Ammonium Dichromate

CHEMICAL SAFETY REPORT

Use of ammonium dichromate as photosensitive component in a polyvinyl alcohol photolithographic lacquer system for the manufacturing of mandrels which are used in nickel electroforming processes

Substance Name: Ammonium dichromate

EC Number: 232-143-1

CAS Number: 7789-09-5

Registrant's Identity: Veco B.V. EC number: Ammonium dichromate CAS number: 232-143-1 7789-09-5 9. EXPOSURE ASSESSMENT (and related risk characterisation) 9.0. Introduction This exposure assessment aims to provide reliable estimates of current work place exposure level at the applicant’s facility. Occupational work place exposure to hexavalent chromium [Cr(VI)] is regulated in most European countries. National Occupational Exposure Limits (OELs) across Europe respect a range of 8 hour Time Weighted Average (TWA) values between 1 µg/m3 and 50 µg/m3. The US Occupational Safety and Health Administration (OSHA) OEL is at 5 µg/m3. In 2014, France introduced a new OEL of 1 µg/m3. This is one of the most stringent OEL currently in place anywhere in the World and compliance requires substantial research and investment. The Carcinogens and Mutagens Directive (2004/37/EC) requires each Member State to ensure employers reduce and replace use of hexavalent chromium substances, and the introduction of a new OEL in France provides one clear example of regulation by Member States to effect a reduction in workplace exposure to Cr(VI). Industry is proactively engaged in delivering continuous reduction through the development and implementation of appropriate RMMs. Best practice across the industry is continually improving, driven by general awareness of workplace hygiene and increasingly stringent regulatory requirements. This commitment to reducing exposure also reflects the widespread recognition that surface treatment including coating with Cr(VI) is critical for several industries and that alternatives are not available in the near-term. 9.0.1. Overview of uses and Exposure Scenarios

Tonnage information:

Assessed tonnage: 0.04 tonnes of ammonium dichromate per year containing approximately 0.016 tonnes Cr(VI)

The following table lists all the exposure scenarios (ES) assessed in this CSR.

Table 6. Overview of exposure scenarios and contributing scenarios

Identifiers Market Titles of exposure scenarios and the related contributing Tonnage Sector scenarios (tonnes per year) ES1 - IW1 Use at industrial site - Use of ammonium dichromate in 0.04 photolithographic lacquers. [0.016 - Use at industrial site - Use of ammonium dichromate in Cr(VI)] photolithographic lacquers. (ERC 5) - Delivery and storage of raw material (PROC 1) - Weighing and dilution of solids, decanting (PROC 8b, 5) - Preparation of PVA lacquers (PROC 8b, 5) - Application photolithographic lacquer onto large plates (1m2 or more) (PROC 8b, 13) - Application photolithographic lacquer onto small plates (less than 0.3 m2) (PROC 8b, 13) - Exposure and development of plates (PROC 13, 7) - Cleaning of equipment – tools cleaning (PROC 8b) - Maintenance activities (PROC 8b) - Waste management (PROC 8b) Manufacture: M-#, Formulation: F-#, Industrial end use at site: IW-#, Professional end use: PW-#, Consumer end use: C-#, Service life (by workers in industrial site): SL-IW-#, Service life (by professional workers): SL-PW-#, Service life (by consumers): SL-C-#.)

9.0.2. Introduction to the assessment

9.0.2.1. Environment

Scope and type of assessment

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The current Chemical Safety Report (CSR) and the associated exposure scenario (ES) and contributing scenarios are tailored to support the Application for Authorization (AfA) to continue use of ammonium dichromate for use in photolithographic polyvinylalcohol (PVA) lacquers during mandrel production after the sunset date in September 2017. The mandrels are used in a nickel electroforming process for the manufacture of nickel articles, such as encoder disks, sugar sieves, shaver foils etc. The finished mandrels do not contain Cr(VI). Ammonium dichromate has been included in Annex XIV to Regulation (EC) No 1907/2006 ('REACH') due to its intrinsic properties as being carcinogenic (Carc. 1B), mutagenic (Mut. 1B), and toxic to reproduction (Repr. 1B). Following Regulation (EC) No 1907/2006, Article 62(4)(d), the CSR supporting an AfA needs to cover only those potential risks arising from the intrinsic properties specified in Annex XIV. Accordingly, only the potential human health risks related to the classification of ammonium dichromate as a carcinogen and reproductive toxicant are considered in the current CSR. The dominating health effect resulting from the intrinsic hazardous properties of ammonium dichromate is lung cancer due to inhalation of dust and/or aerosols. Intestinal cancer following ingestion is also identified as a potential risk: however, the dose-response relationship is lower than that for lung cancer, and ingestion is generally not considered an important exposure route for workers. Additionally, potential risk might relate to the reproductive hazard of ammonium dichromate, which is regarded as a threshold effect. Evaluation of any potential hazards to the environment is not required within the framework of this authorisation application. Health hazards may potentially relate to Cr(VI) exposure of the general population via the environment, and are considered accordingly.

During mandrel production, prevention of releases of all used chemical products to the aquatic environment is a matter of good practice. Water that is used in the developing process and during cleaning is sent to the on-site wastewater treatment plant. There, Cr(VI) is reduced to Cr(III). The Cr(III) is removed from the site as part of a filter cake. The on-site treatment process to reduce hexavalent chromium to trivalent chromium [Cr(III)] in wastewater is highly effective, such that residual concentrations of Cr(VI) in the effluent may be considered negligible. A qualitative, spectrophotometric analysis is conducted based on diphenylcarbazide on a daily basis. This analysis proves that no measurable Cr(VI) is present in the effluent (no violet discolouration is observed). Treated effluent is directed to a municipal sewage treatment plant before release to the river Ijssel. In view of the risk management measures in place at the production facility, emissions to the aquatic environment associated with mandrel production operations are effectively prevented. Any residues of solidified lacquer containing Cr(VI) are collected and sent for incineration. Other waste materials (e.g. personal protective equipment) are collected and sent for incineration as well. Soil exposure is considered negligible, as there are no direct nor indirect releases to soil. The potential risk for carcinogenicity and/or reproductive toxicity due to exposure to ammonium dichromate via the food chain is considered negligible. Dermal exposure potential is not expected for the general population. Due to its low volatility, the low annual amount used, the low energy involved in handling, the low concentrations (<0.5%) in the process and temperatures generally below 50° C, ammonium dichromate will normally not be present in air. All workspaces with potential release to air are either segregated (automated system without employee available) or equipped with exhaust ventilation systems to remove residual particulates from workers breathing zone. When handling solid ammonium dichromate, an extracted fume cabinet is used (air flow 0.45 m/s). When the plates are coated with a layer of ammonium dichromate-containing lacquer, extracted air from the coating machine is directed to atmosphere. While emissions to air are considered very low, they have been considered in this assessment as a factor potentially contributing to Cr(VI) exposure of humans via the environment. The scope and type of the assessment of the pathway “man via the environment” is discussed in section 9.0.2.2 below.

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Table 7. Type of risk characterisation required for the environment Protection target Type of risk characterisation Hazard conclusion (see section 7) Freshwater Not required Not relevant Sediment (freshwater) Not required Not relevant Marine water Not required Not relevant Sediment (marine water) Not required Not relevant Sewage treatment plant Not required Not relevant Air Not required Not relevant Agricultural soil Not required Not relevant Predator Not required Not relevant

Comments on assessment approach: In accordance with Regulation (EC) No 1907/2006, Article 62(4)(d), potential risks to the environment need not be considered.

9.0.2.2. Man via environment

Scope and type of assessment As discussed in 9.0.2.1., humans may potentially be exposed to ammonium dichromate via the environment. Since strict emission control measures are implemented, releases to the aquatic environment (and also to soil), if any, are negligible. The only relevant potential exposure path is inhalation of particulates emitted to air (see also “comments on assessment approach” below). Within the CSR, local concentrations (Clocal) of chromium in air resulting from emissions to air from industrial use are modelled with EUSES 2.1.2., and expressed as Cr(VI). The regional concentrations are reported in section 10.2.1.2 [see Table 20 “Predicted regional exposure concentrations (Regional PEC)”] based on modelling with EUSES 2.1.2., assuming a release factor of 1%, and expressed as Cr(VI).

Table 8. Type of risk characterisation required for man via the environment Route of exposure and Type of risk characterisation Hazard conclusion type of effects Inhalation: Local long- Quantitative Lung cancer: term years* Inhalation: Systemic Quantitative Reproduction: long-term DNEL = 0.7E+01 g Cr(VI)/m³ Oral: Local long-term Not needed. Assume all inhaled Intestinal cancer: material is respirable (worst case). for 70 years* * see RAC/27/2013/06 Rev.1

Comments on assessment approach: The risk assessment for humans exposed via the environment is restricted to inhalation of airborne residues of ammonium dichromate. The oral route (swallowing of the non-respirable fraction) does not need to be explicitly considered here since: (i) the exposure calculations (airborne concentrations) do not provide different particle size fractions (inhalable/thoracic/respirable);

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(ii) the excess lifetime risk (ELR) for intestinal cancer is one order of magnitude lower than that for lung cancer. The assessment of health impacts is therefore dominated by the potential risk of lung cancer due to inhalation of hexavalent chromium; (iii) the document on a reference dose-response relationship for Cr(VI) compounds (RAC/27/2013/06 Rev.1) states that “in cases where the applicant only provides data for the exposure to the inhalable particulate fraction, as a default, it will be assumed that all particles were in the respirable size range.” Therefore, in accordance with the above findings and provisions on the risk assessment for humans exposed via the environment, since it is assumed that all particles are in the respirable size range, no exposure via the oral route needs to be considered. This constitutes a worst case approach, since the potential lung cancer risk, is an order of magnitude higher compared to the potential intestinal cancer risk, based on the dose-response relationships agreed by the Committee of Risk Assessment (RAC). Ammonium dichromate is classified as toxic to reproduction (Repr. 1B) according to harmonised classification under the CLP Regulation. However, the derived inhalation DNEL for the general population (7 µg Cr(VI)/m3) is much higher than the estimated potential local and regional exposure to Cr(VI) resulting in RCR’s < 0.01. Therefore, there is no additional risk for humans exposed via the environment for reproductive toxic effects due to inhalation of Cr(VI).

9.0.2.3. Workers

Scope and type of assessment

The scope of exposure assessment and type of risk characterisation required for workers are described in the following table based on the hazard conclusions presented in section 5.11.

Table 9. Type of risk characterisation required for workers Route Type of effect Type of risk characterisation Hazard conclusion Systemic long-term Quantitative Reproduction: DNEL = 3.0E+01 g Cr(VI)/m³ Systemic acute Not needed Not relevant Inhalation Local long term Quantitative Lung cancer: ELR = 40 years* Local acute Not needed Not relevant Systemic long term Qualitative Reproduction: DNEL = 2.7E+01 g Cr(VI)/kg bw/d Systemic acute Not needed Not relevant Dermal Local long term Not needed Not relevant Local acute Not needed Not relevant

Eye Local Not needed Not relevant * see RAC/27/2013/06 Rev.1

Comments on assessment approach related to toxicological hazard:

Ammonium dichromate has been included into Annex XIV to Regulation (EC) No 1907/2006 ('REACH') due to its intrinsic properties as being carcinogenic (Carc. 1B), mutagenic (Mut. 1B), and toxic to reproduction (Repr. 1B).

Following Regulation (EC) No 1907/2006, Article 62(4)(d), the CSR supporting an AfA needs to cover only those potential risks arising from the intrinsic properties specified in Annex XIV. The dominating health effect resulting from the intrinsic hazardous properties of ammonium dichromate is lung cancer due to inhalation of dust and/or aerosols.

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Ammonium dichromate is classified as toxic to reproduction (Repr. 1B) according to harmonised classification under the CLP Regulation. However, the derived inhalation DNEL for workers (30 µg Cr(VI)/m3) is much higher than the highest estimated potential combined exposure to Cr(VI) in the following Exposure Scenarios (see section 10.1.1) resulting in an RCR < 0.1. Therefore, there is no additional risk of reproductive toxic effects due to inhalation of Cr(VI).

Furthermore, ammonium dichromate is classified as Skin Corr 1B (causes severe skin burns and eye damage) and as Skin Sens. 1 (may cause an allergic skin reaction).according to harmonised classification under the CLP Regulation. Therefore any dermal contact with the substance at the workplace has to be avoided by organizational measures and adequate dermal protection-

Exposure estimates generated by ART 1.5. are given in terms of Cr(VI) and are expressed as 8 hour Time Weighted Average (TWA).

The oral route (mucociliary clearance and swallowing of the non-respirable fractions) is not taken into account for the same reasons as already explained in the context of “man via environment” (section 9.0.2.1 above). In accordance with the RAC document on the dose-response relationship (RAC/27/2013/06 Rev.1) it has to be assumed that all particles are in the respirable size range. Hence no exposure via the oral route needs to be considered.

Comments on assessment approach related to physicochemical hazard:

Not relevant – physicochemical hazards are not subject of this chemical safety report.

General information on risk management related to toxicological hazard:

Potential exposure of worker handling ammonium dichromate during industrial use is restricted to the lowest possible level.

When handling solid, crystalline ammonium dichromate, personnel are required to wear protective clothing, chemical-resistant impermeable gloves (e.g. nitrile rubber gloves with a minimum layer thickness of 0.11 mm and a break through time of at least 480 min) and goggles. No respiratory protective equipment is worn as the substance is in the form of crystals rather than in the form of a powder (no dust formation). Furthermore, the crystals are handled only in an extracted fume cabinet.

When handling ammonium dichromate-containing liquids (dilution, lacquer) and during cleaning with water, personnel are required to wear protective clothing, chemical-resistant impermeable gloves (e.g. nitrile rubber gloves with a minimum layer thickness of 0.11 mm and a break through time of at least 480 min) and goggles.

General information on risk management related to physicochemical hazard:

Not relevant – physicochemical hazards are not subject of this chemical safety report.

9.0.2.4. Consumers

Exposure assessment is not applicable as there are no consumer-related uses for ammonium dichromate.

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9.1. Exposure scenario 1: Use at industrial site - Use of ammonium dichromate in photolithographic lacquers.

An overview of the process to be authorised is provided below, and a more detailed description of each step is set out by contributing scenario. Photos of the process also illustrate this (see respective WCS). Ammonium dichromate is used as a photosensitiser in a photolithographic polyvinylalcohol (PVA) lacquer (‘negative photoresist’) at one facility. Ammonium dichromate is delivered to the site as solid crystals (in small packets, with closed packaging). In a formulation step, the crystals are transferred from packets, a measured amount is diluted in water. A specific amount of the aqueous solution is mixed with the PVA lacquer prior to coating: the final concentration of Cr(VI) in the lacquer is below 0.5%. The lacquer is applied to the substrate, a stainless steel plate, in a closed machine and dried in-situ. The plate is then removed from the machine, covered with a photo-mask and exposed to UV light. In exposed parts of the lacquer, Cr(VI) is reduced to Cr(III), which binds to the PVA and renders the lacquer water insoluble. Approximately 80-90% of the lacquer on a plate will normally become water-insoluble. The unexposed parts (still containing the original Cr(VI) concentration) are rinsed off with water in a process known as ‘development’. Then the plate (without any Cr(VI) present) is dried/baked in an oven before it is used as a mandrel for electroforming nickel. Operating conditions and risk management measures are specified to limit potential worker (inhalation and dermal) exposure to various components in the lacquer and environmental exposure. As noted above, coating is carried out in a closed machine. Air extraction units and local exhaust ventilation (LEV) are provided to minimize concentrations of hexavalent chromium and other components of the coating in the workplace air at the fume cupboard where weighing and mixing is carried out and in the coating machine. Personal protective equipment is also specified to minimize potential dermal exposure. Equipment is cleaned and maintained regularly. In addition, due to the thermal instability of the PVA-Cr(VI) lacquer system, no residual Cr(VI) is expected to be present in the coating after 24 hours. This means there is no Cr(VI) in residual hardened lacquer removed from the machine as part of regular maintenance/cleaning. Workers are skilled, and receive regular training with regards to chemical risk management and how to properly wear the Personal Protective Equipment. Regular housekeeping is also in place and generally speaking, management systems (ISO 9001, ISO 14001, OHSAS 18001) are in place ensuring high standard of operational procedures. As noted, total amount of ammonium dichromate used per year is conservatively estimated to be 0.04 tonnes (0.03 tonnes is a realistic estimate), containing approximately 0.016 tonnes Cr(VI). Weighing and dilution of ammonium dichromate (around 1800g) is carried out only once every three weeks.

Environment contributing scenario(s): Use of ammonium dichromate in photolithographic lacquers ERC 5 Worker contributing scenario(s): Delivery and storage of raw material PROC 1 Weighing and dilution of solid, decanting PROC 8b, 5 Preparation of PVA lacquers PROC 8b, 5 Application photolithographic lacquer onto large plates (1m2 or more) PROC 8b, 13 Exposure and development of plates PROC 13, 7 Cleaning of equipment – tools cleaning (closed system) PROC 8b Maintenance activities PROC 8b Waste management PROC 8b

Subsequent service life exposure scenario(s):

Not relevant, as the finished mandrel and the final nickel product do not contain any residual Cr(VI).

Explanation on the approach taken for the ES

Occupational exposure estimates are based on modelled data. Inhalation exposure has been estimated using the

25/01/15 CHEMICAL SAFETY REPORT 21 EC number: Ammonium dichromate CAS number: 232-143-1 7789-09-5 exposure model ‘Advanced REACH Tool 1.5’ or ‘ART’1. ART is calibrated to assess exposure to inhalable dust, vapours, and mists; this Exposure Scenario is within the scope of ART.

The frequency of a specific activity in the worker sub-scenarios is expressed as daily activity unless otherwise stated. As long-term exposure is the relevant period for long-term health effects, the duration of exposure per day as set out in the ES is expressed as average duration per day over a longer period (e.g. 2 hours each day are equal to 4 hours every second day). Therefore, it can be seen that the duration of exposure per day is not the same as the maximum allowed duration in any one day. 9.1.1. Environmental contributing scenario 1: Use of ammonium dichromate in photolithographic lacquers

Hexavalent chromium releases to the environment are negligible.

Potential releases to air are minimal, if any. All handling of solid and dissolved ammonium dichromate at room temperature is carefully controlled by adhering to procedures (careful handling e.g. when handling solids and decanting mixtures to avoid agitation), use of contained process equipment (coating is carried out in a closed machine) and through provision of extraction e.g. during preparation/mixing and coating). Air extracted from mixing (fume cupboard) and the coating equipment is emitted to the atmosphere via dedicated stacks2. There is no abatement prior to release to atmosphere, however, due to the nature of the activity, discharges are minimal. Indeed, following discussions with the local regulator, the process was not included within the permit as the quantity of Cr(VI ) used was so low and estimated emissions negligible. Therefore, according to the permit of Veco B.V., monitoring is not needed for the ammonium dichromate activities, reflecting the low amounts used3.

The preparation and coating applications (and all related activities involving use of ammoni.um dichromate) are separated from surface waters, i.e. there is no direct release of Cr(VI) to the aquatic environment.

The facility has an on-site wastewater treatment plant and all wastewater, namely rinse water from the ‘development’ process and any cleaning water discharges to this plant. The wastewater treatment plant reduce the hexavalent chromium to trivalent chromium. The pH is neutralized so the solids are precipitated into a filtercake and disposed via a licensed contractor, while the supernatant is discharged from the site to the municipal wastewater treatment system. A schematic overview of the waste-water treatment plant is provided on the next page.

Chromium in the filtercake is predominantly present as chromium (III) hydroxide. Analyses of samples showed that the filtercake contains ca. 2% Cr (total) and no Cr(VI). The wastewater treatment process is very efficient and a daily qualitative analysis showed the absence of hexavalent chromium in treated water. Next to treating nickel-containing waste streams, the on-site wastewater treatment plant treats effluent (mainly cleaning water) from a separate functional chromium plating bath. Annually, the WWTP discharges 20000-26000 m3 effluent to the municipal sewage treatment plant (STP) (capacity 300 m3/h and 45000 inhabitant equivalents), containing max. 110 µg/L of Cr(III). Less than 1 kg of Cr(III) is released annually via the water to the municipal STP. The municipal STP discharges the treated water into the river IJssel (summer average flow of 315 m3/sec).

1 The use of ART for workers exposure assessment under REACH is described in ECHA’s updated Guidance on Information Requirements and chemical safety assessment R.14. 2 Emissions from functional plating are discharged via a separate stack. 3 Monitoring of functional chromium plating activities using chromium trioxide at the same site is required by the permit. Employees who handle ammonium dichromate or PVA lacquer containing ammonium dichromate are normally not exposed to chromium trioxide as they do not work at the hardchrome plating department.

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Waste materials containing Cr(VI) are classified and treated as hazardous wastes according to EU and national regulations.

These conditions are reflected in the environmental contributing scenario below.

9.1.1.1. Conditions of use

Amount used, frequency and duration of use (or from service life) Daily use at site: <= 6.4E-05 tonnes/day [as Cr(VI)] as average Annual use at a site: <= 0.016 tonnes/year [as Cr(VI)] Percentage of tonnage used at regional scale: = 100 % Technical and organisational conditions and measures Negligible discharge of Cr(VI) in wastewater from the site All solid waste and any liquid waste is collected and either the collected waste is directly forwarded to an external waste management company, or Cr(VI) in wastewater is reduced to Cr(III) on-site. The treated wastewater is discharged to municipal sewage system. Any solid or slurry waste resulting from on-site wastewater treatment is forwarded to an external waste management company (licenced contractor) for disposal as hazardous waste Conditions and measures related to sewage treatment plant Not applicable – negligible discharge of Cr(VI) in wastewater from the site Conditions and measures related to treatment of waste (including article waste) Collection of all solid and liquid waste, elimination of Cr(VI) from waste water, disposal as hazardous waste by an external waste management company (licenced contractor) Other conditions affecting environmental exposure

9.1.1.2. Releases

For the use of ammonium dichromate in photolithographic lacquers, no specific air emission data (i.e. measurement of release to the atmosphere) are available.

Significant loss of the substance as a gas or vapour will not occur as ammonium dichromate has a high melting point and is of low volatility. Loss of the substance as a particulate (dust) is likely to be minimal as the substance is provided as crystals measuring between 0.5 – 2 mm in diameter and handling of small quantities in carefully controlled manner minimises potential for dust generation. The crystalline ammonium dichromate is weighed in a fume cabinet. The ammonium dichromate crystals are handled carefully to prevent formation of dust or that they become airborne. Water is added and aqueous solution formed by mixing. In a further step that may be carried out separately, part of this ammonium dichromate solution is added to the PVA lacquer to form a pre-coat (0.01-0.1% ammonium dichromate) and coating (0.1-0.5% ammonium dichromate) solution: there is no air extraction during this activity and therefore no emission to atmosphere.

The PVA lacquer containing ammonium dichromate is applied to larger plates in a dedicated coating machine. The machine is contained. There is a lid to ensure the temperature within the machine is always maintained at 48 oC so the PVA lacquer can dry, and prevent dust/dirt falling onto the plate, as this would disturb the plate and final article. The process in the machine is carefully controlled: the necessary process chemicals are decanted in sequence via a dedicated opening (a hatch measuring 20cm x 20cm) to facilitate decanting of chemicals while minimising worker exposure, avoid temperature decreases and contamination. The coating machine for small plates does not have a hatch in the lid; the lid of this machine is opened only when decanting liquids. The temperature in this smaller machine is also maintained at 48oC, and must be adjusted after decanting of liquids (as the temperature drops when

25/01/15 CHEMICAL SAFETY REPORT 24 EC number: Ammonium dichromate CAS number: 232-143-1 7789-09-5 the lid is open). First the plate is rinsed with water. Then diluted sulfuric acid is decanted into the machine4. The pre-coat (0.01-0.1% ammonium dichromate) and the final coating (0.1-0.5% ammonium dichromate) are then decanted into the machine and applied to the plate. The decanting of the sulfuric acid and the coatings is carried out sequentially. Following application of the coatings, the temperature is re-adjusted to 48° C in order to dry the PVA lacquer. The plate is dried for max. 40 minutes. Neither the ammonium dichromate nor the PVA evaporates during this process. Given the low amount of ammonium dichromate in the lacquer (max 0.5%) and the low vapour pressure of ammonium dichromate, evaporation losses of ammonium dichromate are expected to negligible.

As a reasonable worst case, for the purpose of the exposure assessment, it has been assumed that 1% of the ammonium dichromate will be extracted and emitted to air.

Table 10. Local releases to the environment

Release Release factor estimation Explanation / Justification method Air Release factor Initial release factor: 50% (ERC 5 default) Final release factor: 1% Local release rate: 0.00064 kg/day

9.1.1.3. 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 11. Exposure concentrations and risks for the environment

Protection target Exposure concentration Risk characterisation Freshwater Not relevant - Sediment (freshwater) Not relevant - Marine water Not relevant - Sediment (marine water) Not relevant - Predator (freshwater) Not relevant - Predator (marine water) Not relevant - Top predator (marine water) Not relevant - Sewage treatment plant Not relevant - Air Local PEC: 1.22E-7 mg/m³ - Agricultural soil Not relevant - Predator (terrestrial) Not relevant - Man via Environment – Local PEC: 1.22E-7 mg/m³ Based on the dose-response Inhalation relationship for lung cancer mortality derived by the RAC, considering a 70 year exposure time (24h/day, 7d/week), the following excess lifetime lung cancer mortality risk for the general population is derived based on the estimated exposure: 3.54E-03 per 1000 exposed.

4 Water and sulfuric acid (and small amounts of PVA) are discharged to WWTP. Most of the PVA stays either on the plate or in the machine given the high viscosity. The PVA which falls off the plate dries and is removed once a week as a solid mass. There is no residual Cr(VI) in the final PVA, nor in the dried remainders in the machine.

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Protection target Exposure concentration Risk characterisation Man via Environment – Oral Not relevant -

Conclusion on risk characterisation 3 The estimated exposure concentration of 1.22E-7 mg/m is used as worst-case estimate of PEClocalair,ann. and used as the basis for risk characterisation for man via the environment. Based on the dose-response relationship for lung cancer mortality derived by the RAC, considering a 70 year exposure time (24h/day, 7d/week), the following excess lifetime lung cancer mortality risk for the general population is derived based on the estimated exposure: 3.54E-03 per 1000 exposed. As the mechanistic evidence is suggestive of non-linearity, it is acknowledged by RAC that excess risks inferred in the low exposure range [i.e. below an exposure concentration of 1 µg Cr(VI)/m³] might be an over-estimate. 9.1.2. Worker contributing scenario 1: Delivery and storage of raw material (PROC 1)

Receipt and storage of ammonium dichromate as solid crystals in closed plastic packaging of 1 kg. There is no potential for exposure as the packaging stays closed until use. The substance is stored in dedicated, closed cabinets, which are air-extracted. The cabinets at the laboratory (for storage of small quantities) are not extracted.

1 kg ammonium dichromate package. Smallest particles are ± 0.5 mm in diameter.

Chemicals are stored in dedicated, lockable cabinets Lockable cabinet for chemicals in the lab. which are air-extracted.

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9.1.2.1. Conditions of use

Method Product (article) characteristics • Substance as such Qualitative • Concentration of Cr(VI): < 50% Amount used (or contained in articles), frequency and duration of use/exposure • Duration of activity: < 8 hours Qualitative • Frequency of activity: < 1 time/week Qualitative Technical and organisational conditions and measures • General ventilation: Basic general ventilation (1-3 air changes per hour) Qualitative • Containment: Closed system (minimal contact during routine operations) Qualitative • Local exhaust ventilation: No Qualitative • Occupational Health and Safety Management System: Advanced Qualitative Conditions and measures related to personal protection, hygiene and health evaluation • Respiratory Protection: No Qualitative Other conditions affecting workers exposure • Place of use: Indoor Qualitative • Process temperature (for solid): Ambient Qualitative

9.1.2.2. Exposure and risks for workers

The exposure concentrations and risk characterisation ratios (RCR) are reported in the following table.

Table 12. Exposure concentrations and risks for workers

Route of exposure and type of Exposure concentration Risk characterization effects Inhalation, local, long-term 0 µg/m3 Based on the dose-response relationship for lung cancer mortality derived by the RAC, considering a 40 year working life (8h/day, 5d/week), the following excess lifetime lung cancer mortality risk up to age 89 is derived based on the estimated exposure: 0 per 1000 exposed workers

Conclusion on risk characterisation The qualitatively determined exposure estimate of 0 µg Cr(VI)/m³ is used as the basis for risk characterisation. An excess lifetime lung cancer risk of 0 per 1000 exposed workers is estimated based on the above exposure estimate and the RAC dose-response relationship for lung cancer mortality. 9.1.3. Worker contributing scenario 2: Weighing and dilution of solids, decanting (PROC 8b, 5)

In the preparation of an aqueous solution, crystalline ammonium dichromate is weighed in a glass beaker by pouring the crystals from the packaging into the beaker. Cold water is slowly added and mixed using a mixing device. Then the ammonium dichromate solution (10-20 wt%) is decanted in a jerry can. This procedure is done 4 times in a row

25/01/15 CHEMICAL SAFETY REPORT 27 EC number: Ammonium dichromate CAS number: 232-143-1 7789-09-5 to get 10 L of solution. All handling of crystalline solids and aqueous solution is done inside an extracted fume cabinet. The worker wears goggles, a protective coat and nitrile gloves (0.12 mm thickness). This scenario is performed once every 3 weeks by one out of two laboratory employees.

Cold water is added to the solid ammonium dichromate to make a base solution with the required concentration. Afterwards the solid ammonium dichromate is gently Solid ammonium dichromate is poured into the glass dissolved in the cold water by a magnetic stirrer. Total beaker. Air flow in cabinet: 0.45 m/s. volume is 2.5 liter.

The ammonium dichromate solution is decanted into a 10 liter container.

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9.1.3.1. Conditions of use

9.1.3.1.1. Weighing

Method Product (article) characteristics/substance emission potential Substance product type: Powders, granules or pelletised material ART 1.5 Powder weight fraction [Cr(VI]: Substantial (10 - 50%) ART 1.5 ART 1.5 Moisture content: Dry product (<5 % moisture content) ART 1.5 Activity emission potential Duration of activity: 5 min ART 1.5 Frequency of activity: 1 time/3 weeks (factor of 0.1 is applied) ART 1.5 (extended) 5 Primary emission source located in the breathing zone of the worker: Yes ART 1.5 Activity class: Movement and agitation of powders, granules or pelletised material ART 1.5 Situation: Movement and agitation of 1 - 10 kg ART 1.5 Level of agitation: Low ART 1.5 Containment level: Open process ART 1.5 Surface contamination Process fully enclosed? No ART 1.5 Effective housekeeping practices in place? Yes ART 1.5 Dispersion Work area: Indoors ART 1.5 Room size: Any size workroom ART 1.5 Technical and organisational conditions and measures – localised controls Primary: Fume cupboard (99.00 % reduction) ART 1.5 Secondary: No localized controls (0.0 % reduction) ART 1.5 Ventilation rate: Only good natural ventilation ART 1.5 Conditions and measures related to personal protection, hygiene and health evaluation Respiratory Protection: No ART 1.5

9.1.3.1.2. Dilution

5 The exposure model ART 1.5 does not include protection factors for the use of respiratory protection and no option to account for activities which do not take place every working day. Because these are important factors to be considered in the assessment of long-term exposure, we have extended the ART model by incorporating both parameters in the calculation of the final exposure estimate, where appropriate.

25/01/15 CHEMICAL SAFETY REPORT 29 EC number: Ammonium dichromate CAS number: 232-143-1 7789-09-5

Method Duration of activity: 5 min ART 1.5 Frequency of activity: 1 time/3 weeks (factor of 0.1 is applied) ART 1.5 (extended) Primary emission source located in the breathing zone of the worker: Yes ART 1.5 Activity class: Movement and agitation of powders, granules or pelletised material ART 1.5 Situation: Movement and agitation of 1 - 10 kg ART 1.5 Level of agitation: Low ART 1.5 Containment level: Handling that reduces contact between product and adjacent air. ART 1.5 Surface contamination Process fully enclosed? No ART 1.5 Effective housekeeping practices in place? Yes ART 1.5 Dispersion Work area: Indoors ART 1.5 Room size: Any size workroom ART 1.5 Technical and organisational conditions and measures – localised controls Primary: Fume cupboard (99.00 % reduction) ART 1.5 Secondary: No localized controls (0.0 % reduction) ART 1.5 Ventilation rate: Only good natural ventilation ART 1.5 Conditions and measures related to personal protection, hygiene and health evaluation Respiratory Protection: No ART 1.5

9.1.3.1.3. Decanting

Method Product (article) characteristics/substance emission potential Substance product type: Liquid ART 1.5 Concentration of Cr(VI) in mixture: Minor (5 -10%) ART 1.5 Process temperature: Room temperature ART 1.5 Vapour pressure of substance: < 0.01 Pa ART 1.5 Viscosity: Low ART 1.5 Activity emission potential Duration of activity: 5 min ART 1.5 Frequency of activity: 1 time/3 weeks (factor of 0.1 is applied) ART 1.5 (extended) Primary emission source located in the breathing zone of the worker: Yes ART 1.5 Activity class: Falling liquids ART 1.5 Situation: Transfer of liquid product with flow of 1 - 10 l/minute ART 1.5 Loading type: Splash loading, where the liquid dispenser remains at the top of the ART 1.5 reservoir and the liquid splashes freely Surface contamination Process fully enclosed? No ART 1.5 Effective housekeeping practices in place? Yes ART 1.5 Dispersion

25/01/15 CHEMICAL SAFETY REPORT 30 EC number: Ammonium dichromate CAS number: 232-143-1 7789-09-5

Method Work area: Indoors ART 1.5 Room size: Any size workroom ART 1.5 Technical and organisational conditions and measures – localised controls Primary: Fume cupboard (99.00 % reduction) ART 1.5 Secondary: No localized controls (0.0 % reduction) ART 1.5 Ventilation rate: Only good natural ventilation ART 1.5 Conditions and measures related to personal protection, hygiene and health evaluation Respiratory Protection: No ART 1.5

9.1.3.2. Exposure and risks for workers

Table 13. Exposure concentrations and risks for worker Route of exposure and type of effects Exposure concentration Risk characterisation Inhalation, local, long-term ART model output 4.6E-2 µg/m³ (90th percentile value) Further adjusted for frequency 4.6E-3 µg/m³ Based on the dose- response relationship for lung cancer mortality derived by the RAC, considering a 40 year working life (8h/day, 5d/week), the following excess lifetime lung cancer mortality risk up to age 89 is derived based on the estimated exposure: 0.0184 per 1000 exposed workers

Conclusion on risk characterisation The modelled exposure estimate (ART 1.5) of 4.6E-3 µg Cr(VI)/m³ is used as the basis for risk characterisation (worst case). The estimate is based on several conservative assumptions regarding exposure. An excess lifetime lung cancer risk of 0.0184 per 1000 exposed workers is estimated based on the above exposure estimate and the RAC dose-response relationship for lung cancer mortality. As the mechanistic evidence is suggestive of non-linearity, it is acknowledged by RAC that excess risks inferred in the low exposure range [i.e. below an exposure concentration of 1 µg Cr(VI)/m³] might be an over-estimate. 9.1.4. Worker contributing scenario 3: Preparation of PVA lacquers (PROC 8b, 5)

Ammonium dichromate solution is decanted from the jerry can (see WCS 2) into a glass beaker at dedicated workspaces near the coating machines. Any release from this area would be directed to the WWTP. From the glass beaker it is decanted into a measuring glass. Then it is added to PVA lacquer: the final ammonium dichromate concentration in the PVA is 0.1-0.5 wt%. The PVA lacquer may be diluted with water (before adding ammonium dichromate) to get a thinner lacquer. The dichromate-containing lacquer is mixed for at least 2 hours using a low to moderate speed electrical stirrer. Mixing at high speed must be avoided as this could introduce air to the mixture. There is no risk of splashing due to the speed of the stirrer and the high viscosity of the PVA lacquer. As mixing takes at least 2 hours, speed does not need to be high. Part of the ammonium dichromate-containing lacquer is diluted

25/01/15 CHEMICAL SAFETY REPORT 31 EC number: Ammonium dichromate CAS number: 232-143-1 7789-09-5 by adding water to give an ammonium dichromate concentration of 0.01-0.1 wt%. Potential net exposure time per batch is around 1 min.

The PVA lacquer is decanted in a pressure vessel using compressed air (0.5 bar over pressure) and filtered over a filtration paper. Via a tap, the filtered PVA lacquer enters a glass beaker (3 L). Potential net exposure time per batch is around 1 min. The filtration process itself takes ca. 2 min.

The glass beakers, the mixer and the pressure vessel are cleaned using running hot and cold water. Potential exposure time per batch is less than 15 min. All wastewater is directed to the WWTP.

This preparation step is done twice a day (during 2 separate shifts) by 2 out of 3 workers in production. Veco operates on a three shift basis, five days per week. During the activities a protective coat, goggles and nitrile gloves are worn. There is no air extraction. Rinsing water is treated in the on-site wastewater treatment plant, where Cr(VI) is reduced to Cr(III). Filtration paper is disposed of as hazardous waste for incineration.

Dedicated work station for handling the ammonium dichromate Decanting ammonium dichromate mixtures. solution.

Filling the filtration pressure vessel with PVA/ammonium Cleaning the filtration vessel with hot and dichromate solution. cold water.

25/01/15 CHEMICAL SAFETY REPORT 32 EC number: Ammonium dichromate CAS number: 232-143-1 7789-09-5

9.1.4.1. Conditions of use

9.1.4.1.1. Decanting and further dilution

Method Product (article) characteristics/substance emission potential Substance product type: Liquid ART 1.5 Concentration of Cr(VI) in mixture: Minor (5 -10%) ART 1.5 Process temperature: Room temperature ART 1.5 Vapour pressure of substance: < 0.01 Pa ART 1.5 Viscosity: Low ART 1.5 Activity emission potential Duration of activity: < 5 min ART 1.5 Primary emission source located in the breathing zone of the worker: Yes ART 1.5 Activity class: Falling liquids ART 1.5 Situation: Transfer of liquid product with flow of 1 - 10 l/minute ART 1.5 Loading type: Splash loading, where the liquid dispenser remains at the top of the ART 1.5 reservoir and the liquid splashes freely Surface contamination Process fully enclosed? No ART 1.5 Effective housekeeping practices in place? Yes ART 1.5 Dispersion Work area: Indoors ART 1.5 Room size: Any size workroom ART 1.5 Technical and organisational conditions and measures – localised controls Primary: No localized controls (0.0 % reduction) ART 1.5 Secondary: No localized controls (0.0 % reduction) ART 1.5 Ventilation rate: Only good natural ventilation ART 1.5 Conditions and measures related to personal protection, hygiene and health evaluation Respiratory Protection: No ART 1.5

9.1.4.1.2. Mixing

25/01/15 CHEMICAL SAFETY REPORT 33 EC number: Ammonium dichromate CAS number: 232-143-1 7789-09-5

Method Activity class: Activities with agitated surfaces ART 1.5 Situation: Open surface: < 0.1 m² ART 1.5 Surface contamination Process fully enclosed? No ART 1.5 Effective housekeeping practices in place? Yes ART 1.5 Dispersion Work area: Indoors ART 1.5 Room size: Any size workroom ART 1.5 Technical and organisational conditions and measures – localised controls Primary: No localized controls (0.0 % reduction) ART 1.5 Secondary: No localized controls (0.0 % reduction) ART 1.5 Segregation: No segregation (0.00 % reduction) ART 1.5 Personal enclosure: No personal enclosure (0.00 % reduction) ART 1.5 Ventilation rate: Only good natural ventilation ART 1.5 Conditions and measures related to personal protection, hygiene and health evaluation Respiratory Protection: No ART 1.5

9.1.4.1.3. Decanting of laquer

Method Product (article) characteristics/substance emission potential Substance product type: Liquid ART 1.5 Concentration of Cr(VI) in mixture: Extremely small (0.1 – 0.5%) ART 1.5 Process temperature: Room temperature ART 1.5 Vapour pressure of substance: < 0.01 Pa ART 1.5 Viscosity: Medium ART 1.5 Activity emission potential Duration of activity: < 5 min ART 1.5 Primary emission source located in the breathing zone of the worker: Yes ART 1.5 Activity class: Falling liquids ART 1.5 Situation: Transfer of liquid product with flow of 1 - 10 l/minute ART 1.5 Loading type: Splash loading, where the liquid dispenser remains at the top of the ART 1.5 reservoir and the liquid splashes freely Surface contamination Process fully enclosed? No ART 1.5 Effective housekeeping practices in place? Yes ART 1.5 Dispersion Work area: Indoors ART 1.5 Room size: Any size workroom ART 1.5 Technical and organisational conditions and measures – localised controls Primary: No localized controls (0.0 % reduction) ART 1.5

25/01/15 CHEMICAL SAFETY REPORT 34 EC number: Ammonium dichromate CAS number: 232-143-1 7789-09-5

Method Secondary: No localized controls (0.0 % reduction) ART 1.5 Ventilation rate: Only good natural ventilation ART 1.5 Conditions and measures related to personal protection, hygiene and health evaluation Respiratory Protection: No ART 1.5

9.1.4.1.4. Cleaning of pressure vessel

Method Product (article) characteristics/substance emission potential Substance product type: Liquid ART 1.5 Concentration of Cr(VI) in mixture: Extremely small (0.1 – 0.5%) ART 1.5 Process temperature: 30° C ART 1.5 Vapour pressure of substance: < 0.01 Pa ART 1.5 Viscosity: Low ART 1.5 Activity emission potential Duration of activity: < 15 min ART 1.5 Primary emission source located in the breathing zone of the worker: Yes ART 1.5 Activity class: Handling of contaminated objects ART 1.5 Situation: Activities with treated/contaminated objects (surface > 3 m²) ART 1.5 Contamination level: Contamination > 90 % of surface ART 1.5 Surface contamination Process fully enclosed? No ART 1.5 Effective housekeeping practices in place? Yes ART 1.5 Dispersion Work area: Indoors ART 1.5 Room size: Any size workroom ART 1.5 Technical and organisational conditions and measures – localised controls Primary: Medium level containment (99.00 % reduction) ART 1.5 Secondary: No localized controls (0.0 % reduction) ART 1.5 Ventilation rate: Only good natural ventilation ART 1.5 Conditions and measures related to personal protection, hygiene and health evaluation Respiratory Protection: No ART 1.5

25/01/15 CHEMICAL SAFETY REPORT 35 EC number: Ammonium dichromate CAS number: 232-143-1 7789-09-5

9.1.4.2. Exposure and risks for workers

Table 14. Exposure concentrations and risks for worker Exposure concentration Risk characterisation Route of exposure and type of effects Inhalation, local, long-term Based on the dose- 0.48 µg/m³ response relationship for lung cancer mortality (ART 1.5 prediction, 90th percentile value) derived by the RAC, considering a 40 year working life (8h/day, 5d/week), the following excess lifetime lung cancer mortality risk up to age 89 is derived based on the estimated exposure: 1.92 per 1000 exposed workers

Conclusion on risk characterisation The modelled exposure estimate (ART 1.5) of 0.48 µg Cr(VI)/m³ is used as the basis for risk characterisation (worst case). The estimate is based on several conservative assumptions regarding exposure. An excess lifetime lung cancer risk of 1.92 per 1000 exposed workers is estimated based on the above exposure estimate and the RAC dose-response relationship for lung cancer mortality. As the mechanistic evidence is suggestive of non-linearity, it is acknowledged by RAC that excess risks inferred in the low exposure range [i.e. below an exposure concentration of 1 µg Cr(VI)/m³] might be an over-estimate. 9.1.5. Worker contributing scenario 4: Application photolithographic lacquer onto large plates (1m2 or more) (PROC 8b, 13)

In the application of photolithographic lacquer onto large plates, glass beakers with 500 mL of lacquer are filled.

The diluted PVA lacquer (0.01-0.1 wt% ammonium dichromate) is manually and carefully decanted onto a plate for pre-coating, via a small lid (hatch) on top of the machine.

Thereafter, the (regular or thinner) PVA lacquer (0.1-0.5 wt% ammonium dichromate) is manually and carefully decanted onto a plate for coating via a hatch. Afterwards the hatch is closed to guarantee a uniform drying process. Then the temperature inside the machine is increased to temperatures above room temperature (ca. 46-48°C) for drying of the PVA lacquer. There is LEV inside the closed machine. Finally, the plate is dried inside the machine for max. 40 minutes. This a completely closed process and no worker exposure can occur.

Max. 15 plates per shift are lacquered, by 3 employees (one per shift). Cleaning of the machine is done once a week by one employee.

Any excess lacquer within the machine is removed during the rinsing (with water) of the next plate. Rinsing water is sent to on-site WWTP. Excess lacquer which has not been removed by rinsing during the process, is manually collected as a solidified deposit and removed regularly. This material is disposed as chemical waste for incineration. Due to the thermal instability of the PVA/ammonium dichromate lacquer system, Cr(VI) in this deposit will be reduced to Cr(III) over time.

25/01/15 CHEMICAL SAFETY REPORT 36 EC number: Ammonium dichromate CAS number: 232-143-1 7789-09-5

25/01/15 CHEMICAL SAFETY REPORT 37 EC number: Ammonium dichromate CAS number: 232-143-1 7789-09-5

9.1.5.1. Conditions of use

9.1.5.1.1. Filling glass beaker with diluted lacquer

Method Product (article) characteristics/substance emission potential Substance product type: Liquid ART 1.5 Concentration of Cr(VI) in mixture: Minute (0.01 – 0.1%) ART 1.5 Process temperature: Room temperature ART 1.5 Vapour pressure of substance: < 0.01 Pa ART 1.5 Viscosity: Medium ART 1.5 Activity emission potential Duration of activity: < 5 min ART 1.5

25/01/15 CHEMICAL SAFETY REPORT 38 EC number: Ammonium dichromate CAS number: 232-143-1 7789-09-5

Method Primary emission source located in the breathing zone of the worker: Yes ART 1.5 Activity class: Falling liquids ART 1.5 Situation: Transfer of liquid product with flow of 1 - 10 l/minute ART 1.5 Loading type: Splash loading, where the liquid dispenser remains at the top of the ART 1.5 reservoir and the liquid splashes freely Surface contamination Process fully enclosed? No ART 1.5 Effective housekeeping practices in place? Yes ART 1.5 Dispersion Work area: Indoors ART 1.5 Room size: Any size workroom ART 1.5 Technical and organisational conditions and measures – localised controls Primary: No localized controls (0.0 % reduction) ART 1.5 Secondary: No localized controls (0.0 % reduction) ART 1.5 Ventilation rate: Only good natural ventilation ART 1.5 Conditions and measures related to personal protection, hygiene and health evaluation Respiratory Protection: No ART 1.5

9.1.5.1.2. Filling glass beaker with lacquer

25/01/15 CHEMICAL SAFETY REPORT 39 EC number: Ammonium dichromate CAS number: 232-143-1 7789-09-5

9.1.5.1.3. Decanting of diluted lacquer onto plate

Method Product (article) characteristics/substance emission potential Substance product type: Liquid ART 1.5 Concentration of Cr(VI) in mixture: Extremely small (0.01 – 0.1%) ART 1.5 Process temperature: Above room temperature ART 1.5 Vapour pressure of substance: < 0.01 Pa ART 1.5 Viscosity:Medium ART 1.5 Activity emission potential Duration of activity: < 5 min ART 1.5 Primary emission source located in the breathing zone of the worker: Yes ART 1.5 Activity class: Falling liquids ART 1.5 Situation: Transfer of liquid product with flow of 1 - 10 l/minute ART 1.5 Loading type: Splash loading, where the liquid dispenser remains at the top of the ART 1.5 reservoir and the liquid splashes freely Surface contamination Process fully enclosed? No ART 1.5 Effective housekeeping practices in place? Yes ART 1.5 Dispersion Work area: Indoors ART 1.5 Room size: Any size workroom ART 1.5 Technical and organisational conditions and measures – localised controls Primary: No localized controls (0.0 % reduction) ART 1.5 Secondary: No localized controls (0.0 % reduction) ART 1.5 Ventilation rate: Only good natural ventilation ART 1.5 Conditions and measures related to personal protection, hygiene and health evaluation Respiratory Protection: No ART 1.5

9.1.5.1.4. Decanting of lacquer onto plate

25/01/15 CHEMICAL SAFETY REPORT 40 EC number: Ammonium dichromate CAS number: 232-143-1 7789-09-5

Method Viscosity: Medium ART 1.5 Activity emission potential Duration of activity: < 5 min ART 1.5 Primary emission source located in the breathing zone of the worker: Yes ART 1.5 Activity class: Falling liquids ART 1.5 Situation: Transfer of liquid product with flow of 1 - 10 l/minute ART 1.5 Loading type: Splash loading, where the liquid dispenser remains at the top of the ART 1.5 reservoir and the liquid splashes freely Surface contamination Process fully enclosed? No ART 1.5 Effective housekeeping practices in place? Yes ART 1.5 Dispersion Work area: Indoors ART 1.5 Room size: Any size workroom ART 1.5 Technical and organisational conditions and measures – localised controls Primary: No localized controls (0.0 % reduction) ART 1.5 Secondary: No localized controls (0.0 % reduction) ART 1.5 Ventilation rate: Only good natural ventilation ART 1.5 Conditions and measures related to personal protection, hygiene and health evaluation Respiratory Protection: No ART 1.5

9.1.5.2. Exposure and risks for workers

Table 15. Exposure concentrations and risks for worker Exposure concentration Risk characterisation Route of exposure and type of effects Inhalation, local, long-term Based on the dose- 0.011 µg/m³ response relationship for lung cancer mortality (ART 1.5 prediction, 90th percentile value) derived by the RAC, considering a 40 year working life (8h/day, 5d/week), the following excess lifetime lung cancer mortality risk up to age 89 is derived based on the estimated exposure: 0.044 per 1000 exposed workers

The modelled exposure estimate (ART 1.5) of 0.011 µg Cr(VI)/m³ is used as the basis for risk characterisation (worst case). The estimate is based on several conservative assumptions regarding exposure. An excess lifetime lung cancer risk of 0.044 per 1000 exposed workers is estimated based on the above exposure estimate and the RAC dose-response relationship for lung cancer mortality. As the mechanistic evidence is suggestive of non-linearity, it is acknowledged by RAC that excess risks inferred in the low exposure range [i.e. below an exposure concentration of 1 µg Cr(VI)/m³] might be an over-estimate.

25/01/15 CHEMICAL SAFETY REPORT 41 EC number: Ammonium dichromate CAS number: 232-143-1 7789-09-5

9.1.6. Worker contributing scenario 5: Application photolithographic lacquer onto small plates (less than 0.3m2) (PROC 8b, 13)

In the application of photolithographic lacquer onto small plates, glass beakers with 250 mL of lacquer are filled.

The (thinner) PVA lacquer (0.1-0.5 wt% ammonium dichromate) is manually decanted onto a plate for coating, after which the machine is closed to guarantee a uniform drying process. Then the temperature inside the machine is increased.

Inside the closed machine at temperatures above room temperature (ca. 46-48°C), there is LEV. Any excess lacquer is removed during the rinsing (with water) of the next plate. Rinsing water is sent to on-site WWTP. Excess lacquer which has not been removed by rinsing during the process, is manually collected as a solidified deposit and removed regularly. This material is disposed as chemical waste for incineration. Due to the thermal instability of the PVA/ammonium dichromate lacquer system, Cr(VI) in this deposit will be reduced to Cr(III) over time.

Finally, the plate is dried inside the machine. This a completely closed process and no worker exposure can occur.

Max. 10-20 plates are lacquered each day by 1-2 employees (no shifts here). Cleaning of the coating machines is done once a week by one employee.

9.1.6.1. Conditions of use

9.1.6.1.1. Filling glass beaker with lacquer

Method Product (article) characteristics/substance emission potential Substance product type: Liquid ART 1.5 Concentration of Cr(VI) in mixture: Extremely small (0.1 – 0.5%) ART 1.5

25/01/15 CHEMICAL SAFETY REPORT 42 EC number: Ammonium dichromate CAS number: 232-143-1 7789-09-5

Method Process temperature: Room temperature ART 1.5 Vapour pressure of substance: < 0.01 Pa ART 1.5 Viscosity: Medium ART 1.5 Activity emission potential Duration of activity: < 15 min ART 1.5 Primary emission source located in the breathing zone of the worker: Yes ART 1.5 Activity class: Falling liquids ART 1.5 Situation: Transfer of liquid product with flow of 1 - 10 l/minute ART 1.5 Loading type: Splash loading, where the liquid dispenser remains at the top of the ART 1.5 reservoir and the liquid splashes freely Surface contamination Process fully enclosed? No ART 1.5 Effective housekeeping practices in place? Yes ART 1.5 Dispersion Work area: Indoors ART 1.5 Room size: Any size workroom ART 1.5 Technical and organisational conditions and measures – localised controls Primary: No localized controls (0.0 % reduction) ART 1.5 Secondary: No localized controls (0.0 % reduction) ART 1.5 Ventilation rate: Only good natural ventilation ART 1.5 Conditions and measures related to personal protection, hygiene and health evaluation Respiratory Protection: No ART 1.5

9.1.6.1.2. Decanting of lacquer onto plate

25/01/15 CHEMICAL SAFETY REPORT 43 EC number: Ammonium dichromate CAS number: 232-143-1 7789-09-5

Method Dispersion Work area: Indoors ART 1.5 Room size: Any size workroom ART 1.5 Technical and organisational conditions and measures – localised controls Primary: No localized controls (0.0 % reduction) ART 1.5 Secondary: No localized controls (0.0 % reduction) ART 1.5 Ventilation rate: Only good natural ventilation ART 1.5 Conditions and measures related to personal protection, hygiene and health evaluation Respiratory Protection: No ART 1.5

9.1.6.2. Exposure and risks for workers

Table 16. Exposure concentrations and risks for worker Exposure concentration Risk characterisation Route of exposure and type of effects Inhalation, local, long-term Based on the dose- 0.031 µg/m³ response relationship for lung cancer mortality (ART 1.5 prediction, 90th percentile value) derived by the RAC, considering a 40 year working life (8h/day, 5d/week), the following excess lifetime lung cancer mortality risk up to age 89 is derived based on the estimated exposure: 0.124 per 1000 exposed workers

Conclusion on risk characterisation The modelled exposure estimate (ART 1.5) of 0.031 µg/m³ Cr(VI) is used as the basis for risk characterisation (worst case). The estimate is based on several conservative assumptions regarding exposure. An excess lifetime lung cancer risk of 0.124 per 1000 exposed workers is estimated based on the above exposure estimate and the RAC dose-response relationship for lung cancer mortality. As the mechanistic evidence is suggestive of non-linearity, it is acknowledged by RAC that excess risks inferred in the low exposure range [i.e. below an exposure concentration of 1 µg Cr(VI)/m³] might be an over-estimate. 9.1.7. Worker contributing scenario 6: Exposure and development of plates (PROC 13, 7)

The plates are manually placed on a rack. Workers wear gloves when handling the plates (handling the plates by the edges so as not to disturb the dried lacquer). The rack has a ‘casement window’ to which the film mask is fixed. The window is closed so the film mask lies on (touching) the plate. As the lacquer of the plate is dry, no lacquer remainder will be present on the film after UV exposure when removing the film from the plate. Workers can easily touch (wearing gloves) the edges of the plate, as no important information from the film is present on the edges. The dry plate with the mask on it is put in a machine (by one worker per shift) and exposed to UV light. The photochemical reactions under exposure to UV light is the oxidation of PVA and the reduction of Cr(VI) to Cr(III). This results in crosslinking between PVA and Cr(III) in parts of the plate that are exposed to UV

25/01/15 CHEMICAL SAFETY REPORT 44 EC number: Ammonium dichromate CAS number: 232-143-1 7789-09-5 radiation. After UV exposure, the plate is moved via an automatic hoist system to the development process. The plate is developed with water (washing away non-exposed lacquer) in a two-step process. First, the plate is dipped in water (30° C) and then sprayed with water (30° C) in a segregated, automated system without air extraction. The non-exposed PVA lacquer completely dissolves in water, which is sent to on-site wastewater treatment where Cr(VI) is reduced to Cr(III). In the dipping step, the majority of the Cr(VI)-containing lacquer is removed. After being developed, the plate is moved by the hoist system to an oven for drying/baking at high temperature. This results in further crosslinking of PVA. No free ammonium dichromate is present anymore.

Finally, the plate is transported back and manually removed from the hoist system. Subsequently, the finished matrix plate can be used as a mandrel for electroforming nickel products.

25/01/15 CHEMICAL SAFETY REPORT 45 EC number: Ammonium dichromate CAS number: 232-143-1 7789-09-5

9.1.7.1. Conditions of use

9.1.7.1.1. Developing of plate – removal of non-exposed lacquer

Method Product (article) characteristics/substance emission potential Substance product type: Liquid ART 1.5 Concentration of Cr(VI) in mixture: Extremely small (0.1 – 0.5%) ART 1.5 Process temperature: Above room temperature ART 1.5 Vapour pressure of substance: < 0.01 Pa ART 1.5 Viscosity: Low ART 1.5 Activity emission potential Duration of activity: < 30 min ART 1.5 Primary emission source located in the breathing zone of the worker: No ART 1.5 Activity class: Handling of contaminated objects ART 1.5 Situation: Activities with treated/contaminated objects (surface 1-3 m²) ART 1.5 Contamination level: Contamination 10-90 % of surface ART 1.5 Surface contamination Process fully enclosed? Yes ART 1.5 Dispersion Work area: Indoors ART 1.5 Room size: Any size workroom ART 1.5 Technical and organisational conditions and measures – localised controls

25/01/15 CHEMICAL SAFETY REPORT 46 EC number: Ammonium dichromate CAS number: 232-143-1 7789-09-5

Method Primary: Low level containment (90.00 % reduction) ART 1.5 Secondary: No localized controls (0.0 % reduction) ART 1.5 Segregation: Complete segregation without ventilation (70.00 % reduction) ART 1.5 Ventilation rate: Only good natural ventilation ART 1.5 Conditions and measures related to personal protection, hygiene and health evaluation Respiratory Protection: No ART 1.5

9.1.7.2. Exposure and risks for workers

Table 17. Exposure concentrations and risks for worker Exposure concentration Risk characterisation Route of exposure and type of effects Inhalation, local, long-term Based on the dose- 0.0006 µg/m³ response relationship for lung cancer mortality (ART 1.5 prediction, 90th percentile value) derived by the RAC, considering a 40 year working life (8h/day, 5d/week), the following excess lifetime lung cancer mortality risk up to age 89 is derived based on the estimated exposure:

2.4E-03 per 1000 exposed workers

Conclusion on risk characterisation The modelled exposure estimate (ART 1.5) of 0.0006 µg/m³ Cr(VI) is used as the basis for risk characterisation (worst case). The estimate is based on several conservative assumptions regarding exposure. An excess lifetime lung cancer risk of 2.4E-03 per 1000 exposed workers is estimated based on the above exposure estimate and the RAC dose-response relationship for lung cancer mortality. As the mechanistic evidence is suggestive of non-linearity, it is acknowledged by RAC that excess risks inferred in the low exposure range [i.e. below an exposure concentration of 1 µg Cr(VI)/m³] might be an over-estimate. 9.1.8. Worker contributing scenario 7: Cleaning of equipment – tools cleaning (closed system) (PROC 8b) Tools (e.g. beakers, mixing devices, coating machine) are cleaned with water, which is directed to the on-site WWTP. Cleaning of equipment is carried out in the lab after weighing/dissolving solid ammonium dichromate (i.e. once every three weeks), or at the dedicated workplaces near the coating machines where the ammonium dichromate is added to the PVA lacquer (once per shift). The hardened lacquer remainders in the coating machines are removed by hand (using a spatula) once a week. The model also applies a maximum concentration level of ammonium dichromate [and so Cr(VI)]. In most cleaning processes, the concentration will be much lower.

25/01/15 CHEMICAL SAFETY REPORT 47 EC number: Ammonium dichromate CAS number: 232-143-1 7789-09-5

Example: Cleaning the filtration vessel with hot and cold water.

9.1.8.1. Conditions of use

Method Product (article) characteristics/substance emission potential Substance product type: Liquid ART 1.5 Concentration of Cr(VI) in mixture: Minor (5 - 10%) ART 1.5 Process temperature: Room temperature ART 1.5 Vapour pressure of substance: < 0.01 Pa ART 1.5 Viscosity: Low ART 1.5 Activity emission potential Duration of activity: < 15 min ART 1.5 Primary emission source located in the breathing zone of the worker: No ART 1.5 Activity class: Handling of contaminated objects ART 1.5 Situation: Activities with treated/contaminated objects (surface 0.1-0.3 m²) ART 1.5 Contamination level: Contamination 10-90 % of surface ART 1.5 Surface contamination Process fully enclosed? No ART 1.5 Effective housekeeping practices in place? Yes ART 1.5 Dispersion Work area: Indoors ART 1.5 Room size: Any size workroom ART 1.5 Technical and organisational conditions and measures – localised controls Secondary: No localized controls (0.0 % reduction) ART 1.5

25/01/15 CHEMICAL SAFETY REPORT 48 EC number: Ammonium dichromate CAS number: 232-143-1 7789-09-5

Method Ventilation rate: Only good natural ventilation ART 1.5 Conditions and measures related to personal protection, hygiene and health evaluation Respiratory Protection: No ART 1.5

9.1.8.2. Exposure and risks for workers

The exposure concentrations and risk characterisation ratios (RCR) are reported in the following table.

Table 18. Exposure concentrations and risks for worker Route of exposure and type of effects Exposure concentration Risk characterisation Inhalation, local, long-term 0.026 µg/m³ Based on the dose- (ART 1.5 prediction, 90th percentile value) response relationship for lung cancer mortality derived by the RAC, considering a 40 year working life (8h/day, 5d/week), the following excess lifetime lung cancer mortality risk up to age 89 is derived based on the estimated exposure: 0.104 per 1000 exposed workers

Conclusion on risk characterisation The modelled exposure estimate (ART 1.5) of 0.026 µg/m³ (Cr VI) is used as the basis for risk characterisation (worst case). The estimate is based on several conservative assumptions regarding exposure. An excess lifetime lung cancer risk of 0.104 per 1000 exposed workers is estimated based on the above exposure estimate and the RAC dose-response relationship for lung cancer mortality. As the mechanistic evidence is suggestive of non-linearity, it is acknowledged by RAC that excess risks inferred in the low exposure range [i.e. below an exposure concentration of 1 µg Cr(VI)/m³] might be an over-estimate. 9.1.9. Worker contributing scenario 8: Maintenance activities (PROC 8b)

Maintenance activities on equipment are conducted on an annual average of 0.5 hours per week. These activities comprise e.g. fixing minor disturbances in the equipment, repairing equipment, replacing parts, maintaining extraction units, etc. About 5 maintenance employees are trained to maintain the equipment used for PVA/ammonium dichromate mandrel production.

9.1.9.1. Conditions of use

Method Product (article) characteristics/substance emission potential Substance product type: liquid ART 1.5 Concentration of Cr(VI) in mixture: Extremely small (0.1 – 0.5%) ART 1.5 Process temperature: Room temperature ART 1.5 Vapour pressure of substance: < 0.01 Pa ART 1.5 Viscosity: Low ART 1.5

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Method Activity emission potential Duration of activity: < 30 min ART 1.5 Frequency of activity: 1 time/week ART 1.5 (extended) Activity class: Handling of contaminated solid objects or paste ART 1.5 Situation: Activities with treated/contaminated objects (surface 1-3 m²) ART 1.5 Contamination level: Contamination 10-90 % of surface. ART 1.5 Surface contamination Process fully enclosed? No ART 1.5 Effective housekeeping practices in place? Yes ART 1.5 Dispersion Work area: Indoors ART 1.5 Room size: Any size workroom ART 1.5 Technical and organisational conditions and measures – localised controls Primary: No localized controls (0.0 % reduction) ART 1.5 Secondary: No localized controls (0.0 % reduction) ART 1.5 Ventilation rate: Only good natural ventilation ART 1.5 Conditions and measures related to personal protection, hygiene and health evaluation Respiratory Protection: No ART 1.5

9.1.9.2. Exposure and risks for workers

Table 19. Exposure concentrations and risks for worker Route of exposure and type of effects Exposure concentration Risk characterisation Inhalation, local, long-term ART model output 3.5E-3 µg/m³ (90th percentile value) Further adjusted for frequency 7.0E-4 µg/m³ Based on the dose- response relationship for lung cancer mortality derived by the RAC, considering a 40 year working life (8h/day, 5d/week), the following excess lifetime lung cancer mortality risk up to age 89 is derived based on the estimated exposure: 2.8E-03 per 1000 exposed workers

Conclusion on risk characterisation The modelled exposure estimate (ART 1.5) of 7.0E-4 µg/m³ Cr(VI) is used as the basis for risk characterisation (worst case). The estimate is based on several conservative assumptions regarding exposure. An excess lifetime lung cancer risk of 2.8E-03 per 1000 exposed workers is estimated based on the above exposure

25/01/15 CHEMICAL SAFETY REPORT 50 EC number: Ammonium dichromate CAS number: 232-143-1 7789-09-5 estimate and the RAC dose-response relationship for lung cancer mortality. As the mechanistic evidence is suggestive of non-linearity, it is acknowledged by RAC that excess risks inferred in the low exposure range [i.e. below an exposure concentration of 1 µg Cr(VI)/m³] might be an over-estimate. 9.1.10. Worker contributing scenario 9: Waste management (PROC 8b)

Solid waste (PVA lacquer remainders, filtration paper) from process is collected and sent for incineration.

Remaining solutions containing ammonium dichromate are diluted and sent together with rinse waste liquid, to the on-site WWTP, where Cr(VI) is reduced to Cr(III).

Other waste materials including used containers, overalls and protective gloves are collected and sent for incineration. Used containers are first rinsed with water before transfer to the storage area. The scenario below describes the transfer of used overalls and protective gloves from handling of the crystalline ammonium dichromate (see WCS 2) to the storage area. It represents the highest estimated exposure among different waste handling options.

All chemicals, including chemical waste,are stored in a specialized facility.

9.1.10.1. Conditions of use

Method Product (article) characteristics/substance emission potential Substance product type: Powders, granules or pelletised material ART 1.5 Dustiness: Firm granules, flakes or pellets ART 1.5 Moisture content: Dry product (< 5 % moisture content) ART 1.5 Powder weight fraction [Cr(VI)]: Substantial (10 – 50 %) ART 1.5 Activity emission potential Duration of activity: < 5 min ART 1.5 Frequency of activity: 1 time/3 weeks (factor of 0.1 is applied) ART 1.5 (extended) Activity class: Handling of contaminated solid objects or paste ART 1.5 Situation: Handling of objects with limited residual dust (thin layer visible) ART 1.5

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Method Handling type: Careful handling, involves workers showing attention to potential ART 1.5 danger, error or harm and carrying out the activity in a very exact and thorough (or cautious) manner. Surface contamination Process fully enclosed? No ART 1.5 Effective housekeeping practices in place? Yes ART 1.5 Dispersion Work area: Indoors ART 1.5 Room size: Any size workroom ART 1.5 Technical and organisational conditions and measures – localised controls Primary: No localized controls (0.0 % reduction) ART 1.5 Secondary: No localized controls (0.0 % reduction) ART 1.5 Ventilation rate: Only good natural ventilation ART 1.5 Conditions and measures related to personal protection, hygiene and health evaluation Respiratory Protection: No ART 1.5

9.1.10.2. Exposure and risks for workers

Table 20. Exposure concentrations and risks for worker Route of exposure and type of effects Exposure concentration Risk characterisation Inhalation, local, long-term ART model output 0.12 µg/m³ (90th percentile value) Further adjusted for frequency 0.012 µg/m³ Based on the dose- response relationship for lung cancer mortality derived by the RAC, considering a 40 year working life (8h/day, 5d/week), the following excess lifetime lung cancer mortality risk up to age 89 is derived based on the estimated exposure: 0.048 per 1000 exposed workers

Conclusion on risk characterisation The modelled exposure estimate (ART 1.5) of 0.012 µg/m³ Cr(VI) is used as the basis for risk characterisation (worst case). The estimate is based on several conservative assumptions regarding exposure. An excess lifetime lung cancer risk of 0.048 per 1000 exposed workers is estimated based on the above exposure estimate and the RAC dose-response relationship for lung cancer mortality. As the mechanistic evidence is suggestive of non-linearity, it is acknowledged by RAC that excess risks inferred in the low exposure range [i.e. below an exposure concentration of 1 µg Cr(VI)/m³] might be an over-estimate.

25/01/15 CHEMICAL SAFETY REPORT 52 EC number: Ammonium dichromate CAS number: 232-143-1 7789-09-5 10. RISK CHARACTERISATION RELATED TO COMBINED EXPOSURE 10.1. Human health 10.1.1. Workers

Operators could conduct some combinations of tasks (sub-scenarios) in section 9.1. Employees who work at the laboratory where solid ammonium dichromate is dissolved in water, do not work at the department where the PVA lacquers are formulated and the mandrels are produced. Employees who work at the laboratory or department where mandrels are produced using ammonium dichromate-containing PVA lacquers, do normally not work at the department where the hardchrome plating activities are conducted. Therefore, it is assumed that employees who handle ammonium dichromate or PVA lacquer containing ammonium dichromate are not additionally exposed to chromium trioxide.

For all activities, exposure estimates have been prepared by modeling. By nature, the exposure models used provide worst-case estimates in order to be assuredly conservative and to apply across a broad range of activities and situations. Accordingly, modeling may provide results that are so over-conservative as to be rather unrealistic, depending on the basic assumptions of the model and the specificity, the quality and the currency of the underlying model database.

Summing exposure estimates across sub-scenarios further amplifies the impact of conservative or worst-case assumptions across activities, resulting in potentially substantial over-estimates of potential exposure.

Nevertheless, the exposure estimates from all sub-scenarios (except of WCS 2, this work is done by laboratory staff) have been added. This would result in a combined exposure of 0.56 µg/m³.

As a result and for use in the SEA, a maximum individual exposure value of 0.56 µg/m³ Cr(VI) is seen as a reasonable basis for calculation.

In this case, an excess lifetime lung cancer risk of 2.24 per 1000 exposed workers is estimated based on the above exposure estimate and the RAC dose-response relationship for lung cancer mortality. DNELs for reproductive toxicity are far greater than the relevant exposure levels.

Annually, biological monitoring is performed by taking urine. The background value for chromium in the Netherlands (for non-exposed population) is 1 µg/g creatinine. The biological limit value for chromium in the Netherlands is 30 µg/g creatinine. The limit of detection of chromium in urine is 0.5 µg/L. For several years in a row, the urine of employees at Veco B.V. shows average chromium values below 1 µg/g creatinine. Individual values range between 0.2 and 1.5 µg/g creatinine (2010-2014), thus far below the biological limit value and around the general population background level. 10.1.2. Consumer

Not relevant as there is no consumer use. 10.2. Environment (combined for all emission sources) 10.2.1. All uses (regional scale)

10.2.1.1. Regional exposure

Environment

The regional predicted environmental concentration (PEC regional) and the related risk characterisation ratios when a PNEC is available are presented in the table below.

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The PEC regional has been estimated with EUSES.

Table 21. Predicted regional exposure concentrations (Regional PEC)

Protection target Regional PEC RCR Freshwater Not relevant Not relevant Sediment (freshwater) Not relevant Not relevant Marine water Not relevant Not relevant Sediment (marine water) Not relevant Not relevant Air 9.05E-17 mg/m³ Not relevant Agricultural soil Not relevant Not relevant

Man via environment

The exposure to man via the environment from regional exposure and the related risk characterisation ratios are presented in the table below. The exposure concentration via inhalation is equal to the PEC air.

Table 22. Regional exposure to man via the environment

Route Regional exposure RCR Inhalation 9.05E-17 mg/m³ Based on the dose-response relationship for lung cancer mortality derived by the RAC, considering a 70 year exposure time (24h/day, 7d/week), the following excess lifetime lung cancer mortality risk for the general population is derived based on the estimated exposure: 2.62E-12 per 1000 exposed. Oral Not relevant Not relevant

10.2.2. Local exposure due to all wide dispersive uses

Not relevant as there are not several wide dispersive uses covered in this CSR. 10.2.3. Local exposure due to combined uses at a site

Not relevant as there are no combined uses at a site.

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