Код 05

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ZHIVAS JSC

SAFETY INFORMATION SHEET

According to the requirements for order and way of classification, packing and labeling of existing and new chemical substances, preparations and products, Appendix No. 16 to clause 41, par. 1 (SG issue 5/2002)

Date of issuance: 11.04.2005 г Issue: 01/2005

Supercedes issue: new

1. . Name of the preparation and the company

1.1. Name of the preparation: ”ZHIVAHEX”

1.2. Usage of the preparation:

- preparation for surfaces’ disinfection

1.3. Name and address of the body, releasing the preparation in the market:

“ ZHIVAS” JSC, bul. “ Dondukov” № 36, Sofia

1.4. Telephone in case of emergency: + 359 2 981 78 23

Telephone of Multiprofile hospital of active treatment and emergency medicine MHATEM “N.I.Pirogov”: 915-44-11

2. Preparation contents

The preparation is a mixture of alcohol and chlorchexidine digluconate. It contains certain quantities of lactic acid, dyes and flavours.

2.1.

General properties of the chemical substances and percentage content .

Active components are propane-2-ol (isopropanol) and chlorchexidine digluconate. The content of isopropanol is

60% and ofchlorchexidine digluconate – 0.5% The dye used – green 85 (E102), flavours and lactic acid (E 270) are permitted for usage as nutrition additives with Regulation № 8,/ SG, issue 44/2002 and issue 3/2005).

2.2. Concentrations and limit values of the substances – for preparations, classified as dangerous :

Substance CAS № % concentrate Danger symbol,

R – Phrases

chlorchexidine digluconate 18472-51-0 0.5% Xn R 22

Propane-2-ol 67-63-0 60% F, R 11

Xi R 36, R 67

Limit values for working media air for some substances

Substances CAS №/

EINECS

Limit values for working media air according to

Regulation 13, SG issue 8/2004

Propane-2-ol

(isopropyl alcohol)

67-63-0 /

200-661-7

980 mg/m 3 (8 hours)

1225.0 mg/m 3 (15 min)

2.3. Concentrations and limit values of the substances – for preparations, not classified as dangerous :

The lactic acid, flavours and dye are not classifies as dangerous. There are no limit values for them. Besides, their relative share in the composition is ≤ 0.1% and according to table 2, clause 20, par.1, Council of Ministers

Regulation № 316 (SG, issue 5/2002) they are not taken under consideration upon determining the danger category.

2.4. Classification of substances under preceding item :

Designation and numbers of substances according to EINECS or ELINCS .

SUBSTANCE

Chlorchexidine digluconate propane-2-ol

EINECS or ELINCS.

242-354-0

200-661-7 page 1 of 6

ZHIVAS JSC

SAFETY INFORMATION SHEET

According to the requirements for order and way of classification, packing and labeling of existing and new chemical substances, preparations and products, Appendix No. 16 to clause 41, par. 1 (SG issue 5/2002)

3. Description of hazards

Danger symbol : Xi Irritating

Risk phrases:

R 36 Irritates eyes.

General character of acting: In high concentrations has narcotic impact. Irritates upper respiratory tract and eyes.

Chlorechexidine digluconate is harmful in case of swallowing.

4. First aid measures

4.1. In case of breathing: Take the sufferer out in fresh air. It is required to maintain normal body temperature. In case of indisposition or appearance and development of intoxication symptoms call for medical help immediately.

4.2. In case of skin contact: Immediately take off the contaminated work clothes. Wash the contaminated skin areas thoroughly with water.

4.3. In case of eyes contact: Rinse thoroughly with water and eyelids wide open for 15 - 20 minutes. Consult an ophtamologist.

4.4. In case of swallowing: Rinse the mouth with water. Drink large amount of water. If the person is unconscious, do not give him liquids through the mouth. Immediately call for medical help.

4.5. Necessity of qualified medical help (obligatory or recommended) : In case of contact with the eyes, swallowing and symptomatics or irritation, immediately call for medical help. In case of swallowing – the treatment is symptomatic.

4.6. Special means for first aid on the work place: none.

5. Fire extinguishing measures

5.1. Suitable means for fire extinguishment: СО

2

, fire extinguishing dust.

Stronger fires to be extinguished with alcohol-stable foam.

5.2. Means, unsuitable for fire extinguishment for security reasons: full water stream. It may be used for cooling of containers.

5.3. Specific hazards, related to exposition of the preparation and resulting products of burning and precipitating gases: In case of fire, toxic gases may be formed: СО, СО

2.

In case of burning of PE package, may be formed: СО, СО

2, ethylene, methane, ethane, propane, propylene, cycloaliphatic hydrocarbons, formaldehyde, acetaldehyde, butylenes, butane.

5.4. Special protective means for the fire men: suitable work clothes, respiratory device with full protection of the face.

6. Measures in case of emergency emission

6.1. Personal protection measures: work clothes, latex gloves, protection goggles, providing good general and local ventilation. Avoid contact with the eyes and skin. Remove sources of ignition.

6.2. Environmental protection measures:

In case of incident and/or overflow of the preparation, measures to be taken for its localizing and limitation; the gathered quantity from the preparation to be stored temporarily in tightly closed and designated containers, after which to be handled to persons, holding permission according to par. 37 from Waste management law (SG, issue

83/2003). Do not allow contamination of surface and underground waters, soil and drainage system.

6.3. Means for cleaning: Absorbed by means of inert materials (sand, sawdust or soil). Wash with water and detergent. Gathered quantities are stored in special tightly closed and designated containers .

7. Operation with the preparation and storage

page 2 of 6

ZHIVAS JSC

SAFETY INFORMATION SHEET

According to the requirements for order and way of classification, packing and labeling of existing and new chemical substances, preparations and products, Appendix No. 16 to clause 41, par. 1 (SG issue 5/2002)

7.1. Operation with the preparation: In case of exceeding the limit values for work environment, provide with filter respiratory devices. Avoid contact with eyes. Change work clothes and take a shower after work.

Contaminated work clothes to be replaced by clean and dry one and to be washed before subsequent usage.

Do not throw the excess of the preparation in the drainage system; use it on purpose only.

Do not allow throwing of the preparation and water, obtained after its usage in the drainage system.

After usage, the package is collected in special, tightly closed and designated containers and is stored temporarily at the company’s territory, after which is handled to persons, holding permission according to par.37 from Waste management law.

In case of overflow of the preparation, the gathered quantities are collected in special, tightly closed and designated containers and are stored temporarily at the company’s territory, after which are handled to persons, holding permission according to par.37 from Waste management law.

7.2. Storage : in original, well closed package, in dry and well ventilated rooms, away from food, drinks and under temperature between 15 and 25 о С. Do not expose it to direct sunlight. Do not store with strong oxidizers and acids.

7.3. Specific usage : For professional usage only.

8. Control in exposition and personal protective means

8.1. Limits of exposition

Limit values of air in the work environment

Compound CAS №/

EINECS

67-63-0 /

200-661-7

Limit values of air in the work environment according to Regulation 13,

SG issue 8/2004

980 mg/m 3 (8 hours)

1225.0 mg/m 3 (15 min)

Propane-2-ol

(isopropyl alcohol)

8.2. Control of exposition

8.2.1. Control of exposition in work environment : Providing of general and local ventilation is recommended in order to control limit values of isopropyl alcohol in the air of the work place.

8.2.1.1. Protection of respiratory tract: Do not breathe the vapours. Provide general ventilation and where needed – local ventilation. In case of exceeding the limit values for work environment – use filter respiratory devices.

8.2.1.2. Hands protection: Gloves, resisting to solvents

8.2.1.3. Eyes protection: Fully tight goggles.

8.2.1.4. Protection of skin and body: work clothes from impregnate textile, shoes, gloves, respiratory devices.

Use rubber apron, if required.

8.2.2. Control of the influence of the preparation on the environment: Do not throw the excess preparation in the drainage system and use it on purpose. Avoid contamination of soil, air, water sources and drainage system.

9. Chemical and physical properties

9.1. General information

Appearance – liquid

Colour - green

Odour - nice page 3 of 6

ZHIVAS JSC

SAFETY INFORMATION SHEET

According to the requirements for order and way of classification, packing and labeling of existing and new chemical substances, preparations and products, Appendix No. 16 to clause 41, par. 1 (SG issue 5/2002)

9.2. Important information related to human\s health, safety and environment pH ( 1 % water solution)

Flame point (in closed crucible)

Self-ignition temperature

Boiling point

Explosion properties

5.0 – 6.5 (20º C)

23 о С

No data

82º C

3.28 – 18.95 %

Oxidizing properties

Vapours pressure

Relative density , 20 о С

Refractive index , 20 о С

Solubility in water

Solution in organic solvents

Distribution coefficient n-octanol/water

Viscosity, kinematical

Vapours density

Speed of evaporation none

No data

1.0087

1.376 – 1.381

Very well dissolved

Well dissolved in acetone, benzene, chloroform, methyl and ethyl alcohol

No data

No data

No data

No data

9.3. Other information - none

10. Stability and reactive ability

10.1. Conditions, which shall be avoided : high temperatures over 40 о С, sources of heat and direct sunlight

10.2.

Substances, which shall be avoided : strong oxidizers and acids.

10.3.

Hazardous products of dissociation : not expected, in case of following the instructions.

11. Toxicological information

Parameters of strong toxicity of the preparation ZHIVAHEX, experimentally specified by Certified laboratory

“Toxicology” at National Centre for Human Healthcare – Sofia:

LD50 oral, rat

2000 mg/kg body weight.

LD50 dermal, rat

2000 mg/kg body weight.

12. Environment information

12.1. Ecotoxicity

Isopropanol

LD50 48 hours (fish )

8970-9280mg/l

Strong toxicity for Daphnia magna 24 hours > 10 000 mg/l

Biologic instability – aerobic – 95% after 21 days

12.2. Mobility – upon penetration into the soil, it might be expected that underground waters will be reached; upon overflow on the soil – quick evaporation.

12.3. Stability and instability – Isopropanol is bio instable and dissolves in environmental components.

12.4. Potential for bioaccumulation – bioaccumulation is not expected. The logarithmic coefficient of distribution octanol/water for alcohol is below 30 days. Upon overflow in water, the period of semi elimination is expected to be between 5 and 10 days. Upon dispersing in the air, quick spreading in the atmosphere is expected, depending on the atmospheric draughts. page 4 of 6

ZHIVAS JSC

SAFETY INFORMATION SHEET

According to the requirements for order and way of classification, packing and labeling of existing and new chemical substances, preparations and products, Appendix No. 16 to clause 41, par. 1 (SG issue 5/2002)

12.5. Other undesired effects – no data.

13. Waste treatment

The wastes of the biocide preparation as residual quantities and packages are collected in special, tightly closed and designated containers and are stored temporarily, after which are handled to persons, holding permission according to par.37 from Waste management law.

Wastes’ code according Regulation № 3 for classification of wastes/SG, issue 44/2004:

1. In case of usage of the biocide preparation in public healthcare and stomatology, the wastes should be classified with code and designation: 18-01-06* - chemical substances and preparations, consisting of or containing hazardous substances for human healthcare.

2. In case of usage of biocide preparation in veterinarian practice the wastes should be classified with code and designation: 18-01-05* - chemical substances and preparations, consisting of or containing hazardous substances for veterinarian healthcare.

3. In case of usage of biocide preparation in foodstuff industry, cosmetics etc., the wastes should be classified with code and designation: 07.06.04* - other organic solvents, washing liquids and earth lye.

4. Packages should be classifies with code and designation 15.01.10* - packages, containing residues from hazardous substances or contaminated with hazardous substances.

14. Information about transport

14. Information about transport

To be transported in closed transport vehicles, separated from food and drinks.

Legislation for hazardous goods should be kept during transportation.

15. Information according to the acting regulatory framework

Symbols and signs for danger

Xi

Irritating

Risk phrases :

R 10 Flammable.

R 36 Irritates eyes.

R 67 Vapours could cause dizziness and somnolence.

Safety advice:

S 2

S 7

S 16

S 24/25

To be kept away from children.

Vessel should be kept tightly closed.

To be stored away from sources of fire. Smoking is forbidden

Avoid contact with eyes and skin.

S23

S 26

S 46

S51

Do not inhale aerosol.

In case of contact with eyes, rinse thoroughly with water and call for medical help.

In case of swallowing, call for medical help and show the package or label.

Use at ventilated places only.

16. Other information

page 5 of 6

ZHIVAS JSC

SAFETY INFORMATION SHEET

According to the requirements for order and way of classification, packing and labeling of existing and new chemical substances, preparations and products, Appendix No. 16 to clause 41, par. 1 (SG issue 5/2002)

Information sheet safety data correspond to the level of recent knowledge and date of preparation.

The consumer of the trade product should keep the requirements of the Law for protection from harmful impact of chemical substances and preparations, normative acts in the field of health and labour safety and environmental protection. page 6 of 6

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