SAFETY DATA SHEET according to Regulation (EC) No. 1907/2006 Vitamin A Palmitate 1.7 MIU/g (stabilized with 0418579 tocopherol) Version 5.1 Revision Date 09.09.2011 Print Date 15.02.2012 1. IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE |COMPANY/UNDERTAKING [1.4 Product identifier Trade name Vitamin A Palmitate REACH Registration Number: 01-2119480425-37-0001 ‘Substance name all-trans-3,7-dimethyl-9-(2,6,6-trimethyl--cyclohexene-1-yl)- 2,4,6,8-nonatetraene-1-yl palmitate CAS-No, 79-81-2 11.2 Relevant identified uses of the substance or mixture and uses advised against Use of the For the fortification of foods, Ingredient for pharmaceutical ‘Substance/Mixture products, Ingredient for personal care products 11.3 Details of the supplier of the safety data sheet Company 146 Glasgow Road, Longcroft, Stirlingshire, FK4 1QL United Kingdom. Telephone 01324 841353, i2. Hazards identification 22.1 Classification of the substance or mixture Classification (REGULATION (EC) No 1272/2008) Reproductive toxicity, Category 1B H360D: May damage the unborn child. Chronic aquatic toxicity, Category 4 H413: May cause long lasting harmful effects to aquatic lif. Classification (67/548/EEC, 1999/45/EC) Toxic to Reproduction Category 2 R61: May cause harm to the unborn child. Instant R38: Imitating to skin. Dangerous for the environment 53: May cause long-term adverse effects in the aquatic environment, 2.2 Label elements Labelling (REGULATION (EC) No 1272/2008) Hazard pictograms 1724 MSDS_GB/ENSAFETY DATA SHEET according to Regulation (EC) No. 1907/2006 tocopherol) Vitamin A Palmitate 1.7 MIU/g (stabilized with 0418579 79-81-2 Additional Labelling retinyl palmitate Restricted to professional users. [2.3 Other hazards (selFignition) is possible. Version 5.1 Revision Date 09.09.2011 Print Date 15.02.2012| Signal word Danger Hazard statements H360D May damage the unborn child, Ha13 May cause long lasting harmful effects to aquatic lif. Precautionary statements Prevention: 201 Obtain special instructions before use. 202 Do not handle until all safety precautions have been read and understood. P273 ‘Avoid release to the environment. P281 Use personal protective equipment as required. Response: 308 +P313 _IF exposed or concerned: Get medical advice! attention Storage: P405 Store locked up, Hazardous components which must be listed on the label: EUH208 Contains: l-a-tocopherol: May produce an allergic reaction, In case of extensive air contact (e.g. soaked rags, moistened clothes) an exothermic autoxidation Women of childbearing age must avoid any overexposure. n on ingredients 201-228-5 | Xi, R38 ‘Synonyms: Retinol, hexadecanoate Brief description of the Substance product Stabilized product Molecular formula 36 H60 02 '3.1 Substances Hazardous components Chemical Name CASNo. Classification Classification _ | Concentration EC-No. (67/548/EEC) | (REGULATION (9% Registration (EC) No number 1272/2008) Telinyl palmitate |79-81-2 Repr.Cat2, R61 [Repr. 1B; H360D | >= 90-< 100 ‘Aquatic Chronic 4; o1- R53 H413 2119480425- 37, 2124 MSDS_GB/ENSAFETY DATA SHEET according to Regulation (EC) No. 1907/2006 Vitamin A Palmitate 1.7 MIU/g (stabilized with 0418579 tocopherol) Version 5.1 Revision Date 09.09.2011 Print Date 15.02.2012 Badhydro25,78. |T01e1-a1-0 [RAS ‘Skin Sens. GBI? | _>=1-<5 tetramethyl-2-(4,8,12- |233-466-0 | R53 ‘Aquatic Chronic 4; trimethyitridecyl)-2H- Ha13 benzopyran-6-ol (dl-a- tocopherol) |4. First aid measures [4.1 Description of first aid measures General advice Move out of dangerous area ‘Show this safety data sheet to the doctor in attendance. After any accidental exposure women should seek medical advice from a physician. Itinhaled Move to fresh air in case of accidental inhalation of dust or fumes from overheating or combustion. If symptoms persist, call a physician. In case of skin contact Take off contaminated clothing and shoes immediately. Wash off with soap and plenty of water. If symptoms persist, call a physician. In case of eye contact Flush eyes with water as a precaution. Remove contact lenses. Protect unharmed eye. Keep eye wide open while rinsing. If eye irritation persists, consult a specialist It swallowed Clean mouth with water and drink afterwards plenty of water. Do not give milk or alcoholic beverages. Never give anything by mouth to an unconscious person, Obtain medical attention, {4.2 Most important symptoms and effects, both acute and delayed ‘Symptoms Headache, Iritability, Tiredness, Drowsiness, Nausea, Vomiting, Signs of increased intracranial pressure, Generalized desquamation of the skin (after ca. 24 hours) [4.3 Indication of any immediate medical attention and special treatment needed Treatment Treat symptomaticall. {5. Firefighting measures {5.1 Extinguishing media Suitable extinguishing media: Alcohol-esistant foam Dry chemical Use extinguishing measures that are appropriate to local circumstances and the surrounding environment. 3124 MSDS_GB/ENSAFETY DATA SHEET according to Regulation (EC) No. 1907/2006 Vitamin A Palmitate 1.7 MIU/g (stabilized with 0418579 tocopherol) Version 5.1 Revision Date 09.09.2011 Print Date 15.02.2012 Unsuitable extinguishing High volume water jot media is.2 Special hazards arising from the substance or mixture Specific hazards during None known, firefighting ls.3 Advice for firefighters ‘Special protective equipment: In the event of fire, wear self-contained breathing apparatus. for firefighters Further information Collect contaminated fire extinguishing water separately. This must not be discharged into drains, Fire residues and contaminated fire extinguishing water must be disposed of in accordance with local regulations. \6. Accidental release measures When the spilled material is cleaned up with an absorbant material, attention should be paid to the possibility of exothermic autooxidation (self ignition) in the presence of air, even at room temperature: store in the absence of air (e.g. in water) and send for incineration. (6.1 Personal precautions, protective equipment and emergency procedures Evacuate personnel to safe areas. Use personal protective equipment. Ensure adequate ventilation {6.2 Environmental precautions Do not flush into surface water or sanitary sewer system Prevent further leakage or spillage if safe to do so. If the product contaminates rivers and lakes or drains inform respective authorities. {6.3 Methods and materials for containment and cleaning up ‘Soak up with inert absorbent material (e.g. sand, silica gel, acid binder, universal binder, sawdust) Keep in suitable, closed containers for disposal \6.4 Reference to other sections For personal protection see section 8, For disposal considerations see section 13. [7. Handling and storage [7.1 Precautions for safe handling ‘Advice on safe handling ‘Avoid exposure - obtain special instructions before use, ‘Avoid contact with skin and eyes. For personal protection see section 8. 4124 MSDS_GB/ENSAFETY DATA SHEET according to Regulation (EC) No. 1907/2006 Vitamin A Palmitate 1.7 MIU/g (stabilized with 0418579 tocopherol) Version 5.1 Revision Date 09.09.2011 Print Date 15.02.2012 Dispose of rinse water in accordance with local and national regulations. Handle under inert gas. ‘Smoking, eating and drinking should be prohibited in the application area. ‘Advice on protection against: Take precautionary measures against static discharges. fire and explosion [7.2 Conditions for safe storage, including any Incompatibilities Requirements for storage Protect against light. areas and containers Keep under inert gas. Keep container tightly closed and dry, Prevent unauthorized access. Containers which are opened must be carefully resealed and kept upright to prevent leakage. Storage temperature < 15°C 17.3 Specific end uses Specific use(s) not applicable is. Exposure controls/personal protection '8.1 Control parameters Components | CAS-No. | Value] Control Update Basis parameters, retinyl 79-812 | TWA | 0,37 mgim3 DSM internal Limit palmitate ‘established for men TWA] 0,09 mgind DSM Internal Limit ‘established for women DNEL retinyl palmitate Skin contact, Workers Potential health effects: Systemic effects, long-term Value: 1,8 mgikg bwid Inhalation, Workers Potential health effects: Systemic effects, long-term Value: 0,55 mgim3 ( 8 h) PNEC retinyl palmitate Fresh waler: 0,1 mgfl Fresh water sediment: The equilibrium partitioning method is not applicable. 12h MSDS_GB/ENSAFETY DATA SHEET according to Regulation (EC) No. 1907/2006 Vitamin A Palmitate 1.7 MIU/g (stabilized with tocopherol) Version 5.1 Revision Date 09.09.2011 0418579 Print Date 15.02.2012| Marine water: 0,01 magil Marine sediment: The equilibrium partitioning method is not applicable. Soil: The equilibrium partitioning method is not applicable. Sewage treatment plant: 10 mgil {8.2 Exposure controls Personal protective equipment Respiratory protection In the case of vapour formation use a respirator with an approved filter. Hand protection Glove material: Nitrile rubber Consider the hazard characteristics of this product and any ‘special workplace conditions when selecting the appropriate type of protective gloves. Eye protection Safety glasses with side-shields ‘Skin and body protection Choose body protection according to the amount and concentration of the dangerous substance at the work place. Hygiene measures ‘Avoid contact with skin, eyes and clothing Wash hands before breaks and immediately after handling the product. \9. Physical and chemical properties {2.1 Information on basic physical and chemical properties Appearance oily liquid Colour yellow - brownish Odour characteristic (Odour Threshold No information available. pH no data available Melting pointrange ca. 26°C Flash point > 180°C Evaporation rate not determined Flammability (solid, gas) ‘The substance or mixture does not emit flammable gases in contact with water. Lower explosion limit, not determined Upper explosion limit not determined 6/24 MSDS_GB/ENSAFETY DATA SHEET according to Regulation (EC) No. 1907/2006 Vitamin A Palmitate 1.7 MIU/g (stabilized with 0418579 tocopherol) Version 5.1 Revision Date 09.09.2011 Print Date 15.02.2012 Vapour pressure <0,001 hPa (at 25 °C; calculated (citation from literature)) Relative vapour density not determined Density 0,92 gloms (at 20 °C) Water solubility <0,0001 mgil (25 °C; calculated (citation from iterature)) insoluble Solubility in other solvents Ethanol: slightly soluble Ether: soluble Peanut oll: soluble Partition coefficient: n- log Pow 15,5 ( 25 *C; calculated (citation from literature) ‘octanollwater Ignition temperature > 250°C Viscosity, dynamic not determined Explosive properties Not classified as explosive in the meaning of transport regulations. Oxidizing properties. Not oxidizing .2 Other information Molecular Weight 524,86 gimol [10. Stability and reactivity i10.1 Reactivity No hazards to be specially mentioned. [10.2 Chemical stability Stable under recommended storage conditions. 110.3 Possi lity of hazardous reactions In case of extensive air contact (e.g. soaked rags, moistened clothes) an exothermic. autoxidation (selF-igntion) is possible [10.4 Conditions to avoid Exposure to air. Heat, Exposure to ight. Exposure to moisture. [10.5 Incompatible materials Strong acids and strong bases Strong oxidizing agents Copper Copper alloys Iron Iron salts 7124 MSDS_GB/ENSAFETY DATA SHEET tocopherol) Version 5.1 according to Regulation (EC) No. 1907/2006 Vitamin A Palmitate 1.7 MIU/g (stabilized with 0418579 Revision Date 09.09.2011 Print Date 15.02.2012| [10.6 Hazardous decomposition products No decomposition if used as directed. Acute oral toxicity Skin corrosioniirrtation Serious eye damage/eye imitation Respiratory or skin sensitization Germ cell mutagenicity Genotoxicity in vitro Genotoxicity in vivo Teratogenicity STOT - single exposure STOT - repeated exposure [11. Toxicological information [11.1 Information on toxicological effects LD50 : > 2 500 mg/kg LDS0 : 6 060 mg/kg Mild skin irritation (OECD Test Guideline 404) no phototoxic skin reaction No eye irritation (OECD Test Guideline 405) Did not cause sensitization on laboratory animals, Maximisation Test, OECD Test Guideline 406) Test substance: active ingredient Did not cause sensitization. (Local Lymph Node Assay (LLNA), OECD Test Guideline 429) Tested with a similar product containing 1.5% dl-alpha-tocopherol no photoallergenic skin reaction not mutagenic not genotoxic ‘embryotoxic Teratogenic (several species) ‘The substance or mixture is not classified as specific target organ toxicant, single exposure. NOAEL : 1,43 - 3,32 mgikg bwid Test substance: retinyl acetate Sub-chronie toxicity study (90-day) 812i MSDS_GB/ENSAFETY DATA SHEET according to Regulation (EC) No. 1907/2006 Vitamin A Palmitate 1.7 MIU/g (stabilized with 0418579 tocopherol) Version 5.1 Revision Date 09.09.2011 Print Date 15.02.2012| Aspiration toxicity Further information Experience with human exposure Experience with human exposure: Ingestion No aspiration toxicity classification Danger of cumulative effects. May cause irritation of respiratory tract. RDA (Recommended Daily Allowance) 0,8 mg pure vitamin A (retinol) per day ‘established for men RDA (Recommended Daily Allowance) ca. 0,7 mg pure vitamin A (retinol) per day established for women ‘Acute overdose produces the following symptoms: Headache, Iritability, Tiredness, Drowsiness, Nausea, Vomiting, Signs of increased intracranial pressure, Generalized desquamation of the skin (after ca. 24 hours) [12. Ecological information 12.1 Toxicity Toxicity to fish Toxicity to algae Toxicity to bacteria [12.2 Persistence and degradability Biodegradabilty Leuciscus idus (Golden orfe) LC5O (96 h) > 10.000 maf ‘Test substance: retny! propionate (nominal concentration) (DIN 38412) Desmodesmus subspicatus (green algae) ErC50 (72h) 153 mgfl (nominal concentration) (DIN 38412) Erc10 (72h) 4,4 mgt (nominal concentration) activated sludge EC20 (0,5h) > 1.000 mgil (nominal concentration) (OECD Test Guideline 209) Not readily biodegradable. 40 - 50% (28 d) (OECD Test Guideline 301F) 9124 MSDS_GB/ENSAFETY DATA SHEET according to Regulation (EC) No. 1907/2006 Vitamin A Palmitate 1.7 MIU/g (stabilized with 0418579 tocopherol) Version 5.1 Revision Date 09.09.2011 Print Date 15.02.2012 112.3 Bioaccumulative potential Bioaccumulation Bioaccumulation is unlikely. Partition coefficient: n- log Pow 15,5 ( 25 °C ; calculated (citation from literature)) octanoliwater Distribution among ‘Adsorption, Soil environmental compartments log Koc 9,0 (calculated value) 112.5 Results of PBT and vPvB assessment Assessment This substance is not cansidered to be persistent, bioaccumulating nor toxic (PBT), This substance is not considered to be very persistent nor very bioaccumulating (vPVB). [12.6 Other adverse effects Additional ecological May cause long-term adverse effects in the aquatic information environment, lerations |13. Disposal con: [13.1 Waste treatment methods Product Organic materials (e.g. rags, paper, wood) which are soaked with this product can heat up and catch fire in the presence of air, even at room temperature: store in the absence of air (e.g in water) and send it for incineration. Discharge into the environment must be avoided. Do not contaminate ponds, waterways or ditches with chemical or used container. Do not dispose of waste into sewer. Offer surplus and non-recyclable solutions to a licensed disposal company. Contaminated packaging Dispose of as unused product. Do not re-use empty containers /14. Transport information 114.1 UN number ADR Not dangerous goods RID Not dangerous goods IMDG Not dangerous goods IATA Not dangerous goods 40724 MSDS_GB/ENSAFETY DATA SHEET according to Regulation (EC) No. 1907/2006 Vitamin A Palmitate 1.7 MIU/g (stabilized with tocopherol) Version 5.1 Revision Date 09.09.2011 0418579 Print Date 15.02.2012| 114.2 Proper shipping name ADR Not dangerous goods RID Not dangerous goods IMDG Not dangerous goods IATA Not dangerous goods [14.3 Transport hazard class ADR Not dangerous goods RID Not dangerous goods IMDG Not dangerous goods IATA Not dangerous goods 114.4 Packing group ADR Not dangerous goods RID Not dangerous goods IMDG Not dangerous goods IATA Not dangerous goods [14.5 Environmental hazards ADR Not dangerous goods RID Not dangerous goods IMDG Not dangerous goods IATA Not dangerous goods [14.6 Special precautions for user not applicable Not classified as dangerous in the meaning of transport regulations. [14.7 Transport in bulk according to Annex Il of MARPOL 73/78 and the IBC Code }15. Regulatory information 115.1 Safety, health and environmental regulationsilegislation speci for the substance or mixtui A724 MSDS_GB/ENSAFETY DATA SHEET according to Regulation (EC) No. 1907/2006 Vitamin A Palmitate 1.7 MIU/g (stabilized with 0418579 tocopherol) Version 5.1 Revision Date 09.09.2011 Print Date 15.02.2012 NFPA Classification Health hazard: 0 Fire Hazard: 1 Reactivity Hazard: 0 115.2 Chemical Safety Assessment retinyl palmitate: A Chemical Safety Assessment has been carried out for this substance. [16. Other information Full text of R-phrases referred to under sections 2 and 3 R38 Irritating to skin R43 May cause sensitization by skin contact. R53 May cause long-term adverse effects in the aquatic environment Ret May cause harm to the unborn child. Full text of H-Statements referred to under sections 2 and 3. H317 May cause an allergic skin reaction. H360D May damage the unborn child, 413 May cause long lasting harmful effects to aquatic life ‘The information provided in this Safety Data Sheet is correct to the best of our knowledge, information and belief at the date of its publication. The information given is designed only as a guidance for safe handling, use, processing, storage, transportation, disposal and release and is ot to be considered a warranty or quality specification. The information relates only to the specific material designated and may not be valid for such material used in combination with any other ‘materials or in any process, unless specified in the text ‘Abbreviations: 67/548/EEC= Dangerous Substances Directive. 1999/45/EC= Dangerous Preparations Directive, Regulation (EC) No. 1272/2008 Regulation on classification, labelling and packaging of substances and mixtures. DNEL= Derived No-Effect Level. PNEC= Predicted No-Erfe Concentration. NFPA= National Fire Protection Association. |ATA= International Air Transport Association. IMDG= Intemational Maritime Dangerous Goods. RID= International Rule for Transp of Dangerous Substances by Railway; ADR= European Agreement concerning the International Carriage of Dangerous Goods by Road. TWA= Time Weighted Average. STEL= Short term exposuy limit. 72124 MSDS_GB/ENSAFETY DATA SHEET according to Regulation (EC) No, 1907/2006 Vitamin A Palmitate 1.7 MIU/g (stabilized with tocopherol) Version 5.1 Revision Date 09.09.2011 0418579 Print Date 15.02.2012| |Annex Title of Exposure Scenario ES 1_| Formulation iquid ES2:_| Formulation solid ES 3:_| Private use of cosmetics and personal care products [Abbreviations |ART = Advanced REACH Tool IES = Exposure scenario PEC = Predicted exposure concentration IRCR = Risk characterisation ratio: "Level of Exposure/DNEL" or "PECIPNEC™ 73724 MSDS_GB/ENSAFETY DATA SHEET according to Regulation (EC) No. 1907/2006 Vitamin A Palmitate 1.7 MIU/g (stabilized with 0418579 tocopherol) Version 5.1 Revision Date 09.09.2011 Print Date 16.02.2012 IES 1: Formulation liquid 1. Scenario description Main User Groups SU 3: Industrial uses: Uses of substances as such or in preparations at industrial sites Sectors of end-use SU 10: Formulation Chemical product category C39: Cosmetics, personal care products Process categories PROC1: Use in closed process, no likelihood of exposure PROC2: Use in closed, continuous process with occasional controlled exposure PROC3: Use in closed batch process (synthesis or formulation) PROCS: Mixing or blending in batch processes for formulation of preparations and articles (multistage and/ or significant contact) PROG8a: Transfer of substance or preparation (charging! discharging) from/ to vessels/ large containers at non- dedicated facilities PROC8b: Transfer of substance or preparation (charging! discharging) from/ to vessels’ large containers at dedicated facilities PROCS: Transfer of substance or preparation into small containers (dedicated filling line, including weighing) PROC14: Production of preparations or articles by tabletting, compression, extrusion, pelletisation PROC15: Use as laboratory reagent Environmental Release Categories. : ERC2: Formulation of preparations [2.1 Contributing scenario controlling environmental exposure for: ERC2 [Product characteristics Viscosity, dynamic Very viscous Daily amount per site (Msafe) 11.250 kg Remarks. Msafe is the maximum amount of substance or product which may be used safely under the conditions defined in the environmental part of the exposure scenario. [Environment factors not influenced by risk management Dilution Factor (River) 10 Dilution Factor (Coastal Areas) 100 (Other given operational conditions affecting environmental exposure Emission or Release Factor: Air 2.5% Emission or Release Factor: Water : 2% Emission or Release Factor: Soil 0% [Technical conditions and measures / Organizational measures Air Exhaust ventilation equipped with scrubbers. Water All contaminated waste water must be processed in an industrial or municipal wastewater treatment plant that incorporates both primary and secondary treatments. Soil Avoid subsoil penetration. 1472t MSDS_GB/ENSAFETY DATA SHEET according to Regulation (EC) No. 1907/2006 Vitamin A Palmitate 1.7 MIU/g (stabilized with 0418579 tocopherol) Version 5.1 Revision Date 09.09.2011 Print Date 16.02.2012 (Conditions and measures related to municipal sewage treatment plant Type of Sewage Treatment Plant: Onsite sewage treatment plant, Municipal sewage treatment plant Flow rate of sewage treatment 2.000 maid plant effluent Sludge Treatment Can be landfilled o incinerated, when in compliance with local regulations. (Conditions and measures related to external treatment of waste for disposal Disposal methods Dispose of as hazardous waste in compliance with local and national regulations. [2.2 Contributing scenario controlling worker exposure for: PROC1, PROC2, PROC3, PROCS, PROC8a, PROC8b, PROCS, PROC14, PROC15 [Product characteristics Concentration of the Substance in: Covers the percentage of the substance in the product up to Mixture/Article 5%, Physical Form (at time of use) Liquid mixture, Low volatile liquid [Frequency and duration of use Frequency of use <= 8 hours/day (Other operational conditions affecting workers exposure Outdoor / Indoor Indoor use [Technical conditions and measures Handle substance within a predominantly closed system provided with extract ventilation. n and exposure (Organisational measures to prevent /limit releases, disper Ensure operatives are trained to minimise exposures. {Conditions and measures related to personal protection, hygiene and health evaluation Wear chemically resistant gloves (tested to EN374) in combination with specific activity training. (Effectiveness (of a measure): 95 %) Handle in accordance with good industrial hygiene and safety practice. Wash hands before breaks and immediately after handling the product. Smoking, eating and drinking should be prohibited in the application area. 3. Exposure estimation and reference to its source [Environment Contributing | Exposure] Specific | Compartment | Value | Level of Exposure | | RCR Scenario | Assessm | conditions ent ES) Method ERC2 | EUSES Fresh water <0,0007 mg _|~<0,007 ERC2 | EUSES Marine water <0,0008 mg | <0,08 ERC2 | EUSES ‘Sewage treatment < 10 mgil <1.0 plant Jorkers, 15 /2i MSDS_GB/ENtocopherol) Version 51 SAFETY DATA SHEET according to Regulation (EC) No. 1907/2006 Vitamin A Palmitate 1.7 MIU/g (stabilized with Revision Date 09.09.2011 0418579 Print Date 15.02.2012 Contributing Exposure Specific Value Level of RCR Scenario ‘Assessment | conditions Exposure Method PROCT, PROC2, | ECETOC | Worker | Dermal: longterm, | <= 0,034 mgikg 027 PROC3, PROCS, TRA (industrial), systemic bwid PROC8a, PROC8b, Worker PROCS, PROC14, (Professional) PROC15 see above ECETOC | Worker | Inhalation exposure 025 mgims 048 TRA (Industrial) see above ECETOC | Worker — | inhalation exposure | <= 0,050 mgim3 | <= 0,094 TRA ___| (Professional) EUSES = EUSES version 2.1.1 |4. Guidance to Downstream User to evaluate whether he works inside the boundaries set by the Exposure Scenario 16721 MSDS_GB/ENSAFETY DATA SHEET according to Regulation (EC) No. 1907/2006 Vitamin A Palmitate 1.7 MIU/g (stabilized with 0418579 tocopherol) Version 5.1 Revision Date 09.09.2011 Print Date 16.02.2012 IES 2: Formulation soli 1. Scenario description Main User Groups SU 3: Industrial uses: Uses of substances as such or in preparations at industrial sites Sectors of end-use SU 10: Formulation Chemical product category C39: Cosmetics, personal care products Process categories PROC1: Use in closed process, no likelihood of exposure PROC2: Use in closed, continuous process with occasional controlled exposure PROC3: Use in closed batch process (synthesis or formulation) PROCS: Mixing or blending in batch processes for formulation of preparations and articles (multistage and/ or significant contact) PROG8a: Transfer of substance or preparation (charging! discharging) from/ to vessels/ large containers at non- dedicated facilities PROC8b: Transfer of substance or preparation (charging! discharging) from/ to vessels’ large containers at dedicated facilities PROCS: Transfer of substance or preparation into small containers (dedicated filling line, including weighing) PROC14: Production of preparations or articles by tabletting, compression, extrusion, pelletisation PROC15: Use as laboratory reagent Environmental Release Categories. : ERC2: Formulation of preparations [2.1 Contributing scenario controlling environmental exposure for: ERC2 [Product characteristics Daily amount per site (Msafe) 11.250 kg Remarks. Msafe is the maximum amount of substance or product which may be used safely under the conditions defined in the environmental part of the exposure scenario. [Environment factors not influenced by risk management Dilution Factor (River) 10 Dilution Factor (Coastal Areas) 100 (Other given operational conditions affecting environmental exposure Emission or Release Factor: Air 2.5% Emission or Release Factor: Water : 2% Emission or Release Factor: Soil 0% [Technical conditions and measures / Organizational measures Air Exhaust ventilation equipped with filters. Water All contaminated waste water must be processed in an industrial or municipal wastewater treatment plant that incorporates both primary and secondary treatments, Soil Avoid subsoil penetration, (Conditions and measures related to municipal sewage treatment plant 17724 MSDS_GB/ENSAFETY DATA SHEET according to Regulation (EC) No. 1907/2006 Vitamin A Palmitate 1.7 MIU/g (stabilized with 0418579 tocopherol) Version 5.1 Revision Date 09.09.2011 Print Date 16.02.2012 ‘Type of Sewage Treatment Plant: Onsite sewage treatment plant, Municipal sewage treatment plant Flow rate of sewage treatment 2.000 maid plant effluent Sludge Treatment Can be landfilled or incinerated, when in compliance with loca) regulations (Conditions and measures related to external treatment of waste for disposal Disposal methods Dispose of as hazardous waste in compliance with local and national regulations. i2.2 Contributing scenario controlling worker exposure for: PROC1, PROC2, PROC3, PROC15 Product characteristics Concentration of the Substance in: Covers the percentage of the substance in the product up to Mixture/Article 5%, Physical Form (at time of use) Solid, high dustiness [Frequency and duration of use Frequency of use <= 8 hours/day {Other operational conditions affecting workers exposure Outdoor / Indoor Indoor use [Technical conditions and measures None. (Organisational measures to prevent ilimit releases, dispersion and exposure Ensure operatives are trained to minimise exposures. {Conditions and measures related to personal protection, hygiene and health evaluation Wear chemically resistant gloves (tested to EN374) in combination with specific activity training. (Effectiveness (of a measure): 95 %) Handle in accordance with good industrial hygiene and safety practice. Wash hands before breaks and immediately after handling the product. Smoking, eating and drinking should be prohibited in the application area 12.3 Contributing scenario controlling worker exposure for: PROC5, PROC8a, PROC8b, PROC, PROC14 Product characteristics Concentration of the Substance in: Covers the percentage of the substance in the product up to Mixture/Article 5%, Physical Form (at time of use) Solid, high dustiness [Frequency and duration of use Frequency of use <= 8 hours/day (Other operational conditions affecting workers exposure (Outdoor / Indoor Indoor use [Technical conditions and measures Provide appropriate exhaust ventilation at places where dust is formed. (Effectiveness (of a measure): 90%) 18721 MSDS_GB/ENtocopherol) Version 51 application area. SAFETY DATA SHEET according to Regulation (EC) No. 1907/2006 Vitamin A Palmitate 1.7 MIU/g (stabilized with Revision Date 09.09.2011 0418579 Print Date 15.02.2012 (Organisational measures to prevent /limit releases, dispersion and exposure Ensure operatives are trained to minimise exposures. {Conditions and measures related to personal protection, hygiene and health evaluation Wear chemically resistant gloves (tested to EN374) in combination with specific activity training. (Effectiveness (of a measure): 95 %) Handle in accordance with good industrial hygiene and safety practice. Wash hands before breaks and immediately after handling the product. Smoking, eating and drinking should be prohibited in the Environment 3. Exposure estimation and reference to its source Conitributing [Exposure] Specific | Compartment | Value | Level of Exposure | CR Scenario | Assessm | conditions ent (GEC) Method ERC2 | EUSES Fresh water <0,0007 mail| = 0,007 ERC2__| EUSES Marine water ~0,0008 maf 0,08 ERC2 | EUSES ‘Sewage treatment < 10 mgil <1,0 plant jorkers Contributing Exposure | Specific Value Level of RCR ‘Scenario Assessment | conditions Exposure Method PROCT, PROCZ, | ECETOC | Worker | Dermal: longterm, | <0,004mgikg | <= 0,004 PROC3, PROCIS | TRA (Industrial), systemic wid Worker Professional PROCT, PROC2, | ECETOC | Worker | Inhalation exposure | <=0,.25mgim3 | <=046 PROC3,PROCI5 | TRA | (Industrial), Worker Professional) PROCS, PROCBa, | ECETOC | Worker | Dermal: longterm, | <= 0,034 mgikg PROC8b, PROCS, | TRA (Industrial), systemic bwid PROCI4 Worker Professional PROCS, PROCBa, | ECETOC | Worker | Inhalalion exposure | <=0,25mgima | <=0,46 PROC8b, PROCS, | TRA | (Industrial), PROC14 Worker Professional EUSES = EUSES version 2.1.1 |4. Guidance to Downstream User to evaluate whether he works inside the boundaries set by the Exposure Scenario 19721 MSDS_GB/ENSAFETY DATA SHEET according to Regulation (EC) No. 1907/2006 Vitamin A Palmitate 1.7 MIU/g (stabilized with 0418579 tocopherol) Version 5.1 Revision Date 09.09.2011 Print Date 16.02.2012 IES 3: Private use of cosmetics and personal care products 1. Scenario description Main User Groups SU 21: Consumer uses: Private households (= general public sonsumers) Sectors of end-use ‘SU 21: Consumer uses: Private households (= general public sonsumers) Chemical product category C39: Cosmetics, personal care products Environmental Release Categories: ERC8a: Wide dispersive indoor use of processing aids in open systems, [2.1 Contributing scenario controlling environmental exposure for: ERC8a Product characteristics Viscosity, dynamic not determined |Amount used ‘Annual amount for wide disperse toot uses Remarks amount used for the exposure estimation [Frequency and duration of use Continuous exposure 365 daysiyear [Environment factors not influenced by risk management Dilution Factor (River) 10 Dilution Factor (Coastal Areas) 100 {Other given operational conditions affecting environmental exposure Continuous use/release Number of emission days per year : 365 Emission or Release Factor: Water : 90% {Conditions and measures related to municipal sewage treatment plant ‘Type of Sewage Treatment Plant Municipal sewage treatment plant Flow rate of sewage treatment 2.000 maid plant effluent Sludge Treatment Can be applied on agricultural soil, when in compliance with local regulations. 12.2 Contributing scenario controlling consumer exposure for: PC39 Frequency and duration of use Frequency of use 365 daysiyear Remarks. Continuous use/release \3. Exposure estimation and reference to its source Environment Exposure Level of Exposure | | RCR Assessm Specific conditions Contributing Scenario ‘Compartment Value 20724 MSDS_GB/ENSAFETY DATA SHEET according to Regulation (EC) No. 1907/2006 Vitamin A Palmitate 1.7 MIU/g (stabilized with 0418579 tocopherol) Version 5.1 Revision Date 09.09.2011 Print Date 16.02.2012 ent (PEC) Method ERG8a__| EUSES Fresh water 0.13E-06 mg | 0.000001 ERC&a__| EUSES Marine water 0,15 E-06 mall | 0,000015) ERC8a__| EUSES ‘Sewage treatment 0,0079 mg | 0,00019 plant Risk to consumers’ health does not need to be assessed as this is already covered by the Cosmetic Directive 76/768/EEC. EUSES = EUSES version 2.1.1 |4. Guidance to Downstream User to evaluate whether he works inside the boundaries set by the Exposure Scenario 2i/24 MSDS_GB/EN