1. IDENTIFICATION OF THE SUBSTANCE AND OF THE COMPANY

Transcription

1 1. IDENTIFICATION OF THE SUBSTANCE AND OF THE COMPANY 1.1 Product identifier Chemical name 2-Furanmethanol Synonyms Furan-2-ylmethanol, 2-Furan carbinol, Furfural alcohol, 2-Furyl carbinol, 2-Furyl methanol, 2-Hydroxymethyl furan Formula C 5 H 6 O 2 Molecular mass 98,10 FL-N CAS-N FEMA-N EC-N Annex-1 N Registration number Relevant identified uses of the substance and uses advised against Use / Activity scenario - Manufacturing of blends / formulation ES 2 - Manufacturing of polymers ES 3 - Manufacturing of moulds using formulations containing the substance (foundry) ES 4 - Manufacturing of refractories, abrasive wheels, friction (brake pads, clutch ES 5 facing), carbon impregnation using formulations containing the substance - Wood impregnation / modification ES 6 - Professional end-use of acid resistant coating ES 7 Uses advised against None 1.3 Details of the supplier of the safety data sheet Manufacturer International Furan Chemicals B.V Address Rotterdam Airportplein 7, 3045AP, Rotterdam, The Netherlands Telephone number Telefax number address manfred.van.der.starre@furan.com / adriaan.bonke@furan.com 1.4 Emergency telephone numbers +32(0) (24h/24 h) Information centre on dangerous goods (BIG) Technische Schoolstraat 43 A, B-2440 Geel, Belgium 2. HAZARDS IDENTIFICATION 2.1 Classification of the substance EU-GHS / CLP (inserted CLP00/updated ATP01) Hazard Class(es) / Hazard Class and Category Code(s) EU-DSD / DPD Indication(s) of danger and risk phrase(s) Carc Cat 3 Carcinogenicity Carc. 2 Acute toxicity Acute Tox. 3 * (inhalation) Acute Tox. 4 * (oral) Acute Tox. 4 * (dermal) Specific target organ toxicity repeated exposure STOT RE 2 * Serious eye irritation Eye Irrit. 2 Specific target organ toxicity single exposure STOT SE 3 R40 Toxic R23 Harmful R21/22-48/20 Irritant R36/37 Version 004 Page 1 of 92

2 2.2 Label elements EU-GHS / CLP Hazard pictogram(s) Signal word Hazard statement(s) H351 H331 H312 H302 H373 H319 H335 Danger Suspected of causing cancer. Toxic if inhaled. Harmful in contact with skin. Harmful if swallowed. May cause damage to organs through prolonged or repeated exposure. Causes serious eye irritation. May cause respiratory irritation. Precautionary statements P201 Obtain special instructions before use. P261 Avoid breathing vapours. P271 Use only outdoors or in a well-ventilated area. P281 Use personal protective equipment as required. P301 + P312 IF SWALLOWED: Call a POISON CENTRE or doctor / physician if you feel unwell. P302 + P352 IF ON SKIN: Wash with plenty of soap and water. P304 + P340 IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing. P305 + P351 + P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P314 Get medical advice/attention if you feel unwell. P330 Rinse mouth P337 + P313 If eye irritation persists: Get medical advice / attention. P403 + P233 Store in a well-ventilated place. Keep container tightly closed. P501 Disposal: Dispose of contents / container in accordance with local / regional regulations. 2.3 Other hazards Furfuryl alcohol does not meet the criteria for PBT or vpvb according to Regulation 1907/ COMPOSITION / INFORMATION ON INGREDIENTS Main constituent Identity Percentage Furfuryl alcohol CAS-N >98 % EC N FIRST AID MEASURES 4.1 Description of first aid measures Inhalation Fresh air, rest. Get medical advice / attention if you feel unwell. Skin contact Remove contaminated clothes, rinse skin with water or shower. Version 004 Page 2 of 92

3 Eye contact Ingestion First rinse with plenty of water (remove lenses if possible). If eye irritation persists: Get medical advice / attention. Rinse mouth. Get medical advice / attention if you feel unwell. 4.2 Most important symptoms and effects, both acute and delayed Acute Symptoms and effects Respiratory irritation (nose and upper respiratory tract) Eye irritation. May cause CNS depression, characterized by potential dizziness, drowsiness and nausea. Delayed symptoms and effects Respiratory irritation (nose and upper respiratory tract) and eye/skin irritation. 4.3 Indication of any immediate medical attention and special treatment needed Not applicable. 5. FIRE FIGHTING MEASURES 5.1 Extinguishing media Alcohol-resistant foam, water, powder, carbon dioxide. 5.2 Special hazards arising from the substance Toxic by inhalation. Combustible. In case of fire toxic gases are formed (carbon monoxide and/or carbon dioxide). 5.3 Advice for fire fighters Self-contained breathing apparatus. In case of fire: keep containers cool by spraying with water. 6. ACCIDENTAL RELEASE MEASURES 6.1 Personal precautions, protective equipment and emergency procedures Ventilation. Gloves, boots. Filter respirator for organic vapours (filter type A), safety goggles. 6.2 Environmental precautions Do not discharge into sewer, surface water or soil. 6.3 Methods and material for containment and cleaning up Dam spilled substance in and carefully remove with special vacuum cleaner; recycle if possible. Wash away remainder with water. Flush water into sewage. Take up small amounts spilled product with an inert absorbent. Dispose of as hazardous waste. 6.4 Reference to other sections See also the sections 8 and HANDLING AND STORAGE Version 004 Page 3 of 92

4 7.1 Precautions for safe handling Use only in well ventilated areas. No open flames and no smoking. Above 65 C closed system. 7.2 Conditions for safe storage, including any incompatibilities Keep container tightly closed. Store in a dark area. Keep away from oxidants and strong acids. Recommended storage temperature: 20 ºC. 7.3 Specific end use(s) If used in food: comply with food safety regulation (HACCP). 8. EXPOSURE CONTROLS / PERSONAL PROTECTION 8.1 Control parameters Limit values Country 8 hours (TWA) Short term (15 min.) Notation mg/m 3 ppm mg/m 3 ppm Austria 20 5 skin Belgium skin Czech Republic C (40 mg/m 3 ), skin Denmark 20 5 n.d. n.d. skin Finland 8, skin France n.d. n.d. skin Germany n.d.(previous 40 mg/ m 3 ) n.d. (previous 60 mg/ m 3 ) skin Italy skin Netherlands skin Norway 20 5 n.d. n.d. skin Poland 30 7, Portugal skin Slovakia n.d. n.d. C (41 mg/m 3 ), skin Slovenia n.d. n.d. skin Spain skin Sweden skin Switzerland skin n.d. not determined The exposure limits may be exceeded before the odour is perceived. DNEL / DMEL Workers short term exposition DNEL worker (acute, inhalation - systemic) mg/m 3 DNEL worker (acute, inhalation - local) 8 mg/m 3 DNEL worker (acute, dermal - systemic) 5.6 mg/kg Workers long term exposition DNEL worker (long-term, inhalation - systemic) 8 mg/m 3 DNEL worker (long-term, inhalation - local) 8 mg/m 3 DNEL worker (long-term, dermal - systemic) 4 mg/kg Version 004 Page 4 of 92

5 Consumers short term exposition DNEL general population (acute, inhalation - systemic) mg/m 3 DNEL general population (acute, inhalation - local) 0.82 mg/m 3 DNEL general population (acute, dermal - systemic) 3.3 mg/kg Consumers long term exposition DNEL general population (long-term, inhalation - systemic) 1.6 mg/m 3 DNEL general population (long-term, inhalation - local) 0.82 mg/m 3 DNEL general population (long-term, oral - systemic) 4.4 mg/kg DNEL general population (long-term, dermal - systemic) 3.3 mg/kg PNEC Aquatic - fresh water PNEC aquatic (freshwater) 0.17 mg/l - marine water PNEC aquatic (marine water) mg/l - intermittent release PNEC aquatic (intermittent release) 1.7 mg/l Sedimentary fresh water sediment PNEC sediment : mg/kg sediment dw marine water sediment PNEC marine-sediment mg/kg sediment dw Terrestrial - soil PNEC soil mg/kg dw Secondary poisoning - food chain PNEC oral 5.89 mg/kg food 8.2 controls Appropriate engineering controls Ventilation and local exhaust Individual protection measures, such as personal protective a) Eye/face protection Safety goggles. b) Skin protection Hand protection Gloves butyl rubber 0,7 mm Breakthrough time > 8 hours Gloves neoprene 0,75 mm Breakthrough time > 4 hours Other Protective clothing. c) Respiratory protection In case of insufficient local exhaust: filter respirator for organic vapours (filter type A). d) Thermal hazards Not applicable Environmental exposure controls Direct polluted air of the local exhaust ventilation out of the plant in a manner in accordance with environmental regulations. 9. PHYSICAL AND CHEMICAL PROPERTIES 9.1 Information on basic physical and chemical properties Version 004 Page 5 of 92

6 Appearance Colourless to yellow viscous liquid. Odour Typical; slightly pungent. Odour threshold (mg/m 3 ) 33 ph (30% solution) 4-6 Melting point / freezing point ( C) - 15 Boiling point ( C) at 1013 hpa 170 Flash point ( C) 65 (tag closed cup) Evaporation rate (ether=1) 443 Flammability (solid, gas) Not applicable. Upper / lower explosive limits (vol%) 1,8-16,3 Vapour pressure at 20 C (hpa) 0,53 Vapour density (air=1) 3,38 Relative density (water=1) 1,13 Solubility(ies) - Water solubility at 25 C (g/l) Complete. - Fat solubility Good Partition coefficient (log K octanol/water) 0,28 Auto-ignition temperature ( C) 491 Decomposition temperature Not applicable. Viscosity at 25 C (mpa.s) 4,62 Explosive properties Non explosive Oxidizing properties None 9.2 Other information Miscibility with Solvents (ethanol, ether, chloroform, methanol, 1-propanol, iso-amylalcohol, ethyl acetate). Conductivity (ps/m) Not available Heat of combustion (kj/kg) STABILITY AND REACTIVITY 10.1 Reactivity 10.2 Chemical stability Not reactive. Discolours on exposure to light. Unstable in water Possibility of hazardous reactions Exothermic polymerization with explosive violence in the presence of (strong) acids Conditions to avoid 10.5 Incompatible materials Avoid contact with air and light. Reacts violently with oxidants and strong acids (polymerization) Hazardous decomposition products Upon decomposition emits carbon monoxide, carbon dioxide and/or low molecular weight hydrocarbons. Version 004 Page 6 of 92

7 11. TOXICOLOGICAL INFORMATION 11.1 Information on toxicological effects Acute toxicity LD50 (oral, rat) (mg/kg) 177 LD50 (dermal, rabbit) (mg/kg) 400 LC50 (inhalation, rat, 4 hours) (mg/l) 0,82 2, Skin corrosion/irritation No evidence that the substance is irritating to skin. No classification warranted Serious eye damage/irritation The substance is irritating to eyes Respiratory or skin sensitization Concluded not to be sensitizing Germ cell mutagenicity Concluded not be genotoxic in vivo Carcinogenicity Suspected of causing cancer. Tumours incidence in rats and mice considered to be related to tissue damage resulting from repeat respiratory irritation i.e. represent conversion of highly specialized nasal epithelium to more resistant types of epithelium and represent adaptive responses to chronic irritation Reproductive toxicity No evidence of adverse effects on reproduction or development STOT- single exposure From acute toxicity studies, evident that the substance may cause respiratory irritation particularly to the upper respiratory tract and the nose STOT- repeated exposure From repeated-dose toxicity studies, evident that the substance may cause respiratory irritation particularly to the upper respiratory tract and the nose. May cause damage to the respiratory system - through prolonged or repeated exposure Aspiration hazard Does not present an aspiration hazard Likely routes of exposure The substance may be absorbed into the body by inhalation, after ingestion and through the skin. 12 ECOLOGICAL INFORMATION 12.1 Toxicity LC50 (fish, 96 hours) (mg/l) 362 EC50 (Daphnia, 48 hours) (mg/l) 224 IC50 (algae, 96 hours) (mg/l) Persistence and degradability Biodegradability Readily biodegradable. Oxygen demand biological (5 days) in go2/g (BOD5) 0,81 biological (20 days) in go2/g (BOD20) Not available chemical in go2/g (COD) 1,75 BOD5 : COD 0, Bioaccumulative potential BCF (Bio factor) (conc. in organisms / conc. in water) 0,96 Risk of bio accumulation is low (BCF <500 and log Kow <4). Version 004 Page 7 of 92

8 12.4 Mobility in soil Adsorption coefficient (Koc) solid phase / liquid phase 34 Highly mobile Results of PBT and vpvb The substance is not considered as PBTor vpvb Other adverse effects Ozone depletion potential (ODP) (CCl 3 F = 1) Photochemical ozone creation potential (C 2 H 4 = 1) Global warming potential (GWP) (CO 2 = 1) Water hazard class (WGK Germany) Not applicable Not available Not applicable 1 (slightly hazardous to water) 13 DISPOSAL CONSIDERATIONS 13.1 Waste treatment methods Recycling by distillation. Removal to an authorized waste incinerator for solvents or as chemical waste in accordance with local regulations. Do not discharge wastewater into sewer. European waste list (EURAL) TRANSPORT INFORMATION 14.1 UN Number UN proper shipping name FURFURYL ALCOHOL 14.3 Transport hazard class(es) Packing group III 14.5 Environmental hazards Marine pollutant No 14.6 Specials precautions for user Risk label(s) 6.1 Tunnel category (E) Hazard Identification Number (Kemler code) 60 ERICard 6-03 Emergency Schedules (EmS) - Fire schedule Alfa (F - A) - Spillage schedule Alfa (S - A) 14.7 Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code Ship type required 3 Pollution category Y Version 004 Page 8 of 92

9 15 REGULATORY INFORMATION 15.1 Safety, health and environmental regulations/legislation specific for the substance Approved as a flavouring agent in the EU FL N (Regulation (EC) No 2232/96) 15.2 Chemical safety A Chemical Safety Assessment has been carried out for furfuryl alcohol. 16 OTHER INFORMATION Changes to the previous version. Classification and labelling according to Regulation (EC) No 453/2010 Abbreviations and acronyms DNEL Derived No Effect Level DMEL Derived Minimal Effect Level DSD / DPD Dangerous Substances Directive / Dangerous Preparations Directive EC50 Effect Concentration, 50 percent ERIC Emergency Response Intervention Card GHS / CLP Globally Harmonised System / Classification, Labelling and Packaging IC50 Inhibitory Concentration, 50 percent LC50 Lethal Concentration, 50 percent LD50 Lethal Dose, 50 percent PBT Persistent, Bioaccumulative and Toxic PNEC Predicted No Effect Concentration TOD Total Oxygen Demand TWA Time Weighted Average vpvb very Persistent and very Bioaccumulative Literature references and sources for data Reach Registration Dossier EaSi-Pro View Substance Report, Haskoning, Oct Full text of indication(s) of danger, R phrases and safety advise which are not written out in full under Sections 2 to 15 R21/22 Harmful in contact with skin and if swallowed. R23 Toxic by inhalation. R36/37 Irritating to eyes and respiratory system. R40 Limited evidence of a carcinogenic effect. R48/20 Harmful: danger of serious damage to health by prolonged exposure through inhalation. Version 004 Page 9 of 92

10 Annex 1 Use descriptor system Full text of the sectors of use SU1 SU2 SU3 SU4 SU5 SU6 SU7 SU8 SU9 SU10 SU11 SU12 SU13 SU14 SU15 SU16 SU17 SU18 SU19 SU20 SU21 SU22 SU23 SU24 Agriculture, forestry, fishery Mining (including offshore industries) Industrial Manufacturing (all) Manufacture of food products Manufacture of textiles, leather, fur Manufacture of pulp, paper and paper products Printing and reproduction of recorded media Manufacture of bulk, large scale chemicals (including petroleum products) Manufacture of fine chemicals Formulation [mixing] of preparations and/or re-packaging Manufacture of rubber products Manufacture of plastics products, including compounding and conversion Manufacture of other non-metallic mineral products, e.g. plasters, cement Manufacture of basic metals Manufacture of fabricated metal products, except machinery and equipment Manufacture of computer, electronic and optical products, electrical equipment General manufacturing, e.g. machinery, equipment, vehicles, other transport equipment Manufacture of furniture Building and construction work Health services Private households (general public, consumers) Public domain (administration, education, entertainment, services, craftsmen) Recycling Scientific Research and Development Full text of the process categories PROC0 PROC1 PROC2 PROC3 PROC4 PROC5 PROC6 PROC7 PROC8 PROC9 PROC10 PROC11 PROC12 PROC13 PROC14 PROC15 PROC16 PROC17 PROC18 PROC19 Other Process or activity Use in closed process, no likelihood of exposure Use in closed, continuous process with occasional controlled exposure (e.g. sampling) Use in closed batch process (synthesis or formulation) Use in batch and other process (synthesis) where opportunity for exposure arises Mixing or blending in batch processes for formulation of preparations and articles (multistage and/or significant contact) Calendering operations Spraying in industrial settings and applications Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non dedicated facilities Transfer of substance or preparation into small containers (dedicated filling line, including weighing) Roller application or brushing of adhesiveand other coating Spraying outside industrial settings or applications Use of blow agents in manufacture of foam Treatment of articles by dipping and pouring Production of preparations or articles by tabletting, compression, extrusion, pelettisation Use a laboratory reagent Using material as fuel sources, limited exposure to unburned product to be expected Lubrication at high energy conditions and in partly open process Greasing at high energy conditions Hand-mixing with intimate contact and only PPE available. Version 004 Page 10 of 92

11 PROC20 PROC21 PROC22 PROC23 PROC24 PROC25 Heat and pressure transfer fluids in dispersive use but closed systems Low energy manipulation of substances bound in materials and/or articles Potentially closed processing operations (with minerals) at elevated temperature Open processing and transfer operations (with minerals) at elevated temperature High (mechanical) energy work-up of substances bound in materials and/or articles Hot work operations with metals Full text of the product categories PC0 PC1 PC2 PC3 PC4 PC5 PC6 PC7 PC8 PC9 PC10 PC11 PC12 PC13 PC14 PC15 PC16 PC17 PC18 PC19 PC20 PC21 PC22 PC23 PC24 PC25 PC26 PC27 PC28 PC29 PC30 PC31 PC32 PC33 PC34 PC35 PC36 PC37 PC38 PC39 PC40 Other product Adhesive, sealant Adsorbens Air care product Anti-Freeze or de-icing product Artists supply or hobby preparation Automotive care product Base metals or alloy Biocidal product (e.g. disinfectant, pest control) Coating or paint, filler, puttie, thinner Building and construction mixture (not covered elsewhere) Explosive Fertilizer Fuel Metal surface treatment (including galvanic and electroplating) product Non-metal-surface treatment product Heat transfer fluid Hydraulic fluid Ink or toner Intermediate ph-regulator, flocculant, precipitant, neutralization agent, or other unspecific Laboratory chemical Lawn and garden preparation, including fertilizers Leather tanning, - dye,- finishing,- impregnation or care product Lubricant, greas or release product Metal working fluid Paper and board dye, finishing and impregnation product Plant protection product Perfume or fragrance Pharmaceutical Photochemical Polish or wax blend Polymer preparations and compounds Semiconductor Textile dyes, finishing and impregnating products Washing and cleaning products (including solvent based products) Water softeners Water treatment chemicals Welding and soldering products, flux products Cosmetics, personal care products Extraction agents Version 004 Page 11 of 92

12 Full text of the environmental release categories ERC 1 ERC 2 ERC 3 ERC 4 ERC 5 ERC 6a ERC 6b ERC 6c ERC 6d ERC 7 ERC 8a ERC 8b ERC 8c ERC 8d ERC 8e ERC 8f ERC 9a ERC 9b ERC 10a ERC 10b ERC 11a ERC 11b Manufacture of substances Formulation of preparations (mixtures) Formulation in materials Industrial use of processing aids in processes and products, not becoming part of an article Industrial use resulting in inclusion into or onto a matrix Industrial use resulting in manufacture of another substance (use of intermediates) Industrial use of reactive processing aids Industrial use of monomers for polymerization Industrial use of auxiliaries for polymerisaton processes Industrial use of substances in closed systems Wide dispersive indoor use of processing aids in open systems Wide dispersive indoor use of reactive substances in open systems. Wide dispersive indoor use resulting in inclusion into or onto a matrix. Wide dispersive outdoor use of processing aids in open systems Wide dispersive outdoor use of reactive substances in open systems Wide dispersive outdoor use resulting in inclusion into or onto a matrix Wide dispersive indoor use of substances in closed systems. Wide dispersive outdoor use of substances in closed systems. Wide dispersive outdoor use of long-life articles and materials with low release. Wide dispersive outdoor use of long-life articles and materials with high or intended release Wide dispersive indoor use of long-life articles and materials with low release. Wide dispersive indoor use of long-life articles and materials with high or intended release. Version 004 Page 12 of 92

13 Annex 2 scenario s scenario ES 2 Manufacturing of blends/formulations 2.1 scenario Environment: ERC 2 Worker Mixing in a closed process, no likelihood of exposure PROC 1 Mixing in a closed, continuous process with occasional controlled exposure PROC 2 Mixing in a closed batch process, indoors with LEV PROC 3 Mixing in a batch process where opportunity for exposure arises, indoors with LEV PROC 4 Mixing in a batch process where the process is in stages and provides the opportunity for significant contact at any stage, indoors with LEV Transfer of the substance or transfer of formulations containing the substance (large amounts), indoors without LEV Transfer of the substance or transfer of formulations containing the substance (small amounts), indoors without LEV PROC 5 PROC 8b PROC 9 Quality control, indoors with LEV PROC 15 Transfer of the substance or transfer of formulations containing the substance (small amounts), indoors with LEV Transfer of the substance or transfer of formulations containing the substance (large amounts), outdoors Operational conditions and risk management measures PROC 9 PROC 8b Control of environmental exposure: Manufacturing of blends/formulations Product characteristics Amounts used Daily use at a site <= 6.25 tonnes/day Annual use at a site <= 625 tonnes/year Total tonnage for this stage: 50000, used at approx. 80 sites 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 Version 004 Page 13 of 92

14 Organizational measures to prevent/limit release from site Conditions and measures related to municipal sewage treatment plant Municipal STP Yes [Water: 87.4%] Discharge rate of STP Application of the STP sludge on agricultural soil >= 2E3 m3/d 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 exposure for "Mixing in a closed process, no likelihood of exposure" [PROC 1] Product characteristics Inhal*) Substance in preparation No L L Amounts used Frequency and duration of use/exposure Duration of activity >4 hours L L Human factors not influenced by risk management Other given operational conditions affecting exposure Place of use Indoors L L Derm*) Loc Sys Loc Sys Surface of skin exposed One hand face only (240 cm2) L L Technical conditions and measures at process level (source) to prevent release Level of containment Use in closed process, no likelihood of exposure Technical conditions and measures to control dispersion from source towards the worker Exhaust Ventilation No L L L 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 L Eye protection Wear chemical goggles AL AL Additional good practice advice beyond the REACH CSA *) The route of exposure (Inhalation, Dermal) and type of effect (, and Acute or Long term) for which the determinant has been used for exposure estimation are reported. Control of exposure for "Mixing in a closed, continuous process with occasional controlled exposure" [PROC 2] L L Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L L Version 004 Page 14 of 92

15 Amounts used Frequency and duration of use/exposure Duration of activity >4 hours L L Human factors not influenced by risk management Other given operational conditions affecting exposure Place of use Indoors L L Surface of skin exposed Two hands face (480 cm2) L 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 L Technical conditions and measures to control dispersion from source towards the worker Exhaust Ventilation No L L L 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 L Eye protection Wear chemical goggles AL AL Additional good practice advice beyond the REACH CSA *) The route of exposure (Inhalation, Dermal) and type of effect (, and Acute or Long term) for which the determinant has been used for exposure estimation are reported. Control of exposure for "Mixing in a closed batch process, indoors with LEV" [PROC 3] Product characteristics Inhal*) Substance in preparation No L L Amounts used Frequency and duration of use/exposure Duration of activity >4 hours L L Human factors not influenced by risk management Other given operational conditions affecting exposure Place of use Indoors L L Derm*) Loc Sys Loc Sys Surface of skin exposed One hand face only (240 cm2) L L Technical conditions and measures at process level (source) to prevent release Level of containment Use in closed batch process (synthesis or formulation) Technical conditions and measures to control dispersion from source towards the worker Exhaust Ventilation Yes L L L 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 L Eye protection Wear chemical goggles AL AL L L Version 004 Page 15 of 92

16 Additional good practice advice beyond the REACH CSA *) The route of exposure (Inhalation, Dermal) and type of effect (, and Acute or Long term) for which the determinant has been used for exposure estimation are reported. Control of exposure for "Mixing in a batch process where opportunity for exposure arises, indoors with LEV" [PROC 4] Product characteristics Inhal*) Substance in preparation No L L Amounts used Frequency and duration of use/exposure Duration of activity >4 hours L L Human factors not influenced by risk management Other given operational conditions affecting exposure Place of use Indoors L L Derm*) Loc Sys Loc Sys Surface of skin exposed Two hands face (480 cm2) L 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 Technical conditions and measures to control dispersion from source towards the worker Exhaust Ventilation Yes L L L 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 L Eye protection Wear chemical goggles AL AL Additional good practice advice beyond the REACH CSA *) The route of exposure (Inhalation, Dermal) and type of effect (, and Acute or Long term) for which the determinant has been used for exposure estimation are reported. Control of exposure for "Mixing in a batch process where the process is in stages and provides the opportunity for significant contact at any stage, indoors with LEV" [PROC 5] L L Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L L Amounts used Frequency and duration of use/exposure Duration of activity >4 hours L L Human factors not influenced by risk management Other given operational conditions affecting exposure Version 004 Page 16 of 92

17 Place of use Indoors L L Surface of skin exposed Two hands face (480 cm2) L L Technical conditions and measures at process level (source) to prevent release Technical conditions and measures to control dispersion from source towards the worker Exhaust Ventilation Yes L L L 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 L Eye protection Wear chemical goggles AL AL Additional good practice advice beyond the REACH CSA *) The route of exposure (Inhalation, Dermal) and type of effect (, and Acute or Long term) for which the determinant has been used for exposure estimation are reported. Control of exposure for "Transfer of the substance or transfer of formulations containing the substance (large amounts), indoors without LEV" [PROC 8b] Product characteristics Inhal*) Substance in preparation No L L Amounts used Frequency and duration of use/exposure Duration of activity 15 mins - 1 hour L L Human factors not influenced by risk management Other given operational conditions affecting exposure Place of use Indoors L L Derm*) Loc Sys Loc Sys Surface of skin exposed Two hands face (480 cm2) L L Technical conditions and measures at process level (source) to prevent release Technical conditions and measures to control dispersion from source towards the worker Exhaust Ventilation No L L L 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 L Gloves Wear chemically resistant gloves (tested to AL AL type EN374) with "basic" employee training [Dermal: 90%] Eye protection Wear chemical goggles AL AL Additional good practice advice beyond the REACH CSA *) The route of exposure (Inhalation, Dermal) and type of effect (, and Acute or Long term) for which the determinant has been used for exposure estimation are reported. Version 004 Page 17 of 92

18 Control of exposure for "Transfer of the substance or transfer of formulations containing the substance (small amounts), indoors without LEV" [PROC 9] Product characteristics Inhal*) Substance in preparation No L L Amounts used Frequency and duration of use/exposure Duration of activity 15 mins - 1 hour L L Human factors not influenced by risk management Other given operational conditions affecting exposure Place of use Indoors L L Derm*) Loc Sys Loc Sys Surface of skin exposed Two hands face (480 cm2) L L Technical conditions and measures at process level (source) to prevent release Technical conditions and measures to control dispersion from source towards the worker Exhaust Ventilation No L L L 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 L Gloves Wear chemically resistant gloves (tested to AL AL type EN374) with "basic" employee training [Dermal: 90%] Eye protection Wear chemical goggles AL AL Additional good practice advice beyond the REACH CSA *) The route of exposure (Inhalation, Dermal) and type of effect (, and Acute or Long term) for which the determinant has been used for exposure estimation are reported. Control of exposure for "Quality control, indoors with LEV" [PROC 15] Product characteristics Inhal*) Substance in preparation No L L Amounts used Frequency and duration of use/exposure Duration of activity >4 hours L L Human factors not influenced by risk management Other given operational conditions affecting exposure Place of use Indoors L L Derm*) Loc Sys Loc Sys Surface of skin exposed One hand face only (240 cm2) L L Technical conditions and measures at process level (source) to prevent release Version 004 Page 18 of 92

19 Technical conditions and measures to control dispersion from source towards the worker Exhaust Ventilation Yes L L L 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 L Eye protection Wear chemical goggles AL AL Additional good practice advice beyond the REACH CSA *) The route of exposure (Inhalation, Dermal) and type of effect (, and Acute or Long term) for which the determinant has been used for exposure estimation are reported. Control of exposure for "Transfer of the substance or transfer of formulations containing the substance (small amounts), indoors with LEV" [PROC 9] Product characteristics Inhal*) Substance in preparation No L L Amounts used Frequency and duration of use/exposure Duration of activity >4 hours L L Human factors not influenced by risk management Other given operational conditions affecting exposure Place of use Indoors L L Derm*) Loc Sys Loc Sys Surface of skin exposed Two hands face (480 cm2) L L Technical conditions and measures at process level (source) to prevent release Technical conditions and measures to control dispersion from source towards the worker Exhaust Ventilation Yes L L L 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 L Eye protection Wear chemical goggles AL AL Gloves Wear chemically resistant gloves (tested to type EN374) with "basic" employee training [Dermal: 90%] AL AL Additional good practice advice beyond the REACH CSA *) The route of exposure (Inhalation, Dermal) and type of effect (, and Acute or Long term) for which the determinant has been used for exposure estimation are reported. Control of exposure for "Transfer of the substance or transfer of formulations containing the substance (large amounts), outdoors" [PROC 8b] Inhal*) Derm*) Loc Sys Loc Sys Version 004 Page 19 of 92

20 Product characteristics Substance in preparation No L L Amounts used Frequency and duration of use/exposure Duration of activity 15 mins - 1 hour L L Human factors not influenced by risk management Other given operational conditions affecting exposure Place of use Outdoors L L Surface of skin exposed Two hands face (480 cm2) L L Technical conditions and measures at process level (source) to prevent release Technical conditions and measures to control dispersion from source towards the worker Exhaust Ventilation No L L L 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 L Eye protection Wear chemical goggles AL AL Gloves Wear chemically resistant gloves (tested to type EN374) with "basic" employee training [Dermal: 90%] AL AL Additional good practice advice beyond the REACH CSA *) The route of exposure (Inhalation, Dermal) and type of effect (, and Acute or Long term) for which the determinant has been used for exposure estimation are reported. 2.2 estimation for Manufacturing of blends / formulations estimation for the environment (Manufacturing of blends/formulations) Environmental releases Table 1. Summary of the local releases to the environment Compartment Release factor estimation method Water Release rate Release factor after on site risk management (%): 0.4 release rate (kg/day): 25 Explanation/Justification: There is no company specific data available. The local release rate has been set to the maximum rate at which the local environmental risks are controlled. Air Other method (estimation) Release factor after on site risk management (%): 0.1 release rate (kg/day): 6.25 Explanation/Justification: There is no company specific data available. The 0.1% is an estimation based on the properties and use of the substance. Soil Other method Release factor after on site risk management (%): 0 Version 004 Page 20 of 92

21 Compartment Release factor estimation method (Company specific data) Explanation/Justification: There is no direct emission to soil Summed releases from all life cycle stages: see Supplement Environmental exposure Table 2. Summary of exposure s Protection target Water: Fresh Water (Pelagic) Water: Fresh Water (Sediment) Water: Marine Water (Pelagic) Water: Marine Water (Sediment) Air PEC: 0.16 mg/l : mg/l PEC: mg/kg dw PEC: mg/l : mg/l PEC: mg/kg dw PEC: 4.79E-4 mg/m³ Soil: Agricultural Soil PEC: 0.05 mg/kg dw : mg/kg dw For regional PECs: see Supplement Indirect exposure of humans via the environment EUSES 2.1 via inhalation The exposure s in air are reported in the Table "Summary of exposure s" of the preceding section "Environmental exposure". via food consumption: Total daily intake for humans Table 3. Summary of estimated daily human doses and s in food Type of food Drinking water Fish Daily human dose through intake Total estimated daily intake for humans: mg/kg Estimated daily dose through intake from local exposure Concentration in food from local exposure mg/kg mg/l 3.05E-4 mg/kg mg/kg Leaf crops 6.2E-4 mg/kg mg/kg Version 004 Page 21 of 92

22 Type of food Root crops Meat Milk Daily human dose through intake 1.88E-4 mg/kg mg/kg 3.09E-8 mg/kg 7.18E-6 mg/kg 5.75E-7 mg/kg 7.18E-5 mg/kg Dose from regional exposure: see Supplement estimation for Worker for Mixing in a closed process, no likelihood of exposure Table 4. Summary of exposure s for contributing scenario: Mixing in a closed process, no likelihood of exposure Acute, mg/m³ Method: External exposure Name: TRA Acute, local = long-term, local Acute, mg/m³ Method: External exposure Name: TRA term, term, mg/m³ Method: Extended TRA Name: TRA extended mg/m³ Method: Extended TRA Name: TRA extended Method: Conditions of use (OC/RMM) Name: Conditions of use mg/kg Method: External exposure Name: TRA 0.1 mg/cm² Method: Extended TRA Name: TRA extended mg/kg Method: Extended TRA Name: TRA extended estimation for Worker for Mixing in a closed, continuous process with occasional controlled exposure Version 004 Page 22 of 92

23 Table 5. Summary of exposure s for contributing scenario: Mixing in a closed, continuous process with occasional controlled exposure Acute, mg/m³ Method: External exposure Name: TRA Acute, local = long-term, local Acute, mg/m³ Method: External exposure Name: TRA term, term, mg/m³ Method: Extended TRA Name: TRA extended mg/m³ Method: Extended TRA Name: TRA extended Method: Conditions of use (OC/RMM) Name: Conditions of use mg/kg Method: External exposure Name: TRA 0.2 mg/cm² Method: Extended TRA Name: TRA extended mg/kg Method: Extended TRA Name: TRA extended estimation for Worker for Mixing in a closed batch process, indoors with LEV Table 6. Summary of exposure s for contributing scenario: Mixing in a closed batch process, indoors with LEV Acute, mg/m³ Method: External exposure Name: TRA Acute, local = long-term, local mg/m³ Method: External exposure Version 004 Page 23 of 92

24 Acute, Name: TRA term, term, mg/m³ Method: Extended TRA Name: TRA extended mg/m³ Method: Extended TRA Name: TRA extended Method: Conditions of use (OC/RMM) Name: Conditions of use mg/kg Method: External exposure Name: TRA 0.01 mg/cm² Method: Extended TRA Name: TRA extended mg/kg Method: Extended TRA Name: TRA extended estimation for Worker for Mixing in a batch process where opportunity for exposure arises, indoors with LEV Table 7. Summary of exposure s for contributing scenario: Mixing in a batch process where opportunity for exposure arises, indoors with LEV Acute, mg/m³ Method: External exposure Name: TRA Acute, local = long-term, local Acute, mg/m³ Method: External exposure Name: TRA mg/m³ Method: Extended TRA Name: TRA extended Version 004 Page 24 of 92

25 2.044 mg/m³ Method: Extended TRA Name: TRA extended Method: Conditions of use (OC/RMM) Name: Conditions of use mg/kg Method: External exposure Name: TRA term, term, 0.1 mg/cm² Method: Extended TRA Name: TRA extended mg/kg Method: Extended TRA Name: TRA extended estimation for Worker for Mixing in a batch process where the process is in stages and provides the opportunity for significant contact at any stage, indoors with LEV Table 8. Summary of exposure s for contributing scenario: Mixing in a batch process where the process is in stages and provides the opportunity for significant contact at any stage, indoors with LEV Acute, mg/m³ Method: External exposure Name: TRA Acute, local = long-term, local Acute, mg/m³ Method: External exposure Name: TRA mg/m³ Method: Extended TRA Name: TRA extended mg/m³ Method: Extended TRA Name: TRA extended Method: Conditions of use (OC/RMM) Name: Conditions of use Version 004 Page 25 of 92

26 0.207 mg/kg Method: External exposure Name: TRA term, term, 0.01 mg/cm² Method: Extended TRA Name: TRA extended mg/kg Method: Extended TRA Name: TRA extended estimation for Worker for Transfer of the substance or transfer of formulations containing the substance (large amounts), indoors without LEV Table 9. Summary of exposure s for contributing scenario: Transfer of the substance or transfer of formulations containing the substance (large amounts), indoors without LEV Acute, mg/m³ Method: External exposure Name: TRA Acute, local = long-term, local Acute, mg/m³ Method: External exposure Name: TRA term, mg/m³ Method: Extended TRA Name: TRA extended mg/m³ Method: Extended TRA Name: TRA extended Method: Conditions of use (OC/RMM) Name: Conditions of use mg/kg Method: External exposure Name: TRA 0.1 mg/cm² Method: Extended TRA Name: TRA extended Version 004 Page 26 of 92

27 term, mg/kg Method: Extended TRA Name: TRA extended estimation for Worker for Transfer of the substance or transfer of formulations containing the substance (small amounts), indoors without LEV Table 10. Summary of exposure s for contributing scenario: Transfer of the substance or transfer of formulations containing the substance (small amounts), indoors without LEV Acute, mg/m³ Method: External exposure Name: TRA Acute, local = long-term, local Acute, mg/m³ Method: External exposure Name: TRA term, term, mg/m³ Method: Extended TRA Name: TRA extended mg/m³ Method: Extended TRA Name: TRA extended Method: Conditions of use (OC/RMM) Name: Conditions of use mg/kg Method: External exposure Name: TRA 0.1 mg/cm² Method: Extended TRA Name: TRA extended mg/kg Method: Extended TRA Name: TRA extended Version 004 Page 27 of 92

28 estimation for Worker for Quality control, indoors with LEV Table 11. Summary of exposure s for contributing scenario: Quality control, indoors with LEV Acute, mg/m³ Method: External exposure Name: TRA Acute, local = long-term, local Acute, mg/m³ Method: External exposure Name: TRA term, term, mg/m³ Method: Extended TRA Name: TRA extended mg/m³ Method: Extended TRA Name: TRA extended Method: Conditions of use (OC/RMM) Name: Conditions of use mg/kg Method: External exposure Name: TRA 0.01 mg/cm² Method: Extended TRA Name: TRA extended mg/kg Method: Extended TRA Name: TRA extended estimation for Worker for Transfer of the substance or transfer of formulations containing the substance (small amounts), indoors with LEV Table 12. Summary of exposure s for contributing scenario: Transfer of the substance or transfer of formulations containing the substance (small amounts), indoors with LEV Acute, mg/m³ Method: External exposure Name: TRA Version 004 Page 28 of 92

29 Acute, local = long-term, local Acute, mg/m³ Method: External exposure Name: TRA term, term, mg/m³ Method: Extended TRA Name: TRA extended mg/m³ Method: Extended TRA Name: TRA extended Method: Conditions of use (OC/RMM) Name: Conditions of use mg/kg Method: External exposure Name: TRA 0.01 mg/cm² Method: Extended TRA Name: TRA extended mg/kg Method: Extended TRA Name: TRA extended estimation for Worker for Transfer of the substance or transfer of formulations containing the substance (large amounts), outdoors Table 14. Summary of exposure s for contributing scenario: Transfer of the substance or transfer of formulations containing the substance (large amounts), outdoors Acute, mg/m³ Method: External exposure Name: TRA Acute, local = long-term, local Acute, mg/m³ Method: External exposure Name: TRA Version 004 Page 29 of 92

30 2.861 mg/m³ Method: Extended TRA Name: TRA extended mg/m³ Method: Extended TRA Name: TRA extended Method: Conditions of use (OC/RMM) Name: Conditions of use mg/kg Method: External exposure Name: TRA term, term, 0.1 mg/cm² Method: Extended TRA Name: TRA extended mg/kg Method: Extended TRA Name: TRA extended Version 004 Page 30 of 92

31 SUPPLEMENT Regional environmental exposure from the releases of all exposure scenarios covered in the CSR of the lead-registrant The following PECs are calculated based on the releases of all generic exposure scenarios, taking into account the total EU tonnages for the 7 life cycle stages. 1. Total releases Water: 465 tonnes/year Air: 115 tonnes/year Soil: 0 tonnes/year 2. Regional exposure: environment Table. Summary of predicted regional exposure s (Regional PEC) Protection target Fresh Water (Pelagic) Fresh Water (Sediment) Marine Water (Pelagic) Marine Water (Sediment) Air Agricultural Soil Regional PEC mg/l mg/kg dw 1.53E-4 mg/l 6.86E-4 mg/kg dw 2.5E-6 mg/m³ 8.03E-4 mg/kg dw 3. Regional exposure: man via environment Regional total estimated daily intake for humans: 8.701E-5 mg/kg Table. Summary of estimated daily human doses through intake and s in food from regional exposure Type of food Estimated daily dose from regional exposure Drinking water 4.67E-5 mg/kg mg/l Fish 3.79E-6 mg/kg mg/kg Leaf crops 3.2E-5 mg/kg mg/kg Root crops 4.51E-6 mg/kg 8.23E-4 mg/kg Meat 7.4E-10 mg/kg 1.72E-7 mg/kg Milk 1.38E-8 mg/kg 1.72E-6 mg/kg Concentration in food from regional exposure Version 004 Page 31 of 92

32 scenario ES 3 Manufacturing of polymers 3.1 scenario Environment: Worker ERC 6c Manufacturing polymers in a closed process, no likelihood of exposure (indoors) PROC 1 Manufacturing polymers in a closed, continuous process with occasional controlled exposure (indoors) PROC 2 Manufacturing polymers in a closed batch process (indoors with LEV) PROC 3 Manufacturing polymers in a batch process where opportunity for exposure arises (indoors with LEV) Transfer of the substance (indoors) PROC 4 PROC 8b Quality control, indoors with LEV PROC 15 Manufacturing polymers in a closed process, no likelihood of exposure (outdoors) PROC 1 Manufacturing polymers in a closed, continuous process with occasional controlled exposure (outdoors) Transfer of the substance (outdoors) PROC 2 PROC 8b Manufacturing polymers in a closed batch process (outdoors) PROC 3 Manufacturing polymers in a batch process where opportunity for exposure arises (outdoors) Operational conditions and risk management measures PROC 4 Control of environmental exposure: Manufacturing of polymers Product characteristics Amounts used Daily use at a site <= tonnes/day Annual use at a site <= 625 tonnes/year Total tonnage for this stage is 5000, used at approx. 8 sites 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 Version 004 Page 32 of 92

33 Municipal STP Yes [Water: 87.4%] 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 exposure for "Manufacturing polymers in a closed process, no likelihood of exposure (indoors) " [PROC 1] Product characteristics Inhal*) Substance in preparation No L L Amounts used Frequency and duration of use/exposure Duration of activity >4 hours L L Human factors not influenced by risk management Other given operational conditions affecting exposure Place of use Indoors L L Derm*) Loc Sys Loc Sys Surface of skin exposed One hand face only (240 cm2) L L Technical conditions and measures at process level (source) to prevent release Level of containment Use in closed process, no likelihood of exposure Technical conditions and measures to control dispersion from source towards the worker Exhaust Ventilation No L L L 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 L Eye protection Wear chemical goggles AL AL Additional good practice advice beyond the REACH CSA *) The route of exposure (Inhalation, Dermal) and type of effect (, and Acute or Long term) for which the determinant has been used for exposure estimation are reported. Control of exposure for "Manufacturing polymers in a closed, continuous process with occasional controlled exposure (indoors) " [PROC 2] L L Inhal*) Derm*) Loc Sys Loc Sys Product characteristics Substance in preparation No L L Amounts used Version 004 Page 33 of 92