SAFETY DATA SHEET N-butyl acetate, Grade A Page 1 / 12 "Dmitrievsky chemical plant – Production", LLC Date 11/04/2011 Previous date: 03/03/2011 SECTION 1. IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/ UNDERTAKING 1.1 1.1.1 Product identifier Commercial Product Name N-butyl acetate, Grade A 1.1.2 Product code CAS-No.: 123-86-4 EINECS-No.: 204-658-1 Common name(s), synonym(s) of the substance: 1-butyl acetate, 1-butyl ethanoate, Acetic acid n-butyl ester 1.2 Relevant identified uses of the substance or mixture and uses advised against 1.2.1 Recommended use 1.3 1.3.3 Industrial: manufacture, distribution; formulation & (re)packaging; use in coatings and cleaning agents; use in laboratories. Professional: use in coatings and cleaning agents, use in laboratories. Details of the supplier of the safety data sheet Identification of the manufacturer "Dmitrievsky chemical plant – Production", LLC 1, Proizvodstvennaya street 155800 Kineshma, Ivanovo region Russia Telephone: (49331) 5-72-89, (495) 988-68-42 Email: http://www.dhz.ru 1.4 1.4.1 Emergency telephone number Telephone number, name and address Poison centres, Europe: http://www.who.int/pcs/poisons/centre/directory/euro/en/ See SECTION 16.6 for the list of telephone numbers of poison centers in the European Economic Area. SECTION 2. HAZARDS IDENTIFICATION 2.1 In accordance with Directive 67/548/EEC and Regulation 1272/2008 this substance is classified as hazardous. The substance is a flammable liquid (H226). Exposure to vapours may cause drowsiness or dizziness (H336). Frequent contact can lead to skin dryness of cracking of the skin (EUH066). Classification of the substance or mixture 67/548/EEC (DSD) R10 R66 R67 1272/2008 (CLP) Flam. Liq. 3, H226 STOT SE 3, H336 SAFETY DATA SHEET N-butyl acetate, Grade A Page 2 / 12 "Dmitrievsky chemical plant – Production", LLC Date 11/04/2011 Previous date: 03/03/2011 EUH066 2.2 Label elements 1272/2008 (CLP) GHS07 - GHS02 Signal word Warning Hazard Statements H226 Flammable liquid and vapour. H336 May cause drowsiness or dizziness. EUH066 Repeated exposure may cause skin dryness or cracking. Precautionary Statements P210 Keep away from heat/sparks/open flames/hot surfaces. - No smoking. P233 Keep container tightly closed. P235 Keep cool. P261 Avoid breathing dust/fume/gas/mist/vapours/spray. P280 Wear protective gloves/protective clothing/eye protection/face protection. P303+P361+P353 IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing. Rinse skin P304+P340 P312 2.3 with water/shower. IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTER or doctor/physician if you feel unwell. Other hazards Vapour is heavier than air and can travel considerable distance to a source ignition and flashback. Vapours may form explosive mixture with air. Components of the product may be absorbed into the body by inhalation. Seveso substance: Main Seveso Category 6. Flammable The substance does not fulfil the PBT criteria (not PBT) nor the vPvB criteria (not vPvB), see section 12 for further information. SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS 3.1 Substances N-butyl acetate is a mono-constituent substance of organic origin. CAS/EC and EINECS Chemical name of the Concentration Classification Reg.number substance 123-86-4 204-658-1 n-butyl acetate > 99 % DSD: R10; R66; R67 CLP: Flam. Liq. 3, H226; STOT SE 3, H336 SECTION 4. FIRST AID MEASURES 4.1 Description of first aid measures 4.1.2 Inhalation Remove contaminated, soaked clothing immediately and dispose of safely. First aider needs to protect himself. 4.1.3 4.1.4 4.1.5 Keep at rest. Move to fresh air. When symptoms persist or in all cases of doubt seek medical advice. Skin contact Wash off immediately with soap and plenty of water. When symptoms persist or in all cases of doubt seek medical advice. Eye contact Rinse immediately with plenty of water, also under the eyelids, for at least 15 minutes. Remove contact lenses. Immediate medical attention is required. Ingestion Call a physician immediately. Do not induce vomiting without medical advice. SAFETY DATA SHEET N-butyl acetate, Grade A Page 3 / 12 "Dmitrievsky chemical plant – Production", LLC Date 11/04/2011 Previous date: 03/03/2011 4.2 Most important symptoms and effects, both acute and delayed Exposure to vapours may cause drowsiness or dizziness. Frequent contact can lead to skin dryness of cracking of the skin. 4.3 Cough, nausea, vomiting, headache, unconsciousness, shortness of breath, dizziness, narcosis. Special hazard: Lung oedema, central nervous system effects, Prolonged skin contact may defat the skin and produce dermatitis. Indication of immediate medical attention and special treatment needed Notes to physician: Treat symptomatically. SECTION 5. FIREFIGHTING MEASURES The substance is classified as a flammable liquid cat. 3 (H226). Exposure to vapours may cause drowsiness or dizziness (H336). 5.1 5.1.1 5.1.2 5.2 5.3 5.4 Vapour is heavier than air and can travel considerable distance to a source of ignition and flashback. Vapours may form explosive mixtures with air. Extinguishing media Suitable extinguishing media Foam, dry chemical, carbon dioxide (CO2), water spray. Extinguishing media which must not be used for safety reasons Do not use a solid water stream as it may scatter and spread fire. Special hazards arising from the substance or mixture Under conditions giving incomplete combustion, hazardous gases produced may consist of: - carbon monoxide (CO) - carbon dioxide (CO2) Combustion gases of organic materials must in principle be graded as inhalation poisons. Vapour is heavier than air and can travel considerable distance to a source of ignition and flashback. Vapours may form explosive mixtures with air. Advice for firefighters Fire fighter protection should include a self-contained breathing apparatus (NIOSH-approved or EN 133) and full fire-fighting turn out gear. Specific methods Cool containers / tanks with water spray. Dike and collect water used to fight fire. Water run-off can cause environmental damage. Keep people away from and upwind of fire. SECTION 6. ACCIDENTAL RELEASE MEASURES 6.1 6.2 6.3 Personal precautions, protective equipment and emergency procedures Avoid contact with skin and eyes. Avoid breathing vapors or mists. Keep people away from and upwind of spill/leak. Ensure adequate ventilation, especially in confined areas. Keep away from heat and sources of ignition. For emergency responders: Personal protection see section 8. Environmental precautions Prevent further leakage or spillage. Do not discharge product into the aquatic environment without pretreatment (biological treatment plant). See Section 8: Environmental exposure controls. Methods and materials for containment and cleaning up Methods for containment Stop the flow of material, if possible without risk. Dike spilled material, where this is possible. Methods for cleaning up Soak up with inert absorbent material. Keep in suitable, closed containers for disposal. If liquid has been spilt in large quantities clean up promptly by scoop or vacuum. Dispose of in accordance with local regulations. Take necessary action to avoid static electricity discharge (which might cause ignition of organic vapours). SAFETY DATA SHEET N-butyl acetate, Grade A Page 4 / 12 "Dmitrievsky chemical plant – Production", LLC Date 11/04/2011 Previous date: 03/03/2011 6.4 Reference to other sections For personal protection see section 8. SECTION 7. HANDLING AND STORAGE 7.1 Precautions for safe handling General industrial hygiene practice. Ensure that eyewash stations and safety showers are close to the workstation location. When using, do not eat, drink or smoke. Take off all contaminated clothing immediately. 7.2 7.3 Avoid contact with skin, eyes and clothing. Do not breathe vapours or spray mist. Wash hands before breaks and immediately after handling the product. Provide sufficient air exchange and/or exhaust in work rooms. Keep away from sources of ignition - No smoking. Take necessary action to avoid static electricity discharge (which might cause ignition of organic vapours). In case of fire, emergency cooling with water spray should be available. Ground and bond containers when transferring material. Vapour is heavier than air and can travel considerable distance to a source of ignition and flashback. Vapours may form explosive mixture with air. Conditions for safe storage, including any incompatibilities Keep containers tightly closed in a cool, well-ventilated place. Handle and open container with care. Suitable storage material : stainless steel, mild steel, aluminium Unsuitable storage material : copper, attacks some forms of plastic and rubber Specific end use(s) The quantitative exposure assessment for the substance n-Butyl Acetate was performed using the Chesar tool (version 1.1.2). Only the inhalative exposure route is taken into account (DNELs for dermal route have not been derived). The methodology and all input parameters are described in the Exposure Scenarios (ES) available in the Annexes to this Safety Data Sheet. The following uses are covered by the exposure scenarios: Industrial: ES1 Manufacture of Butyl acetate; ES2 Distribution of Butyl acetate; ES3 Formulation; ES4 Use in coatings; ES7 Use in cleaning agents; ES10 Use in laboratories. Professional: ES5 Use in coatings; ES8 Use in cleaning agents; ES11 Use in laboratories. See further the information provided in the Annexes to this SDS. The technical conditions and measures at process level as well as for controlling dispersion from source towards the workers and environment are also summarized in sections 7 and 8 of this SDS. SECTION 8. EXPOSURE CONTROLS/PERSONAL PROTECTION 8.1 Control parameters 8.1.1 Threshold limits 123-86-4 n-butyl acetate 8.1.2 Other information on limit values 8.1.3 no other information available Limit values in other countries 150 ppm (8 h) 720 mg/m3 (8 h) 200 ppm (15 min) 960 mg/m3 (15 min) SAFETY DATA SHEET N-butyl acetate, Grade A Page 5 / 12 "Dmitrievsky chemical plant – Production", LLC Date 11/04/2011 Previous date: 03/03/2011 Germany MAK: 100 ppm, 480 mg/m3 (8h), 960 mg/m3 (short-term); Peak limitation category: I(2); Pregnancy risk group: C; (DFG 2003). NIOSH REL: TWA 150 ppm (710 mg/m3); STEL 200 ppm (950 mg/m3) 8.1.4 OSHA PEL: TWA 150 ppm (710 mg/m3); STEL 200 ppm (950 mg/m3) DNELs Based on available data, the classification criteria are not met for acute toxicity, nor for skin or respiratory irritation. The DNELs for dermal acute exposure (systemic and local) and the DNEL for dermal long-term exposure (systemic and local) are not derived, because no relevant hazards leading to classification have been identified. The German MAK commission determined a scientific OEL for n-butyl acetate of 100 ppm (480 mg/m3), 8 hours of exposure. Regarding the occupational situation, the critical toxic effect of exposure to nbutyl acetate is considered the irritative effect on the eyes and the mucosa of the upper respiratory tract. The MAK value is based on available human data that indicates that the aforementioned effects do not appear at concentrations of 100 ppm or below. In addition, there are no systemic toxic effects expected, even on reproduction and development, if the MAK value will be adhered to. Therefore the German MAK values were adopted for acute and long-term (systemic and local) inhalation limit values. Workers Acute exposure - Systemic inhalation: 960 mg/m3 (derived based on MAK short-term limit) Acute exposure - Local inhalation: 960 mg/m3 (derived based on MAK short-term limit) 8.1.5 Long-term exposure - Systemic inhalation: 480 mg/m3 (derived based on MAK long-term limit) Long-term exposure - Local inhalation: 480 mg/m3 (derived based on MAK long-term limit) PNECs The PNEC values for the water compartment are derived based on the lowest short-term toxicity test results for freshwater fish ( Pimephales promelas) with LC50 (96h) value of 18 mg/l. The following assessment factors (AF) are used: PNEC aqua (freshwater): 0.18 mg/l (AF=100) PNEC aqua (marine water): 0.018 mg/l (AF=1000) PNEC aqua (intermittent releases): 0.36 mg/l (AF=50) PNEC sediment: No data for sediment organisms are available. However, the PNEC sediment can also be calculated according to the equilibrium partitioning method and the PNEC aqua. This calculated PNEC was converted to dry weight (conversion factor: 4.6). PNEC sediment (freshwater): 0.981 mg/kg sediment dw (calculated to be 0.213 mg/kg ww; Koc = 18.5; PNEC aqua (freshwater) = 0.18 mg/L). PNEC sediment (marine water): 0.0981 mg/kg sediment dw (calculated to be 0.0213 mg/kg ww; Koc = 18.5; PNEC aqua (marine water) = 0.018 mg/L). PNEC soil: direct and indirect exposure of the soil compartment is unlikely. However, the PNEC soil can also be calculated according to the equilibrium partitioning method and the PNEC aqua. This PNEC was converted to dry weight (conversion factor: 1.13). PNEC soil: 0.0903 mg/kg soil dw (calculated to be 0.0799 mg/kg ww (Henry's Law constant = 28.5 Pa; Koc = 18.5; PNEC aqua (freshwater) = 0.18 mg/L). The PNEC value for sewage treatment plant (STP) is derived based on the growth inhibiting effect of n-butyl acetate on the ciliate ( Tetrahymena pyriformis) with EC50/LC50/40h value of 356 mg/L. The following assessment factor (AF) was applied: PNEC STP: 35.6 mg/L (AF=10) SAFETY DATA SHEET N-butyl acetate, Grade A Page 6 / 12 "Dmitrievsky chemical plant – Production", LLC Date 11/04/2011 Previous date: 03/03/2011 8.2 8.2.1 8.2.2 8.2.2.1 8.2.2.2 Exposure controls Appropriate engineering controls General or dilution ventilation is frequently insufficient as the sole means of controlling employee exposure. Local ventilation is usually preferred. Explosion-proof equipment (for example fans, switches, and grounded ducts) should be used in mechanical ventilation systems. Individual protection measures Respiratory protection Respirator with A filter. Full mask with above mentioned filter according to producers using requirements or self-contained breathing apparatus. Equipment should conform to respiratory protection standards EN 136 or EN 140 and EN 143. Hand protection Wear protective gloves. Recommendations are listed below. Other protective material may be used, depending on the situation, if adequate degradation and permeation data is available. If other chemicals are used in conjunction with this chemical, material selection should be based on protection for all chemicals present. Suitable material: butyl-rubber Evaluation according to protective glove standard EN 374: level 3 Glove thickness approx 0.3 mm Break through time approx 60 min 8.2.2.3 8.2.2.4 8.2.3 Suitable material: polyvinylchloride / nitrile rubber Evaluation according to protective glove standard EN 374: level 2 Glove thickness approx 0.9 mm Break through time approx 30 min Eye/face protection Tightly fitting safety goggles. In addition to goggles, wear a face shield if there is a reasonable chance for splash to the face. Equipment should conform to eye&face protection standard EN 166. Skin protection Impervious clothing. Wear face-shield and protective suit for abnormal processing problems. Environmental exposure controls If possible use in closed systems. If leakage cannot be prevented, the substance needs to be sucked off at the emersion point, if possible without danger. Observe the exposure limits, clean exhaust air if needed. If recycling is not practicable, dispose of in compliance with local regulations. Inform the responsible authorities in case of leakage into the atmosphere, or of entry into waterways, soil or drains. SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES 9.1 9.1.1 Important Health Safety and Environmental Information Appearance 9.1.9 Clear, colorless liquid. Odour Odour threshold pH Melting point/freezing point Initial boiling point and boiling range Flash point Evaporation rate Flammability (solid, gas) 9.1.10 9.1.10.1 Explosive properties Lower explosion limit 9.1.2 9.1.3 9.1.4 9.1.5 9.1.6 9.1.7 9.1.8 no data available no data available no data available < -90°C (at 1013 hPa) (no test method specified) 126 °C (at 1013 hPa) (no test method specified) 27 °C (at 1013 hPa), EU test method A.9: closed-cup no data available Flammable liquid Cat. 3 (based on flash point). No chemical groups associated with pyrophoric properties or flammability on contact with water. 1.2 vol% (no test method specified) SAFETY DATA SHEET N-butyl acetate, Grade A Page 7 / 12 "Dmitrievsky chemical plant – Production", LLC Date 11/04/2011 Previous date: 03/03/2011 9.1.10.2 Upper explosion limit 9.1.11 Vapour pressure 9.1.12 Vapour density 9.1.13 Relative density 9.1.14 9.1.14.1 Solubility(ies) Water solubility 9.1.14.2 9.1.15 9.1.16 9.1.17 9.1.18 9.1.19 9.1.20 9.2 7.6 vol% (no test method specified) 15 hPa at 20 °C (no test method specified) no data available 0.8812 g/cm³ (at 20°C) (no test method specified) 5.3 g/L (at 20 °C) OECD Guideline 105 and EU test method A.6: flask method Fat solubility (solvent - oil to be specified) no data available Partition coefficient: n-octanol/water Log Kow = 2.3 (at 25 °C) OECD Guideline 117 and EU test method A.8: HPLC Auto-ignition temperature 415 °C (at 1013 hPa), EU test method A.15 Decomposition temperature not applicable (see boiling point) Viscosity 0.83 mm²/s (static; at 20°C) OECD Guideline 114 Explosive properties non explosive (no chemical groups associated with explosive properties present in the molecule). Vapours may form explosive mixture with air. Oxidising properties not applicable (substance is flammable) Other information Surface tension of aqueous solution: 61.3 mN/m (at 20°C and 1000 mg/L) OECD Guideline 115 and EU test method A.5: ring method. SECTION 10. STABILITY AND REACTIVITY 10.1 10.2 10.3 10.4 10.5 10.6 Reactivity Stable under recommended storage conditions. Chemical stability no data available Possibility of hazardous reactions Vapours may form explosive mixture with air. Conditions to avoid Avoid contact with heat, sparks, open flame, and static discharge. Avoid any source of ignition. Incompatible materials Strong acids and strong bases, strong oxidizing agents. Hazardous decomposition products No decomposition if stored and applied as directed. SECTION 11. TOXICOLOGICAL INFORMATION 11.1 11.1.1 11.1.2 Information on toxicological effects Exposure to vapours may cause drowsiness or dizziness (STOT SE 3 - H336). Due to the defatting solvent character of n-butyl acetate it is assumed that frequent contact can lead to skin dryness of cracking of the skin (Additional hazard statement: EUH066). Acute toxicity Based on available data, the classification criteria are not met. LD50/oral/rat: 10760 mg/kg bw (method similar to OECD Guideline 423) LD50/dermal/rabbit: 14000 mg/kg bw (method similar to OECD Guideline 402) Data on acute toxicity of n-butyl acetate after inhalation exposure are inconsistent. No definite LC50 value can be stated. Irritation and corrosion SAFETY DATA SHEET N-butyl acetate, Grade A Page 8 / 12 "Dmitrievsky chemical plant – Production", LLC Date 11/04/2011 Previous date: 03/03/2011 Based on available data, the classification criteria are not met. Skin irritation (rabbits): not irritating (OECD Guideline 404) Eye irritation (rabbits): not irritating (OECD Guideline 405) Respiratory irritation (human): not irritating (no guideline followed, Iregren et al. (1993)) Investigations with human volunteers indicate, that weak irritation of the eyes and respiratory tract occurs after short term inhalation exposure to concentrations of about 200 ppm. 11.1.3 11.1.4 11.1.5 11.1.6 11.1.7 11.1.8 Due to the defatting solvent character of n-butyl acetate it is assumed that frequent contact can lead to skin dryness of cracking of the skin (Additional hazard statement: EUH066 - Repeated exposure may cause skin dryness or cracking). Sensitisation Based on available data, the classification criteria are not met. Animal experiments (Gad et al., 1986; mouse, guinea pig) and investigations with humans (Gad et al., 1986; Roed-Petersen, 1980; Anon., 1989) revealed that n-butyl acetate is not sensitising to skin. Subacute, subchronic and prolonged toxicity Repeated dose toxicity: Based on available data, the classification criteria are not met. NOAEC (inhalation/rat): 2400 mg/m³ (subchronic), test method EPA OTS 798.2450 Mutagenicity: Based on available data, the classification criteria are not met. Used test methods in vitro: similar to OECD Guideline 471, OECD Guideline 476; in vivo: OECD Guideline 474, EU Method B.12, EPA OTS 798.5395. Test substance: n-butyl acetate and butan-1-ol (metabolite of n-butyl acetate) Reproductive toxicity: Based on available data, the classification criteria are not met: - - Effects on fertility: NOAEC (inhalation/rat): 9640 mg/m³, test methods OECD Guideline 416, EPA OPPTS 870.3800 - - Developmental toxicity: LOAEC (inhalation/rabbit): 7230 mg/m³, test method similar to OECD Guideline 414 Carcinogen: Based on available data, the classification criteria are not met. STOT-single exposure Classified as STOT SE 3 - H336 - May cause drowsiness or dizziness. Route: inhalation. N-Butyl acetate induced neurotoxicity (mainly sedatory effects) in rats exposed to 1500 ppm (7.2 mg/L) test item for a single 6 hour period or subchronically. Effects occurred only transiently during exposure, no effects were detectable shortly after stop of exposure. No neurotoxicity could be detected in rats exposed subchronically to 500 ppm (2.4 mg/L) n-butyl acetate, whereas transient sedation was seen at 1500 ppm and above. NOAEC (inhalation/rats): 2410 mg/m³, test methods EPA OTS 798.6050, EPA OTS 798.6200, EPA OTS 798.6500, 40 CFR Part 798.2450. STOT-repeated exposure Based on available data, the classification criteria are not met. Aspiration hazard Based on available data, the classification criteria are not met. Other information on acute toxicity no data available SECTION 12. ECOLOGICAL INFORMATION 12.1 12.1.1 Toxicity Aquatic toxicity SAFETY DATA SHEET N-butyl acetate, Grade A Page 9 / 12 "Dmitrievsky chemical plant – Production", LLC Date 11/04/2011 Previous date: 03/03/2011 Based on available data, the classification criteria are not met (Acute toxicity is >10 mg/L, the substance is readily biodegradable and does not bioaccumulate significantly (experimentally determined log Kow <= 4). Moreover, the chronic toxicity is > 1 mg/L). Short-term aquatic toxicity: LC50/96h/freshwater fish ( Pimephales promelas) = 18 mg/l (similar to OECD Guideline 203). EC50/48h/freshwater invertebrates ( Daphnia Sp.) = 44 mg/l (similar to OECD Guideline 202). NOEC/72h/freshwater algae ( Desmodesmus subspicatus) = 200 mg/l (Method according to Umweltbundesamt (German Federal Environment Agency) proposal/draft, version February 1984). 12.1.2 12.2 12.2.1 12.2.2 Long-term aquatic toxicity: NOEC/21d/freshwater invertebrates ( Daphnia Magna) = 23 mg/l (OECD Guideline 211). Test substance: isobutyl acetate Toxicity to other organisms Aquatic micro-organisms: EC50/LC50/40h for ciliate ( Tetrahymena pyriformis): 356 mg/L (TETRATOX assay; Schultz, 2006) NOEC/28d for domestic activated sewage sludge : >10 mg/L (OECD Guideline 301 D, Waggy et al., 1994) Terrestrial plants: EC50/14d for lettuce ( Lactuca sativa) : > 1000 mg/kg soil dry weight (similar to OECD Guideline 208) Persistence and degradability Biodegradation n-Butyl acetate is readily biodegradable according to OECD criteria in the Closed Bottle test (OECD Guideline 301 D: 83 % in 28 d, 10-d window met; Waggy et al., 1994). Chemical degradation n-Butyl acetate will hydrolyze slowly in contact with water. The hydrolytic half-life was estimated by calculation (HYDROWIN v2.00) to be 78 d at pH 8 and 2 years at pH 7 (ECT, 2009). The substance will also degrade in contact with air by reaction with OH-radicals. The overall OH rate constant was determined to be 4.9 -12 cm3/molecule*sec. The half-life was calculated to be 3.3 days (24 -h d; 0.5 E+06 OH/cm3). These values were determined experimentally (Kwok & Atkinson, 1994; cited in AOP v1.92). 12.3 Bioaccumulative potential 12.4 The substance has a low potential for bioaccumulation. The log Kow of 2.3 for n-butyl acetate indicates a low potential for bioaccumulation. In addition, the substance is readily biodegradable. Based on a measured log Pow of 2.3, the bioconcentration factor (BCF) of n-butyl acetate was estimated to be 15 by using the BCFBAF program (v3.00). This estimate refers to the uncharged molecule. According to the BCF, n-butyl acetate has a low potential for bioaccumulation in aquatic organisms. Mobility in soil The substance is readily biodegradable and has a low potential for adsorption due to a low octanol-water partition coefficient (log Kow=2.3) and estimated adsorption coefficient (log Koc < 3). The determined Henry's Law constant indicated that low volatilisation is expected. Therefore, adsorption to soil is not expected and the substance may be mobile in soil. It is also not expected that the substance will contaminate ground waters since it is readily biodegradable in water. The adsorption coefficient (log Koc) was estimated by calculation (KOCWIN v2.00) to be less than 3 (MCI method: 1.3; Kow method: 1.8). Koc: 18.54 - 69.84; log Koc: 1.268 - 1.844 The Henry's Law constant (HLC) of n-butyl acetate was experimental determined to be 28.5 Pa*m³/mol (Kieckbusch and King, 1976, as cited in ECT, 2009). The calculated value lies slightly above this value (HENRYWIN v3.20 41.6 Pa*m³/mol at 25 °C). SAFETY DATA SHEET N-butyl acetate, Grade A Page 10 / 12 "Dmitrievsky chemical plant – Production", LLC Date 11/04/2011 Previous date: 03/03/2011 12.5 12.6 Results of PBT and vPvB assessment The substance is not persistent (not P) and not very persistent (not vP) in the environment. The substance is not bioaccumulative (not B) and not very bioaccumulative (not vB). The substance is not toxic (not T). Taking into account all available data on biotic and abiotic degradation, bioaccumulation and toxicity it can be stated that the substance does not fulfil the PBT criteria (not PBT) nor the vPvB criteria (not vPvB). Other adverse effects No other adverse effects identified for this substance. SECTION 13. DISPOSAL CONSIDERATIONS 13.1 The choice of the appropriate disposal method depends on the product composition by the time of disposal as well as the local statutes and possibilities for disposal. Waste codes in accordance with the list of European Waste Catalogue (EWC) should be assigned by the user prior to final disposal. Dispose of product residue in accordance with the instructions of the person responsible for waste disposal. Refer to local and national waste management regulations and dispose of in accordance with selected waste classification. Waste treatment methods Dispose of in accordance with waste classification. The primary waste management option for unused substance and contaminated packaging is hazardous waste incineration. Refer to local or national waste management regulations. Waste from residues / unused products Contaminated packaging should be emptied as far as possible and after appropriate cleansing may be taken for reuse. Disposal as hazardous waste. SECTION 14. TRANSPORT INFORMATION 1123 Butyl acetates Class 3; Classification code F1 III 14.1 UN number 14.2 UN proper shipping name 14.3 Transport hazard class(es) 14.4 Packing group 14.5 Environmental hazards 14.6 Special precautions for users 14.7 IMDG Marine trasport EmS number: F-E; S-D Not a marine pollutant. Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code IBC-Code Product name Butyl acetate Ship type 3 Pollution category Y Not classified as hazardous to the environment. See Section 8 for environmental exposure controls. SECTION 15. REGULATORY INFORMATION 15.1 15.2 Safety, health and environmental regulations/legislation specific for the substance or mixture n-Butyl Acetate is classified in Main Seveso Category 6. Flammable according to Annex I of Council Directive 96/82/EC of 9 December 1996 on the control of major-accident hazards involving dangerous substances (OJ L 10, 14.1.1997, p. 13). Chemical safety assessment In accordance with REACH Article 14, a Chemical Safety Assessment has been carried out for this substance. SAFETY DATA SHEET N-butyl acetate, Grade A Page 11 / 12 "Dmitrievsky chemical plant – Production", LLC Date 11/04/2011 Previous date: 03/03/2011 SECTION 16. OTHER INFORMATION 16.1 16.2 16.3 16.4 16.5 Additions, Deletions, Revisions Version 3.0, The Lead Registrant has adapted the DNEL values to the German MAK values. Consequently the Chemical Safety Report was updated, and Exposure Assessment and Risk Characterisation was corrected. All sections of this SDS are aligned with the updated REACH Chemical Safety Report. This safety data sheet is drawn up to comply with the requirements of Regulation (EC) No. 1907/2006 (REACH), as amended by Annex I to Commission Regulation (EU) No 453/2010 of 20 May 2010. Key or legend to abbreviations and acronyms -AF - Assessment factor -BCF - Bioconcentration factor -CAS - Registry Numbers assigned by the "Chemical Abstracts Service" -CLP - Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 -DNEL - Derived no-effect level -DSD - Council Directive 67/548/EEC (Dangerous Substances Directive) -dw - dry weight -EC50 - Concentration of the substance that causes 50 % reduction of a certain effect on test organisms -EINECS - Registry number in the European Inventory of Existing Commercial Chemical Substances -EPA OPPTS - Environmental Protection Agency, Office for Prevention, Pesticides & Toxic Substances (USA) -EPA OTS - Environmental Protection Agency, Office for Toxic Substances (USA) -ES - Exposure scenario -EU - European Union -Koc - Soil adsorption coefficient -LC50 -Lethal concentration of the substance that causes 50 % mortality of the test population -LOAEC - Lowest observed adverse effect concentration -MAK - Maximale Arbeitsplatzkonzentrationen (Germany): maximum concentration of a chemical substance in the workplace, expressed as daily 8-hour time-weighed average values and apply to healthy adults. -NIOSH - NAtional Institute for Occupational Safety and Health (USA) -NOAEC - No observed adverse effect concentration -NOAEL- No observed adverse effect level -NOEC - No observed effect concentration -OECD - Organisation for Economic Co-operation and Development -OEL - Occupational exposure limit -OSHA - Occupational Safety and Health Administration (USA) -PBT/vPvB - Persistent, bioaccumulative and toxic/ very persistent and very bioaccumulative -PEL - Permissible exposure limit -PNEC - Predicted no-effect concentration -REACH - Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals -REL - Recommended exposure limit -STEL - Short term exposure limit -STP - Sewage treatment plant -TWA - Time weighted average Key literature references and sources for data REACH Chemical Safety Report Part B for n-butyl acetate. All referenced studies within this safety data sheet can be found from the original Chemical Safety Report. Classification procedure This substance has a harmonized classification according to Annex VI to Regulation (EC) No 1272/2008 (CLP). List of relevant R phrases, hazard statements, safety phrases and/or precautionary statements R10 Flammable. R66 Repeated exposure may cause skin dryness or cracking. R67 Vapours may cause drowsiness and dizziness. SAFETY DATA SHEET N-butyl acetate, Grade A Page 12 / 12 "Dmitrievsky chemical plant – Production", LLC Date 11/04/2011 Previous date: 03/03/2011 16.6 Emergency telephone number Europe-wide emergency number: 112 16.7 Contact a poison control centre. List of Telephone Numbers : AUSTRIA (Vienna Wien) +43 1 406 43 43; BELGIUM (Brussels Bruxelles) +32 70 245 245; BULGARIA (Sofia) + 359 2 9154 409; CZECH REPUBLIC (Prague Praha) +420 224 919 293; DENMARK (Copenhagen) 82 12 12 12; ESTONIA (Tallinn) 112; FINLAND (Helsinki) +358 9 471 977; FRANCE (Paris) +33 1 40 0548 48; GERMANY (Berlin) +49 30 19240; GREECE (Athens Athinai) +30 10 779 3777; HUNGARY (Budapest) 06 80 20 11 99; ICELAND (Reykjavik) +354 525 111, +354 543 2222; IRELAND (Dublin) +353 1 8379964; ITALY (Rome) +39 06 305 4343; LATVIA (Riga) +371 704 2468; LITHUANIA (Vilnius) +370 5 236 20 52 or +370 687 53378; MALTA (Valletta) 2425 0000; NETHERLANDS (Bilthoven) +31 30 274 88 88; NORWAY (Oslo) 22 591300; POLAND (Gdansk) +48 58301 65 16 or +48 58 349 2831; PORTUGAL (Lisbon Lisboa) 808 250 143; ROMANIA (Bucharest) +40 21 3183606 SLOVAKIA (Bratislava) +421 2 54 77 4166; SLOVENIA (Ljubljana) + 386 41 650 500; SPAIN (Barcelona) +34 93 227 98 33 or +34 93 227 54 00 bleep 190; SWEDEN (Stockholm) 112 or +46 8 33 12 31 (mon-fri 9.00-17.00); UNITED KINGDOM (London) 112 or 0845 4647 (NHS Direct). Recommended restrictions DISCLAIMER OF LIABILITY: The information in this SDS was obtained from recent Chemical Safety Report of this substance from REACH registration 2010. However, the information is provided without any warranty, express or implied, regarding its correctness. The conditions or methods of handling, storage, use or disposal of the product are beyond our control and may be beyond our knowledge. For this and other reasons, we do not assume responsibility and expressly disclaim liability for loss, damage or expense arising out of or in any way connected with the handling, storage, use or disposal of the product. This SDS was prepared and is to be used only for this product. If the product is used as a component in another product, this SDS information may not be applicable. SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 1 of 51 ES 1 - Manufacture of Butyl Acetate Manufacture of Butyl Acetate Environment: ERC 1 Worker Use in closed process, no likelihood of exposure PROC 1 Use in closed, continuous process with occasional controlled exposure PROC 2 Use in closed batch process (synthesis or formulation) PROC 3 Use in batch and other process (synthesis) where opportunity for exposure arises PROC 4 Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non-dedicated facilities PROC 8a Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities PROC 8b Use as laboratory reagent PROC 15 Operational conditions and risk management measures Control of environmental exposure: Manufacture of Butyl Acetate Product characteristics Amounts used Daily use at a site <= 400 tonnes/day Annual use at a site <= 1.2E5 tonnes/year Percentage of tonnage used at regional scale = 100 % Frequency and duration of use Environment factors not influenced by risk management Receiving surface water flow rate >= 3.456E6 m3/d Other given operational conditions affecting environmental exposure Technical conditions and measures at process level (source) to prevent release Technical onsite conditions and measures to reduce or limit discharges, air emissions and releases to soil Organizational measures to prevent/limit release from site Conditions and measures related to municipal sewage treatment plant Municipal STP Yes [Water: 89.1%] Discharge rate of STP >= 2.88E4 m3/d Application of the STP sludge on agricultural soil No Conditions and measures related to external treatment of waste for disposal Conditions and measures related to external recovery of waste Additional good practice advice beyond the REACH CSA Control of workers exposure for "Use in closed process, no likelihood of exposure" [PROC 1] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 2 of 51 Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Level of containment Use in closed process, no likelihood of exposure L Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Use in closed, continuous process with occasional controlled exposure" [PROC 2] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Level of containment Use in closed, continuous process with occasional controlled exposure L Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Use in closed batch process (synthesis or formulation) " [PROC 3] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors Technical conditions and measures at process level (source) to prevent release L SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 3 of 51 Level of containment L Use in closed batch process (synthesis or formulation) Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Use in batch and other process (synthesis) where opportunity for exposure arises" [PROC 4] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Level of containment Use in batch and other process (synthesis) where opportunity for exposure arises L Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non-dedicated facilities" [PROC 8a] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 4 of 51 Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities" [PROC 8b] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Use as laboratory reagent" [PROC 15] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA *) The route of exposure (Inhalation, Dermal) and type of effect (Local, Systemic and Acute or Long term) for which the determinant has been used for exposure estimation are reported. SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 5 of 51 Workers – Quantitative Exposure Assessment (TRA workers) and Risk Characterisation. Derived DNEL covers both systemic and local effects. Exposure assessment for dermal exposures is not required (DNEL was not derived as no respective hazard was observed). According to ECHA Guidance on Information Requirements and Chemical Safety Assessment, R.14 (Occupational Exposure Assessment), shift average estimates obtained by ECETOC TRA can be considered to represent conservative 90th percentiles of the distribution of exposure concentrations. According to the Guidance document, potential peak exposure concentrations at the workplace (representing 95th percentiles of the peak exposure concentrations) can be extrapolated from these shift average concentrations by an additional factor of 2. No information is available from the use and practical experience with the substance, which would require a higher factor. Based on this extrapolation peak exposures may exceed ECETOC TRA estimated shift averages by a factor of 2, whereas the DNEL for short-term exposure is twice the long-term DNEL. Hence, it can be concluded that for all workplace situations, where safe use could be demonstrated based on exposure estimates from ECETOC TRA, that also potential peak exposures would not give rise to increased risks. DNEL dermal = DNEL inhalation long-term systemic = RCR TOTAL Not derived 480 mg/m 3 (100 ppm) PROC (inhalation + Estimated Estimated dermal) RCR RCR 3 exposure (mg/m ) exposure PROC 1 0.048 NA NA 1E-4 1E-4 PROC 2 48.4 NA NA 0.101 0.101 PROC 3 121 NA NA 0.252 0.252 PROC 4 96.8 NA NA 0.202 0.202 PROC 8a 242 NA NA 0.504 0.504 PROC 8b 242 NA NA 0.504 0.504 PROC 15 48.4 NA NA 0.101 0.101 Environment – Quantitative Exposure Assessment (EUSES 2.1) and Risk Characterisation The values for the parameters river flow and effluent discharge rate have been refined to reflect a realistic dilution rate (river). Furthermore it is taken into account that the sludge from STP is not discharged to soil. The RCR values for marine compartments are not considered as relevant for the manufacturing scenario as the production site is located in a sufficient distance from sea (*). Environment type Water: Fresh Water (Pelagic) Water: Fresh Water (Sediment) Water: Marine Water (Pelagic) Water: Marine Water (Sediment) Water: Sewage Treatment Plant (Effluent) Soil: Agricultural Soil PNEC PEC/Local RCR 0.18 mg/l 0.048 mg/l 0.267 0.981 mg/kgdwt 0.963 mg/kgdwt 0.982 0.018 mg/l 0.058 mg/l 3.2 (*) 0.0981 mg/kgdwt 1.15 mg/kgdwt 11.72 (*) 35.6 mg/l 5.75 mg/l 0.162 0.0903 mg/kgdwt 0.07 mg/kgdwt 0.78 SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 6 of 51 ES 2 – Distribution of Butyl Acetate Distribution of Butyl Acetate Environment: ERC 1 Worker Use in closed process, no likelihood of exposure PROC 1 Use in closed, continuous process with occasional controlled exposure PROC 2 Use in closed batch process (synthesis or formulation) PROC 3 Use in batch and other process (synthesis) where opportunity for exposure arises PROC 4 Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non-dedicated facilities PROC 8a Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities PROC 8b Transfer of substance or preparation into small containers (dedicated filling line, including weighing) PROC 9 Use as laboratory reagent PROC 15 Operational conditions and risk management measures Control of environmental exposure: Distribution of Butyl Acetate Product characteristics Amounts used Daily use at a site <= 400 tonnes/day Annual use at a site <= 1.2E5 tonnes/year Percentage of tonnage used at regional scale = 100 % Frequency and duration of use Environment factors not influenced by risk management Receiving surface water flow rate >= 1.8E4 m3/d Other given operational conditions affecting environmental exposure Technical conditions and measures at process level (source) to prevent release Technical onsite conditions and measures to reduce or limit discharges, air emissions and releases to soil Organizational measures to prevent/limit release from site Conditions and measures related to municipal sewage treatment plant Municipal STP Yes [Water: 89.1%] Discharge rate of STP >= 2E3 m3/d Application of the STP sludge on agricultural soil Yes Conditions and measures related to external treatment of waste for disposal Conditions and measures related to external recovery of waste Additional good practice advice beyond the REACH CSA Control of workers exposure for "Use in closed process, no likelihood of exposure" [PROC 1] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation Amounts used Frequency and duration of use/exposure No L SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 7 of 51 Duration of activity L >4 hours Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Level of containment Use in closed process, no likelihood of exposure L Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Use in closed, continuous process with occasional controlled exposure" [PROC 2] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Level of containment Use in closed, continuous process with occasional controlled exposure L Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Use in closed batch process (synthesis or formulation) " [PROC 3] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 8 of 51 Place of use L Indoors Technical conditions and measures at process level (source) to prevent release Level of containment Use in closed batch process (synthesis or formulation) L Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Use in batch and other process (synthesis) where opportunity for exposure arises" [PROC 4] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Level of containment Use in batch and other process (synthesis) where opportunity for exposure arises L Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non-dedicated facilities" [PROC 8a] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors Technical conditions and measures at process level (source) to prevent release L SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 9 of 51 Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities" [PROC 8b] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Transfer of substance or preparation into small containers (dedicated filling line, including weighing) " [PROC 9] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used Additional good practice advice beyond the REACH CSA L SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 10 of 51 Control of workers exposure for "Use as laboratory reagent" [PROC 15] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA *) The route of exposure (Inhalation, Dermal) and type of effect (Local, Systemic and Acute or Long term) for which the determinant has been used for exposure estimation are reported. SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 11 of 51 Workers – Quantitative Exposure Assessment (TRA workers) and Risk Characterisation. Derived DNEL covers both systemic and local effects. Exposure assessment for dermal exposures is not required (DNEL was not derived as no respective hazard was observed). According to ECHA Guidance on Information Requirements and Chemical Safety Assessment, R.14 (Occupational Exposure Assessment), shift average estimates obtained by ECETOC TRA can be considered to represent conservative 90th percentiles of the distribution of exposure concentrations. According to the Guidance document, potential peak exposure concentrations at the workplace (representing 95th percentiles of the peak exposure concentrations) can be extrapolated from these shift average concentrations by an additional factor of 2. No information is available from the use and practical experience with the substance, which would require a higher factor. Based on this extrapolation peak exposures may exceed ECETOC TRA estimated shift averages by a factor of 2, whereas the DNEL for short-term exposure is twice the long-term DNEL. Hence, it can be concluded that for all workplace situations, where safe use could be demonstrated based on exposure estimates from ECETOC TRA, that also potential peak exposures would not give rise to increased risks. DNEL dermal = DNEL inhalation long-term systemic = RCR TOTAL Not derived 480 mg/m 3 (100 ppm) (inhalation + PROC Estimated Estimated dermal) RCR RCR 3 exposure (mg/m ) exposure PROC 1 0.048 NA NA 1E-4 1E-4 PROC 2 48.4 NA NA 0.101 0.101 PROC 3 121 NA NA 0.252 0.252 PROC 4 96.8 NA NA 0.202 0.202 PROC 8a 242 NA NA 0.504 0.504 PROC 8b 242 NA NA 0.504 0.504 PROC 15 48.4 NA NA 0.101 0.101 Environment – Quantitative Exposure Assessment (EUSES 2.1) and Risk Characterisation Environment type Water: Fresh Water (Pelagic) Water: Fresh Water (Sediment) Water: Marine Water (Pelagic) Water: Marine Water (Sediment) Water: Sewage Treatment Plant (Effluent) Soil: Agricultural Soil PNEC PEC/Local RCR 0.18 mg/l 0.022 mg/l 0.124 0.981 mg/kgdwt 0.447 mg/kgdwt 0.456 0.018 mg/l 0.002 mg/l 0.123 0.0981 mg/kgdwt 0.044 mg/kgdwt 0.454 35.6 mg/l 0.218 mg/l 0.006 0.0903 mg/kgdwt 0.083 mg/kgdwt 0.915 SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 12 of 51 ES 3 - Formulation Formulation Market sector: Environment: ERC 2 Worker Use in closed process, no likelihood of exposure PROC 1 Use in closed, continuous process with occasional controlled exposure PROC 2 Use in closed batch process (synthesis or formulation) PROC 3 Use in batch and other process (synthesis) where opportunity for exposure arises PROC 4 Mixing or blending in batch processes for formulation of preparations and articles (multistage and/or significant contact) PROC 5 Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non-dedicated facilities PROC 8a Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities PROC 8b Transfer of substance or preparation into small containers (dedicated filling line, including weighing) PROC 9 Production of preparations or articles by tabletting, compression, extrusion, pelletisation PROC 14 Use as laboratory reagent PROC 15 Operational conditions and risk management measures Control of environmental exposure: Formulation Product characteristics Amounts used Daily use at a site <= 13.33 tonnes/day Annual use at a site <= 4E3 tonnes/year Percentage of tonnage used at regional scale = 100 % Frequency and duration of use Environment factors not influenced by risk management Receiving surface water flow rate >= 1.8E4 m3/d Other given operational conditions affecting environmental exposure Technical conditions and measures at process level (source) to prevent release Technical onsite conditions and measures to reduce or limit discharges, air emissions and releases to soil Organizational measures to prevent/limit release from site Conditions and measures related to municipal sewage treatment plant Municipal STP Yes [Water: 89.1%] Discharge rate of STP >= 2E3 m3/d Application of the STP sludge on agricultural soil Yes Conditions and measures related to external treatment of waste for disposal Conditions and measures related to external recovery of waste Additional good practice advice beyond the REACH CSA Control of workers exposure for "Use in closed process, no likelihood of exposure" [PROC 1] Inhal*) Derm*) SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 13 of 51 Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Level of containment Use in closed process, no likelihood of exposure L Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Use in closed, continuous process with occasional controlled exposure" [PROC 2] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Level of containment Use in closed, continuous process with occasional controlled exposure L Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Use in closed batch process (synthesis or formulation) " [PROC 3] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 14 of 51 Amounts used Frequency and duration of use/exposure Duration of activity >4 hours L Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Level of containment Use in closed batch process (synthesis or formulation) L Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Use in batch and other process (synthesis) where opportunity for exposure arises" [PROC 4] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Level of containment Use in batch and other process (synthesis) where opportunity for exposure arises L Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Mixing or blending in batch processes for formulation of preparations and articles (multistage and/or significant contact) " [PROC 5] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation Amounts used Frequency and duration of use/exposure No L SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 15 of 51 Duration of activity L >4 hours Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non-dedicated facilities" [PROC 8a] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities" [PROC 8b] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors Technical conditions and measures at process level (source) to prevent release Technical conditions and measures to control dispersion from source towards the worker L SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 16 of 51 Local Exhaust Ventilation L No Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Transfer of substance or preparation into small containers (dedicated filling line, including weighing) " [PROC 9] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Production of preparations or articles by tabletting, compression, extrusion, pelletisation" [PROC 14] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used Additional good practice advice beyond the REACH CSA L SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 17 of 51 Control of workers exposure for "Use as laboratory reagent" [PROC 15] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA *) The route of exposure (Inhalation, Dermal) and type of effect (Local, Systemic and Acute or Long term) for which the determinant has been used for exposure estimation are reported. SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 18 of 51 Workers – Quantitative Exposure Assessment (TRA workers) and Risk Characterisation. Derived DNEL covers both systemic and local effects. Exposure assessment for dermal exposures is not required (DNEL was not derived as no respective hazard was observed). According to ECHA Guidance on Information Requirements and Chemical Safety Assessment, R.14 (Occupational Exposure Assessment), shift average estimates obtained by ECETOC TRA can be considered to represent conservative 90th percentiles of the distribution of exposure concentrations. According to the Guidance document, potential peak exposure concentrations at the workplace (representing 95th percentiles of the peak exposure concentrations) can be extrapolated from these shift average concentrations by an additional factor of 2. No information is available from the use and practical experience with the substance, which would require a higher factor. Based on this extrapolation peak exposures may exceed ECETOC TRA estimated shift averages by a factor of 2, whereas the DNEL for short-term exposure is twice the long-term DNEL. Hence, it can be concluded that for all workplace situations, where safe use could be demonstrated based on exposure estimates from ECETOC TRA, that also potential peak exposures would not give rise to increased risks. DNEL dermal = DNEL inhalation long-term systemic = RCR TOTAL Not derived 480 mg/m 3 (100 ppm) (inhalation + PROC Estimated Estimated dermal) RCR RCR 3 exposure (mg/m ) exposure PROC 1 0.048 NA NA 1E-4 1E-4 PROC 2 48.4 NA NA 0.101 0.101 PROC 3 121 NA NA 0.252 0.252 PROC 4 96.8 NA NA 0.202 0.202 PROC 5 242 NA NA 0.504 0.504 PROC 8a 242 NA NA 0.504 0.504 PROC 8b 242 NA NA 0.504 0.504 PROC 9 242 NA NA 0.504 0.504 PROC 14 242 NA NA 0.504 0.504 PROC 15 48.4 NA NA 0.101 0.101 Environment – Quantitative Exposure Assessment (EUSES 2.1) and Risk Characterisation Environment type Water: Fresh Water (Pelagic) Water: Fresh Water (Sediment) Water: Marine Water (Pelagic) Water: Marine Water (Sediment) Water: Sewage Treatment Plant (Effluent) Soil: Agricultural Soil PNEC PEC/Local RCR 0.18 mg/l 0.015 mg/l 0.083 0.981 mg/kgdwt 0.301 mg/kgdwt 0.307 0.018 mg/l 0.002 mg/l 0.083 0.0981 mg/kgdwt 0.03 mg/kgdwt 0.306 35.6 mg/l 0.145 mg/l 0.004 0.0903 mg/kgdwt 0.065 mg/kgdwt 0.724 SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 19 of 51 ES 4 - Use in coatings (industrial) use in coatings (industrial) Market sector: PC 9a - Coatings and Paints, Thinners, paint removers Sector of use: SU 7 - Printing and reproduction of recorded media Environment: ERC 4 Worker Use in closed process, no likelihood of exposure PROC 1 Use in closed, continuous process with occasional controlled exposure PROC 2 Use in closed batch process (synthesis or formulation) PROC 3 Use in batch and other process (synthesis) where opportunity for exposure arises PROC 4 Mixing or blending in batch processes for formulation of preparations and articles (multistage and/or significant contact) PROC 5 Industrial spraying PROC 7 Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non-dedicated facilities PROC 8a Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities PROC 8b Roller application or brushing PROC 10 Treatment of articles by dipping and pouring PROC 13 Use as laboratory reagent PROC 15 Operational conditions and risk management measures Control of environmental exposure: use in coatings Product characteristics Amounts used Daily use at a site <= 16.66 tonnes/day Annual use at a site <= 5E3 tonnes/year Percentage of tonnage used at regional scale = 100 % Frequency and duration of use Environment factors not influenced by risk management Receiving surface water flow rate >= 1.8E4 m3/d Other given operational conditions affecting environmental exposure Technical conditions and measures at process level (source) to prevent release Technical onsite conditions and measures to reduce or limit discharges, air emissions and releases to soil Organizational measures to prevent/limit release from site Conditions and measures related to municipal sewage treatment plant Municipal STP Yes [Water: 89.1%] Discharge rate of STP >= 2E3 m3/d Application of the STP sludge on agricultural soil Yes Conditions and measures related to external treatment of waste for disposal Conditions and measures related to external recovery of waste SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 20 of 51 Additional good practice advice beyond the REACH CSA Control of workers exposure for "Use in closed process, no likelihood of exposure" [PROC 1] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Level of containment Use in closed process, no likelihood of exposure L Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Use in closed, continuous process with occasional controlled exposure" [PROC 2] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Level of containment Use in closed, continuous process with occasional controlled exposure L Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Use in closed batch process (synthesis or formulation) " [PROC 3] Inhal*) Derm*) SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 21 of 51 Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Level of containment Use in closed batch process (synthesis or formulation) L Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Use in batch and other process (synthesis) where opportunity for exposure arises" [PROC 4] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Level of containment Use in batch and other process (synthesis) where opportunity for exposure arises L Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Mixing or blending in batch processes for formulation of preparations and articles (multistage and/or significant contact) " [PROC 5] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 22 of 51 Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Industrial spraying" [PROC 7] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation Yes L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non-dedicated facilities" [PROC 8a] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 23 of 51 Place of use L Indoors Technical conditions and measures at process level (source) to prevent release Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities" [PROC 8b] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Roller application or brushing" [PROC 10] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation L SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 24 of 51 Respiratory protection L Respiratory protection is not used Additional good practice advice beyond the REACH CSA Control of workers exposure for "Treatment of articles by dipping and pouring" [PROC 13] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Use as laboratory reagent" [PROC 15] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA *) The route of exposure (Inhalation, Dermal) and type of effect (Local, Systemic and Acute or Long term) for which the determinant has been used for exposure estimation are reported. SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 25 of 51 Workers – Quantitative Exposure Assessment (TRA workers) and Risk Characterisation. Derived DNEL covers both systemic and local effects. Exposure assessment for dermal exposures is not required (DNEL was not derived as no respective hazard was observed). According to ECHA Guidance on Information Requirements and Chemical Safety Assessment, R.14 (Occupational Exposure Assessment), shift average estimates obtained by ECETOC TRA can be considered to represent conservative 90th percentiles of the distribution of exposure concentrations. According to the Guidance document, potential peak exposure concentrations at the workplace (representing 95th percentiles of the peak exposure concentrations) can be extrapolated from these shift average concentrations by an additional factor of 2. No information is available from the use and practical experience with the substance, which would require a higher factor. Based on this extrapolation peak exposures may exceed ECETOC TRA estimated shift averages by a factor of 2, whereas the DNEL for short-term exposure is twice the long-term DNEL. Hence, it can be concluded that for all workplace situations, where safe use could be demonstrated based on exposure estimates from ECETOC TRA, that also potential peak exposures would not give rise to increased risks. DNEL dermal = DNEL inhalation long-term systemic = RCR TOTAL Not derived 480 mg/m 3 (100 ppm) PROC (inhalation + Estimated Estimated dermal) RCR RCR 3 exposure (mg/m ) exposure PROC 1 0.048 NA NA 1E-4 1E-4 PROC 2 48.4 NA NA 0.101 0.101 PROC 3 121 NA NA 0.252 0.252 PROC 4 96.8 NA NA 0.202 0.202 PROC 5 242 NA NA 0.504 0.504 PROC 7 60.5 NA NA 0.126 0.126 PROC 8a 242 NA NA 0.504 0.504 PROC 8b 242 NA NA 0.504 0.504 PROC 10 242 NA NA 0.504 0.504 PROC 13 242 NA NA 0.504 0.504 PROC 15 48.4 NA NA 0.101 0.101 Environment – Quantitative Exposure Assessment (EUSES 2.1) and Risk Characterisation Environment type Water: Fresh Water (Pelagic) Water: Fresh Water (Sediment) Water: Marine Water (Pelagic) Water: Marine Water (Sediment) Water: Sewage Treatment Plant (Effluent) Soil: Agricultural Soil PNEC PEC/Local RCR 0.18 mg/l 0.019 mg/l 0.103 0.981 mg/kgdwt 0.374 mg/kgdwt 0.381 0.018 mg/l 0.002 mg/l 0.103 0.0981 mg/kgdwt 0.037 mg/kgdwt 0.379 35.6 mg/l 0.181 mg/l 0.005 0.0903 mg/kgdwt 0.073 mg/kgdwt 0.811 SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 26 of 51 ES 5- Use in coatings (professional) Use in coatings (professional) Market sector: PC 9a - Coatings and Paints, Thinners, paint removers Environment: ERC 8a Worker Use in closed process, no likelihood of exposure PROC 1 Use in closed, continuous process with occasional controlled exposure PROC 2 Use in closed batch process (synthesis or formulation) PROC 3 Use in batch and other process (synthesis) where opportunity for exposure arises PROC 4 Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non-dedicated facilities PROC 8a Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities PROC 8b Roller application or brushing PROC 10 Non industrial spraying PROC 11 Treatment of articles by dipping and pouring PROC 13 Mixing or blending in batch processes for formulation of preparations and articles (multistage and/or significant contact) PROC 5 Use as laboratory reagent PROC 15 Hand-mixing with intimate contact and only PPE available PROC 19 Operational conditions and risk management measures Control of environmental exposure: use in coatings (professional) Product characteristics Amounts used Daily wide dispersive use = 5.5E-4 tonnes/day Frequency and duration of use Environment factors not influenced by risk management Receiving surface water flow rate >= 1.8E4 m3/d Other given operational conditions affecting environmental exposure Technical conditions and measures at process level (source) to prevent release Technical onsite conditions and measures to reduce or limit discharges, air emissions and releases to soil Organizational measures to prevent/limit release from site Conditions and measures related to municipal sewage treatment plant Municipal STP Yes [Water: 89.1%] Discharge rate of STP >= 2E3 m3/d Application of the STP sludge on agricultural soil Yes Conditions and measures related to external treatment of waste for disposal Conditions and measures related to external recovery of waste Additional good practice advice beyond the REACH CSA Control of workers exposure for "Use in closed process, no likelihood of exposure" [PROC 1] Inhal*) Derm*) Loc Sys Loc Sys SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 27 of 51 Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Level of containment Use in closed process, no likelihood of exposure L Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Use in closed, continuous process with occasional controlled exposure" [PROC 2] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Level of containment Use in closed, continuous process with occasional controlled exposure L Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Use in closed batch process (synthesis or formulation) " [PROC 3] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation Amounts used No L SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 28 of 51 Frequency and duration of use/exposure Duration of activity >4 hours L Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Level of containment Use in closed batch process (synthesis or formulation) L Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Use in batch and other process (synthesis) where opportunity for exposure arises" [PROC 4] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Level of containment Use in batch and other process (synthesis) where opportunity for exposure arises L Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non-dedicated facilities" [PROC 8a] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation Yes L Concentration of substance in product 5 – 25% L Amounts used Frequency and duration of use/exposure SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 29 of 51 Duration of activity L >4 hours Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities" [PROC 8b] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Roller application or brushing" [PROC 10] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation Yes L Concentration of substance in product 5 – 25% L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors Technical conditions and measures at process level (source) to prevent release L SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 30 of 51 Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Non industrial spraying" [PROC 11] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection capable offering a 90% reduction in inhaled concentrations of the substance L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Treatment of articles by dipping and pouring" [PROC 13] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation Yes L Concentration of substance in product 5 – 25% L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 31 of 51 Additional good practice advice beyond the REACH CSA Control of workers exposure for "Mixing or blending in batch processes for formulation of preparations and articles (multistage and/or significant contact) " [PROC 5] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation Yes L Concentration of substance in product 5 – 25% L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Use as laboratory reagent" [PROC 15] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Hand-mixing with intimate contact and only PPE available" [PROC 19] Inhal*) Derm*) Loc Sys Loc Sys SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 32 of 51 Product characteristics Substance in preparation Yes L Concentration of substance in product 5 – 25% L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA *) The route of exposure (Inhalation, Dermal) and type of effect (Local, Systemic and Acute or Long term) for which the determinant has been used for exposure estimation are reported. SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 33 of 51 Workers – Quantitative Exposure Assessment (TRA workers) and Risk Characterisation. Derived DNEL covers both systemic and local effects. Exposure assessment for dermal exposures is not required (DNEL was not derived as no respective hazard was observed). According to ECHA Guidance on Information Requirements and Chemical Safety Assessment, R.14 (Occupational Exposure Assessment), shift average estimates obtained by ECETOC TRA can be considered to represent conservative 90th percentiles of the distribution of exposure concentrations. According to the Guidance document, potential peak exposure concentrations at the workplace (representing 95th percentiles of the peak exposure concentrations) can be extrapolated from these shift average concentrations by an additional factor of 2. No information is available from the use and practical experience with the substance, which would require a higher factor. Based on this extrapolation peak exposures may exceed ECETOC TRA estimated shift averages by a factor of 2, whereas the DNEL for short-term exposure is twice the long-term DNEL. Hence, it can be concluded that for all workplace situations, where safe use could be demonstrated based on exposure estimates from ECETOC TRA, that also potential peak exposures would not give rise to increased risks. DNEL dermal = DNEL inhalation long-term systemic = RCR TOTAL Not derived 480 mg/m 3 (100 ppm) (inhalation + PROC Estimated Estimated dermal) RCR RCR 3 exposure (mg/m ) exposure PROC 1 0.048 NA NA 1E-4 1E-4 PROC 2 96.8 NA NA 0.202 0.202 PROC 3 121 NA NA 0.252 0.252 PROC 4 242 NA NA 0.504 0.504 PROC 5 290.4 NA NA 0.605 0.605 PROC 8a 290.4 NA NA 0.605 0.605 PROC 8b 242 NA NA 0.504 0.504 PROC 10 290.4 NA NA 0.605 0.605 PROC 11 242 NA NA 0.504 0.504 PROC 13 290.4 NA NA 0.605 0.605 PROC 15 48.4 NA NA 0.101 0.101 PROC 19 290.4 NA NA 0.605 0.605 Environment – Quantitative Exposure Assessment (EUSES 2.1) and Risk Characterisation Environment type Water: Fresh Water (Pelagic) Water: Fresh Water (Sediment) Water: Marine Water (Pelagic) Water: Marine Water (Sediment) Water: Sewage Treatment Plant (Effluent) Soil: Agricultural Soil PNEC PEC/Local RCR 0.18 mg/l 5.37E-4 mg/l 0.003 0.981 mg/kgdwt 0. 011 mg/kgdwt 0.011 0.018 mg/l 4.68E-5 mg/l 0.003 0.0981 mg/kgdwt 9.38E-4 mg/kgdwt 0.01 35.6 mg/l 3E-4 mg/l 8.427E-6 0.0903 mg/kgdwt 1.25E-4 mg/kgdwt 0.002 SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 34 of 51 ES 7 -Use in cleaning agents (industrial) Use in cleaning agents (industrial) Market sector: PC 35 - Washing and Cleaning Products (including solvent based products) Sector of use: SU 8 - Manufacture of bulk, large scale chemicals (including petroleum products) Environment: ERC 4 Worker Use in closed process, no likelihood of exposure PROC 1 Use in closed, continuous process with occasional controlled exposure PROC 2 Use in closed batch process (synthesis or formulation) PROC 3 Use in batch and other process (synthesis) where opportunity for exposure arises PROC 4 Industrial spraying PROC 7 Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non-dedicated facilities PROC 8a Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities PROC 8b Roller application or brushing PROC 10 Treatment of articles by dipping and pouring PROC 13 Operational conditions and risk management measures Control of environmental exposure: use in cleaning agents Product characteristics Amounts used Daily use at a site <= 5 tonnes/day Annual use at a site <= 100 tonnes/year Percentage of tonnage used at regional scale = 100 % Frequency and duration of use Environment factors not influenced by risk management Receiving surface water flow rate >= 1.8E4 m3/d Other given operational conditions affecting environmental exposure Technical conditions and measures at process level (source) to prevent release Technical onsite conditions and measures to reduce or limit discharges, air emissions and releases to soil Organizational measures to prevent/limit release from site Conditions and measures related to municipal sewage treatment plant Municipal STP Yes [Water: 89.1%] Discharge rate of STP >= 2E3 m3/d Application of the STP sludge on agricultural soil Yes Conditions and measures related to external treatment of waste for disposal Conditions and measures related to external recovery of waste Additional good practice advice beyond the REACH CSA Control of workers exposure for "Use in closed process, no likelihood of exposure" [PROC 1] Inhal*) Derm*) SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 35 of 51 Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Level of containment Use in closed process, no likelihood of exposure L Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Use in closed, continuous process with occasional controlled exposure" [PROC 2] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Level of containment Use in closed, continuous process with occasional controlled exposure L Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Use in closed batch process (synthesis or formulation) " [PROC 3] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 36 of 51 Amounts used Frequency and duration of use/exposure Duration of activity >4 hours L Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Level of containment Use in closed batch process (synthesis or formulation) L Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Use in batch and other process (synthesis) where opportunity for exposure arises" [PROC 4] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Level of containment Use in batch and other process (synthesis) where opportunity for exposure arises L Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Industrial spraying" [PROC 7] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 37 of 51 Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation Yes L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non-dedicated facilities" [PROC 8a] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities" [PROC 8b] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 38 of 51 Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Roller application or brushing" [PROC 10] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Treatment of articles by dipping and pouring" [PROC 13] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA *) The route of exposure (Inhalation, Dermal) and type of effect (Local, Systemic and Acute or Long term) for which the determinant has been used for exposure estimation are reported. SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 39 of 51 Workers – Quantitative Exposure Assessment (TRA workers) and Risk Characterisation. Derived DNEL covers both systemic and local effects. Exposure assessment for dermal exposures is not required (DNEL was not derived as no respective hazard was observed). According to ECHA Guidance on Information Requirements and Chemical Safety Assessment, R.14 (Occupational Exposure Assessment), shift average estimates obtained by ECETOC TRA can be considered to represent conservative 90th percentiles of the distribution of exposure concentrations. According to the Guidance document, potential peak exposure concentrations at the workplace (representing 95th percentiles of the peak exposure concentrations) can be extrapolated from these shift average concentrations by an additional factor of 2. No information is available from the use and practical experience with the substance, which would require a higher factor. Based on this extrapolation peak exposures may exceed ECETOC TRA estimated shift averages by a factor of 2, whereas the DNEL for short-term exposure is twice the long-term DNEL. Hence, it can be concluded that for all workplace situations, where safe use could be demonstrated based on exposure estimates from ECETOC TRA, that also potential peak exposures would not give rise to increased risks. DNEL dermal = DNEL inhalation long-term systemic = RCR TOTAL Not derived 480 mg/m 3 (100 ppm) (inhalation + PROC Estimated Estimated dermal) RCR RCR 3 exposure (mg/m ) exposure PROC 1 0.048 NA NA 1E-4 1E-4 PROC 2 48.4 NA NA 0.101 0.101 PROC 3 121 NA NA 0.252 0.252 PROC 4 96.8 NA NA 0.202 0.202 PROC 7 60.5 NA NA 0.126 0.126 PROC 8a 242 NA NA 0.504 0.504 PROC 8b 242 NA NA 0.504 0.504 PROC 10 242 NA NA 0.605 0.605 PROC 13 242 NA NA 0.605 0.605 Environment – Quantitative Exposure Assessment (EUSES 2.1) and Risk Characterisation Environment type Water: Fresh Water (Pelagic) Water: Fresh Water (Sediment) Water: Marine Water (Pelagic) Water: Marine Water (Sediment) Water: Sewage Treatment Plant (Effluent) Soil: Agricultural Soil PNEC PEC/Local RCR 0.18 mg/l 0.003 mg/l 0.018 0.981 mg/kgdwt 0. 065 mg/kgdwt 0.066 0.018 mg/l 3.16E-4 mg/l 0.018 0.0981 mg/kgdwt 0.006 mg/kgdwt 0.065 35.6 mg/l 0.027 mg/l 7.64E-4 0.0903 mg/kgdwt 0.014 mg/kgdwt 0.151 SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 40 of 51 ES 8 - Use in cleaning agents (professional) Use in cleaning agents (professional) Market sector: PC 35 - Washing and Cleaning Products (including solvent based products) Environment: ERC 8a Worker Use in closed process, no likelihood of exposure PROC 1 Use in closed, continuous process with occasional controlled exposure PROC 2 Use in closed batch process (synthesis or formulation) PROC 3 Use in batch and other process (synthesis) where opportunity for exposure arises PROC 4 Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non-dedicated facilities PROC 8a Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities PROC 8b Roller application or brushing PROC 10 Non industrial spraying PROC 11 Treatment of articles by dipping and pouring PROC 13 Operational conditions and risk management measures Control of environmental exposure: use in cleaning agents (professional) Product characteristics Amounts used Daily wide dispersive use = 2.7E-4 tonnes/day Frequency and duration of use Environment factors not influenced by risk management Receiving surface water flow rate >= 1.8E4 m3/d Other given operational conditions affecting environmental exposure Technical conditions and measures at process level (source) to prevent release Technical onsite conditions and measures to reduce or limit discharges, air emissions and releases to soil Organizational measures to prevent/limit release from site Conditions and measures related to municipal sewage treatment plant Municipal STP Yes [Water: 89.1%] Discharge rate of STP >= 2E3 m3/d Application of the STP sludge on agricultural soil Yes Conditions and measures related to external treatment of waste for disposal Conditions and measures related to external recovery of waste Additional good practice advice beyond the REACH CSA Control of workers exposure for "Use in closed process, no likelihood of exposure" [PROC 1] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation Amounts used No L SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 41 of 51 Frequency and duration of use/exposure Duration of activity >4 hours L Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Level of containment Use in closed process, no likelihood of exposure L Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Use in closed, continuous process with occasional controlled exposure" [PROC 2] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Level of containment Use in closed, continuous process with occasional controlled exposure L Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Use in closed batch process (synthesis or formulation) " [PROC 3] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 42 of 51 Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Level of containment Use in closed batch process (synthesis or formulation) L Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Use in batch and other process (synthesis) where opportunity for exposure arises" [PROC 4] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Level of containment Use in batch and other process (synthesis) where opportunity for exposure arises L Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non-dedicated facilities" [PROC 8a] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation Yes L Concentration of substance in product 5 – 25% L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 43 of 51 Place of use L Indoors Technical conditions and measures at process level (source) to prevent release Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities" [PROC 8b] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Roller application or brushing" [PROC 10] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation Yes L Concentration of substance in product 5 – 25% L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No Organisational measures to prevent /limit releases, dispersion and exposure L SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 44 of 51 Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Non industrial spraying" [PROC 11] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection capable offering a 90% reduction in inhaled concentrations of the substance L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Treatment of articles by dipping and pouring" [PROC 13] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation Yes L Concentration of substance in product 5 – 25% L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA *) The route of exposure (Inhalation, Dermal) and type of effect (Local, Systemic and Acute or Long term) for which the determinant has been used for exposure estimation are reported. SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 45 of 51 Workers – Quantitative Exposure Assessment (TRA workers) and Risk Characterisation. Derived DNEL covers both systemic and local effects. Exposure assessment for dermal exposures is not required (DNEL was not derived as no respective hazard was observed). According to ECHA Guidance on Information Requirements and Chemical Safety Assessment, R.14 (Occupational Exposure Assessment), shift average estimates obtained by ECETOC TRA can be considered to represent conservative 90th percentiles of the distribution of exposure concentrations. According to the Guidance document, potential peak exposure concentrations at the workplace (representing 95th percentiles of the peak exposure concentrations) can be extrapolated from these shift average concentrations by an additional factor of 2. No information is available from the use and practical experience with the substance, which would require a higher factor. Based on this extrapolation peak exposures may exceed ECETOC TRA estimated shift averages by a factor of 2, whereas the DNEL for short-term exposure is twice the long-term DNEL. Hence, it can be concluded that for all workplace situations, where safe use could be demonstrated based on exposure estimates from ECETOC TRA, that also potential peak exposures would not give rise to increased risks. DNEL dermal = DNEL inhalation long-term systemic = RCR TOTAL Not derived 480 mg/m 3 (100 ppm) (inhalation + PROC Estimated Estimated dermal) RCR RCR 3 exposure (mg/m ) exposure PROC 1 0.048 NA NA 1E-4 1E-4 PROC 2 96.8 NA NA 0.202 0.202 PROC 3 121 NA NA 0.252 0.252 PROC 4 242 NA NA 0.504 0.504 PROC 8a 290.4 NA NA 0.605 0.605 PROC 8b 242 NA NA 0.504 0.504 PROC 10 290.4 NA NA 0.605 0.605 PROC 11 242 NA NA 0.504 0.504 PROC 13 290.4 NA NA 0.605 0.605 Environment – Quantitative Exposure Assessment (EUSES 2.1) and Risk Characterisation Environment type Water: Fresh Water (Pelagic) Water: Fresh Water (Sediment) Water: Marine Water (Pelagic) Water: Marine Water (Sediment) Water: Sewage Treatment Plant (Effluent) Soil: Agricultural Soil PNEC PEC/Local RCR 0.18 mg/l 5.07E-4 mg/l 0.003 0.981 mg/kgdwt 0.01 mg/kgdwt 0.01 0.018 mg/l 4.38E-5 mg/l 0.002 0.0981 mg/kgdwt 8.78E-4 mg/kgdwt 0.009 35.6 mg/l 1.47E-8 mg/l 4.129E-10 0.0903 mg/kgdwt 3.39E-5 mg/kgdwt 3.754E-4 SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 46 of 51 ES 10 - Use in laboratories (ind) Use in laboratories (ind) Market sector: PC 21 - Laboratory Chemicals Sector of use: SU 9 - Manufacture of fine chemicals Environment: ERC 4 Worker Roller application or brushing PROC 10 Use as laboratory reagent PROC 15 Operational conditions and risk management measures Control of environmental exposure: use in laboratories (ind) Product characteristics Amounts used Daily use at a site <= 0.05 tonnes/day Annual use at a site <= 1 tonnes/year Percentage of tonnage used at regional scale = 100 % Frequency and duration of use Environment factors not influenced by risk management Receiving surface water flow rate >= 1.8E4 m3/d Other given operational conditions affecting environmental exposure Technical conditions and measures at process level (source) to prevent release Technical onsite conditions and measures to reduce or limit discharges, air emissions and releases to soil Organizational measures to prevent/limit release from site Conditions and measures related to municipal sewage treatment plant Municipal STP Yes [Water: 89.1%] Discharge rate of STP >= 2E3 m3/d Application of the STP sludge on agricultural soil Yes Conditions and measures related to external treatment of waste for disposal Conditions and measures related to external recovery of waste Additional good practice advice beyond the REACH CSA Control of workers exposure for "Roller application or brushing" [PROC 10] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 47 of 51 Technical conditions and measures at process level (source) to prevent release Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Use as laboratory reagent" [PROC 15] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA *) The route of exposure (Inhalation, Dermal) and type of effect (Local, Systemic and Acute or Long term) for which the determinant has been used for exposure estimation are reported. SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 48 of 51 Workers – Quantitative Exposure Assessment (TRA workers) and Risk Characterisation. Derived DNEL covers both systemic and local effects. Exposure assessment for dermal exposures is not required (DNEL was not derived as no respective hazard was observed). According to ECHA Guidance on Information Requirements and Chemical Safety Assessment, R.14 (Occupational Exposure Assessment), shift average estimates obtained by ECETOC TRA can be considered to represent conservative 90th percentiles of the distribution of exposure concentrations. According to the Guidance document, potential peak exposure concentrations at the workplace (representing 95th percentiles of the peak exposure concentrations) can be extrapolated from these shift average concentrations by an additional factor of 2. No information is available from the use and practical experience with the substance, which would require a higher factor. Based on this extrapolation peak exposures may exceed ECETOC TRA estimated shift averages by a factor of 2, whereas the DNEL for short-term exposure is twice the long-term DNEL. Hence, it can be concluded that for all workplace situations, where safe use could be demonstrated based on exposure estimates from ECETOC TRA, that also potential peak exposures would not give rise to increased risks. DNEL dermal = DNEL inhalation long-term systemic = RCR TOTAL Not derived 480 mg/m 3 (100 ppm) (inhalation + PROC Estimated Estimated dermal) RCR RCR 3 exposure (mg/m ) exposure PROC 10 242 NA NA 0.504 0.504 PROC 15 48.4 NA NA 0.101 0.101 Environment – Quantitative Exposure Assessment (EUSES 2.1) and Risk Characterisation Environment type Water: Fresh Water (Pelagic) Water: Fresh Water (Sediment) Water: Marine Water (Pelagic) Water: Marine Water (Sediment) Water: Sewage Treatment Plant (Effluent) Soil: Agricultural Soil PNEC PEC/Local RCR 0.18 mg/l 0.006 mg/l 0.033 0.981 mg/kgdwt 0.119 mg/kgdwt 0.121 0.018 mg/l 5.88E-4 mg/l 0.033 0.0981 mg/kgdwt 0.012 mg/kgdwt 0.12 35.6 mg/l 0.054 mg/l 0.002 0.0903 mg/kgdwt 0.02 mg/kgdwt 0.225 SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 49 of 51 ES 11 - Use in laboratories (prof) Use in laboratories (prof) Market sector: PC 21 - Laboratory Chemicals Environment: ERC 8a Worker Roller application or brushing PROC 10 Use as laboratory reagent PROC 15 Operational conditions and risk management measures Control of environmental exposure: use in laboratories (prof) Product characteristics Amounts used Daily wide dispersive use = 1.37E-7 tonnes/day Frequency and duration of use Environment factors not influenced by risk management Receiving surface water flow rate >= 1.8E4 m3/d Other given operational conditions affecting environmental exposure Technical conditions and measures at process level (source) to prevent release Technical onsite conditions and measures to reduce or limit discharges, air emissions and releases to soil Organizational measures to prevent/limit release from site Conditions and measures related to municipal sewage treatment plant Municipal STP Yes [Water: 89.1%] Discharge rate of STP >= 2E3 m3/d Application of the STP sludge on agricultural soil Yes Conditions and measures related to external treatment of waste for disposal Conditions and measures related to external recovery of waste Additional good practice advice beyond the REACH CSA Control of workers exposure for "Roller application or brushing" [PROC 10] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation Yes L Concentration of substance in product 5 – 25% L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 50 of 51 Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA Control of workers exposure for "Use as laboratory reagent" [PROC 15] Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L >4 hours L Amounts used Frequency and duration of use/exposure Duration of activity Human factors not influenced by risk management Other given operational conditions affecting workers exposure Place of use Indoors L Technical conditions and measures at process level (source) to prevent release Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation No L Organisational measures to prevent /limit releases, dispersion and exposure Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Respiratory protection is not used L Additional good practice advice beyond the REACH CSA *) The route of exposure (Inhalation, Dermal) and type of effect (Local, Systemic and Acute or Long term) for which the determinant has been used for exposure estimation are reported. SAFETY DATA SHEET "Dmitrievsky chemical plant – Production", LLC n-Butyl acetate Annex to extended safety data sheet (eSDS) Date: 11/04/2011 Previous date: 03/03/2010 Page 51 of 51 Workers – Quantitative Exposure Assessment (TRA workers) and Risk Characterisation. Derived DNEL covers both systemic and local effects. Exposure assessment for dermal exposures is not required (DNEL was not derived as no respective hazard was observed). According to ECHA Guidance on Information Requirements and Chemical Safety Assessment, R.14 (Occupational Exposure Assessment), shift average estimates obtained by ECETOC TRA can be considered to represent conservative 90th percentiles of the distribution of exposure concentrations. According to the Guidance document, potential peak exposure concentrations at the workplace (representing 95th percentiles of the peak exposure concentrations) can be extrapolated from these shift average concentrations by an additional factor of 2. No information is available from the use and practical experience with the substance, which would require a higher factor. Based on this extrapolation peak exposures may exceed ECETOC TRA estimated shift averages by a factor of 2, whereas the DNEL for short-term exposure is twice the long-term DNEL. Hence, it can be concluded that for all workplace situations, where safe use could be demonstrated based on exposure estimates from ECETOC TRA, that also potential peak exposures would not give rise to increased risks. DNEL dermal = DNEL inhalation long-term systemic = RCR TOTAL Not derived 480 mg/m 3 (100 ppm) (inhalation + PROC Estimated Estimated dermal) RCR RCR 3 exposure (mg/m ) exposure PROC 10 290.4 NA NA 0.605 0.605 PROC 15 48.4 NA NA 0.101 0.101 Environment – Quantitative Exposure Assessment (EUSES 2.1) and Risk Characterisation Environment type Water: Fresh Water (Pelagic) Water: Fresh Water (Sediment) Water: Marine Water (Pelagic) Water: Marine Water (Sediment) Water: Sewage Treatment Plant (Effluent) Soil: Agricultural Soil PNEC PEC/Local RCR 0.18 mg/l 5.07E-4 mg/l 0.003 0.981 mg/kgdwt 0.01 mg/kgdwt 0.01 0.018 mg/l 4.38E-5 mg/l 0.002 0.0981 mg/kgdwt 8.79E-4 mg/kgdwt 0.009 35.6 mg/l 3.73E-6 mg/l 1.048E-7 0.0903 mg/kgdwt 3.53E-5 mg/kgdwt 3.909E-4