Sicherheitsdatenblatt gemäß Verordnung (EG) Nr. 1907/ PDF

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Seite 1 von 33 ANNEX: EXPOSURE ASSESSMENT Note on exposure assessments. Because both the concentrations in sediment (PEC sed ) and the no effect concentration in sediment (PNEC sed ) are calculated by

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Seite 1 von 33 ANNEX: EXPOSURE ASSESSMENT Note on exposure assessments. Because both the concentrations in sediment (PEC sed ) and the no effect concentration in sediment (PNEC sed ) are calculated by the partitioning method, the RCR for the sediment will be identical to the RCR for the water compartment(s). For this reason, exposure calculations for the sediment compartment have not been documented separately. 1 TITLE: EXPOSURE SCENARIO FOR INDUSTRIAL MANUFACTURING OF, OR USE AS INTERMEDIATE OR PROCESS CHEMICAL SU3, SU8, SU9 PROC1, PROC2, PROC3, PROC4, PROC8a, PROC8b ERC1, ERC4, ERC6A Covers the industrial manufacture of Ethanol at controlled manufacturing plants in continuous and batch processes. Includes recycling/ recovery, material transfers, filling, storage, maintenance and loading, sampling and use as an intermediate or process chemical. Assessment Method Ecetoc TRA integrated model version 2, EUSES v Exposure Scenario Operational conditions and measures Process categories: Continuous process in high integrity contained systems with little potential for exposure (sampling via closed loop system) and continuous process not specifically aimed at minimizing emissions. Occasional exposure possible through e.g. maintenance and sampling. Sampling, loading, filling, storage and transfer under controlled conditions at the manufacturing site is also included. Environmental categories: Manufacture, and industrial use as intermediate or process chemical of organic substances using continuous processes or batch processes applying dedicated or multi-purpose equipment, either technically controlled or operated by manual interventions Control of workers exposure Product characteristic (including package design affecting exposure) Amounts used Human factors not influenced by risk management affecting workers exposure Technical conditions and measures to control dispersion from source towards the worker Organisational measures to prevent /limit s, dispersion and exposure Vapour pressure of substance 5,73 kpa n.a. in tier1 TRA model Frequency of exposure (weekly) Frequency of exposure (annual) Duration of exposure Potentially exposed body parts Exposed skin surface 4 Days/week 240 Days/year 4 Hours/day Two hands face side only (automated processes/proc1, 2) Two hands (transfer, filling, etc./proc8a,b) 480 cm 2 (automated processes/proc1, 2, 3,4) 960 cm 2 (transfer, filling, etc./proc8a,b) Assumes a good basic standard of occupational hygiene is implemented. Setting (indoor/outdoor) Outdoor No specific technical prevention measures required for process in high integrity contained systems with little potential for exposure or with only occasional minor exposure through e.g. maintenance and sampling. Ventilation Efficiency rate 95 % None required Handle substances within a predominantly closed system. Ensure material transfers are under containment or extract ventilation. No specific organizational measures required for processes in high integrity contained systems with little potential for exposure or with only occasional minor exposure through e.g. maintenance and sampling.provide extract ventilation to points where emissions occur. Wear suitable gloves tested to EN374 during the activities where skin contact is possible. Seite 2 von 33 personal protection, hygiene and health evaluation PPE: Respiratory Protection - not required for normal operations PPE: Eye Protection suitable eye protection should be worn when handling product if there is a risk of splashing Control of environmental exposure Annually at point source 400,000 t/year (maximum plant size, worst case) 4,600,000 t/year total market use Pattern of Continuous 350 days per year Technical onsite conditions and measures to reduce or limit discharges, air emissions and s to soil Organizational measures to prevent/limit from site 18,000m3/day (default) Indoor and/or outdoor Keep containers tightly closed. Store in a bounded area. Do not discharge into sewers or drains. Use appropriate emission abatement equipment from LEV systems if required by local legislation. Waste product and empty containers should be disposed of as hazardous waste in accordance with all local and national regulations Apply technical measures aiming at reducing s to air (containment by preference or catalytic or thermal gas oxidation) Apply technical measures aiming at reduction and cleaning of waste water (WWTP /local STP (e.g. biological treatment)) Do not wastewater directly into environment Size of STP Degradation efficacy Sludge treatment Efficacy 70% (for ethanol) Efficacy 87% (for ethanol) Wastewater into local or municipal STP. = 2000 m 3 /day 90% (for ethanol) Disposal or recovery treatment of waste Hazardous waste incineration or dispose for use in recycled fuels 1.2. Exposure estimation Workers exposure estimation is calculated with Ecetoc TRA model v2.. Below given exposure estimates are based on the PROC with the highest exposure levels in this scenario (PROC8a). Workers exposure Exposure estimate DNEL Comment Inhalation (mg/m 3 ) (OEL) PROC 8a results in the highest exposure in this Dermal (mg/kd/day) exposure scenario Combined (mg/kg/day) Environmental exposure estimation is calculated with EUSES 2.0 model. Ethanol is fully soluble in water, readily biodegradable, not bio-accumulative, does not accumulate in the sediments or soil and is assumed to degrade by 90% in the local and/or municipal STP under evaluated conditions. Release times per year (day/year) 350 Local to air (kg/day) Fraction used at main local source Local to waste water (kg/day) 11.3 Amount used locally (kg/day) 0 Local to soil (kg/day) 0 In STP / untreated wastewater(mg/l) In local freshwater (mg/l) 0, ,96 - In local soil (mg/kg) 0,63 (mg/kgwwt) - In local marine water (mg/l) 0, ,79 - Total daily intake via local environment Negligible compared to daily dietary intake and endogenous formation. Seite 3 von 33 Guidance to DU to evaluate whether he works inside the boundaries set by the ES The workers exposure and environmental emissions have been evaluated using Ecetoc TRA integrated tool version 2 and EUSES v2.0 respectively. If the local environmental emission conditions deviate significantly from the used default values, please use the algorithm below to estimate the correct local emissions and RCRs: PECcorrected = PECcalculated * (local emission fraction) * (local WWTP flow rate fraction) * (local river flow rate fraction) * (local STP efficiency fraction) Example for calculating your local freshwater PEC: Corrected local freshwater PEC = 0, * (your local emission [kg/day] / 350) * (2000 / your local WWTP flow rate [m3/day]) * (18000 / your local river flow rate [m3/day]) * ((1 your local WWTP efficiency)/0.1) Note: The measures reported in this section have not been taken into account in the exposure estimates related to the exposure scenario above. They are not subject to obligation laid down in Article 37 (4) of REACH exposure beyond the level estimated based on the exposure scenario when possible. 2 TITLE: EXPOSURE SCENARIO FOR INDUSTRIAL DISTRIBUTION OF SU3, SU8, SU9 PROC8a, PROC8b, PROC9 ERC2 Assessment Method Ecetoc TRA integrated model version 2 Covers transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non-dedicated and dedicated facilities, loading (including marine vessel/barge, rail/road car and IBC loading), storage, and repacking (including drums and small packs) of substance, including its distribution. Intended for e.g. traders, distributors, transporters, etc. 2.1 Exposure Scenario Operational conditions and measures Process categories: Sampling, loading, filling, transfer, drumming, bagging in non-dedicated facilities. Exposure related to vapour, aerosols or spillage, and cleaning of equipment to be expected. Environmental category: Mixing, blending, diluting, transferring, filling, drumming and distributing activities of substances in all types of drumming, distribution and trading industry. Also includes drumming, filling and distribution activities in formulating industries, such as paints and do-it-yourself products, pigment pastes, fuels, household products (cleaning products), cosmetics, lubricants etc Control of workers exposure Product characteristic (including package design affecting exposure) Amounts used Human factors not influenced by risk management affecting workers exposure Technical conditions and measures to control dispersion from source Vapour pressure of substance 5,73 kpa n.a. in tier1 TRA model Frequency of exposure (weekly) Frequency of exposure (annual) Duration of exposure Potentially exposed body parts 4 Days/week 240 Days/year 4 Hours/day Two hands Exposed skin surface 960 cm 2 Assumes a good basic standard of occupational hygiene is implemented. Setting (indoor/outdoor) No specific technical prevention measures required Outdoors If indoors Outdoor or in ventilated (open) spaces Provide a good standard of general or Seite 4 von 33 towards the worker Organisational measures to prevent /limit s, dispersion and exposure personal protection, hygiene and health evaluation Control of environmental exposure controlled ventilation (5 to 15 air changes per hour). Ensure material transfers are under containment or extract ventilation. Provide good ventilation to points where emissions occur. Wear suitable gloves tested to EN374 during the activities where skin contact is possible. PPE: Eye Protection suitable eye protection should be worn when handling product if there is a risk of splashing. Annually at point source 75,000 t/year (worst case scenario, at point source) 3,800,000 t/year total market use Pattern of 300 days per year Organizational measures to prevent/limit from site 18,000m3/day (default) Outdoor Keep containers tightly closed. Store in a bounded area. Do not discharge into sewers or drains. Waste product and empty containers should be disposed of as hazardous waste in accordance with all local and national regulations Do not wastewater directly into environment Size of STP Degradation efficacy Sludge treatment Wastewater into local or municipal STP. 2000 m 3 /day 90% (for ethanol) Disposal or recovery treatment of waste Hazardous waste incineration or dispose for use in recycled fuels 2.2. Exposure estimation Workers exposure estimation is calculated with Ecetoc TRA model v2.. Below given exposure estimates are based on the PROC with the highest exposure levels in this scenario (PROC8a). Workers exposure Exposure estimate DNEL Comment Inhalation (mg/m 3 ) (OEL) PROC 8a results in the highest exposure in this Dermal (mg/kd/day) exposure scenario Combined (mg/kg/day) Environmental exposure estimation is based on Ecetoc TRA model v2 including the data from TGD A&B tables (MC-Ib, IC-2, UC- 48, fraction main source 0,1) and based on the worst-case scenario with point-source production volume of 15,000 tpa. Ethanol is fully soluble in water, readily biodegradable, not bio-accumulative, does not accumulate in the sediments or soil and is assumed to degrade for 90% in the local and/or municipal STP under evaluated conditions. Release times per year (day/year) 300 Local to air (kg/day) 50 Fraction used at main local source 0.1 Local to waste water (kg/day) 15 Amount used locally (kg/day) 5000 Local to soil (kg/day) 1 In STP / untreated wastewater(mg/l) In local freshwater (mg/l) 0,52 0,96 - In local soil (mg/kg) 0,63 (mg/kgwwt) - In local marine water (mg/l) 0,0515 0,79 - Total daily intake via local environment Negligible compared to daily dietary intake and endogenous formation. Seite 5 von 33 Guidance to DU to evaluate whether he works inside the boundaries set by the ES The workers exposure and environmental emissions have been evaluated using Ecetoc TRA integrated tool version 2 and EUSES v2.0 respectively. If the local environmental emission conditions deviate significantly from the used default values, please use the algorithm below to estimate the correct local emissions and RCRs: PECcorrected = PECcalculated * (local emission fraction) * (local WWTP flow rate fraction) * (local river flow rate fraction) * (local STP efficiency fraction) Example for calculating your local freshwater PEC: Corrected freshwater PEC = 0,104 * (your local emission [kg/day] / 15) * (2000 / your local WWTP flow rate [m3/day]) * (18000 / your local river flow rate [m3/day]) * ((1 your local WWTP efficiency)/0.1) Note: The measures reported in this section have not been taken into account in the exposure estimates related to the exposure scenario above. They are not subject to obligation laid down in Article 37 (4) of REACH exposure beyond the level estimated based on the exposure scenario when possible. 3 TITLE: EXPOSURE SCENARIO FOR INDUSTRIAL FORMULATION AND (RE)PACKING OF, AND ITS MIXTURES SU3, SU10 PROC3, PROC5, PROC8a, PROC8b, PROC9, PROC14 ERC 2 Covers industrial formulation, packing and re-packing of the substance and its mixtures in batch or continuous operations, including storage, materials transfers, mixing, large and small scale packing, maintenance. Includes formulation of fuels containing ethanol. Assessment Method Ecetoc TRA integrated model version 2, EUSES v Exposure Scenario Operational conditions and measures Process category: Manufacture or formulation of chemical products or articles using technologies related to mixing and blending of solid or materials, and where the process is in stages and provides the opportunity for significant contact at any stage. Filling lines specifically designed to both capture vapour and aerosol emissions and minimise spillage. Sampling, loading, filling, transfer, dumping, bagging in non-dedicated and dedicated facilities with possible exposure related to dust, vapour, aerosols or spillage, and cleaning of equipment. Environmental category: Manufacture of organic and inorganic substances in chemical, petrochemical, primary metals and minerals industry including intermediates, monomers using continuous processes or batch processes applying dedicated or multipurpose equipment, either technically controlled or operated by manual interventions Control of workers exposure Product characteristic (including package design affecting exposure) Amounts used Human factors not influenced by risk management Vapour pressure of substance 5,73 kpa n.a. in tier1 TRA model Frequency of exposure (weekly) Frequency of exposure (annual) Duration of exposure Potentially exposed body parts Exposed skin surface 4 Days/week 240 Days/year 4 Hours/day Two hands face side only (automated processes/proc3) Two hands (transfer, filling, etc./proc8a,b) 480 cm 2 (automated processes/proc3) 960 cm 2 (transfer, filling, etc./proc8a,b) affecting workers exposure Assumes a good basic standard of occupational hygiene is implemented. Setting (indoor/outdoor) Indoors Seite 6 von 33 Technical conditions and measures to control dispersion from source towards the worker Ensure material transfers are under containment or extract ventilation. Provide good ventilation to points where emissions occur. Provide a good standard of general or controlled ventilation (5 to 15 air changes per hour). Organisational measures to prevent /limit s, dispersion and exposure personal protection, hygiene and health evaluation Control of environmental exposure Wear suitable gloves tested to EN374 during the activities where excessive skin contact is possible. PPE: Eye Protection suitable eye protection should be worn when handling product if there is a risk of splashing. Annually at point source 280,000 t/year (maximum at point source in worst case) 3,800,000 t/year use Pattern of Continuous 300 days per year Technical onsite conditions and measures to reduce or limit discharges, air emissions and s to soil 18,000m3/day (default) Indoor Keep containers tightly closed. Store in a bounded area. Do not discharge into sewers or drains. Waste product and empty containers should be disposed of as hazardous waste in accordance with all local and national regulations. Formulation activity is assumed to be a predominantly enclosed process. Apply technical measures aiming at reduction and cleaning of waste water (WWTP/local STP (e.g. biological treatment)) Efficacy 90% Organizational measures to prevent/limit from site Do not wastewater directly into environment Size of STP Degradation efficacy Sludge treatment Wastewater into municipal STP. 2000 m 3 /day 90% (for ethanol) Disposal or recovery treatment of waste Hazardous waste incineration or dispose for use in recycled fuels 3.2. Exposure estimation Workers exposure estimation is calculated with Ecetoc TRA model v2.. Below given exposure estimates are based on the PROC with the highest exposure levels in this scenario (PROC8a). Workers exposure Exposure estimate DNEL Comment Inhalation (mg/m 3 ) PROC 8a results in the highest exposure in this Dermal (mg/kd/day) exposure scenario Combined (mg/kg/day) Environmental exposure estimation is based on Ecetoc TRA model v2 including the data from TGD A&B tables (MC-Ib, IC-9, UC- 27, fraction main source 0,1) and based on the worst-case scenario. Ethanol is fully soluble in water, readily biodegradable, not bio-accumulative, does not accumulate in the sediments or soil and is assumed to degrade by 90% in the local and/or municipal STP under evaluated conditions. Release times per year (day/year) 300 Local to air (kg/day) 469 Fraction used at main local source 0.1 Local to waste water (kg/day) 28 Amount used locally (kg/day) Local to soil (kg/day) 9 Seite 7 von 33 In STP / untreated wastewater(mg/l) In local freshwater (mg/l) 0,185 0,96 - In local soil (mg/kg) 0,63 (mg/kgwwt) - In local marine water (mg/l) 0,0186 0,79 - Total daily intake via local environment Negligible compared to daily dietary intake and endogenous formation. Guidance to DU to evaluate whether he works inside the boundaries set by the ES The workers exposure and environmental emissions have been evaluated using Ecetoc TRA integrated tool version 2. If the local environmental emission conditions deviate significantly from the used default values, please use the algorithm below to estimate the correct local emissions and RCRs: PECcorrected = PECcalculated * (local emission fraction) * (local WWTP flow rate fraction) * (local river flow rate fraction) * (local STP efficiency fraction) Example for calculating your local freshwater PEC: Corrected local freshwater PEC = 0,185 * (your local emission [kg/day] / 28) * (2000 / your local WWTP flow rate [m3/day]) * (18000 / your local river flow rate [m3/day]) * ((1 your local WWTP efficiency)/0.1) Note: The measures reported in this section have not been taken into account in the exposure estimates related to the exposure scenario above. They are not subject to obligation laid down in Article 37 (4) of REACH exposure beyond the level estimated based on the exposure scenario when possible. 4 TITLE: EXPOSURE SCENARIO FOR INDUSTRIAL USE OF IN NON- SPRAY APPLICATIONS SU3 PROC10, PROC13 ERC4 Assessment Method Ecetoc TRA integrated model version 2 Covers industrial (end) use of ethanol as such or in preparations in nonspray application (e.g. as processing aid, cleaning agent, solvent or ingredient in coatings). Indoor roller application, brushing and treatment of surfaces, treatment of articles by dipping/ pouring/ immersing/ soaking, etc. 4.1 Exposure Scenario Operational conditions and measures Process category: Low energy spreading of e.g. coatings. Including cleaning of surfaces. Substance can be inhaled as vapours, skin contact can occur through droplets, splashes, working with wipes and handling of treated surfaces. Immersion operations. Treatment of articles by dipping, pouring, immersing, soaking, washing out or washing in substances; including cold formation or resin type matrix. Includes handling of treated objects (e.g. after dying, plating,). Substance is applied to a surface by low energy techniques such as dipping the article into a ba
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