gasoline), the tank bottom water contains
about 6 gram per litre.
It can be generally accepted that STPs in Western Europe situated near tank farms have a hydraulic retention time of 1
day in the aerator, as opposed to the 6.9 hour which is taken into account in standard municipal STPs.
It is assumed that the tonnage for the regional assessment is already covered under the sub-scenario „Transport and
distribution‟.
Table 78: Summary of the releases to the environment from storage
Compartment
Local source release
Regional source release
Air (kg/d)
0.00E+00
7.14E+04
Waste water (kg/d)
8.40E+00
1.74E+04
Surface water (kg/d)
---
0
Industrial soil (kg/d)
---
1.02E+03
Agricultural soil (kg/d)
---
0
9.5.2.4.2. Exposure concentration in the aquatic pelagic compartment
The Predicted Exposure Concentrations (PEC) in the aquatic compartment for transport and distribution calculated
with EUSES (2008) are given in Table 79 and 80.
For the determination of the PECSTP, homogeneous mixing in the aeration tank is assumed. The PECstp is therefore
equal to the dissolved concentration of the substance. The Predicted Exposure Concentrations (PEC) in the sewage
treatment plant for transport and distribution calculated with EUSES (2008) are listed in Tables 79 and 80.
Table 79: Predicted Exposure Concentrations (PEC) in the aquatic compartment - distribution
Local
Regional
Total
Compartment
concentration
concentration
concentration
Surface water (mg/l)
1.39E-03
4.22E-04
1.81E-03
Marine water (mg/l)
5.37E-03
5.47E-05
5.42E-03
Surface water – annual avg (mg/l)
1.21E-03
---
1.21E-03
Marine water – annual avg. (mg/l)
4.42E-03
---
4.42E-03
STP effluent (mg/l)
9.64E-03
---
9.64E-03
Table 80: Predicted Exposure Concentrations (PEC) in the aquatic compartment - storage
Local
Regional
Total
Compartment
concentration
concentration
concentration
Surface water (mg/l)
1.40E-03
4.22E-04
1.82E-03
Marine water (mg/l)
1.52E-04
5.47E-05
2.08E-04
Surface water – annual avg (mg/l)
1.40E-03
---
1.40E-03
Marine water – annual avg. (mg/l)
1.53E-04
---
1.53E-04
STP effluent (mg/l)
9.78E-03
---
9.78E-03
Storage
The predicted PEC of 1.24 µg/l for freshwater is in line with reportede background concentrations. In a report
prepared by DSC consulting (Wagner and Stupp, 2008) in which the possible release of a typical tank farm located at
the river Lippe was investigated, MTBE concentrations are detected typically up to 3 µg/l.
A comprehensive summary of existing concentration measurements in German rivers is available in a report from the
Rhine water works association (IAWR, 2008). This report contains the information about MTBE concentrations in the
environment for example from two theses from the university of Frankfurt (Achten, 2001 and Kolb, 2004), as well as
publications from Pahlke et al. (2000), Schmidt et al. (2001), Klinger et al. (2002) and others.
All these data demonstrate MTBE background levels in urban areas in the range of 0.1 up to 0.2 µg/l in comparison
with 0.05 µg/l or below in rural areas. If tank bottom water is a real issue these comprehensive data would
demonstrate much more industrial effluents as a source of MTBE concentrations in rivers in urban areas. This is not
the case and again confirms that for tank farms in general the discharges are similar or less than those of the tank farm
near Hünxe at the Lippe.
A typical location for a MTBE release is the MIRO refinery in Karlsruhe at the Rhine which is the second biggest
MTBE production facility in Germany. The IAWR report 2008 demonstrated that the concentrations north of
Karlsruhe are increased in comparison with the rural area south of Karlsruhe. But this increase can be explained by
diffuse sources of MTBE use in cars which occurs more in urban areas and they are in the same range as usual in
industrial or urban areas. From 2004 to 2007 only one exceptional measurement value above typical background for
urban areas with 2.8 µg/l was observed north of Karlsruhe. Therefore for the refinery in Karlsruhe the same
conclusion is valid as for the tank farm at the Lippe.
Additionally, monitoring data (daily measurements) from the Dutch monitoring station near Lobith is available. The
data of this monitoring station is available to the public and can be extracted from www.aqualarm.nl, also monitoring
data from other Dutch sites is available from www.waterbase.nl. The geometric mean of MTBE concentrations at the
Lobith station since September 2000 is 0.22 μg/l (n = 9,560). The highest observed peak of MTBE in the Rhine is 62
μg/l, these peak exposures in the River Rhine occur only very sporadically and can therefore be seen as intermittent
releases. Also monthly averages on MTBE concentrations are available for three Dutch sites (including the abovementioned Lobith station) from www.waterbase.nl. The geometric mean of MTBE concentrations in Maasluis from
2001 to 2008 is 0.39 μg/l (n = 103) and in Nieuwegein the geometric mean of the concentrations from 2004 to 2008 is
0.17 μg/l (n = 64).
Therefore it can be concluded that 8.4 kg MTBE in tank bottom water adopted from the report by Wagner and Stupp
(2008) is a theoretical worst-case scenario.
9.5.2.4.3. Exposure concentration in soils and sediments
The exposure routes taken into account in PEClocal calculations are application of sewage sludge in agriculture and dry
and wet deposition from the atmosphere. Concentration in soil (Clocal soil) can be estimated using the aerial deposition
flux per kg of soil and the sludge concentration (see Tables 81 and 82).
The concentration of MTBE in groundwater is calculated for indirect exposure of humans through drinking water. As
an indication for potential groundwater levels, the concentration in porewater of agricultural soil is taken. This is a
worst-case assumption, neglecting transformation and dilution in deeper soil layers.
The Predicted Exposure Concentrations (PEC) in soil and groundwater for transport and distribution calculated with
EUSES (2008) are given in Tables 81 and 82.
Table 81: Predicted Exposure Concentrations (PEC) in soils and sediments - distribution
Local
Regional
Total
Compartment
concentration
concentration
concentration
Freshwater sediment (mg/kgwwt)
1.36E-03
3.69E-04
1.73E-03
Marine sediment (mg/kgwwt)
5.26E-03
4.84E-05
5.31E-03
Agricultural soil – 30 d (mg/kgwwt)
1.55E-03
8.53E-05
1.64E-03
Agricultural soil – 180 d (mg/kgwwt)
7.57E-04
3.41E-05
7.91E-04
Grassland – 180 d (mg/kgwwt)
5.20E-04
---
5.20E-04
Groundwater (mg/l)
2.71E-03
---
2.71E-03
Table 82: Predicted Exposure Concentrations (PEC) in soils and sediments - storage
Local
Regional
Total
Compartment
concentration
concentration
concentration
Freshwater sediment (mg/kgwwt)
1.37E-03
3.69E-04
1.74E-03
Marine sediment (mg/kgwwt)
1.50E-04
4.84E-05
1.98E-04
Agricultural soil – 30 d (mg/kgwwt)
8.93E-03
8.53E-05
9.02E-03
Local
concentration
Regional
concentration
Total
concentration
Agricultural soil – 180 d (mg/kgwwt)
2.70E-03
3.41E-05
2.73E-03
Grassland – 180 d (mg/kgwwt)
6.20E-04
---
6.20E-04
Groundwater (mg/l)
9.66E-03
---
9.66E-03
Compartment
9.5.2.4.4. Atmospheric compartment
The concentration of the substance in air is estimated at a distance of 100 m from a point source (Reach Guidance
R.16, 2008). In the calculation of PEClocal for air, both emissions from a point source as well as the emissions from a
STP are taken into account. The Predicted Exposure Concentrations (PEC) in air for use as a process and extraction
agent calculated with EUSES (2008) are given in Tables 83 and 84.
Table 83: Predicted Exposure Concentration (PEC) in air - distribution
Local
Regional
Compartment
concentration
concentration
Air – episodic (mg/m3)
3
Air – annual avg (mg/m )
2.95E-03
---
2.95E-03
2.43E-03
1.30E-03
3.73E-03
Table 84: Predicted Exposure Concentration (PEC) in air - storage
Local
Regional
Compartment
concentration
concentration
Air – episodic (mg/m3)
3
Air – annual avg (mg/m )
Total
concentration
Total
concentration
7.07E-05
---
7.07E-05
7.07E-05
1.30E-03
1.37E-03
9.5.2.4.5. Exposure concentration relevant for the food chain (Secondary poisoning)
Exposure assessment through secondary poisoning has not been carried out for MTBE since it has low potential to
accumulate to living organisms, and it is not classified as very toxic (T+), toxic (T) or harmful (Xn) according to
mammalian toxicity data.
Annex to the extended Safety Data Sheet (eSDS)
Exposure Scenario 6: Fuel use – industrial
MTBE used in as fuel additive in fuels in industrial applications of fuels. MTBE containing fuels are stored,
loaded and unladed in industrial settings and engines are maintenaned.
9.6.1. Exposure scenario
Section 1
Title
Exposure Scenario Title
Use in Fuels of MTBE;CAS RN1634-04-4
Use Descriptor
Sector of Use: Industrial (SU3)
Process Categories: PROC1, PROC2, PROC3, PROC8a,
PROC8b, PROC16
Environmental Release Categories: ERC8b
Specific Environmental Release Categories: ESVOC28 SpERC
Covers the use as a fuel (or fuel additive) and includes
activities associated with its transfer, use, equipment
maintenance and handling of waste.
Operational conditions and risk management measures
Processes, tasks, activities covered
Section 2
Section 2.1
Product characteristics
Physical form of product
Concentration of substance in product
Amounts used
Frequency and duration of use
Human factors not influenced by risk
management
Other Operational Conditions affecting
worker exposure
Contributing Scenarios
General measures (skin irritants) [G19].
Bulk transfers [CS14]. ;
Batch process [CS55]. With sample
collection [CS56]. ;
Filling / preparation of equipment from
drums or containers. [CS45].
Drum/batch transfers [CS8]. ;
Filling / preparation of equipment from
drums or containers. [CS45]. Bulk transfers
[CS14]. ;
Dedicated facility [CS81]
General exposures (closed systems) [CS15].
General exposures (closed systems) [CS15];
With sample collection [CS56].
General exposures (closed systems) [CS15];
Use in contained batch processes [CS37] ;
With sample collection [CS56].
Control of worker exposure
Liquid, vapour pressure > 10 kPa [OC5].
Covers percentage substance in the product up to 15% [Gnew].
Not applicable
Covers daily exposures up to 8 hours (unless stated differently)
[G2]
Not applicable
Assumes a good basic standard of occupational hygiene is
implemented [G1].
Risk Management Measures
Avoid all skin contact with product, clean up
contamination/spills as soon as they occur. Wear gloves (tested
to EN374) if hand contamination likely, wash off any skin
contamination immediately. Provide basic employee training to
prevent / minimise exposures and to report any skin problems
that may develop [E3].
Ensure material transfers are under containment or extract
ventilation [E66].
Use drum pumps [E53].
No specific measures identified [EI18].
No specific measures identified [EI18].
Avoid carrying out activities involving exposure for more than
4 hours [OC28], or: Wear a respirator conforming to EN140
with Type A filter or better. [PPE22]
(closed systems) [CS107] Use of fuel
(closed systems) [CS107] Batch process
[CS55].
Equipment cleaning and maintenance
[CS39]. Non-dedicated facility [CS82] e.g
fuel pump repair indoor
No specific measures identified [EI18].
Avoid carrying out activities involving exposure for more than
4 hours [OC28], or: Wear a respirator conforming to EN140
with Type A filter or better. [PPE22]
Avoid carrying out activities involving exposure for more than
4 hours [OC28] Wear a respirator conforming to EN140 with
Type A filter or better. [PPE22]
Storage [CS67];
General exposures (closed systems) [CS15].
Storage [CS67];
General exposures (closed systems) [CS15];
With sample collection [CS56].
No specific measures identified [EI18].
Section 2.2
Product characteristics
Control of environmental exposure
Substance is a unique structure [PrC1].
Predominantly hydrophobic [PrC4a].
Readily biodegradable [PrC5a].
Outdoor use [OOC1].
Ensure operation is undertaken outdoors [E69].
Operational conditions
Amounts used
Fraction of EU tonnage used in region [A1]: 0.15
Regional use tonnage (tonnes/year) [A2]:
100,376
Fraction of regional tonnage used locally
0.02
[A3]:
Average local daily tonnage (kg/d) [A5]:
5,500
Annual site tonnage (tonnes/year) [A6]
2,008
Frequency and duration of use
Continuous release [FD2].
Type of release
365
Emission days (days/year) [FD4]:
Use in closed systems.
Other Operational Conditions of use
affecting environmental exposure
Either wet or dry processes.
Release fraction to air from process:
2.50E-03
Release fraction to wastewater from process: 1.00E-05
Release fraction to soil from process
0
(regional only):
RMMs
Common practices vary across sites thus conservative process
Technical conditions and measures at
release estimates used [TCS 1].
process level (source) to prevent release
Technical onsite conditions and measures to reduce or limit discharges, air emissions and releases to soil
Air:
No air emission controls required; required removal efficiency
is 0% [TCR5].
Wastewater:
Treat onsite wastewater (prior to receiving water discharge) to
provide the required removal efficiency of >95% [TCR9].
Soil:
No soil emission controls required; required removal efficiency
is 0% [TCR7].
Prevent discharge of undissolved substance to or recover from
Organisation measures to prevent/limit
wastewater [OMS1].
release from site
Assumed industrial sewage treatment plant effluent flow is
Conditions and measures related to
2000 m3/d.
municipal sewage treatment plant
Not applicable
Conditions and measures related to
external treatment of waste for disposal
Not applicable
Conditions and measures related to
external recovery of waste
None
Other environmental control measures
additional to above
9.6.2. Exposure estimation – Fuel Use – industrial
9.6.2.1. Workers exposure
The release includes handling of blended fuels containing a variety of percentage of MTBE (up to 15%). The
worker exposure estimates for the activities associated with the handling of MTBE containing fuel have been
assessed using ECETOC TRA version 2. (See Annex A6). In contrast to the default of the ECETOC TRA
model, no influence of local exhaust ventilation (LEV) was taken into account for assessment of dermal
exposure. In Annex A6.1 general information, including the DNELs, of the exposure scenario is presented. In
Annex A6.2 the contributing scenarios with typical mapped operational conditions and Risk Management
Measures are presented. Annex A6.3 is explained in the next section.
When modeling resulted in risk characterization ratios above 1 exposure data was used to estimate exposure
(tier-2). Only tier-2 data as presented in the EU RAR for MTBE (European Commission, 2002) was used (see
Annex B2.2 and B3.2, containing a summary of data from the EU RAR of MTBE).
Acute/Short term exposure
Table A.6-3 contain the two subtables (1&2) describing the mapping of uses in the supply chain (contributing
scenarios) (table 1) and the characterising of the risk, the Chemical Safety Assessment (table 2). This table, in
the CEFIC-GES format, contains all operating conditions and the efficiencies of the exposure modifiers
including RPE, PPE and LEV (efficiencies are from the ECETOC TRA model, version 2) choosen for
estimation of worker exposure (long term and short term). When deviating from the standard ecetoc values or
when tier 2 assessement (Annex B 2.2 and B3.2) is used, this is explained in the free text column of the table.
The RMMs associated with the estimated exposure in for each contributing scenario are presented in chapter
9.6.1.
Operational conditions and worker exposure data (short term and long term) corresponding with the handling
MTBE containing fuel as described in the EU RAR of MTBE (European Commission, 2002) are summarized in
annex B2.1/B2.2 (activities at service stations) and B3.1/B3.2 (use of vehicles).
Long-term exposure
See references provided in chapter 9.6.2.1.1
Justification for use of additional efficiency factors:
- The Mandatory use of Stage I Vapour Recovery systems is calculated to result in the same efficiency as
LEV (80%). This is considered a good estimate as the minimal efficiency for environmental exposure
is already 70% (BUA, 1996, as reported in Euriopean Commission, 2002)
- The use of drum pumps are considered to provide an inhalation efficency reduction of 80%, because it
is considered to be equivalent to contained transfer (only applicable for material transfers).
9.6.2.2. Consumer exposure
Not applicable.
9.6.2.3. Indirect exposure of humans via the environment
The human intake of MTBE from indirect exposure from use as a process and extraction agent is presented in
Table 85. All food products are considered to come from the vicinity of the point source. The estimations are
results of EUSES (2008) calculations.
Table 85: Local concentrations for indirect exposure of humans via the environment
Local
concentration
Regional
concentration
Total
concentration
Fish (mg/kg)
1.90E-03
6.70E-04
2.57E-03
Root crops (mg/kg)
1.54E-02
3.27E-04
1.57E-02
Leaf crops (mg/kg)
1.97E-03
1.00E-04
2.07E-03
Grass (mg/kg)
1.97E-03
1.00E-04
2.07E-03
Drinking water (mg/l)
1.43E-02
4.22E-04
1.47E-02
Meat (mg/kg)
3.22E-06
1.50E-07
3.37E-06
Milk (mg/l)
3.22E-05
1.50E-06
3.37E-05
3
2.43E-02
---
2.43E-02
Human intake media
Air (mg/m )
9.6.2.4. Environmental exposure
9.6.2.4.1. Environmental releases
Industrial uses covers emissions from the use of petrol as a fuel in spark ignition engines. In addition, this
scenario covers use as a fuel (or fuel additive) and includes activities associated with its transfer, use, equipment
maintenance and handling of waste). Emissions to all environmental compartments are possible although
emissions into environment are mainly atmospheric. Emissions to air from the use of petrol are the main source
of MTBE released to the environment. It covers the majority of the total emitted mass volume. Emissions are
divided into two main categories: evaporative emissions and exhaust emissions.
The default emission factor to waste water from the Technical Guidance Document (2003) for mineral oil and
fuel; fuel additives (IC9, UC28) are replaced by the emission factors from the ESVOC 28 SpERC. The release
factor for air is set at 0.0025, the release factor for waste water at zero, and the factor to soil at zero. The releases
to the environment from wide-dispersive uses calculated with EUSES (2008) are listed in Table 86.
Table 86: Summary of the releases to the environment from industrial fuel use
Compartment
Local source release
Regional source release
Air (kg/d)
1.07E+02
7.14E+04
Waste water (kg/d)
4.26E-01
1.74E+04
Surface water (kg/d)
---
0
Industrial soil (kg/d)
---
1.02E+03
Agricultural soil (kg/d)
---
0
9.6.2.4.2. Exposure concentration in the aquatic pelagic compartment
The Predicted Exposure Concentrations (PEC) in the aquatic compartment for use as an intermediate calculated
with EUSES (2008) are given in Table 87.
For the determination of the PECSTP, homogeneous mixing in the aeration tank is assumed. The PECstp is
therefore equal to the dissolved concentration of the substance. The Predicted Exposure Concentrations (PEC) in
the sewage treatment plant for use as an intermediate calculated with EUSES (2008) are listed in Table 87.
Table 87: Predicted Exposure Concentrations (PEC) in the aquatic compartment
Compartment
Surface water (mg/l)
Local
concentration
Regional
concentration
Total
concentration
1.36E-03
4.22E-04
1.78E-03
Local
concentration
Regional
concentration
Total
concentration
Marine water (mg/l)
1.49E-04
5.47E-05
2.04E-04
Surface water – annual avg (mg/l)
1.20E-03
---
1.20E-03
Marine water – annual avg. (mg/l)
1.32E-04
---
1.32E-04
STP effluent (mg/l)
9.43E-03
---
9.43E-03
Compartment
9.6.2.4.3. Exposure concentration in soils and sediments
The exposure routes taken into account in PEClocal calculations are application of sewage sludge in agriculture
and dry and wet deposition from the atmosphere. Concentration in soil (Clocal soil) can be estimated using the
aerial deposition flux per kg of soil and the sludge concentration (see Table 88).
The concentration of MTBE in groundwater is calculated for indirect exposure of humans through drinking
water. As an indication for potential groundwater levels, the concentration in porewater of agricultural soil is
taken. This is a worst-case assumption, neglecting transformation and dilution in deeper soil layers.
The Predicted Exposure Concentrations (PEC) in soil and groundwater for use as a process and extraction agent
calculated with EUSES (2008) are given in Table 88.
The Predicted Exposure Concentrations (PEC) in sediment for use as a process and extraction agent calculated
with EUSES (2008) are given in Table 88.
Table 88: Predicted Exposure Concentrations (PEC) in soils and sediments
Local
Regional
Compartment
concentration
concentration
Total
concentration
Freshwater sediment (mg/kgwwt)
1.34E-03
3.69E-04
1.71E-03
Marine sediment (mg/kgwwt)
1.46E-04
4.84E-05
1.94E-04
Agricultural soil – 30 d (mg/kgwwt)
4.33E-03
8.53E-05
4.42E-03
Agricultural soil – 180 d (mg/kgwwt)
4.01E-03
3.41E-05
4.04E-03
Grassland – 180 d (mg/kgwwt)
4.18E-03
---
4.18E-03
Groundwater (mg/l)
1.43E-02
---
1.43E-02
9.6.2.4.4. Atmospheric compartment
The concentration of the substance in air is estimated at a distance of 100 m from a point source (Reach
Guidance R.16, 2008). In the calculation of PEClocal for air, both emissions from a point source as well as the
emissions from a STP are taken into account. The Predicted Exposure Concentrations (PEC) in air for use as a
process and extraction agent calculated with EUSES (2008) are given in Table 89.
Table 89: Predicted Exposure Concentration (PEC) in air
Local
Regional
Compartment
concentration
concentration
Air – episodic (mg/m3)
3
Air – annual avg (mg/m )
Total
concentration
2.96E-02
---
2.96E-02
2.43E-02
1.30E-03
2.56E-02
9.6.2.4.5. Exposure concentration relevant for the food chain (Secondary poisoning)
Exposure assessment through secondary poisoning has not been carried out for MTBE since it has low potential
to accumulate to living organisms, and it is not classified as very toxic (T+), toxic (T) or harmful (Xn) according
to mammalian toxicity data.
Annex to the extended Safety Data Sheet (eSDS)
Exposure Scenario 7: Fuel use – professional
MTBE used in as fuel additive in fuels in professional applications of fuels.
9.7.1. Exposure scenario
Section 1
Title
Exposure Scenario Title
Use in Fuels of MTBE;CAS RN1634-04-4
Use Descriptor
Sector of Use: Professional (SU22)
Process Categories: PROC1, PROC2, PROC3, PROC8a,
PROC8b, PROC9, PROC16
Environmental Release Categories: ERC8b, ERC8e
Specific Environmental Release Categories: ESVOC30
SpERC
Covers the use as a fuel (or fuel additive) and includes
activities associated with its transfer, use, equipment
maintenance and handling of waste.
Operational conditions and risk management measures
Processes, tasks, activities covered
Section 2
Section 2.1
Product characteristics
Physical form of product
Concentration of substance in product
Amounts used
Frequency and duration of use
Human factors not influenced by risk
management
Other Operational Conditions affecting worker
exposure
Control of worker exposure
Liquid, vapour pressure > 10 kPa [OC5].
Covers percentage substance in the product up to 15%
[Gnew].
Not applicable
Covers daily exposures up to 8 hours (unless stated
differently) [G2]
Not applicable
Assumes a good basic standard of occupational hygiene is
implemented [G1].
Contributing Scenarios
Risk Management Measures
General measures (skin irritants) [G19].
Avoid all skin contact with product, clean up
contamination/spills as soon as they occur. Wear gloves
(tested to EN374) if hand contamination likely, wash off any
skin contamination immediately. Provide basic employee
training to prevent / minimise exposures and to report any skin
problems that may develop [E3].
Ensure material transfers are under containment or extract
ventilation [E66].
Bulk transfers [CS14]. ;
Batch process [CS55]. Filling / preparation of
equipment from drums or containers. [CS45].
Drum/batch transfers [CS8]. ;
Filling / preparation of equipment from drums
or containers. [CS45]. Bulk transfers [CS14]. ;
Dedicated facility [CS81]
Refuelling [CS507]
General exposures (closed systems) [CS15]. ;
With sample collection [CS56].
General exposures (closed systems) [CS15]. ;
Use in contained batch processes [CS37]. ;
With sample collection [CS56].
Ensure material transfers are under containment or extract
ventilation [E66].
Provide a good standard of controlled ventilation (10 to 15 air
changes per hour) [E40].
No specific measures identified [EI18].
Ensure operation is undertaken outdoors [E69].
Drum and small package filling [CS6].
Dedicated facility [CS81]
(closed systems) [CS107]use a fuel
Equipment cleaning and maintenance [CS39].
Non-dedicated facility [CS82]e.g fuel pump
repair indoor
Equipment cleaning and maintenance [CS39].
Non-dedicated facility [CS82]e.g fuel pump
repair outdoor
Storage [CS67];
General exposures (closed systems) [CS15].
Section 2.2
Product characteristics
Use drum pumps or carefully pour from container
[E64].Avoid carrying out activities involving exposure for
more than 1 hour [OC27], or: Wear a respirator conforming to
EN140 with Type A filter or better. [PPE22]
No specific measures identified [EI18].
Drain down system prior to equipment break-in or
maintenance [E65].Avoid carrying out activities involving
exposure for more than 4 hours [OC28], or: Wear a respirator
conforming to EN140 with Type A filter or better. [PPE22]
Drain down system prior to equipment break-in or
maintenance [E65].Avoid carrying out activities involving
exposure for more than 4 hours [OC28], or: Wear a respirator
conforming to EN140 with Type A filter or better. [PPE22]
No specific measures identified [EI18].
Control of environmental exposure
Substance is a unique structure [PrC1].
Predominantly hydrophobic [PrC4a].
Readily biodegradable [PrC5a].
Outdoor use [OOC1].
Operational conditions
Amounts used
Average daily use over a year for wide
14.7
dispersive use (kg/d):
Frequency and duration of use
Dispersive use [FD3].
Type of release
365
Emission days (days/year) [FD4]:
Use in open systems.
Other Operational Conditions of use
affecting environmental exposure
Release fraction to air from wide dispersive use
0.01
(regional only):
Release fraction to wastewater from wide
1.00E-05
dispersive use:
Release fraction to soil from wide dispersive use
1.00E-05
(regional only):
RMMs
Technical conditions and measures at process Common practices vary across sites thus conservative process
release estimates used [TCS 1].
level (source) to prevent release
Technical onsite conditions and measures to reduce or limit discharges, air emissions and releases to soil
Air:
No air emission controls required; required removal efficiency
is 0% [TCR5].
Wastewater:
Treat onsite wastewater (prior to receiving water discharge) to
provide the required removal efficiency of 37% [TCR9].
Soil:
No soil emission controls required; required removal
efficiency is 0% [TCR7].
Prevent discharge of undissolved substance to or recover from
Organisation measures to prevent/limit
wastewater [OMS1].
release from site
Assumed domestic sewage treatment plant effluent flow is
Conditions and measures related to
2000 m3/d [STP7].
municipal sewage treatment plant
Not applicable
Conditions and measures related to external
treatment of waste for disposal
Not applicable
Conditions and measures related to external
recovery of waste
None
Other environmental control measures
additional to above
9.7.2. Exposure estimation – Fuel Use - professional
9.7.2.1. Workers exposure
The release includes handling of blended fuels containing a variety of percentage of MTBE (up to 15%). The
worker exposure estimates for the activities associated with the handling of MTBE containing fuel have been
assessed using ECETOC TRA version 2. (See Annex A7). In contrast to the default of the ECETOC TRA
model, no influence of local exhaust ventilation (LEV) was taken into account for assessment of dermal
exposure. In Annex A7.1 general information, including the DNELs, of the exposure scenario is presented. In
Annex A7.2 the contributing scenarios with typical mapped operational conditions and Risk Management
Measures are presented. Annex A7.3 is explained in the next section.
When modeling resulted in risk characterization ratios above 1 exposure data was used to estimate exposure
(tier-2). Only tier-2 data as presented in the EU RAR for MTBE (European Commission, 2002) was used (see
Annex B2.2 and B3.2, containing a summary of data from the EU RAR of MTBE).
Acute/Short term exposure
Table A.7-3 contain the two subtables (1&2) describing the mapping of uses in the supply chain (contributing
scenarios) (table 1) and the characterising of the risk, the Chemical Safety Assessment (table 2). This table, in
the CEFIC-GES format, contains all operating conditions and the efficiencies of the exposure modifiers
including RPE, PPE and LEV (efficiencies are from the ECETOC TRA model, version 2) choosen for
estimation of worker exposure (long term and short term). When deviating from the standard ecetoc values or
when tier 2 assessement (Annex B 1.2) is used, this is explained in the free text column of the table. The RMMs
associated with the estimated exposure in for each contributing scenario are presented in chapter 9.7.1.
Operational conditions and worker exposure data (short term and long term) corresponding with the handling of
MTBE containing fuel as described in the EU RAR of MTBE (European Commission, 2002) are summarized in
annex B2.1/B2.2 (activities at service stations) and B3.1 and B3.2 (use of vehicles). Only data for refuelling of
cars and for car mechanics was available. It is assumed that when refuelling or repairing other vehicles (boats,
motor bikes, jet skis or other two or four stroke engines) or fuel tanks, the exposure is comparable or lower. If
the situation is safe for refuelling or repairing cars, the situation is also safe for refuelling in other situations. No
data for exposure among forest, agri- and horticultural workers refuelling (e.g. by cans) is available either.
Long-term exposure
See references provided in chapter 9.7.2.1.1
Justification for use of additional efficiency factors:
- The Mandatory use of Stage I Vapour Recovery systems is calculated to result in the same efficiency as
LEV (80%). This is considered a good estimate as the minimal efficiency for environmental exposure
is already 70% (BUA, 1996, as reported in Euriopean Commission, 2002)
- The use of drum pumps are considered to provide an inhalation efficency reduction of 80%, because it
is considered to be equivalent to contained transfer (only applicable for material transfers).
- Draining prior to maintenance (Drain down and flush system prior to equipment break-in or
maintenance [E55]) delivers a reduction of 90% of the exposure estimate. Reduction is based on
comparison of CONCAWE data on exposures resulting from spills and those arising from same/similar
task when SOP invoked (only applicable in industrial settings).
9.7.2.2. Consumer exposure
Not applicable.
9.7.2.3. Indirect exposure of humans via the environment
Covered under Exposure Scenario 9.8.
9.7.2.4. Environmental exposure
Covered under Exposure Scenario 9.8.
Annex to the extended Safety Data Sheet (eSDS)
Exposure Scenario 8: Fuel use – consumer
9.8.1. Exposure scenario
Section 1
Exposure Scenario Title
Title
Use in Fuels of MTBE; CAS RN1634-04-4
Use Descriptor
Sector of Use: Consumer (SU21)
Product Categories:
PC13
Environmental Release Categories:
ERC8d
Specific Environmental Release Categories:
ESVOC30 SpERC
Processes, tasks, activities covered
Use of fuel for refuelling 2-stroke and 4-stroke
engines
Operational conditions and risk management
measures
Section 2
Section 2.1
Control of consumer exposure
Product characteristics
Physical form of product
Liquid, vapour pressure > 10 kPa [OC5].
Vapour pressure
Concentration of substance in product
330 hPa at 25 ºC
Gasoline, containing <15% of substance
Amounts used
Up to 60 litres per refuelling
Frequency and duration of use/exposure
Up to 3 times a week
Other Operational Conditions affecting exposure
Unless otherwise stated assumes use at ambient
temperatures [ConsOC15]
Technical conditions and measures at process
level (source) to prevent release
Product Categories
PC13: Fuels
OC
Unless otherwise stated, covers concentrations up to
15% [ConsOC1]; covers use up to 150
days/year[ConsOC3]; covers use up to 1 time/on day
of use[ConsOC4]; for each use event, covers
exposure up to 15 min/event[ConsOC14];
RMM
No specific RMMs identified beyond those OCs
stated
Control of environmental exposure
Section 2.2
Product characteristics
Operational conditions
Amounts used
Substance is a unique structure [PrC1].
Predominantly hydrophobic [PrC4a].
Readily biodegradable [PrC5a].
Outdoor use [OOC1].
Release fraction to surface water from wide
dispersive use (regional only):
Fraction of EU tonnage used in region [A1]:
Regional use tonnage (tonnes/year) [A2]:
Fraction of regional tonnage used locally [A3]:
Average local daily tonnage (kg/d) [A5]:
Annual site tonnage (tonnes/year) [A6]
Average daily use over a year for wide dispersive
use (kg/d):
Frequency and duration of use
1.00E-04
Type of release
Emission days (days/year)
Other Operational Conditions of use affecting
Dispersive use [FD3].
365
Use in open systems.
0.15
181
6.25E-04
497
100,376
14.7
environmental exposure
Release fraction to wastewater from wide
dispersive use:
Release fraction to surface water from wide
dispersive use (regional only):
Release fraction to soil from wide dispersive use
(regional only):
RMMs
Technical conditions and measures at process
level (source) to prevent release
0.01
1.00E-05
1.00E-05
Common practices vary across sites thus conservative
process release estimates used [TCS 1].
Technical onsite conditions and measures to reduce or limit discharges, air emissions and releases to soil
Air:
No air emission controls required; required removal
efficiency is 0% [TCR5].
Wastewater:
Treat onsite wastewater (prior to receiving water discharge)
to provide the required removal efficiency of 37% [TCR9].
Soil:
No soil emission controls required; required removal
efficiency is 0% [TCR7].
Organisation measures to prevent/limit release
from site
Prevent discharge of undissolved substance to or recover
from wastewater [OMS1].
Conditions and measures related to municipal
sewage treatment plant
Assumed domestic sewage treatment plant effluent flow is
2000 m3/d [STP7].
Conditions and measures related to external
treatment of waste for disposal
Not applicable
Conditions and measures related to external
recovery of waste
Not applicable
Other environmental control measures
additional to above
None
9.8.2. Exposure estimation Fuel Use – consumer
9.8.2.1. Workers exposure
Not applicable.
9.8.2.2. Consumer exposure
Only exposure data for refuelling of cars was available. It is assumed that when refuelling other vehicles (boats,
motor bikes, jet skis or other two or four stroke engines) or fuel tanks, the exposure is comparable or lower. The
reason is that these activities take place less frequent. If the situation is safe for refuelling cars, the situation is
also safe for refuelling in other situations. Even if the RCRs for refuelling other engines would be comparable
to the RCR for refuelling of cars, the risk would still be negligible (RCR for car fuelling is <<1).
Acute/Short term exposure
It is assumed that a reasonable worst case concentration in Stage 1 station refuelling is 29 mg/m 3 MTBE for 1
minute, occurring maximal 3 times a week, when average MTBE content is around 11% (see further details in
section 9.8.2.2.2).
Long-term exposure
In Table 90, the long-term exposure value is given for consumer exposure. It is assumed no oral exposure is
possible. Refuelling may cause dermal contact with MTBE.
Table 90: Long term exposure concentrations to consumers
Routes of exposure
Estimated
Exposure
Concentrations
Value
Measured exposure
concentrations
Unit
11.4
μg/kg
bw/day
2.9
μg/cm2/day
26
μg/m3
Value
Unit
The
reasonable
worst-case
scenario
presented (for concentration of 0.08 g/cm3)
and duration of contact: 0.5 hour) is based
on modeling (presented as described in the
RAR, European Commission, 2002). Dermal
deposition/exposure was estimated using
EUSES (EUSES, 1997).
Great variation is observed in the studies
(European Commission, 2002), due to
environmental factors. Considering different
references (See Annex A.8), it is assessed
that the normal concentration of MTBE
during refuelling is 10 mg/m3.
It is assumed that a reasonable worst case
concentration in Stage 1 station refuelling is
29 mg/m3 MTBE for 1 minute, per day of
refuelling, when average MTBE content is
around 11%. The reasonable worst-case
daily MTBE dose by inhalation for
refuelling is 522 μg/day, assuming 1 minute
exposure inhaling 0.018 m3 in 1 minute
(assuming light activity and short term
exposure (see Guidance table R15-9)). When
respiration on average 20 m3 (see Guidance
appendix R.15-4), the daily airborne
exposure is 26 g/m3.
Dermal exposure
Inhalation exposure
Explanation / source of measured data
A summary of the long-term exposure values for consumers is given in the following table.
Table 91: Summary of long term exposure concentrations to consumers
Routes of exposure
Concentrations Justification
Oral exposure
(in mg/kg bw/d)
-
Dermal local exposure
(in mg/cm2 /d)
0.0029
Dermal systemic exposure
(in mg /kg bw/d)
Inhalation exposure
(mg/m3/d)
0.0114
0.026
No oral exposure is expected.
In the RAR it is concluded that real skin exposure can be regarded
as insignificant (European commission, 2002), because:
1) skin contact during refuelling is exceptional rather than normal,
2) refuelling occurs infrequently and,
3) rapid evaporation from the skin and brief contact time reduce
the potential absorption through the skin. Dermal exposure
regarded as insignificant.
Conclusion is adopted from the RAR (European Commission,
2002). In the RAR (European Commission, 2002), it is concluded
that dermal exposure is insignificant.
The reasonable worst-case (RWC) for inhalation exposure for
consumers to blended fuels containing MTBE is based on the
above described measurement data. Exposure estimation based on
short term exposure during 1 minute, 3 times a week.
9.8.2.3. Indirect exposure of humans via the environment
The human intake of MTBE from indirect exposure from wide-dispersive uses is presented in Table 92. All food
products are considered to come from the vicinity of the point source. The estimations are results of EUSES
(2008) calculations.
Table 92: Local concentrations for indirect exposure of humans via the environment
Total
Local
Regional
Human intake media
concentration
concentration
concentration
Local
concentration
Regional
concentration
Total
concentration
Fish (mg/kg)
6.71E-04
6.70E-04
1.34E-03
Root crops (mg/kg)
1.37E-04
3.27E-04
4.64E-04
Leaf crops (mg/kg)
1.01E-04
1.00E-04
2.01E-04
Grass (mg/kg)
1.01E-04
1.00E-04
2.01E-04
Drinking water (mg/l)
4.22E-04
4.22E-04
8.44E-04
Meat (mg/kg)
1.51E-07
1.50E-07
3.01E-07
Milk (mg/l)
1.51E-06
1.50E-06
3.01E-06
3
9.71E-06
---
9.71E-06
Human intake media
Air (mg/m )
9.8.2.4. Environmental exposure
9.8.2.4.1. Environmental releases
Private use scenario covers emissions from the use of petrol as a fuel in spark ignition engines (cars, boats,
stationary engines, etc.). Emissions to all environmental compartments are possible although emissions into
environment are mainly atmospheric. Emissions to air from the use of petrol are the main source of MTBE
released to the environment. It covers the majority of the total emitted mass volume. Emissions are divided into
two main categories: evaporative emissions and exhaust emissions.
The default emission factor to waste water from the Technical Guidance Document (2003) for mineral oil and
fuel Private use; fuel additives (IC9, UC28) are replaced by the emission factors from the ESVOC 30 SpERC.
The release factor for air is set at 0.01, the release factor for waste water at 0.00001, and the factor to soil at
0.00001. The releases to the environment from wide-dispersive uses calculated with EUSES (2008) are listed in
Table 93.
Table 93: Summary of the releases to the environment
Compartment
Local source release
Regional source release
Air (kg/d)
3.49E-02
7.14E+04
Waste water (kg/d)
1.15E-05
1.74E+04
Surface water (kg/d)
---
0
Industrial soil (kg/d)
---
1.02E+03
Agricultural soil (kg/d)
---
0
9.8.2.4.2. Exposure concentration in the aquatic pelagic compartment
The Predicted Exposure Concentrations (PEC) in the aquatic compartment for wide-dispersive uses calculated
with EUSES (2008) are given in Table 94.
For the determination of the PECSTP, homogeneous mixing in the aeration tank is assumed. The PECstp is
therefore equal to the dissolved concentration of the substance. The Predicted Exposure Concentrations (PEC) in
the sewage treatment plant for wide-dispersive uses calculated with EUSES (2008) are listed in Table 94.
Table 94: Predicted Exposure Concentrations (PEC) in the aquatic compartment
Local
Regional
Total
Compartment
concentration
concentration
concentration
Surface water (mg/l)
4.22E-04
4.22E-04
8.44E-04
Marine water (mg/l)
5.47E-05
5.47E-05
1.09E-04
Surface water – annual avg (mg/l)
4.22E-04
---
4.22E-04
Local
concentration
Regional
concentration
Total
concentration
Marine water – annual avg. (mg/l)
5.47E-05
---
5.47E-05
STP effluent (mg/l)
2.94E-06
---
2.94E-06
Compartment
Road traffic
Because of the extensive and wide use of petrol as a fuel in road traffic, direct releases to surface water from
road traffic are likely. Direct releases may take place especially from bridges, ferry boards etc. in connection
with malfunctioning petrol distribution systems in vehicles like leaking carburettors, piping etc. Runoff from
roads after rain may also contain trace amounts of petrol components.
Of the 592 samples that were analysed from 1991 through 1995, 41 contained MTBE. The MTBE
concentrations ranged from 0.2 to 8.7 µg/l, with a median of 1.5 µg/l.
As a realistic worst-case situation, the PEC for MTBE can be estimated in a small stream receiving drainage
from a long stretch of motorway. According to existing studies the PEC of MTBE is most probably less than 10
μg/l and the influence of other road traffic based contaminants (BTEX, PAH, heavy metals) in terms of aquatic
toxicity potential or concentration exceeds that of MTBE‟s. Based on the monitoring data, and if additional
dilution in receiving surface water is not taken into account, the PEClocal aquatic, road runoff is:
PEClocalaquatic, road runoff = 1.5 µg/l
Petrol fuelled watercrafts
Motorboating and comparable activities lead to direct emissions of petrol to the aquatic environment through
spills and exhaust gases.
Certain types of watercrafts (most outboard motors and jet skis) direct their exhaust gases directly under the
water surface. Two cycle engines commonly used on recreational watercrafts are particularly inefficient in their
use of fuel. Even >>25% of the fuel is passed through properly functioning engines and into the water via
exhausts. Exhaust TOC emissions from four-stroke engines (and injection fuelled two-stroke engines) are
normally far lower than from traditional two-stroke engines.
Petrol can be spilled directly into the surface water while switching or loading of petrol tanks and carburettor
overflow while tilting the motor. This release is estimated to be less than 0.1% of total fuel consumption and
very low compared to exhaust emissions.
Average measured concentrations of MTBE in surface water where boating is the major source of MTBE are
<0.1-12 μg/l. Depending on local conditions “moderate” boat traffic seems to cause 2-3 μg/l and high traffic >10
μg/l concentration. Maximum measured values 100 μg/l are considered as short-term peak values. It is assumed
that the high traffic period average concentration represents realistic local concentrations, therefore the
PEClocalsurface water boating is:
PEClocalsurface water boating = 12 μg/l
9.8.2.4.3. Exposure concentration in soils and sediments
The exposure routes taken into account in PEClocal calculations are application of sewage sludge in agriculture
and dry and wet deposition from the atmosphere. Concentration in soil (Clocal soil) can be estimated using the
aerial deposition flux per kg of soil and the sludge concentration (see Table 95).
The concentration of MTBE in groundwater is calculated for indirect exposure of humans through drinking
water. As an indication for potential groundwater levels, the concentration in pore water of agricultural soil is
taken. This is a worst-case assumption, neglecting transformation and dilution in deeper soil layers.
The Predicted Exposure Concentrations (PEC) in soil and pore water for wide-dispersive uses calculated with
EUSES (2008) are given in Table 95.
The Predicted Exposure Concentrations (PEC) in sediment for wide-dispersive uses calculated with EUSES
(2008) are given in Table 95.
Table 95: Predicted Exposure Concentrations (PEC) in soils and sediments
Local
Regional
Compartment
concentration
concentration
Freshwater sediment (mg/kgwwt)
4.14E-04
3.69E-04
Total
concentration
7.83E-04
Marine sediment (mg/kgwwt)
5.37E-05
4.84E-05
1.02E-04
Agricultural soil – 30 d (mg/kgwwt)
3.56E-05
8.53E-05
1.21E-04
Agricultural soil – 180 d (mg/kgwwt)
3.56E-05
3.41E-05
6.97E-05
Grassland – 180 d (mg/kgwwt)
3.57E-05
---
3.57E-05
Groundwater (mg/l)
1.27E-04
---
1.27E-04
Road traffic
Direct release
Release to the soil may occur directly from cars because of malfunctioning leaking fuel systems and of car
accidents. It can be assumed that environmental concentrations would locally be highest along the roadsides. On
the other hand there is not much evidence that leaking fuel systems in vehicles would cause remarkable general
petrol based soil contamination on road banks, parking- and related areas. The high volatility rate of petrol and
its components from the top surface of ground decreases the possibility of soil contamination contrary to less
volatile leaking motor oil and diesel gasoil.
Accidental spillages during transport of petrol (tank trucks) and car accidents are undoubtedly potential sources
of soil and groundwater contamination with MTBE. However, quantitative local estimation has not been carried
out from sources mentioned above.
Wet precipitation and infiltrated runoff
The release of MTBE to the soil occurs as precipitation after release to the air from different sources. The
highest measured concentrations of MTBE in urban wet precipitation in US have been 2-4 μg/l (Rykowski,
1996; Squillace et al., 1997). Highest measured concentration in urban runoff is 8.7 μg/l (0.2 to 8.7 (μg/l) with a
median of 1.5 μg/l) (Delzer et al., 1996).
If the runoff is infiltrated to topsoil, the maximum concentration in porewater is 8.7 μg/l. Using the equilibrium
partitioning method, the PEClocalsoil from wet precipitation and infiltrated runoff (worst-case assumption)
would be:
PEC localsoil = 67.6 μg/kg ww
9.8.2.4.4. Atmospheric compartment
The concentration of the substance in air is estimated at a distance of 100 m from a point source (Reach
Guidance R.16, 2008). In the calculation of PEClocal for air, both emissions from a point source as well as the
emissions from a STP are taken into account. The Predicted Exposure Concentration (PEC) in air for widedispersive uses calculated with EUSES (2008) are given in Table 96.
Table 96: Predicted Exposure Concentration (PEC) in air
Local
Regional
Compartment
concentration
concentration
Air – episodic (mg/m3)
3
Air – annual avg (mg/m )
Total
concentration
9.71E-06
---
9.71E-06
9.71E-06
1.30E-03
1.31E-03
Petrol fuelled vehicles
There are monitoring data available from urban air concentrations of MTBE, from rush hour concentrations to
long-term averages. Traffic based air concentration is highly dependent on local situations and local fleet
composition.
The measured background in the USA is in the range of 0.7-2.7 μg/m3 (mixed) and the measured average
concentrations in highly urbanised areas in the USA are 3.5 to 17 μg/m3. It is difficult to compare directly
regional values and measured US data because of different traffic volumes, vehicle fleet and average
concentration of MTBE in petrol. Therefore, large US metropolitan areas are most probable higher consumption
and emission areas than the EUSES regional area and monitored and modelled results are in good agreement.
9.8.2.4.5. Exposure concentration relevant for the food chain (Secondary poisoning)
Exposure assessment through secondary poisoning has not been carried out for MTBE since it has low potential
to accumulate to living organisms, and it is not classified as very toxic (T+), toxic (T) or harmful (Xn) according
to mammalian toxicity data.
RISK CHARACTERISATION
The risk characterisation of MTBE has been conducted based on the PNECs and DNELs presented in Tables 9799.
Regarding local dermal effects (short-term and long-term exposure) only qualitative data is available which
makes it difficult to identify the leading health effect for the relevant exposure patterns. A priori, it cannot be
excluded that the „quantitative‟ endpoints will be more critical than the „qualitative‟ endpoints. Therefore, the
risk characterisation for MTBE needs to be both (semi-)quantitative (systemic effects after inhalation and
dermal exposure) as well as qualitative, for local dermal effects. Both assessments should demonstrate control of
risks.
Table 97: PNECs used in the risk assessment
Compartments
PNEC
Freshwater (mg/l)
Marine water (mg/l)
Freshwater sediment (mg/kg ww)
Marine water sediment (mg/kg ww)
Soil (mg/kg ww)
STP (mg/l)
5.1
0.26
5
1.17
1.43
71
Table 98: DNELs for workers used in the risk assessment
Route
DNEL
Acute - systemic effects
Dermal (mg/kg bw/day)
3
Inhalation (mg/m )
-
Acute - local effects
Dermal (mg/cm2)
3
Inhalation (mg/m )
not quantifiable
357
Long-term - systemic effects
Dermal (mg/kg bw/day)
3
Inhalation (mg/m )
5100
178.5
Long-term – local effects
Dermal (mg/cm2)
3
Inhalation (mg/m )
-
Table 99: DNELs for the general population used in the risk assessment
Route
DNEL
Acute - systemic effects
Dermal (mg/kg bw/day)
3
Inhalation (mg/m )
-
Acute - local effects
Dermal (mg/cm2)
3
Inhalation (mg/m )
not quantifiable
214
Long-term - systemic effects
Dermal (mg/kg bw/day)
3
3750
Inhalation (mg/m )
53.6
Oral (mg/kg bw/day)
7.1
10.2. Formulation
10.2.1. Human health
10.2.1.1. Workers
The worker exposure estimates and risk characterisation ratios (RCRs) for the activities associated with the
Formulation of MTBE have been assessed using ECETOC TRA version 2 and exposure data (tier 2 assessment:
data from the EU RAR of MTBE (European Union, 2002)) where needed. The combinations of Operational
Conditions and Risk Management Measures corresponding to RCRs of less than 1 are presented in chapter 9.2.
In Table 105, the full shift and short term exposure estimates/values and the RCRs (inhalation, dermal and
combined exposure) for the contributing scenarios are presented.
Table 105: Exposure levels and the risk characterisation ratios after assessment of safe use for ES2
Formulation of MTBE using the ECETOC TRA v2 model.
Tier-2 assessment is in bold.
Full shift exposure and RCR
Short term exposure
Contributing Scenarios
Predicted
Exposure
(ppm)
Predicted
Dermal
Exposure
(mg/kg/d)
RCR
(inhalation)
RCR
(dermal)
RCR
(all routes)
Predicted
Exposure
(ppm)
RCR
(inhalation)
General exposures
(closed systems) [CS15]
0.01
(=0.04
mg/m3)
0.34
0.0002
0.0001
0.0003
0.01
(=0.04
mg/m3)
0.0001
35 (=125
mg/m3)
0.27
0.70
0.00005
0.70
35 (=125
mg/m3)
0.35
10 (=36
mg/m3)
0.07
0.20
0.00001
0.20
97 (=346
mg/m3)
0.97
10 (=36
mg/m3)
1.37
0.20
0.0003
0.20
10 (=36
mg/m3)
0.10
10 (=36
mg/m3)
0.07
0.20
0.00001
0.20
10 (=36
mg/m3)
0.10
10 (=35.7
mg/m3)
0.07
0.20
0.00001
0.20
10 (=36
mg/m3)
0.10
5 (=18
mg/m3)
0.07
0.10
0.00001
0.10
5 (=18
mg/m3)
0.05
4.5 (=16
mg/m3)
1.37
0.09
0.0003
0.09
4.5 (=16
mg/m3)
0.05
25 (=89
mg/m3)
2.74
0.50
0.0005
0.50
25 (=89
mg/m3)
0.25
General exposures
(closed systems) [CS15];
With sample collection
[CS56]
General exposures
(closed systems) [CS15];
Use in contained batch
processes [CS37];
With sample collection
[CS56]
General exposures (open
systems) [CS16];
Batch process [CS55];
With sample collection
[CS56];
Filling / preparation of
equipment from drums or
containers. [CS45]
General exposures
(closed systems) [CS15];
Batch processes at
elevated temperatures
[CS136]; With sample
collection [CS56]
Process sampling [CS2]
Laboratory activities
[CS36]; Cleaning [CS47]
[wiping, brushing,
flushing]
Bulk closed loading and
unloading [CS501];
Dedicated facility [CS81]
Mixing operations (open
systems) [CS30]; Batch
Full shift exposure and RCR
Contributing Scenarios
Short term exposure
Predicted
Exposure
(ppm)
Predicted
Dermal
Exposure
(mg/kg/d)
RCR
(inhalation)
RCR
(dermal)
RCR
(all routes)
Predicted
Exposure
(ppm)
RCR
(inhalation)
25 (=89
mg/m3)
2.74
0.50
0.0005
0.50
25 (=89
mg/m3)
0.25
4.5 (=16
mg/m3)
1.37
0.09
0.0003
0.09
4.5 (=16
mg/m3)
0.05
20 (=71
mg/m3)
1.37
0.40
0.0003
0.40
20 (=71
mg/m3)
0.20
15 (=54
mg/m3)
2.74
0.30
0.0005
0.30
25 (=89
mg/m3)
0.25
0.01
(=0.04
mg/m3)
0.07
0.0002
0.00001
0.0002
0.01
(=0.04
mg/m3)
0.0001
30 (=107
mg/m3)
0.27
0.60
0.00005
0.60
50 (=179
mg/m3)
0.50
process [CS55]
Manual [CS34];
Transfer from/pouring
from containers [CS22];
Non-dedicated facility
[CS82]
Drum/batch transfers
[CS8]; Dedicated facility
[CS81]
Drum and small package
filling [CS6]; Dedicated
facility [CS81]
Equipment cleaning and
maintenance [CS39];
Non-dedicated facility
[CS82]
Storage [CS67];
General exposures
(closed systems) [CS15]
Storage [CS67];
General exposures
(closed systems) [CS15];
With sample collection
[CS56]
The RCRs regarding inhalation, dermal and combined exposure for the full shift and short term exposure
estimates/values of the contriburing scenarios are all below 1. Therefore, „control of risks‟ is guaranteed for the
quantitative endpoints based on the available data for formulation of MTBE.
Qualitative risk characterisation for workers
MTBE has the property that repeated skin exposure may result in skin fatigue (and consequent risk of toxic
eczema) due to the effective lipid extraction properties, an effect common to a variety of organic solvents. In
addition (and probably in relation), MTBE is classified for skin irritation based on a skin irritation study in
which exposure was under occlusive conditions. No quantitative risk characterisation can be performed for both
skin fatigue and for skin irritation since the data available are not appropriate for a quantitative assessment.
Therefore, a qualitative risk characterization should be performed according to the REACH guidance on
information requirements and chemical safety assessment, Part E: „Risk Characterisation‟.
Skin irritation
Because of the skin irritation properties of MTBE, from a hazard point of view, appropriate protective gloves
have to be used when handling preparations with more than 10% MTBE ** ) (such as neat MTBE) and in case of
risk of accidental spills, when handling contaminated surfaces or parts (for more details on the type of the
recommended gloves: see chapter 9.1.1).
**) The general concentration limit for Category 2 skin irritating substances in Regulation (EC) 1272/2008 is
10%.
Skin fatigue
Skin fatigue due to dermal contact with fuel ethers will only occur in case of prolonged continuous dermal
contact with neat liquid for periods longer than 10 minutes, repeated each working day (Alderman, M.H. and
Hanley M.J., 1982). Under these conditions the skin lipids will partly be dissolved and rinsed off from the skin.
The defattened skin will become more vulnerable to dermatitis and allergic dermatitis because the skin barrier
got lost.
The risk that skin fatigue will occur due to dermal exposure to MTBE is determined by the actual dermal
exposure. Due to the volatility of the fuel ethers most of the fuel ethers will quickly disappear from the skin due
to fast evaporation. It can be calculated that a skin dose of 5 mg/cm2/day MTBE (a worse-case daily dose
estimated with ECETOC TRA version 2) will be evaporated from the skin in less than 1 minute, based on the
evaporation rate of MTBE of 16.8 mg/cm2/min (see Appendix R.14-1 of the “Guidance on information
requirements and chemical safety assessment” (Chapter R.14: Occupational Exposure Estimation). Therefore, it
can be concluded that the risk of the occurrence of skin fatigue is negligible due to the high evaporation rate of
MTBE and the fact that protective gloves are used to prevent skin irritation.
10.2.1.2.Consumers
Not applicable.
10.2.1.3. Indirect exposure of humans via the environment
The risk characterisation (inhalation, oral and combined exposure) for indirect exposure of humans via the
environment is given in Table 106.
Table 106: Risk characterisation for humans exposed via the environment
Human Dose
Indirect Receptor
RCR
DNEL
Local
Regional
Local
Regional
Drinking water (mg/kg/day)
7.1
1.01E-02
1.21E-05
1.42E-03
1.70E-06
Fish (mg/kg/day)
7.1
3.27E-06
1.10E-06
4.61E-07
1.55E-07
Leaf crops (mg/kg/day)
7.1
8.29E-04
1.71E-06
1.17E-04
2.41E-07
Root crops (mg/kg/day)
7.1
2.09E-03
1.80E-06
2.94E-04
2.54E-07
Meat (mg/kg/day)
7.1
3.40E-07
6.44E-10
4.79E-08
9.07E-11
Milk (mg/kg/day)
7.1
6.34E-06
1.20E-08
8.93E-07
1.69E-09
Air (mg/kg/day)
7.1
1.80E-01
3.71E-04
2.54E-02
5.23E-05
Total daily intake (mg/kg/day)
7.1
1.93E-01
3.88E-04
2.72E-02
5.46E-05
10.2.2. Environment
10.2.2.1. Aquatic compartment (including sediment)
The risk characterisation for the aquatic compartment is given in Table 107.
Table 107: Risk characterisation for the aquatic compartment
PEC
Compartment
RCR
PNEC
Local
Regional
Local
Regional
Freshwater aquatic (mg/l)
5.1
1.43E-03
4.22E-04
2.81E-04
8.27E-05
Marine aquatic (mg/l)
0.26
1.56E-04
5.47E-05
5.99E-04
2.10E-04
5
1.40E-03
3.69E-04
2.81E-04
7.38E-05
1.17
1.53E-04
4.84E-05
1.31E-04
4.14E-05
Freshwater sediment (mg/kgwwt)
Marine sediment (mg/kgwwt)
10.2.2.2. Terrestrial compartment
The risk characterisation for the terrestrial compartment is given in Table 108.
Table 108: Risk characterisation for the terrestrial compartment
Compartment
PNEC
PEC
RCR
Soil (mg/kgwwt)
1.43
Local
Regional
Local
Regional
9.94E-02
8.53E-05
6.96E-02
5.98E-05
10.2.2.3. Atmospheric compartment
There are no indications or studies available that ambient air concentrations of MTBE may cause direct adverse
effects for plants or animal species. Because there are no tested data for the air compartment and the calculation
of PNECatmopsheric is not possible, no quantitative characterisation of risk as a PEC/PNEC comparison is possible.
10.2.2.4. Microbiological activity in sewage treatment plants
The risk characterisation for sewage treatment plants is given in Table 109.
Table 109: Risk characterisation for STPs
PEC
Compartment
STP effluent (mg/l)
RCR
PNEC
71
Local
Regional
Local
Regional
1.01E-02
---
1.42E-04
---
10.2.2.5. Secondary poisoning
A risk characteristion through secondary poisoning has not been carried out for MTBE since it has low potential
to accumulate to living organisms, and it is not classified as very toxic (T+), toxic (T) or harmful (Xn) according
to mammalian toxicity data.
10.5 Transport and distribution
10.5.1. Human health
10.5.1.1. Workers
The worker exposure estimates and risk characterisation ratios (RCRs) for the activities associated with
Transport and distribution of MTBE have been assessed using ECETOC TRA version 2 and exposure data (tier
2 assessment: data from the EU RAR of MTBE (European Union, 2002)) where needed. The combinations of
Operational Conditions and Risk Management Measures corresponding to RCRs of less than 1 are presented in
chapter 9.5. In Table 120, the full shift and short term exposure estimates/values and the RCRs (inhalation,
dermal and combined exposure) for the contributing scenarios are presented.
Table 120: Exposure levels and the risk characterisation ratios after assessment of safe use for ES5
Transport and distributions of MTBE using the ECETOC TRA v2 model.
Tier-2 assessments are in bold.
Full shift exposure and RCR
Short term exposure
Contributing Scenarios
Predicted
Exposure
(ppm)
Predicted
Dermal
Exposure
(mg/kg/d)
RCR
(inhalation)
RCR
(dermal)
RCR
(all routes)
Predicted
Exposure
(ppm)
RCR
(inhalation)
General exposures (closed
systems) [CS15]
0.01
(=0.04
mg/m3)
0.34
0.0002
0.0001
0.0003
0.01
(=0.04
mg/m3)
0.0001
35 (=125
mg/m3)
0.27
0.70
0.0001
0.70
35
(=125
mg/m3)
0.35
42 (=150
mg/m3)
0.07
0.84
0.00001
0.84
70
(=250
mg/m3)
0.70
10 (=36
mg/m3)
1.37
0.20
0.0003
0.20
10 (=36
mg/m3)
0.10
10 (=36
mg/m3)
0.07
0.20
0.00001
0.20
17.5
(=63
mg/m3)
0.18
5 (=17.9
mg/m3)
0.07
0.10
0.00001
0.10
5 (=18
mg/m3)
0.05
21 (=75.0
mg/m3)
1.37
0.42
0.0003
0.42
50
(=179
mg/m3)
0.50
25 (=89
mg/m3)
1.37
0.50
0.0003
0.50
25 (=89
mg/m3)
0.25
20 (=71
mg/m3)
1.37
0.40
0.0003
0.40
20 (=71
mg/m3)
0.20
25 (=89
mg/m3)
2.7
0.50
0.001
0.50
25 (=89
mg/m3)
0.25
0.01 (=0
mg/m3)
0.34
0.0002
0.0001
0.0003
0.01 (=0
mg/m3)
0.0001
General exposures (closed
systems) [CS15];
With sample collection
[CS56]
General exposures (closed
systems) [CS15];
Use in contained batch
processes [CS37];
With sample collection
[CS56]
General exposures (open
systems) [CS16];
Batch process [CS55]; With
sample collection [CS56];
Filling / preparation of
equipment from drums or
containers [CS45]
Process sampling [CS2]
Laboratory activities
[CS36]; Cleaning [CS47]
[wiping, brushing, flushing]
Bulk closed loading and
unloading [CS501];
Dedicated facility [CS81]
Bulk open loading and
unloading [CS503]; Nondedicated facility [CS82]
Drum and small package
filling [CS6]; Dedicated
facility [CS81]
Equipment cleaning and
maintenance [CS39]. Nondedicated facility [CS82]
Storage [CS67];
General exposures (closed
Full shift exposure and RCR
Contributing Scenarios
Short term exposure
Predicted
Exposure
(ppm)
Predicted
Dermal
Exposure
(mg/kg/d)
RCR
(inhalation)
RCR
(dermal)
RCR
(all routes)
Predicted
Exposure
(ppm)
RCR
(inhalation)
10 (=36
mg/m3)
0.27
0.20
0.0001
0.20
50
(=179
mg/m3)
0.50
systems) [CS15]
Storage [CS67];
General exposures (closed
systems) [CS15];
With sample collection
[CS56]
The RCRs regarding inhalation, dermal and combined exposure for the full shift and short term exposure
estimates/values of the contriburing scenarios are all ≤ 1. Therefore, „control of risks‟ is guaranteed for the
quantitative endpoints based on the available data for transport and distribution of MTBE.
Qualitative risk characterisation for workers
MTBE has the property that repeated skin exposure may result in skin fatigue (and consequent risk of toxic
eczema) due to the effective lipid extraction properties, an effect common to a variety of organic solvents. In
addition (and probably in relation), MTBE is classified for skin irritation based on a skin irritation study in
which exposure was under occlusive conditions. No quantitative risk characterisation can be performed for both
skin fatigue and for skin irritation since the data available are not appropriate for a quantitative assessment.
Therefore, a qualitative risk characterization should be performed according to the REACH guidance on
information requirements and chemical safety assessment, Part E: „Risk Characterisation‟.
Skin irritation
Because of the skin irritation properties of MTBE, from a hazard point of view, appropriate protective gloves
have to be used when handling preparations with more than 10% MTBE ** (such as neat MTBE) and in case of
risk of accidental spills, when handling contaminated surfaces or parts (for more details on the type of the
recommended gloves: see chapter 9.1.1).
** The general concentration limit for Category 2 skin irritating substances in Regulation (EC) 1272/2008 is
10%.
Skin fatigue
Skin fatigue due to dermal contact with fuel ethers will only occur in case of prolonged continuous dermal
contact with neat liquid for periods longer than 10 minutes, repeated each working day (Alderman, M.H. and
Hanley M.J., 1982). Under these conditions the skin lipids will partly be dissolved and rinsed off from the skin.
The defattened skin will become more vulnerable to dermatitis and allergic dermatitis because the skin barrier
got lost.
The risk that skin fatigue will occur due to dermal exposure to MTBE is determined by the actual dermal
exposure. Due to the volatility of the fuel ethers most of the fuel ethers will quickly disappear from the skin due
to fast evaporation. It can be calculated that a skin dose of 5 mg/cm2/day MTBE (a worse-case daily dose
estimated with ECETOC TRA version 2) will be evaporated from the skin in less than 1 minute, based on the
evaporation rate of MTBE of 16.8 mg/cm2/min (see Appendix R.14-1 of the “Guidance on information
requirements and chemical safety assessment” (Chapter R.14: Occupational Exposure Estimation). Therefore, it
can be concluded that the risk of the occurrence of skin fatigue is negligible due to the high evaporation rate of
MTBE and the fact that protective gloves are used to prevent skin irritation.
10.5.1.2. Consumers
Not applicable.
10.5.1.3. Indirect exposure of humans via the environment
The risk characterisation (inhalation, oral and combined exposure) for indirect exposure of humans via the
environment is given in Tables 121 and 122.
Table 121: Risk characterisation for humans exposed via the environment - distribution
Human Dose
Indirect Receptor
RCR
DNEL
Local
Regional
Local
Regional
Drinking water (mg/kg/day)
7.1
7.73E-05
1.21E-05
1.09E-05
1.70E-06
Fish (mg/kg/day)
7.1
3.17E-06
1.10E-06
4.46E-07
1.55E-07
Leaf crops (mg/kg/day)
7.1
4.92E-06
1.71E-06
6.93E-07
2.41E-07
Root crops (mg/kg/day)
7.1
1.59E-05
1.80E-06
2.24E-06
2.54E-07
Meat (mg/kg/day)
7.1
2.13E-09
6.44E-10
3.00E-10
9.07E-11
Milk (mg/kg/day)
7.1
3.97E-08
1.20E-08
5.59E-09
1.69E-09
Air (mg/kg/day)
7.1
1.07E-03
3.71E-04
1.51E-04
5.23E-05
Total daily intake (mg/kg/day)
7.1
1.17E-03
3.88E-04
1.65E-04
5.46E-05
Table 122: Risk characterisation for humans exposed via the environment - storage
Human Dose
Indirect Receptor
RCR
DNEL
Local
Regional
Local
Regional
Drinking water (mg/kg/day)
7.1
2.76E-04
1.21E-05
3.89E-05
1.70E-06
Fish (mg/kg/day)
7.1
3.65E-06
1.10E-06
5.14E-07
1.55E-07
Leaf crops (mg/kg/day)
7.1
1.83E-06
1.71E-06
2.58E-07
2.41E-07
Root crops (mg/kg/day)
7.1
5.69E-05
1.80E-06
8.01E-06
2.54E-07
Meat (mg/kg/day)
7.1
2.41E-09
6.44E-10
3.39E-10
9.07E-11
Milk (mg/kg/day)
7.1
4.49E-08
1.20E-08
6.32E-09
1.69E-09
Air (mg/kg/day)
7.1
3.92E-04
3.71E-04
5.52E-05
5.23E-05
Total daily intake (mg/kg/day)
7.1
7.30E-04
3.88E-04
1.03E-04
5.46E-05
10.5.2. Environment
10.5.2.1. Aquatic compartment (including sediment)
The risk characterisation for the aquatic compartment is given in Tables 123 and 124.
Table 123: Risk characterisation for the aquatic compartment - distribution
PEC
Compartment
RCR
PNEC
Local
Regional
Local
Regional
Freshwater aquatic (mg/l)
5.1
1.39E-03
4.22E-04
2.72E-04
8.27E-05
Marine aquatic (mg/l)
0.26
5.37E-03
5.47E-05
2.06E-02
2.10E-04
Freshwater sediment (mg/kgwwt)
5
1.36E-03
3.69E-04
2.72E-04
7.38E-05
Marine sediment (mg/kgwwt)
1.17
5.26E-03
4.84E-05
4.50E-03
4.14E-05
Table 124: Risk characterisation for the aquatic compartment - storage
PEC
Compartment
RCR
PNEC
Local
Regional
Local
Regional
Freshwater aquatic (mg/l)
5.1
1.40E-03
4.22E-04
2.75E-04
8.27E-05
Marine aquatic (mg/l)
0.26
1.52E-04
5.47E-05
5.87E-04
2.10E-04
5
1.37E-03
3.69E-04
2.75E-04
7.38E-05
1.17
1.50E-04
4.84E-05
1.28E-04
4.14E-05
Freshwater sediment (mg/kgwwt)
Marine sediment (mg/kgwwt)
10.5.2.2. Terrestrial compartment
The risk characterisation for the terrestrial compartment is given in Tables 125 and 126.
Table 125: Risk characterisation for the terrestrial compartment - distribution
PEC
RCR
Compartment
PNEC
Local
Regional
Local
Regional
Soil (mg/kgwwt)
1.43
1.55E-03
8.53E-05
1.09E-03
Table 126: Risk characterisation for the terrestrial compartment - storage
PEC
Compartment
PNEC
Local
Regional
Soil (mg/kgwwt)
1.43
8.93E-03
8.53E-05
5.98E-05
RCR
Local
Regional
6.26E-03
5.98E-05
10.5.2.3. Atmospheric compartment
There are no indications or studies available that ambient air concentrations of MTBE may cause direct adverse
effects for plants or animal species. Because there are no tested data for the air compartment and the calculation
of PNECatmopsheric is not possible, no quantitative characterisation of risk as a PEC/PNEC comparison is possible.
10.5.2.4. Microbiological activity in sewage treatment plants
The risk characterisation for sewage treatment plants is given in Tables 127 and 128.
Table 127: Risk characterisation for STPs - distribution
PEC
Compartment
STP effluent (mg/l)
RCR
PNEC
71
Local
Regional
Local
Regional
9.64E-03
---
1.36E-04
---
Table 128: Risk characterisation for STPs - storage
PEC
Compartment
STP effluent (mg/l)
RCR
PNEC
71
Local
Regional
Local
Regional
9.78E-03
---
1.38E-04
---
10.5.2.5. Secondary poisoning
A risk characteristion through secondary poisoning has not been carried out for MTBE since it has low potential
to accumulate to living organisms, and it is not classified as very toxic (T+), toxic (T) or harmful (Xn) according
to mammalian toxicity data.
10.6. Fuel use - industrial
10.6.1. Human health
10.6.1.1. Workers
The worker exposure estimates and risk characterisation ratios (RCRs) for the activities associated with Fuel use
(industrial) have been assessed using ECETOC TRA version 2 and exposure data (tier 2 assessment: data from
the EU RAR of MTBE (European Union, 2002)) where needed. The combinations of Operational Conditions
and Risk Management Measures corresponding to RCRs of less than 1 are presented in chapter 9.6. In Table
129, the full shift and short term exposure estimates/values and the RCRs (inhalation, dermal and combined
exposure) for the contributing scenarios are presented.
Table 129: Exposure levels and the risk characterisation ratios after assessment of safe use for ES6 –
Industrial use of fuel, using the ECETOC TRA v2 model
Full shift exposure and RCR
Contributing Scenarios
Bulk transfers [CS14];
Batch process [CS55];
With sample collection
[CS56];
Filling / preparation of
equipment from drums
or containers [CS45]
Drum/batch transfers
[CS8];
Filling / preparation of
equipment from drums
or containers. [CS45];
Bulk transfers [CS14];
Dedicated facility
[CS81]
General exposures
(closed systems) [CS15]
General exposures
(closed systems) [CS15];
With sample collection
[CS56]
General exposures
(closed systems) [CS15];
Use in contained batch
processes [CS37];
With sample collection
[CS56]
(closed systems)
[CS107] Use of fuel
(closed systems)
[CS107]; Batch process
[CS55].
Equipment cleaning and
maintenance [CS39];
Non-dedicated facility
[CS82] e.g fuel pump
repair indoor
Storage [CS67];
General exposures
Short term exposure
Predicted
Exposure
(ppm)
Predicted
Dermal
Exposure
(mg/kg/d)
RCR
(inhalation)
RCR
(dermal)
RCR
(all routes)
Predicted
Exposure
(ppm)
RCR
(inhalation)
18 (=64
mg/m3)
0.82
0.36
0.0002
0.36
18 (=64
mg/m3)
0.18
18 (=64
mg/m3)
0.82
0.36
0.0002
0.3602
18 (=64
mg/m3)
0.18
0.006
(=0.02
mg/m3)
0.20
0.0001
0.00004
0.0002
0.006
(=0.02
mg/m3)
0.0001
30 (=107
mg/m3)
0.16
0.60
0.00003
0.60
30
(=107
mg/m3)
0.30
36 (=129
mg/m3)
0.04
0.72
0.00001
0.72
60
(=214
mg/m3)
0.60
15 (=54
mg/m3)
0.04
0.30
0.00001
0.30
36 (=129
mg/m3)
0.04
0.72
0.000008
0.72
9 (=32
mg/m3)
1.65
0.18
0.0003
0.18
15 (=54
mg/m3)
0.15
0.006
(=0.02
0.20
0.0001
0.00004
0.0002
0.006
(=0.02
0.0001
15 (=54
mg/m3)
60
(=214
mg/m3)
0.15
0.60
Full shift exposure and RCR
Contributing Scenarios
Predicted
Exposure
(ppm)
(closed systems) [CS15]
mg/m3)
Storage [CS67];
General exposures
(closed systems) [CS15];
With sample collection
[CS56]
21 (=75
mg/m3)
Predicted
Dermal
Exposure
(mg/kg/d)
RCR
(inhalation)
RCR
(dermal)
Short term exposure
RCR
(all routes)
Predicted
Exposure
(ppm)
RCR
(inhalation)
mg/m3)
0.16
0.42
0.00003
0.4200
21 (=75
mg/m3)
0.21
The RCRs regarding inhalation, dermal and combined exposure for the full shift and short term exposure
estimates/values of the contriburing scenarios are all below 1. Therefore, „control of risks‟ is guaranteed for the
quantitative endpoints based on the available data for fuel use (industrial).
Qualitative risk characterisation for workers
MTBE has the property that repeated skin exposure may result in skin fatigue (and consequent risk of toxic
eczema) due to the effective lipid extraction properties, an effect common to a variety of organic solvents. In
addition (and probably in relation), MTBE is classified for skin irritation based on a skin irritation study in
which exposure was under occlusive conditions. No quantitative risk characterisation can be performed for both
skin fatigue and for skin irritation since the data available are not appropriate for a quantitative assessment.
Therefore, a qualitative risk characterization should be performed according to the REACH guidance on
information requirements and chemical safety assessment, Part E: „Risk Characterisation‟.
Skin irritation
Because of the skin irritation properties of MTBE, from a hazard point of view, appropriate protective gloves
have to be used when handling preparations with more than 10% MTBE ** ) (such as neat MTBE) and in case of
risk of accidental spills, when handling contaminated surfaces or parts (for more details on the type of the
recommended gloves: see chapter 9.1.1).
**) The general concentration limit for Category 2 skin irritating substances in Regulation (EC) 1272/2008 is
10%.
Skin fatigue
Skin fatigue due to dermal contact with fuel ethers will only occur in case of prolonged continuous dermal
contact with neat liquid for periods longer than 10 minutes, repeated each working day (Alderman, M.H. and
Hanley M.J., 1982). Under these conditions the skin lipids will partly be dissolved and rinsed off from the skin.
The defattened skin will become more vulnerable to dermatitis and allergic dermatitis because the skin barrier
got lost.
The risk that skin fatigue will occur due to dermal exposure to MTBE is determined by the actual dermal
exposure. Due to the volatility of the fuel ethers most of the fuel ethers will quickly disappear from the skin due
to fast evaporation. It can be calculated that a skin dose of 5 mg/cm2/day MTBE (a worse-case daily dose
estimated with ECETOC TRA version 2) will be evaporated from the skin in less than 1 minute, based on the
evaporation rate of MTBE of 16.8 mg/cm2/min (see Appendix R.14-1 of the “Guidance on information
requirements and chemical safety assessment” (Chapter R.14: Occupational Exposure Estimation). Therefore, it
can be concluded that the risk of the occurrence of skin fatigue is negligible due to the high evaporation rate of
MTBE and the fact that protective gloves are used to prevent skin irritation.
10.6.1.2. Consumers
Not applicable.
10.6.1.3. Indirect exposure of humans via the environment
Table 130: Risk characterisation for humans exposed via the environment
Human Dose
Indirect Receptor
RCR
DNEL
Local
Regional
Local
Regional
Drinking water (mg/kg/day)
7.1
4.10E-04
1.21E-05
5.77E-05
1.70E-06
Fish (mg/kg/day)
7.1
3.12E-06
1.10E-06
4.39E-07
1.55E-07
Leaf crops (mg/kg/day)
7.1
3.38E-05
1.71E-06
4.76E-06
2.41E-07
Root crops (mg/kg/day)
7.1
8.44E-05
1.80E-06
1.19E-05
2.54E-07
Meat (mg/kg/day)
7.1
1.38E-08
6.44E-10
1.94E-09
9.07E-11
Milk (mg/kg/day)
7.1
2.58E-07
1.20E-08
3.63E-08
1.69E-09
Air (mg/kg/day)
7.1
7.33E-03
3.71E-04
1.03E-03
5.23E-05
Total daily intake (mg/kg/day)
7.1
7.86E-03
3.88E-04
1.11E-03
5.46E-05
10.6.2. Environment
10.6.2.1. Aquatic compartment (including sediment)
The risk characterisation for the aquatic compartment is given in Table 131.
Table 131: Risk characterisation for the aquatic compartment
PEC
Compartment
RCR
PNEC
Local
Regional
Local
Regional
Freshwater aquatic (mg/l)
5.1
1.36E-03
4.22E-04
2.68E-04
8.27E-05
Marine aquatic (mg/l)
0.26
1.49E-04
5.47E-05
5.73E-04
2.10E-04
Freshwater sediment (mg/kgwwt)
5
1.34E-03
3.69E-04
2.68E-04
7.38E-05
Marine sediment (mg/kgwwt)
1.17
1.46E-04
4.84E-05
1.25E-04
4.14E-05
10.6.2.2. Terrestrial compartment
The risk characterisation for the terrestrial compartment is given in Table 132.
Table 132: Risk characterisation for the terrestrial compartment
PEC
Compartment
Soil (mg/kgwwt)
RCR
PNEC
1.43
Local
Regional
Local
Regional
4.33E-03
8.53E-05
3.04E-03
5.98E-05
10.6.2.3. Atmospheric compartment
There are no indications or studies available that ambient air concentrations of MTBE may cause direct adverse
effects for plants or animal species. Because there are no tested data for the air compartment and the calculation
of PNECatmopsheric is not possible, no quantitative characterisation of risk as a PEC/PNEC comparison is possible.
10.6.2.4. Microbiological activity in sewage treatment plants
The risk characterisation for sewage treatment plants is given in Table 133.
Table 133: Risk characterisation for STPs
PEC
Compartment
STP effluent (mg/l)
RCR
PNEC
71
Local
Regional
Local
Regional
9.43E-03
---
1.33E-04
---
10.6.2.5. Secondary poisoning
A risk characteristion through secondary poisoning has not been carried out for MTBE since it has low potential
to accumulate to living organisms, and it is not classified as very toxic (T+), toxic (T) or harmful (Xn) according
to mammalian toxicity data.
10.7. Fuel use - professionals
10.7.1. Human health
10.7.1.1. Workers
The worker exposure estimates and risk characterisation ratios (RCRs) for the activities associated with Fuel use
(professionals) have been assessed using ECETOC TRA version 2. The combinations of Operational Conditions
and Risk Management Measures corresponding to RCRs of less than 1 are presented in chapter 9.7. In Table
134, the full shift and short term exposure estimates/values and the RCRs (inhalation, dermal and combined
exposure) for the contributing scenarios are presented.
Table 134: Exposure levels and the risk characterisation ratios after assessment of safe use for ES7
Proffesional use of fuel, using the ECETOC TRA v2 model
Full shift exposure and RCR
Contributing Scenarios
Bulk transfers [CS14];
Batch process [CS55]; Filling
/ preparation of equipment
from drums or containers.
[CS45]
Drum/batch transfers [CS8];
Filling / preparation of
equipment from drums or
containers. [CS45]; Bulk
transfers [CS14];
Dedicated facility [CS81]
Refuelling [CS507]
General exposures (closed
systems) [CS15];
With sample collection
[CS56]
General exposures (closed
systems) [CS15];
Use in contained batch
processes [CS37];
With sample collection
[CS56]
Drum and small package
filling [CS6]; Dedicated
facility [CS81]
(closed systems) [CS107] Use
a fuel
Equipment cleaning and
maintenance [CS39]; Nondedicated facility [CS82] e.g
fuel pump repair indoor
Equipment cleaning and
maintenance [CS39]; Nondedicated facility [CS82] e.g
fuel pump repair outdoor
Short term exposure
Predicted
Exposure
(ppm)
Predicted
Dermal
Exposure
(mg/kg/d)
RCR
(inhalation)
RCR
(dermal)
RCR
(all routes)
Predicted
Exposure
(ppm)
RCR
(inhalation)
30
(=107
mg/m3)
0.82
0.60
0.0002
0.60
30
(=107
mg/m3)
0.30
30
(=107
mg/m3)
0.41
0.60
0.0000
8
0.60
30
(=107
mg/m3)
0.30
45
(=161
mg/m3)
0.41
0.90
0.0000
8
0.90
45
(=161
mg/m3)
0.45
30
(=107
mg/m3)
0.16
0.60
0.0000
3
0.60
30
(=107
mg/m3)
0.30
42
(=150
mg/m3)
0.04
0.84
0.0000
08
0.84
42
(=150
mg/m3)
0.42
6 (=21
mg/m3)
0.82
0.12
0.0002
0.12
30
(=107
mg/m3)
0.04
0.60
0.0000
08
0.60
36
(=129
mg/m3)
1.65
0.72
0.0003
0.72
60
(=214
mg/m3)
0.60
36
(=129
mg/m3)
1.65
0.72
0.0003
0.72
60
(=214
mg/m3)
0.60
30
(=107
mg/m3)
30
(=107
mg/m3)
0.30
0.30
Full shift exposure and RCR
Contributing Scenarios
Storage [CS67];
General exposures (closed
systems) [CS15]
Short term exposure
Predicted
Exposure
(ppm)
Predicted
Dermal
Exposure
(mg/kg/d)
RCR
(inhalation)
RCR
(dermal)
RCR
(all routes)
Predicted
Exposure
(ppm)
RCR
(inhalation)
0.06
(=0.21
mg/m3)
0.20
0.001
0.0000
4
0.001
0.06
(=0.21
mg/m3)
0.0006
The RCRs regarding inhalation, dermal and combined exposure for the full shift and short term exposure
estimates/values of the contriburing scenarios are all below 1. Therefore, „control of risks‟ is guaranteed for the
quantitative endpoints based on the available data for fuel use (professionals).
Qualitative risk characterisation for workers
MTBE has the property that repeated skin exposure may result in skin fatigue (and consequent risk of toxic
eczema) due to the effective lipid extraction properties, an effect common to a variety of organic solvents. In
addition (and probably in relation), MTBE is classified for skin irritation based on a skin irritation study in
which exposure was under occlusive conditions. No quantitative risk characterisation can be performed for both
skin fatigue and for skin irritation since the data available are not appropriate for a quantitative assessment.
Therefore, a qualitative risk characterization should be performed according to the REACH guidance on
information requirements and chemical safety assessment, Part E: „Risk Characterisation‟.
Skin irritation
Because of the skin irritation properties of MTBE, from a hazard point of view, appropriate protective gloves
have to be used when handling preparations with more than 10% MTBE ** ) (such as neat MTBE) and in case of
risk of accidental spills, when handling contaminated surfaces or parts (for more details on the type of the
recommended gloves: see chapter 9.1.1).
**) The general concentration limit for Category 2 skin irritating substances in Regulation (EC) 1272/2008 is
10%.
Skin fatigue
Skin fatigue due to dermal contact with fuel ethers will only occur in case of prolonged continuous dermal
contact with neat liquid for periods longer than 10 minutes, repeated each working day (Alderman, M.H. and
Hanley M.J., 1982). Under these conditions the skin lipids will partly be dissolved and rinsed off from the skin.
The defattened skin will become more vulnerable to dermatitis and allergic dermatitis because the skin barrier
got lost.
The risk that skin fatigue will occur due to dermal exposure to MTBE is determined by the actual dermal
exposure. Due to the volatility of the fuel ethers most of the fuel ethers will quickly disappear from the skin due
to fast evaporation. It can be calculated that a skin dose of 5 mg/cm2/day MTBE (a worse-case daily dose
estimated with ECETOC TRA version 2) will be evaporated from the skin in less than 1 minute, based on the
evaporation rate of MTBE of 16.8 mg/cm2/min (see Appendix R.14-1 of the “Guidance on information
requirements and chemical safety assessment” (Chapter R.14: Occupational Exposure Estimation). Therefore, it
can be concluded that the risk of the occurrence of skin fatigue is negligible due to the high evaporation rate of
MTBE and the fact that protective gloves are used to prevent skin irritation.
10.7.1.2. Consumers
Not applicable.
10.7.1.3. Indirect exposure of humans via the environment
Covered under Section 10.8.
10.7.2. Environment
Covered under Section 10.8.
10.8. Fuel use - consumers
10.8.1. Human health
10.8.1.1. Workers
Not applicable.
10.8.1.2. Consumers
Quantitative risk characterisation for consumers
Short term exposure
It is assumed that a reasonable worst case concentration in Stage 1 station refuelling is 29 mg/m3 MTBE for 1
minute, occurring maximal 3 times a week, when average MTBE content is around 11% (see further details in
section 9.8.2.2.2).
Comparing the exposure concentration of 29 mg/m3 with the short-term DNEL of 214 mg/m3 (which is even
applicable for 15 minutes), it is concluded that „control of risks‟ is guaranteed (RCR=0.14).
Long-term exposure
Table 135: Quantitative risk characterisation for consumers (long-term exposure)
DNEL
Exposure
Risk characterisation
Route
dose/concentration
ratio
Dermal systemic exposure
(in mg /kg bw/d)
0.0114*
3750 mg/kg bw/day
3.04·10-6
Inhalation exposure
(mg/m3)
0.026**
53.6 mg/m3
4.85·10-4
Combined routes
4.88·10-4
* Conclusion is adopted from the RAR (European Commission, 2002).
** The reasonable worst-case (RWC) for inhalation exposure for consumers to blended fuels containing MTBE
is based on the above described measurement data. Exposure estimation based on short term exposure during 1
minute, 3 times a week.
The RCRs for consumers regarding inhalation, dermal and combined exposure for fuel use are below 1.
Therefore, „control of risk‟ has been shown for all contributing scenarios.
Qualitative risk characterisation for consumers
MTBE has the property that repeated skin exposure may result in skin fatigue (and consequent risk of toxic
eczema) due to the effective lipid extraction properties, an effect common to a variety of organic solvents. In
addition (and probably in relation), MTBE is classified for skin irritation based on a skin irritation study in
which exposure was under occlusive conditions. No quantitative risk characterisation can be performed for both
skin fatique and for skin irritation since the data available are not appropriate for a quantitative assessment.
Therefore, a qualitative risk characterization should be performed according to the REACH guidance on
information requirements and chemical safety assessment, Part E: „Risk Characterisation‟.
Because of the skin irritation properties of MTBE, from a hazard point of view, appropriate protective gloves
have to be used when handling preparations with more than 10% MTBE ** (such as neat MTBE) and in case of
risk of accidental spills, when handling contaminated surfaces or parts.
The risk that skin fatigue and/or skin irritation will occur due to skin exposure to MTBE is also determined by
the actual dermal exposure. It can be calculated that a skin dose of 5 mg/cm2/day MTBE (a worse-case daily
dose estimated with ECETOC TRA version 2) will be evaporated from the skin in less than 1 minute, based on
the evaporation rate of MTBE of 16.8 mg/cm2/min (see Appendix R.14-1 of the “Guidance on information
requirements and chemical safety assessment” (Chapter R.14: Occupational Exposure Estimation).
As skin exposure for consumers is considered a one minute occurrence, three times a week, it can be concluded,
based on the calculation presented above, that the risk of the occurrence of skin fatigue and/or skin irritation is
negligible due to the high evaporation rate of MTBE. Therefore, the use of protective gloves is considered
unnecessary.
** The general concentration limit for Category 2 skin irritating substances in Regulation (EC) 1272/2008 is
10%.
10.8.1.3. Indirect exposure of humans via the environment
The risk characterisation (inhalation, oral and combined exposure) for indirect exposure of humans via the
environment is given in Table 136.
Table 136: Risk characterisation for humans exposed via the environment
Human Dose
Indirect Receptor
RCR
DNEL
Local
Regional
Local
Regional
Drinking water (mg/kg/day)
7.1
1.21E-05
1.21E-05
1.70E-06
1.70E-06
Fish (mg/kg/day)
7.1
1.10E-06
1.10E-06
1.55E-07
1.55E-07
Leaf crops (mg/kg/day)
7.1
1.73E-06
1.71E-06
2.44E-07
2.41E-07
Root crops (mg/kg/day)
7.1
7.49E-07
1.80E-06
1.05E-07
2.54E-07
Meat (mg/kg/day)
7.1
6.48E-10
6.44E-10
9.13E-11
9.07E-11
Milk (mg/kg/day)
7.1
1.21E-08
1.20E-08
1.70E-09
1.69E-09
Air (mg/kg/day)
7.1
3.74E-04
3.71E-04
5.27E-05
5.23E-05
Total daily intake (mg/kg/day)
7.1
3.90E-04
3.88E-04
5.49E-05
5.46E-05
10.8.2. Environment
10.8.2.1. Aquatic compartment (including sediment)
The risk characterisation for the aquatic compartment is given in Table 137.
Table 137: Risk characterisation for the aquatic compartment
PEC
Compartment
RCR
PNEC
Local
Regional
Local
Regional
Freshwater aquatic (mg/l)
5.1
4.22E-04
4.22E-04
8.28E-05
8.27E-05
Marine aquatic (mg/l)
0.26
5.47E-05
5.47E-05
2.11E-04
2.10E-04
Freshwater sediment (mg/kgwwt)
5
4.14E-04
3.69E-04
8.28E-05
7.38E-05
Marine sediment (mg/kgwwt)
1.17
5.37E-05
4.84E-05
4.59E-05
4.14E-05
10.8.2.2. Terrestrial compartment
The risk characterisation for the terrestrial compartment is given in Table 138.
Table 138: Risk characterisation for the terrestrial compartment
PEC
Compartment
Soil (mg/kgwwt)
RCR
PNEC
1.43
Local
Regional
Local
Regional
3.56E-05
8.53E-05
2.49E-05
5.98E-05
10.8.2.3. Atmospheric compartment
There are no indications or studies available that ambient air concentrations of MTBE may cause direct adverse
effects for plants or animal species. Because there are no tested data for the air compartment and the calculation
of PNECatmopsheric is not possible, no quantitative characterisation of risk as a PEC/PNEC comparison is possible.
10.8.2.4. Microbiological activity in sewage treatment plants
The risk characterisation for sewage treatment plants is given in Table 139.
Table 139: Risk characterisation for STPs
PEC
Compartment
STP effluent (mg/l)
RCR
PNEC
71
Local
Regional
Local
Regional
2.94E-06
---
4.14E-08
---
10.8.2.5. Secondary poisoning
A risk characteristion through secondary poisoning has not been carried out for MTBE since it has low potential
to accumulate to living organisms, and it is not classified as very toxic (T+), toxic (T) or harmful (Xn) according
to mammalian toxicity data.
10.9. Overall exposure (combined for all relevant emission/release
sources)
10.9.1. Human health (combined for all exposure routes)
Workers are never exposed in more than one worker situation at the same time. Workers are also part of the
public and therefore might experience additional exposure from e.g. consumer sources or by indirect exposure
from the environment. Adding risks due to acute effects by short term exposure is not relevant, as short term
exposures will never happen at the same time. Risks due to exposure by consumer activities (RCR of 4.19·10-4
for Fuel use) and indirect exposure from the environment (highest RCR is 2.72·10-2 for Formulation) are
considered negligible and will therefore not add any risk. In conclusion, „control of risks‟ is guaranteed for
combined exposures.