C.I. Pigment Yellow 34

Transcription

1 9.6. Exposure scenario 6: Formulation - Distribution and mixing pigment powder in an industrial environment into liquid or solid premix to colour plastic/plasticised articles. Pigment choice depends on product specifications on visibility, colour, heat stability, durability and Regulations Market sector: Colouration of plastic or plasticised articles Distribution and formulation (compounding) of C.I. Pigment Yellow 34 and C.I. Pigment Red 104 powder in an industrial environment into a solid or liquid premix with other additives (masterbatch) to be used in the conversion process for the colouration of plastic or plasticised articles for non-consumer use. Examples of articles are technical specialty parts, canvas for truck trailer covers, safety covers on agricultural equipment, hot melt road marking, safety signage, safety helmets, medical waste containers, etc. The high quality of the pigments is crucial for the long-term integrity of the plastic material and the functioning of the article. The choice for these pigments is based on end product specifications and requirements related to: VISIBILITY AND SAFETY - Based on their bright, vivid, durable colours, these pigments are often used when visibility and safety play an important role, in particular in regulated applications, e.g. hot melt road marking; DURABILITY - The pigments respond to the demand for high performance pigments, e.g. in aggressive atmospheric conditions in industrialized areas, providing excellent light and weather fastness, preventing applications to darken or fade if exposed to light and humidity; excellent resistance to sulfur dioxide, preventing discolouration (greyness) as required for exterior applications; SHADE FUNCTIONALITY - The pigments provide colour, covering a wide range from green to red shade yellow and yellow to blue shade red; COLOURISTIC AND TECHNICAL PERFORMANCE - Within the mentioned colour range, these pigments provide clean, vivid colours (chroma); excellent opacity or hiding power; excellent weather fastness; superior dispersion properties and high heat stability for processing in high temperature matrices. These pigments also provide excellent non-migration properties in plastics. PC 32: Polymer Preparations and Compounds; PC 34: Textile dyes, finishing and impregnating products; including bleaches and other processing aids Environment contributing scenario(s): Distribution and mixing pigment powder in an industrial environment into a premix or pre-compound to add colour to plastic or plasticised articles Worker contributing scenario(s): ERC 3 Delivery, storage and handling of closed paper bags with pigment powder PROC 3 Pigment powder quality control / lab work PROC 15 Manual dosing of pigment powder Automated dosing of pigment powder PROC 8a PROC 8b Mixing of pigment with resins and additives to form a liquid pre-mix/pre-compound PROC 5 Storage of premix/pre-compound / Transfer of pre-mix/pre-compound through closed piping Premix/pre-compound charging/discharging by gravity or manual handling Premix/pre-compound charging/discharging using a dedicated installation PROC 2 PROC 8a PROC 8b Premix/pre-compound filling into drums/cans at a filling line PROC 9 Manual cleaning / scraping of mixing vessels, equipment and lids PROC 21 Cleaning of vessel with resin PROC 10 Premix/pre-compound quality control / lab work PROC 15 Production of coloured plastic granules or masterbatch by extrusion, compression and/or pelletisation PROC CSR-PI CHEMICAL SAFETY REPORT 259

2 Mixing pigment powder or premix/pre-compound into matrix in closed mixing vessel PROC 3 Production of plastic articles by extrusion, injection moulding and other processes PROC 14 Quality control / lab work with coloured plastics PROC 15 Handling of articles and single coloured granules PROC 21 Handling of mixed coloured granules and articles PROC 21 Transfer of articles and single coloured granules Transfer of articles and single coloured granules Transfer of mixed coloured granules and articles Transfer of mixed coloured granules and articles Pigment powder dosing before mixing PROC 8a PROC 8b PROC 8a PROC 8b PROC 8b Mixing of pigment powder with other solid additives PROC 3 Filling of small packages with pigment powder PROC 9 Manual handling of pigment contained in small sealed plastic bags (<1 kg) PROC 1 Pigment powder manual cleaning, wiping, scraping etc. PROC 19 Description of the activities and technical processes covered in the exposure scenario: Pigment powders are typically delivered by truck in bags on pallets. The pallets are stored inside. Order picking is usually performed manually, internal transport with hand pallet truck or forklift. Some formulators only repack into sealed plastic sachets with precautionary measures in place. The bags as delivered by the supplier are cut manually or automated and the contents are emptied into a hopper that is connected to an automated filling machine to fill and seal the plastic sachets. In a next formulation step the sealed sachets are manually added to a large volume of hotmelt mixture. A colour matrix (liquid or solid) consists of a mixture of resins, additives and up to 70% pigments, usually prepared in dedicated equipment. Dosing of pigment powder is done manually or automated by cutting the bags and emptying the contents into a hopper or directly into mixing vessels and blenders in order to generate a premix or precompound. The mixing vessels and blenders at this stage normally contain other resins and additives required to complete the formulation. Mixing is done in vessels of varying sizes. The surface area of the mixing vessels varies and is between 1-3 m2 for the smaller containers and over 3 m2 for the large containers. After premixing the colour premix or precompound is then normally processed further such as packing for use or dispersed further using appropriate equipment such as extruders, three roll mills, beadmills etc. The vessels are closed during the mixing and dispersing operations. At the end of the process the final colour matrix has been dispersed and mixed to achieve the required specification in terms of colour strength, hiding power/opacity, colour shade, brightness/chroma. The pigment as such is fully embedded in the matrix. Subsequent in plant process steps may be to mix the final colour matrix with other colour matrices or further diluting the product with resins and additives to form plastic or road marking compounds. Several processing techniques can be used such as tableting, compression, extrusion, pelletisation etc. This secondary processing takes place in an industrial environment for products for industrial and non-consumer use. During processing, local exhaust ventilation is present and good housekeeping practices are followed. The mixing room is ventilated by means of good natural ventilation or by mechanical room ventilation. For quality control purposes a sample can be taken from the coloured liquid or solid matrix. Powdered pigment is used during Quality Control and product development in small quantities inside fume cupboards. An operator, formulating a full day, typically handles 1,000 kg of pigment powder per shift. During activities where exposure to pigment powder is to be expected the workers use respiratory protection, a coverall, gloves and goggles. Equipment is cleaned using solvents or resins as needed. The subsequent material is then dosed into a product, or collected and recycled or treated as hazardous waste. No water is used to clean mixing vessels, piping and other equipment. Spills are collected, using absorbent if needed, the material is disposed of as hazardous waste. If water is used during cleanup of spills, it is collected and disposed of as hazardous waste. Emptied bags of pigment powder are collected and disposed of as hazardous waste. The production area is a contained area with liquid-proof floors CSR-PI CHEMICAL SAFETY REPORT 260

3 Environmental contributing scenario 1: Distribution and mixing pigment powder in an industrial environment into a premix or pre-compound to add colour to plastic or plasticised articles Conditions of use Product (article) characteristics Correction for Pb content of pigment (60%): Correction applicable (The pigment contains 60% lead) [Effectiveness Water: 40%; Air: 40%] Correction for water solubility of Pb in pigment (10%): Correction applicable (Transformation/dissolution tests were carried out with the pigment. Based on the results of these tests, 10% dissolution is applied as a worst-case.) [Effectiveness Water: 90%] Amount used, frequency and duration of use (or from service life) Daily use at site: <= 4 tonnes/day Worst-case tonnage per site per day based on formulators questionnaire Annual use at a site: <= 800 tonnes/year Worst-case tonnage per site per year based on formulators questionnaire Percentage of tonnage used at regional scale: = 100 % Emission days per year: = 200 days/year Number of emission days per year used for worst-case volume calculations Technical and organisational conditions and measures Waste water treatment: If any process waste water is generated, this should be treated as hazardous waste In general, no water is used in the process. If any process waste water is generated, this should be treated as hazardous waste and should not be released to the waste water leaving the site. Relevant RMM to achieve emission reduction to air: Direct air emissions should be reduced by implementing RMM To reduce the emissions to air, one or more of the following RMM may be applied: Fabric or bag filters Wet scrubbers Electrostatic precipitators Wet electrostatic precipitators Cyclones as primary collector Ceramic and metal mesh filters Conditions and measures related to sewage treatment plant Municipal STP: Yes [Effectiveness Water: 100%] Discharge rate of STP: >= 2E3 m3/d Application of the STP sludge on agricultural soil: Yes Conditions and measures related to treatment of waste (including article waste) Particular considerations on the waste treatment operations: No (low risk) (ERC based assessment demonstrating control of risk with default conditions. Low risk assumed for waste life stage. Waste disposal according to national/local legislation is sufficient.) Other conditions affecting environmental exposure Receiving surface water flow rate: >= 1.8E4 m3/d Releases The local releases to the environment are reported in the following table CSR-PI CHEMICAL SAFETY REPORT 261

4 Table 124. Local releases to the environment Release Water Air Soil Release factor estimation method Release factor (Site-specific information) Release factor (SpERC Eurometaux 2.2a.v2.1 ) Release factor (SpERC Eurometaux 2.2a.v2.1 ) Explanation / Justification Initial release factor: 0% Final release factor: 0% Local release rate: 0 kg/day Explanation / Justification: During the formulation of premixes and pre-compounds using C.I. Pigment Yellow 34 and C.I. Pigment Red 104 no water is used. If any waste water is generated, this is treated as hazardous waste. Initial release factor: 0.005% Final release factor: 0.003% Local release rate: 0.12 kg/day Explanation / Justification: Release fraction from Eurometaux 2.2a.v2.1 - Formulation of metal compounds in plastics and rubber industry sector. Derived from a multi-metal background database of measured site-specific release factors collected from peer-reviewed EU Risk Assessment Reports under the former Directive of New and Existing Substances and REACH 2010 registration dossiers. The specific release factor fort his SpERC is the 90th percentile of reported site-specific release factors to air for 15 sites. This release fraction is considered worst-case, as the release to air is 0% according to Emission Scenario Document on Plastic Additives, OECD, July 2009 [ te=env/jm/mono(2004)8/rev1&doclanguage=en]. Final release factor: 0% Explanation / Justification: No release to soil takes place during formulation of premixes and pre-compounds. This is supported by SpERC Eurometaux 2.2a.v2.1 and Emission Scenario Document on Plastic Additives, OECD, July 2009 [ te=env/jm/mono(2004)8/rev1&doclanguage=en], which does not consider any release to soil. Releases to waste Release factor to waste from the process: 1% In accordance with SpERC Eurometaux 2.2a.v2.1. The 90th percentile of reported site-specific release factors to solid waste for 32 downstream user sites covering zinc, nickel, lead, antimony. This is supported by Emission Scenario Document on Plastic Additives, OECD, July 2009 [ en], which also takes into account 1% release to waste during raw material handling Exposure and risks for the environment and man via the environment The exposure concentrations and risk characterisation ratios (RCR) are reported in the following table. Table 125. s and risks for the environment Protection target CSR-PI CHEMICAL SAFETY REPORT 262

5 Protection target Freshwater Local PEC: 0 mg/l RCR < 0.01 Sediment (freshwater) Local PEC: 0 mg/kg dw RCR < 0.01 Marine water Local PEC: 0 mg/l RCR < 0.01 Sediment (marine water) Local PEC: 0 mg/kg dw RCR < 0.01 Sewage treatment plant Local PEC: 0 mg/l RCR < 0.01 Agricultural soil Local PEC: mg/kg dw RCR < 0.01 Conclusion on risk characterisation Under the conditions of this contributing scenario, the local concentrations and associated risk characterisation ratios due to the use of C.I. Pigment Yellow 34 and C.I. Pigment Red 104 are orders of magnitude lower than the background concentrations of lead for all environmental compartments assessed Worker contributing scenario 1: Delivery, storage and handling of closed paper bags with pigment powder (PROC 3) Conditions of use Product (article) characteristics Substance product type: Powders, granules or pelletised material Dustiness: 1006 mg/kg for inhalable fraction (Measured according to EN 15051) Corresponding dustiness category in Advanced REACH Tool: "Coarse dust". Moisture Content of the product: Dry product (<5 % moisture content) Concentration of substance in mixture: Substance as such Concentration of substance in mixture: Substance as such Amount used (or contained in articles), frequency and duration of use/exposure Duration of activity: < 8 hours Technical and organisational conditions and measures Surface Contamination/Fugitive Emission Sources: The process is not fully enclosed or the integrity of that enclosure is not regularly monitored but demonstrable and effective housekeeping practices are in place (Demonstrable and effective housekeeping practices (examples include daily cleaning using appropriate methods (eg vacuum), preventive maintenance of machinery and control measures, and use of protective clothing that will repel spills and reduce personal cloud).) Dispersion - Indoors: Ventilation rate of the general ventilation system in the work area: 3 ACH (ACH = air changes per hour.) Personal enclosure of the worker from the emission source: Complete personal enclosure without ventilation (Worker resides inside an enclosed cabin or room (door & windows closed) for the entire duration of the activity. The air within the separate room is not actively ventilated.) Applicable to far field exposure. Containment: Closed batch process with occasional controlled exposure Occupational Health and Safety Management System: Advanced Conditions and measures related to personal protection, hygiene and health evaluation Dermal Protection: Yes (chemically resistant gloves conforming to EN374 with CSR-PI CHEMICAL SAFETY REPORT 263

6 specific activity training) [Effectiveness Dermal: 95%] Other conditions affecting workers exposure Handling of Contaminated Solid Objects or Paste - Activity: Handling of apparently clean objects (Examples: Drums coming out of a cleaning machine) Handling of Contaminated Solid Objects or Paste: Careful handling, involves workers showing attention to potential danger, error or harm and carrying out the activity in a very exact and thorough (or cautious) manner Dispersion - Indoor: Room size of the work area: Any size workroom Skin surface potentially exposed: One hand face only (240 cm2) Exposure and risks for workers The exposure concentrations and risk characterisation ratios (RCR) are reported in the following table. Table 126. s and risks for workers Inhalation, local, long-term 2.5E-03 mg/m³ ( ) Exposure/DMEL = Qualitative Dermal, systemic, long-term mg/kg bw/day () Exposure/DMEL = Dermal, local, long-term Combined routes, systemic, long-term (neurodevelopmental damage) (carcinogenicity, lung) Oral, systemic, long-term (carcinogenicity, intestinal) Remarks on exposure data 2.5E-03 mg/m³ ( ) µg/kg bw/day (calculated from exposure value for: Inhalation, systemic, long-term) Qualitative Ʃ(Exposure/DMEL) = Exposure/DMEL = RCR = : ART calculation: The inter-quartile confidence interval is mg/m³ to mg/m³. The predicted 90th percentile long-term exposure is mg/m³. Conclusion on risk characterisation Semi-quantitative risk characterisation Carcinogenicity: CSR-PI CHEMICAL SAFETY REPORT 264

7 Performing this specific activity for an entire working career leads to excess lung cancer mortality of 4.05E-06, which is lower than the indicative tolerable risk level for workers as mentioned in the REACH Guidance on information requirements R.8. For intestinal cancer there is no excess morbidity as the RCR is below 1 for this specific activity. Neurodevelopmental damage: The performance of this task prior to and during pregnancy and lactation leads to a predicted loss in the IQ of the offspring of less than one IQ point (= combined RCR for lead <1). As this number of loss is considered toxicologically insignificant, the risk on neurodevelopmental damage caused by pigment use is deemed controlled. Please refer to section for an additional explanation on the risk characterization of the carcinogenicity and neurodevelopmental effect. The operational conditions and risk management measures are in line with the qualitative risk assessment as described in section of the CSR Worker contributing scenario 2: Pigment powder quality control / lab work (PROC 15) Conditions of use For example QC at shipment receival. Product (article) characteristics Substance product type: Powders, granules or pelletised material Applicable to transfer activity. Moisture Content of the product: Dry product (<5 % moisture content) Applicable to activities with powder. Dustiness: 1006 mg/kg for inhalable fraction (Measured according to EN 15051) Corresponding dustiness category in Advanced REACH Tool: "Coarse dust". Concentration of substance in mixture: Substance as such Concentration of substance in mixture: Substance as such Amount used (or contained in articles), frequency and duration of use/exposure Duration of activity: < 8 hours Technical and organisational conditions and measures Surface Contamination/Fugitive Emission Sources: The process is not fully enclosed or the integrity of that enclosure is not regularly monitored but demonstrable and effective housekeeping practices are in place (Demonstrable and effective housekeeping practices (examples include daily cleaning using appropriate methods (eg vacuum), preventive maintenance of machinery and control measures, and use of protective clothing that will repel spills and reduce personal cloud).) Dispersion - Indoors: Ventilation rate of the general ventilation system in the work area: 3 ACH (ACH = air changes per hour.) General Control Measures: Local exhaust ventilation (LEV) - Enclosing hoods - Fume cupboard (Any form of permanent encapsulation or encasing of the source of which maximally one side is open with a well designed local exhaust ventilation system (e.g. laminar air flow). The design of both the enclosure and the ventilation system is such that the influence of worker behaviour is minimal (e.g. an alarm system prevents the worker from using the fume cupboard in case the system is not working properly).) Effectiveness of RMM: 99% CSR-PI CHEMICAL SAFETY REPORT 265

8 Containment: No Occupational Health and Safety Management System: Advanced Conditions and measures related to personal protection, hygiene and health evaluation Dermal Protection: Yes (chemically resistant gloves conforming to EN374 with specific activity training) [Effectiveness Dermal: 95%] Other conditions affecting workers exposure Activity class (solids): Transfer of powders, granules or pelletised material - Falling of powders, granules or pelletised material (Activities where a stream of powder is transferred from one reservoir (or container, vessel) to the receiving vessel. The product may either fall due to gravity from a high to a lower point (dumping of powders), be transferred horizontally (scooping of powders) or is transferred through a hose or tube with pressure (vacuum transfer). Example Activities: Bagging solids Dumping solids in mixers Loading barges with minerals or cereals Scooping Scattering Filling of bottles) Transferring of Powders, Granules or Pelletised Material - Activity: Transferring gram/minute (Examples: Small-scale scooping for sampling) Falling of Powders, Granules or Pelletised Material - Drop height: Drop height < 0.5 m Falling of Powders, Granules or Pelletised Material - level of containment of the process: Handling that reduces contact between product and adjacent air (Note: This does not include processes that are fully contained by localised controls (see next questions). Example situation: Contained sieving of big bags with only small opening ) Falling of Powders, Granules or Pelletised Material - Type of handling: Careful transfer involves workers showing attention to potential danger, error or harm and carrying out the activity in a very exact and thorough (or cautious) manner e.g. careful weighing in laboratory Dispersion - Indoor: Room size of the work area: Any size workroom Skin surface potentially exposed: One hand face only (240 cm2) Exposure and risks for workers The exposure concentrations and risk characterisation ratios (RCR) are reported in the following table. Table 127. s and risks for workers Inhalation, local, long-term Dermal, systemic, long-term Dermal, local, long-term Combined routes, systemic, long-term (neurodevelopmental 7.6E-4 mg/m³ ( ) Exposure/DMEL = Qualitative mg/kg bw/day () Exposure/DMEL = Qualitative Ʃ(Exposure/DMEL) = CSR-PI CHEMICAL SAFETY REPORT 266

9 damage) (carcinogenicity, lung) Oral, systemic, long-term (carcinogenicity, intestinal) 7.6E-4 mg/m³ ( ) µg/kg bw/day (calculated from exposure value for: Inhalation, systemic, long-term) Exposure/DMEL = RCR = Remarks on exposure data Remarks on exposure data : ART calculation: The inter-quartile confidence interval is mg/m³ to mg/m³. The predicted 90th percentile long-term exposure is mg/m³. Conclusion on risk characterisation Semi-quantitative risk characterisation Carcinogenicity: Performing this specific activity for an entire working career leads to excess lung cancer mortality of 1.23E-06, which is lower than the indicative tolerable risk level for workers as mentioned in the REACH Guidance on information requirements R.8. For intestinal cancer there is no excess morbidity as the RCR is below 1 for this specific activity. Neurodevelopmental damage: The performance of this task prior to and during pregnancy and lactation leads to a predicted loss in the IQ of the offspring of less than one IQ point (= combined RCR for lead <1). As this number of loss is considered toxicologically insignificant, the risk on neurodevelopmental damage caused by pigment use is deemed controlled. Please refer to section for an additional explanation on the risk characterization of the carcinogenicity and neurodevelopmental effect. The operational conditions and risk management measures are in line with the qualitative risk assessment as described in section of the CSR Worker contributing scenario 3: Manual dosing of pigment powder (PROC 8a) Conditions of use Manual discharge of bags of pigment, for example in hoppers, in facilities with general protection measures. Removal of empty bags is included. Product (article) characteristics Substance product type: Powders, granules or pelletised material Moisture Content of the product: Dry product (<5 % moisture content) CSR-PI CHEMICAL SAFETY REPORT 267

10 Dustiness: 1006 mg/kg for inhalable fraction (Measured according to EN 15051) Corresponding dustiness category in Advanced REACH Tool: "Coarse dust". Concentration of substance in mixture: Substance as such Concentration of substance in mixture: Substance as such Amount used (or contained in articles), frequency and duration of use/exposure Duration of activity: < 8 hours Technical and organisational conditions and measures Surface Contamination/Fugitive Emission Sources: The process is not fully enclosed or the integrity of that enclosure is not regularly monitored but demonstrable and effective housekeeping practices are in place (Demonstrable and effective housekeeping practices (examples include daily cleaning using appropriate methods (eg vacuum), preventive maintenance of machinery and control measures, and use of protective clothing that will repel spills and reduce personal cloud).) Dispersion - Indoors: Ventilation rate of the general ventilation system in the work area: 3 ACH (ACH = air changes per hour.) General Control Measures: Local exhaust ventilation (LEV) - Capturing hoods - Fixed capturing hood (Fixed capturing hoods located in close proximity of and directed at the source of emission. The design is such that the work is performed in the capture zone of the ventilation system and the capture is indicated at the workplace.) Effectiveness of RMM: 90%. Containment: No Occupational Health and Safety Management System: Advanced Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection according to EN 529:2005 (APF only): Minimum APF of 100 [Effectiveness Inhal: 99%] Dermal Protection: Yes (chemically resistant gloves conforming to EN374 with specific activity training) [Effectiveness Dermal: 95%] Other conditions affecting workers exposure Activity class (solids): Transfer of powders, granules or pelletised material - Falling of powders, granules or pelletised material (Activities where a stream of powder is transferred from one reservoir (or container, vessel) to the receiving vessel. The product may either fall due to gravity from a high to a lower point (dumping of powders), be transferred horizontally (scooping of powders) or is transferred through a hose or tube with pressure (vacuum transfer). Example Activities: Bagging solids Dumping solids in mixers Loading barges with minerals or cereals Scooping Scattering Filling of bottles) Transferring of Powders, Granules or Pelletised Material - Activity: Transferring kg/minute (Examples: Manual dumping of powders) Falling of Powders, Granules or Pelletised Material - Drop height: Drop height < 0.5 m Falling of Powders, Granules or Pelletised Material - level of containment of the process: Handling that reduces contact between product and adjacent air (Note: This does not include processes that are fully contained by localised controls (see next questions). Example situation: Contained sieving of big bags with only small opening ) Falling of Powders, Granules or Pelletised Material - Type of handling: Careful transfer involves workers showing attention to potential danger, error or harm and carrying out the activity in a very exact and thorough (or cautious) manner e.g. careful weighing in laboratory CSR-PI CHEMICAL SAFETY REPORT 268

11 Dispersion - Indoor: Room size of the work area: Any size workroom Skin surface potentially exposed: Two hands (960 cm2) Exposure and risks for workers The exposure concentrations and risk characterisation ratios (RCR) are reported in the following table. Table 128. s and risks for workers Inhalation, local, long-term Dermal, systemic, long-term Dermal, local, long-term Combined routes, systemic, long-term (neurodevelopmental damage) (carcinogenicity, lung) Oral, systemic, long-term (carcinogenicity, intestinal) mg/m³ ( ) Exposure/DMEL = Qualitative mg/kg bw/day () Exposure/DMEL = mg/m³ ( ) µg/kg bw/day (calculated from exposure value for: Inhalation, systemic, long-term) Qualitative Ʃ(Exposure/DMEL) = Exposure/DMEL = RCR = Remarks on exposure data : ART calculation: The inter-quartile confidence interval is 0.11 mg/m³ to 0.48 mg/m³. The predicted 90th percentile long-term exposure is 0.23 mg/m³. The result of the ART calculation was corrected by applying respiratory protection with APF 20 (95% effectiveness). Conclusion on risk characterisation Semi-quantitative risk characterisation Carcinogenicity: Performing this specific activity for an entire working career leads to excess lung cancer mortality of 3.73E-06, which is lower than the indicative tolerable risk level for workers as mentioned in the REACH Guidance on information requirements R.8. For intestinal cancer there is no excess morbidity as the RCR is below 1 for this specific activity. Neurodevelopmental damage: The performance of this task prior to and during pregnancy and lactation leads to a predicted loss in the IQ of the offspring of less than one IQ point (= combined RCR for lead <1). As this number of loss is considered CSR-PI CHEMICAL SAFETY REPORT 269

12 toxicologically insignificant, the risk on neurodevelopmental damage caused by pigment use is deemed controlled. Please refer to section for an additional explanation on the risk characterization of the carcinogenicity and neurodevelopmental effect. The operational conditions and risk management measures are in line with the qualitative risk assessment as described in section of the CSR Worker contributing scenario 4: Automated dosing of pigment powder (PROC 8b) Conditions of use Automated discharge of bags of pigment, for example in hoppers, in facilities with high level of protection protective measures. Bag is placed on conveyor belt using a vacuum transporter. The bag is cut and emptied within the machine. Machine is in isolated room, which is underpressured. Product (article) characteristics Substance product type: Powders, granules or pelletised material Moisture Content of the product: Dry product (<5 % moisture content) Dustiness: 1006 mg/kg for inhalable fraction (Measured according to EN 15051) Corresponding dustiness category in Advanced REACH Tool: "Coarse dust". Concentration of substance in mixture: Substance as such Concentration of substance in mixture: Substance as such Amount used (or contained in articles), frequency and duration of use/exposure Duration of activity: < 8 hours Technical and organisational conditions and measures Surface Contamination/Fugitive Emission Sources: The process is not fully enclosed or the integrity of that enclosure is not regularly monitored but demonstrable and effective housekeeping practices are in place (Demonstrable and effective housekeeping practices (examples include daily cleaning using appropriate methods (eg vacuum), preventive maintenance of machinery and control measures, and use of protective clothing that will repel spills and reduce personal cloud).) Dispersion - Indoors: Ventilation rate of the general ventilation system in the work area: 3 ACH (ACH = air changes per hour.) General Control Measures: Local exhaust ventilation (LEV) - Capturing hoods - Fixed capturing hood (Fixed capturing hoods located in close proximity of and directed at the source of emission. The design is such that the work is performed in the capture zone of the ventilation system and the capture is indicated at the workplace.) Effectiveness of RMM: 90%. Containment - no extraction: Medium level containment (Physical containment or enclosure of the source of emission. The air within the enclosure is not actively ventilated or extracted. The enclosure is not opened during the activity. The material transfer is enclosed with the receiving vessel being docked or sealed to the source vessel. Examples include sealing heads, transfer containers and multiple o- rings. Inflatable packing head with continuous liner ensures a seal is maintained during the powder transfer and the continuous plastic liner prevents direct contact CSR-PI CHEMICAL SAFETY REPORT 270

13 with the product. The correct type of tie off must be used.) [Effectiveness Inhal: 99%] Containment: Semi-closed process with occasional controlled exposure Occupational Health and Safety Management System: Advanced Conditions and measures related to personal protection, hygiene and health evaluation Dermal Protection: Yes (chemically resistant gloves conforming to EN374 with specific activity training) [Effectiveness Dermal: 95%] Other conditions affecting workers exposure Activity class (solids): Transfer of powders, granules or pelletised material - Falling of powders, granules or pelletised material (Activities where a stream of powder is transferred from one reservoir (or container, vessel) to the receiving vessel. The product may either fall due to gravity from a high to a lower point (dumping of powders), be transferred horizontally (scooping of powders) or is transferred through a hose or tube with pressure (vacuum transfer). Example Activities: Bagging solids Dumping solids in mixers Loading barges with minerals or cereals Scooping Scattering Filling of bottles) Transferring of Powders, Granules or Pelletised Material - Activity: Transferring kg/minute (Examples: Manual dumping of powders) Falling of Powders, Granules or Pelletised Material - Drop height: Drop height < 0.5 m Falling of Powders, Granules or Pelletised Material - Type of handling: Careful transfer involves workers showing attention to potential danger, error or harm and carrying out the activity in a very exact and thorough (or cautious) manner e.g. careful weighing in laboratory Falling of Powders, Granules or Pelletised Material - level of containment of the process: Open process Dispersion - Indoor: Room size of the work area: Any size workroom Segregation of the emission source from the work environment: Complete segregation with ventilation and filtration of recirculated air (Sources are completely segregated from the work environment by isolating the source in a fully enclosed and separate room (incl. closed doors & windows). The air within the separate area is actively ventilated and the recirculated air is filtered or there is no air recirculation. The segregated area is generally not entered by the worker during a given activity or working shift.) Skin surface potentially exposed: Two hands (960 cm2) Exposure and risks for workers The exposure concentrations and risk characterisation ratios (RCR) are reported in the following table. Table 129. s and risks for workers Inhalation, local, long-term Dermal, systemic, long-term 3.3E-4 mg/m³ ( ) Exposure/DMEL = Qualitative mg/kg bw/day () Exposure/DMEL = CSR-PI CHEMICAL SAFETY REPORT 271

14 Dermal, local, long-term Combined routes, systemic, long-term (neurodevelopmental damage) (carcinogenicity, lung) Oral, systemic, long-term (carcinogenicity, intestinal) Remarks on exposure data 3.3E-4 mg/m³ ( ) µg/kg bw/day (calculated from exposure value for: Inhalation, systemic, long-term) Qualitative Ʃ(Exposure/DMEL) = Exposure/DMEL = RCR = : ART calculation (far field exposure only): The inter-quartile confidence interval is mg/m³ to mg/m³. The predicted 90th percentile long-term exposure is mg/m³. Conclusion on risk characterisation Semi-quantitative risk characterisation Carcinogenicity: Performing this specific activity for an entire working career leads to excess lung cancer mortality of 5.35E-07, which is lower than the indicative tolerable risk level for workers as mentioned in the REACH Guidance on information requirements R.8. For intestinal cancer there is no excess morbidity as the RCR is below 1 for this specific activity. Neurodevelopmental damage: The performance of this task prior to and during pregnancy and lactation leads to a predicted loss in the IQ of the offspring of less than one IQ point (= combined RCR for lead <1). As this number of loss is considered toxicologically insignificant, the risk on neurodevelopmental damage caused by pigment use is deemed controlled. Please refer to section for an additional explanation on the risk characterization of the carcinogenicity and neurodevelopmental effect. The operational conditions and risk management measures are in line with the qualitative risk assessment as described in section of the CSR Worker contributing scenario 5: Mixing of pigment with resins and additives to form a liquid pre-mix/pre-compound (PROC 5) Conditions of use Mixing and blending in mixing vessel with loose fitting cover. A liquid is present in the mixing vessel before the pigment is added CSR-PI CHEMICAL SAFETY REPORT 272

15 Product (article) characteristics Concentration of substance in mixture: >25% Solid in solid mixtures: Yes Substance product type: Powders dissolved in a liquid or incorporated in a liquid matrix Viscosity: Liquids with medium viscosity (like oil) Liquid Weight Fraction: Main component (50-90%) [Effectiveness Inhal: 10%] Amount used (or contained in articles), frequency and duration of use/exposure Duration of activity: < 8 hours Technical and organisational conditions and measures Containment: No Occupational Health and Safety Management System: Advanced Surface Contamination/Fugitive Emission Sources: The process is not fully enclosed or the integrity of that enclosure is not regularly monitored but demonstrable and effective housekeeping practices are in place (Demonstrable and effective housekeeping practices (examples include daily cleaning using appropriate methods (eg vacuum), preventive maintenance of machinery and control measures, and use of protective clothing that will repel spills and reduce personal cloud).) Dispersion - Indoors: Ventilation rate of the general ventilation system in the work area: 3 ACH (ACH = air changes per hour.) Applicable to activity with agitated liquid surfaces. Containment - no extraction: Medium level containment (Physical containment or enclosure of the source of emission. The air within the enclosure is not actively ventilated or extracted. The enclosure is not opened during the activity. The material transfer is enclosed with the receiving vessel being docked or sealed to the source vessel. Examples include sealing heads, transfer containers and multiple o- rings. Inflatable packing head with continuous liner ensures a seal is maintained during the powder transfer and the continuous plastic liner prevents direct contact with the product. The correct type of tie off must be used.) [Effectiveness Inhal: 99%] Conditions and measures related to personal protection, hygiene and health evaluation Dermal Protection: Yes (chemically resistant gloves conforming to EN374 with specific activity training) [Effectiveness Dermal: 95%] Respiratory protection according to EN 529:2005 (APF only): Minimum APF of 10 [Effectiveness Inhal: 90%] Other conditions affecting workers exposure Skin surface potentially exposed: Two hands face (480 cm2) Dispersion - Indoor: Room size of the work area: Any size workroom Activity Class: Activities with open liquid surfaces or open reservoirs - Activities CSR-PI CHEMICAL SAFETY REPORT 273

16 with agitated surfaces (Handling of a liquid product in a bath or other reservoir. The liquid may either be relatively undisturbed (e.g. manual stirring, dipping in bath) or agitated (e.g. gas bubbling, mechanical mixing in vessel).) Open Surface: Surface 1-3 m² Exposure and risks for workers The exposure concentrations and risk characterisation ratios (RCR) are reported in the following table. Table 130. s and risks for workers Inhalation, local, long-term Dermal, systemic, long-term Dermal, local, long-term Combined routes, systemic, long-term (neurodevelopmental damage) (carcinogenicity, lung) Oral, systemic, long-term (carcinogenicity, intestinal) 3.5E-4 mg/m³ ( ) Exposure/DMEL = 0.06 Qualitative mg/kg bw/day () Exposure/DMEL = E-4 mg/m³ ( ) µg/kg bw/day (calculated from exposure value for: Inhalation, systemic, long-term) Qualitative Ʃ(Exposure/DMEL) = Exposure/DMEL = RCR = Remarks on exposure data : ART calculation (far field exposure only): The inter-quartile confidence interval is mg/m³ to mg/m³. The predicted 90th percentile long-term exposure is mg/m³. The result of the ART calculation was corrected by applying respiratory protection with APF 10 (90% effectiveness). Conclusion on risk characterisation Semi-quantitative risk characterisation Carcinogenicity: Performing this specific activity for an entire working career leads to excess lung cancer mortality of 5.68E-07, which is lower than the indicative tolerable risk level for workers as mentioned in the REACH Guidance on information requirements R.8. For intestinal cancer there is no excess morbidity as the RCR is below 1 for this specific activity CSR-PI CHEMICAL SAFETY REPORT 274

17 Neurodevelopmental damage: The performance of this task prior to and during pregnancy and lactation leads to a predicted loss in the IQ of the offspring of less than one IQ point (= combined RCR for lead <1). As this number of loss is considered toxicologically insignificant, the risk on neurodevelopmental damage caused by pigment use is deemed controlled. Please refer to section for an additional explanation on the risk characterization of the carcinogenicity and neurodevelopmental effect. The operational conditions and risk management measures are in line with the qualitative risk assessment as described in section of the CSR Worker contributing scenario 6: Storage of premix/pre-compound / Transfer of pre-mix/pre-compound through closed piping (PROC 2) Conditions of use Handling of closed packagings of premix/pre-compound: delivery, storage, transport etc. Sampling for QC. Product (article) characteristics Concentration of substance in mixture: >25% Solid in solid mixtures: Yes Substance product type: Powders dissolved in a liquid or incorporated in a liquid matrix Viscosity: Liquids with medium viscosity (like oil) Liquid Weight Fraction: Main component (50-90%) [Effectiveness Inhal: 10%] Amount used (or contained in articles), frequency and duration of use/exposure Duration of activity: < 8 hours Technical and organisational conditions and measures Containment: Closed continuous process with occasional controlled exposure Occupational Health and Safety Management System: Advanced Surface Contamination/Fugitive Emission Sources: The process is not fully enclosed or the integrity of that enclosure is not regularly monitored but demonstrable and effective housekeeping practices are in place (Demonstrable and effective housekeeping practices (examples include daily cleaning using appropriate methods (eg vacuum), preventive maintenance of machinery and control measures, and use of protective clothing that will repel spills and reduce personal cloud).) Dispersion - Indoors: Ventilation rate of the general ventilation system in the work area: 3 ACH (ACH = air changes per hour.) Applicable to activity with agitated liquid surfaces. Containment - no extraction: Medium level containment (Physical containment or enclosure of the source of emission. The air within the enclosure is not actively ventilated or extracted. The enclosure is not opened during the activity. The CSR-PI CHEMICAL SAFETY REPORT 275

18 material transfer is enclosed with the receiving vessel being docked or sealed to the source vessel. Examples include sealing heads, transfer containers and multiple o- rings. Inflatable packing head with continuous liner ensures a seal is maintained during the powder transfer and the continuous plastic liner prevents direct contact with the product. The correct type of tie off must be used.) [Effectiveness Inhal: 99%] Conditions and measures related to personal protection, hygiene and health evaluation Dermal Protection: Yes (chemically resistant gloves conforming to EN374 with specific activity training) [Effectiveness Dermal: 95%] Other conditions affecting workers exposure Skin surface potentially exposed: Two hands face (480 cm2) Dispersion - Indoor: Room size of the work area: Any size workroom Activity Class: Activities with open liquid surfaces or open reservoirs - Activities with undisturbed surfaces (no aerosol formation) (Handling of a liquid product in a bath or other reservoir. The liquid may either be relatively undisturbed (e.g. manual stirring, dipping in bath) or agitated (e.g. gas bubbling, mechanical mixing in vessel).) Open Surface: Surface m² Exposure and risks for workers The exposure concentrations and risk characterisation ratios (RCR) are reported in the following table. Table 131. s and risks for workers Inhalation, local, long-term Dermal, systemic, long-term Dermal, local, long-term Combined routes, systemic, long-term (neurodevelopmental damage) (carcinogenicity, lung) Oral, systemic, long-term (carcinogenicity, intestinal) 8.1E-5 mg/m³ ( ) Exposure/DMEL = Qualitative mg/kg bw/day () Exposure/DMEL = E-5 mg/m³ ( ) µg/kg bw/day (calculated from exposure value for: Inhalation, systemic, long-term) Qualitative Ʃ(Exposure/DMEL) = Exposure/DMEL = RCR = CSR-PI CHEMICAL SAFETY REPORT 276

19 Remarks on exposure data : ART calculation (far field exposure only): The inter-quartile confidence interval is mg/m³ to mg/m³. The predicted 90th percentile long-term exposure is mg/m³. Conclusion on risk characterisation Semi-quantitative risk characterisation Carcinogenicity: Performing this specific activity for an entire working career leads to excess lung cancer mortality of 1.31E-07, hich is lower than the indicative tolerable risk level for workers as mentioned in the REACH Guidance on information requirements R.8. For intestinal cancer there is no excess morbidity as the RCR is below 1 for this specific activity. Neurodevelopmental damage: The performance of this task prior to and during pregnancy and lactation leads to a predicted loss in the IQ of the offspring of less than one IQ point (= combined RCR for lead <1). As this number of loss is considered toxicologically insignificant, the risk on neurodevelopmental damage caused by pigment use is deemed controlled. Please refer to section for an additional explanation on the risk characterization of the carcinogenicity and neurodevelopmental effect. The operational conditions and risk management measures are in line with the qualitative risk assessment as described in section of the CSR Worker contributing scenario 7: Premix/pre-compound charging/discharging by gravity or manual handling (PROC 8a) Conditions of use Product (article) characteristics Concentration of substance in mixture: >25% Solid in solid mixtures: Yes Substance product type: Powders dissolved in a liquid or incorporated in a liquid matrix Viscosity: Liquids with medium viscosity (like oil) Liquid Weight Fraction: Main component (50-90%) [Effectiveness Inhal: 10%] Amount used (or contained in articles), frequency and duration of use/exposure Duration of activity: < 8 hours Technical and organisational conditions and measures Containment: No Occupational Health and Safety Management System: Advanced CSR-PI CHEMICAL SAFETY REPORT 277

20 Surface Contamination/Fugitive Emission Sources: The process is not fully enclosed or the integrity of that enclosure is not regularly monitored and no demonstrable and effective housekeeping practices are in place but general housekeeping practices are in place (General good housekeeping practices.) Dispersion - Indoors: Ventilation rate of the general ventilation system in the work area: 3 ACH (ACH = air changes per hour.) Containment - no extraction: Low level containment (Physical containment or enclosure of the source of emission. The air within the enclosure is not actively ventilated or extracted. The enclosure is not opened during the activity. The process is contained with a loose lid or cover, which is not air tight. This includes tapping molten metal through covered launders and placing a loose lid on a ladle. This class also includes bags or liners fitted around transfer points from source to receiving vessel. These include Muller seals, Stott head and single bag, and associated clamps and closures.) [Effectiveness Inhal: 90%] Conditions and measures related to personal protection, hygiene and health evaluation Dermal Protection: Yes (chemically resistant gloves conforming to EN374 with specific activity training) [Effectiveness Dermal: 95%] Respiratory protection according to EN 529:2005 (APF only): Minimum APF of 10 [Effectiveness Inhal: 90%] Other conditions affecting workers exposure Skin surface potentially exposed: Two hands (960 cm2) Dispersion - Indoor: Room size of the work area: Any size workroom Activity Class: Transfer of liquid products - Falling liquids (Activities where a stream of liquid product is transferred from one reservoir to the next. The stream may either fall or glide from high to a lower point (falling liquids) or is transferred with pressure (pressurized transfer: e.g. bottom loading).) Falling Liquids - Activity: Transfer of liquid product with flow of: l/minu (Examples: (Re)fuelling cars Manual topping up Manual calibration of fuel pump) Falling Liquids - Level of containment of the process: Open process Transfer Loading Type: Splash loading, where the liquid dispenser remains at the top of the reservoir and the liquid splashes freely Exposure and risks for workers The exposure concentrations and risk characterisation ratios (RCR) are reported in the following table. Table 132. s and risks for workers mg/m³ ( ) Exposure/DMEL = CSR-PI CHEMICAL SAFETY REPORT 278