9. exposure assessment (and related risk … acid, dichromic acid and oligomers of the mentioned...

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Afa_EC215-607-8_chromium_trioxide_en 2015-12-04 CSR-PI-5.5.3 CHEMICAL SAFETY REPORT 17 9. EXPOSURE ASSESSMENT (and related risk characterisation) 9.0. Introduction Description of manufacturing process Step 1, dissolving: tons of high grade recycled copper (photo 1) are dissolved to a copper electrolyte solution. Step 2, plating: the copper electrolyte solution is pumped into large plating tanks containing partially immersed titanium drums. Each of them rotates and is polarized against a conforming anode. As the drum rotates, a thin film of very pure copper is electrodeposited onto its surface (photo 2). Step 3, treating: the rolls of base foil, or drums foil, are processed through a sequence of chemical and electro-chemical processing steps. The final processes apply protective chemical conversion coatings (chromium trioxide is used) that prevent corrosion to both surface of the foil during storage or lamination (photo 3). Photo 1. storage of high grade copper Photo 2. thin film of copper manufactured by electrodeposition

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Afa_EC215-607-8_chromium_trioxide_en

2015-12-04 CSR-PI-5.5.3 CHEMICAL SAFETY REPORT 17

9. EXPOSURE ASSESSMENT (and related riskcharacterisation)

9.0. Introduction Description of manufacturing process Step 1, dissolving: tons of high grade recycled copper (photo 1) are dissolved to a copper electrolyte solution. Step 2, plating: the copper electrolyte solution is pumped into large plating tanks containing partially immersed titanium drums. Each of them rotates and is polarized against a conforming anode. As the drum rotates, a thin film of very pure copper is electrodeposited onto its surface (photo 2). Step 3, treating: the rolls of base foil, or drums foil, are processed through a sequence of chemical and electro-chemical processing steps. The final processes apply protective chemical conversion coatings (chromium trioxide is used) that prevent corrosion to both surface of the foil during storage or lamination (photo 3).

Photo 1. storage of high grade copper

Photo 2. thin film of copper manufactured by electrodeposition

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Photo 3. treating of the thin foil copper by applying protective chemical conversion coatings (chromium trioxide) that prevent corrosion

This exposure assessment is based on both measured data and modelled data (using ART 1.5 and EUSES).

The exposure assessment takes into account that when chromium trioxide is added to water (Worker contributing scenario 3, 4 and 5). The dissolution of chromium trioxide leads to an equilibrium between chromium trioxide, chromic acid, dichromic acid and oligomers of the mentioned acids as reaction products with water. As the toxicity of chromium trioxide and its equilibrium products are the same, the exposure assessment for chromium trioxide is also representative of chromic acid.

Moreover the company is certified BS-OHSAS 18001 until 2012 and also have a high security policy based on continual improvement of their procedures, sensitization and security equipment (collective and individual).

9.0.1. Overview of uses and Exposure Scenarios

Tonnage information:

Assessed tonnage: 15.8 tonnes/year based on:

• 15.8 tonnes/year imported

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

Table 4. Overview of exposure scenarios and contributing scenarios

Identifiers Market Sector

Titles of exposure scenarios and the related contributing scenarios

Tonnage (tonnes per year)

ES1 - IW1 Use at industrial site - Use at industrial site - Use at industrial site (ERC 6b) - Delivery and storage (PROC 1) - Dilution of the substance into a large container (PROC 5) - Electrochemical surface treatment (PROC 13) - Maintenance of equipment (PROC 8b) - Sampling for laboratory analysis and control (PROC 15)

15.8

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9.0.2. Introduction to the assessment

9.0.2.1. Environment

Scope and type of assessment

Regarding the intrinsic hazardous properties of the substance (carcinogenic 1A and Mutagenic 1B) and in accordance with article 62- 4. d) of the REACH regulation (EC) No 1907/2006, potential risks to the environment does not need to be considered.

Obviously the company takes care of its release in the environment and respects the national regulatory. Before to be released in the environment, chromium trioxide effluents are going flow through a sewage treatment plant where chromium trioxide is reduced to trivalent chromium using bisulfite. The limit of release of chromium trioxide is fixed on 0.1 ppm and 0.5 ppm for total chromium. The company measure continually the concentration in chromium trioxide of their effluents and must provide to the national authority each 3 months an analysis report. During the continually measurement if the concentration exceed the limit, the effluent is directed to a buffer tank and is not released in the environment.

Air release are not monitoring as it is not a legal obligation and because due to the low volatility, chromium trioxide will not normally be present in air. But all the exhausted air is passed through filters (minimum of 90% efficiency) before being released to atmosphere.

Release to soil is strictly excluded as the basements are on retention. Therefore releases to soil are considered as negligible.

Table 5. Type of risk characterisation required for the environment Protection target Type of risk characterisation Hazard conclusion

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

9.0.2.2. Man via environment

Humans may potentially be exposed to chromium trioxide via the environment. Due to the strict control of water effluents, releases to aquatic environment are negligible. The only relevant potential exposure path is inhalation of particles and/or aerosols released in the air.

As there is no threshold for effect, conclusions of RAC report RAC/27/2013/06 Rev.1 were used to conclude on the hazardous of the exposure.

Table 6. Type of risk characterisation required for man via the environment Route of exposure and type of effects

Type of risk characterisation

Hazard conclusion (see RAC/27/2013/06 Rev. 1)

Inhalation: local, long-term Quantitative ELR for lung cancer mortality: 2.9E-2 per µg Cr(VI)/m3 for 70 years 24h/day, every day (general population)

Oral: local, long-term Not needed: see below

ELR for intestinal cancer mortality: 8.0E-4 per µg Cr(VI)/kg bw/day for 70 years 24h/day, every day(general population)

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Oral route take into account the non-respirable fraction of particles which is also swallow. The company decided to not consider this route for the following reasons:

• Technical reasons: during the measurement (to evaluate the exposure to chromium trioxide), no sizefractioning has been done and for the calculated exposure, the model used (ART 1.5) does not distinguish the size fractions. In such case, the recommendation of the RAC report RAC/27/2013/06 Rev.1 is: “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”.

• Moreover, considering that all particles are respirable is the worst case as the ELR for lung cancer ishigher than the ELR for intestinal cancer.

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 RAC/27/2013/06 Rev.1 document. RAC linear dose-response relationships were used as there is no threshold for chromium trioxide.

Table 7. Type of risk characterisation required for workers Route Type of effect Type of risk

characterisation Hazard conclusion (see RAC/27/2013/06 Rev. 1)

Inhalation

Systemic, long-term Not needed

Not relevant

Systemic, acute Not needed

Not relevant

Local, long-term Quantitative ELR lung cancer mortality: 4.0E-3 per µg Cr(VI)/m3 for 40 years 8h/day, 5 days/week (workers)

Local, acute Not needed Not relevant

Dermal

Systemic, long-term Not needed

Not relevant

Systemic, acute Not needed Not relevant

Local, long-term Not needed Not relevant

Local, acute Not needed Not relevant

Eye Local Not needed Not relevant

Considering the RAC report RAC/27/2013/Rev. 1, the only relevant route to consider is the inhalation route. Regarding the oral route, it will not be taking into account as explain in section 9.0.2.2.

9.0.2.4. Consumers

Exposure assessment is not applicable as there are no consumer-related uses for the substance.

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9.1. Exposure scenario 1: Use at industrial site – Surface treatment

Sector of use:

SU 16, Manufacture of computer, electronic and optical products, electrical equipment

Environment contributing scenario(s):

Surface treatment ERC 6b

Worker contributing scenario(s):

Use in closed process, no likelihood of exposure PROC 1

Dilution of the substance into a large container PROC 5

Electrochemical surface treatment PROC 13

Maintenance of equipment PROC 8b

Sampling for laboratory analysis and control PROC 15

Personal protective equipment (PPE) management process

The PPE are part of the individual allocation of each worker of the company. PPE are provided according to the department. The workers who may be exposed to substances such as chromium trioxide (preparation of the dilution, maintenance task) have overall chemical types of PPE, full face respirator, specific glove, closed goggles, face shield, boots. The replacement of PPE is done by the workers or its overseer by visiting the company's shop where is made a standard and immediate exchange of the PPE. Regular field audits are planned (integrated quality, safety and environment audits as the company is certified ISO 9001, ISO 14001 and BS-OHSAS 18001) as well as spot checks permit to ensure that PPE are in good condition and not expired. Moreover, regular training and periodic sensitization (bimonthly 1/4 hour security) to the specific risks of the activity and the importance of wearing the PPE are conducted. The non-wearing of the PPE is systematically identified by department heads who gives a written warning for repeated offenses. Repeated offenses can lead to dismissal for serious misconduct.

List of PPE

PPE Type PPE supplier Tychem c overall (CEE/89/686 Directive) Tychem c mod. Cha5

Dupont de Nemours

Full face respirator with A2B2E2K2HgP3 Cartridge (CE 0158) Panorama Nova + X-Plore RD40 Filter

Dräger

Safety boots (EN ISO 20345:2011) Technostiv Nitrile Gloves (EN 374) TouchNTuff NBR 92-600

Ansell

CSM Gloves (Dry box gloves)(EN374) (CE 0333) Polyethylen Chlorosulfon

Piercan

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9.1.1. Environmental contributing scenario 1: Surface treatment

9.1.1.1. Conditions of use Amount used, frequency and duration of use (or from service life)

• Daily use at site: <= 0.044 tonnes/day

• Annual use at a site: <= 15.8 tonnes/year

• Percentage of EU tonnage used at regional scale: = 100 %

Conditions and measures related to sewage treatment plant

• Municipal STP: Yes [Effectiveness Water: 0.148%]

• Discharge rate of STP: >= 600 m3/d

• Application of the STP sludge on agricultural soil: No

Conditions and measures related to treatment of waste (including article waste)

• Particular considerations on the waste treatment operations: No (Waste disposal according to national/locallegislation)

Other conditions affecting environmental exposure

• Receiving surface water flow rate: >= 1.8E4 m3/d

Effluent and air release are treated as described in section 9.0.2.1 before to be rejected in the environment.

9.1.1.2. Releases

The local releases to the environment are reported in the following table.

Table 8. Local releases to the environment

Release Release factor estimation method

Explanation / Justification

Water Release factor Initial release factor: 0.05% Final release factor: 0.05% Local release rate: 0.022 kg/day Explanation / Justification: see below

Air Release factor Initial release factor: 0.005% Final release factor: 0.005% (considering the efficiency of the 90% efficiency of air filtering) Local release rate: 0.002 kg/day Explanation / Justification: see below

Soil Release factor Final release factor: 0%

It is assumed that 99.9% of the substance is consumed during the scenario. A part is included on the matrix as chromium (copper foil) and the other part is reduce and precipitate in reduced forms of chromium and become part of a waste sludge. The sludges which do not contain chromium trioxide are obtained by washing the matrix. They are disposed of by a certified company according to the regulation of waste.

Consequently, 15.8 kg of chromium trioxide are supposed emitted on 365 emission days, i.e. 0.0433 kg/day. Half of the amount, i.e. 0.022 kg/day is assumed to be emitted to water which directed to the sewage treatment plant and the other half (0.022 kg/day) to the air which is going through scrubbers (90% efficiency) before to be released in the atmosphere (final release: 0.002 kg/day).

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9.1.1.3. Exposure and risks for man via the environment

The exposure concentrations (using EUSES) and risk characterization are reported in the following table.

Table 9. Exposure concentrations and risks for the environment Protection target Exposure concentration Risk characterisation

Freshwater Local PEC: 0.001 mg/L Not relevant

Sediment (freshwater) Local PEC: 0.006 mg/kg dw Not relevant

Marine water Local PEC: 3.661E-4 mg/L Not relevant

Sediment (marine water) Local PEC: 0.002 mg/kg dw Not relevant

Predator (freshwater) Local PEC: 8.21E-4 mg/kg ww Not relevant

Predator (marine water) Local PEC: 2.544E-4 mg/kg ww Not relevant

Top predator (marine water) Local PEC: 5.091E-5 mg/kg ww Not relevant

Sewage treatment plant Local PEC: 0.037 mg/L Not relevant

Air Local PEC: 6.017E-7 mg/m3 Not relevant

Agricultural soil Local PEC: 8.893E-8 mg/kg dw Not relevant

Predator (terrestrial) Local PEC: 9.913E-8 mg/kg ww Not relevant

Man via environment - Inhalation

Local PEC: 6.017E-7 mg/m3 RAC dose-response relationship

Man via environment - Oral Local PEC: 1.269E-4 mg/kg bw/day Not relevant

Table 10. Contribution to oral intake for man via the environment from local contribution

Type of food Estimated daily dose Concentration in food

Drinking water 3.321E-5 mg/kg bw/day 0.001 mg/L

Fish 2.697E-6 mg/kg bw/day 0.002 mg/kg ww

Leaf crops 9.091E-5 mg/kg bw/day 0.005 mg/kg ww

Root crops 1.25E-8 mg/kg bw/day 2.278E-6 mg/kg ww

Meat 1.443E-9 mg/kg bw/day 3.356E-7 mg/kg ww

Milk 2.689E-8 mg/kg bw/day 3.356E-6 mg/kg ww

Conclusion on risk characterization

Based on the a 70 year exposure time (24h/day, 7 days/week) the ELR for lung cancer mortality to the Local PEC exposure man via environment, inhalation (6.017E-7 mg/m3) is equal to 1.74E-5 (regarding the ELR per µg/m3 of chromium trioxide given by the report RAC/27/2013/06 Rev.1 for general population). Regarding the below remark, the value of the ELR and the localization of the production site (not near to a town) we consider this exposition as negligible.

Remark: as it is explained by the RAC this ELR might be an overestimate. In fact, extrapolating outside the range of observation inevitably introduces uncertainties. As the mechanistic evidence is suggestive of non-linearity, it is acknowledged that the excess risks in the low exposure range might be an overestimate.

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9.1.2. Worker contributing scenario 1: Delivery and storage (PROC 1)

9.1.2.1. Conditions of use Chromium trioxide is delivered in 25 kg sealed drums. The drums are stored near the location of the preparation of chromium trioxide (see exposure scenario 2) solutions to avoid hazardous transfer of drums. Moreover, the drums are stored in a locked cabinet. As the drums are sealed, there is no potential for exposure.

Method

Product (article) characteristics

• Dustiness of material: Medium (flakes) Qualitative assessment

• Concentration of substance in mixture: 99,7% Qualitative assessment

Amount used (or contained in articles), frequency and duration of use/exposure

• Duration of activity: < 1 hour Qualitative assessment

Technical and organisational conditions and measures

• General ventilation: Enhanced general ventilation (5-10 air changes per hour) Qualitative assessment

• Containment: Closed system (minimal contact during routine operations) Qualitative assessment

• Local exhaust ventilation: no [Effectiveness Inhal: 0%] Qualitative assessment

• Occupational Health and Safety Management System: Advanced Qualitative assessment

Conditions and measures related to personal protection, hygiene and health evaluation

• Respiratory Protection: No [Effectiveness Inhal: 0%] Qualitative assessment

• Gloves (according to EN 374), safety googles (according to EN 166) and protective suite.

Qualitative assessment

Other conditions affecting workers exposure

• Place of use: Indoor Qualitative assessment

• Process temperature (for solid): Ambient Qualitative assessment

9.1.2.2. Exposure and risks for workers

The exposure concentration and risk characterisation are reported in the following table.

Table 11. Exposure concentrations and risks for workers

Route of exposure and type of effects

Exposure concentration Risk characterisation

Inhalation, local, long-term 0 µg/m³ ELR = 0

Conclusion on risk characterisation

Based on the a 40 year working life (8h/day, 5 days/week) the ELR for lung cancer mortality is equal to 0 (regarding the ELR per µg Cr(VI)/m3 given by the report RAC/27/2013/06 Rev.1).

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9.1.3. Worker contributing scenario 2: Dilution of the substance into a large container (PROC 5)

9.1.3.1. Conditions of use Chromium trioxide flakes are dissolved in a concentrated solution (250g/L).

The conditions of this task are described in the below table.

Method

Product (article) characteristics

• Dustiness of material: Medium (flakes) Measured data

• Concentration of substance in mixture: 99,7% Measured data

Amount used (or contained in articles), frequency and duration of use/exposure

• Duration of activity: < 15 minutes Measured data

• One dilution is done every week. Four people skilled and instructed are carrying out the task. Frequency: about 50 dilution preparation per year, about 12 dilution preparation per year per people.

Measured data

Technical and organisational conditions and measures

• General ventilation: Enhanced general ventilation (5-10 air changes per hour) Measured data

• Containment: drums are turned into a large container using a gloves box which is connected to a local exhaust ventilation. Drums are rinse in the gloves box (See photo 4 in section 9.2)

Measured data

• Local exhaust ventilation: no [Effectiveness Inhal: 0%] Measured data

• Occupational Health and Safety Management System: only four people are authorized for doing this work, they are regularly made aware about the extremely hazardous of chromium trioxide.

Measured data

• This part of the company where is located the gloves box is not a place where the employees are working, except of course the dilution of chromium trioxide.

Measured data

• During this task, nobody is allowed to come into this part of the hall. Measured data

Conditions and measures related to personal protection, hygiene and health evaluation

• Respiratory Protection: Yes (Respirator with APF of 20) [Effectiveness Inhal: 95%]

Measured data

• The employee has to put in addition of the respiratory mask, protective rubber gloves, rubber boots and a disposable all-in-one suit (see photo 5 in section 9.2).

Measured data

Other conditions affecting workers exposure

• Place of use: Indoor Measured data

• Process temperature (for solid): Ambient Measured data

9.1.3.2. Exposure and risks for workers

For this PROC the company decided to make measurement. The strategy for this PROC was to realize a static measure during 8 hours near the preparation gloves box. Static measure represents the worst case because when the preparation of the dilution is finished, the worker leaves the place. The measurement was made during one shift of the 4 workers that are authorized doing this task.

The exposure concentrations and risk characterization are reported in the following table.

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Table 12. Exposure concentrations and risks for workers

Route of exposure and type of effects

Exposure concentration Risk characterisation

Inhalation, local, long-term 0.19 µg/m³ (Measured data) ELR = 7.60E-4

Conclusion on risk characterisation

Based on the a 40 year working life (8h/day, 5 days/week) the ELR for lung cancer mortality is equal to 7.60E-4 (regarding the ELR per µg Cr(VI)/m3 given by the report RAC/27/2013/06 Rev.1).

Remark: as it is explained by the RAC this ELR might be an overestimate. In fact, extrapolating outside the range of observation inevitably introduces uncertainties. As the mechanistic evidence is suggestive of non-linearity, it is acknowledged that the excess risks in the low exposure range might be an overestimate.

9.1.4. Electrochemical surface treatment (PROC 13)

9.1.4.1. Conditions of use The concentrated solution of chromium trioxide is automatically diluted to solutions with a concentration less than 1 g/L. These solutions are used for the bath electrochemical surface treatment of copper foil. The employees are never in contact with this solution.

The conditions of this task are described in the below table.

Method

Product (article) characteristics

• Concentration of substance in mixture: <1% Measured data

• Substance product type: liquid Measured data

Amount used (or contained in articles), frequency and duration of use/exposure

• Duration of activity: < 1 hour (during a work day, workers are maximum one hour near the bath)

Measured data

Technical and organisational conditions and measures

• General ventilation: Enhanced general ventilation (5-10 air changes per hour) Measured data

• Containment: No, but the bath are accessible for the workers. Measured data

• Local exhaust ventilation: yes [Effectiveness Inhal: 90%], lip extraction on bath (see photo 6 in section 9.2)

Measured data

• Occupational Health and Safety Management System: employees are made aware about the hazardous of chromium trioxide.

Measured data

Conditions and measures related to personal protection, hygiene and health evaluation

• Respiratory Protection: No [Effectiveness Inhal: 0%] Measured data

• Gloves (according to EN 374), safety googles (according to EN 166) and protective suite.

Measured data

Other conditions affecting workers exposure

• Place of use: Indoor Measured data

• Process temperature (for solid): Ambient Measured data

9.1.4.2. Exposure and risks for workers

For this PROC the company decided to make some measurements. A sampler was placed on a worker to measure the real exposure to chromium trioxide during a day work (8 hours). The selected worker is representative of the

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activity made during a normal work day.

The exposure concentrations and risk characterization are reported in the following table.

Table 13. Exposure concentrations and risks for workers

Route of exposure and type of effects

Exposure concentration Risk characterisation

Inhalation, local, long-term < 0.15 µg/m³ (Measured data) 0.15 is detection limit of the method

ELR < 6.00E-4

Conclusion on risk characterisation

Based on the a 40 year working life (8h/day, 5 days/week) the ELR fir lung cancer mortality is less than 6.00E-4 (regarding the ELR per µg Cr(VI)/m3 given by the report RAC/27/2013/06 Rev.1).

Remark: as it is explained by the RAC this ELR might be an overestimate. In fact, extrapolating outside the range of observation inevitably introduces uncertainties. As the mechanistic evidence is suggestive of non-linearity, it is acknowledged that the excess risks in the low exposure range might be an overestimate.

9.1.5. Worker contributing scenario 4: Maintenance of equipment (PROC 8b)

9.1.5.1. Conditions of use About 2 times per year maintenance operations are planned on a treater bath. Baths are emptied to a storage vessel (without contact through drain pipe) and they are rinsed with water before the intervention of the maintenance worker. The employee has to wear a respiratory mask, protective nitrile gloves, rubber boots and a disposable all-in-one suit.

The conditions of this task are described in the below table.

Method

Product (article) characteristics

• Substance product type: liquid ART 1.5

• Concentration of substance in mixture: <1% ART 1.5

• Vapour pressure 0.01 Pa ART 1.5

• Viscosity: low ART 1.5

Amount used (or contained in articles), frequency and duration of use/exposure

• Duration of activity: < 15 minutes/per day/per year ART 1.5

Activity emission potential

• Activity class: Handling of contaminated objects ART 1.5

• Situation: Activities with treated/contaminated objects (surface > 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

Technical and organisational conditions and measures

• Localised controls – Primary: No localized controls (0.00 % reduction) ART 1.5

• Localised controls – Secondary: No localized controls (0.00 % reduction) ART 1.5

• Local exhaust ventilation: no [Effectiveness Inhal: 0%] ART 1.5

• Occupational Health and Safety Management System: Advanced ART 1.5

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Method

• Dispersion: Specialised room ventilation with more than 10 ACH ART 1.5

Conditions and measures related to personal protection, hygiene and health evaluation

• Respiratory Protection: Yes (Respirator with APF of 20) [Effectiveness Inhal: 95%]

ART 1.5

• The employee has to wear in addition of the respiratory mask, protective nitrile gloves, rubber boots and a disposable all-in-one suit.

ART 1.5

Other conditions affecting workers exposure

• Place of use: Indoor ART 1.5

• Process temperature: Ambient ART 1.5

• Room size: > 3000 m3 ART 1.5

9.1.5.2. Exposure and risks for workers

For this PROC the company decided to use ART 1.5 method.

The exposure concentrations and risk characterization are reported in the following table.

Table 14. Exposure concentrations and risks for workers

Route of exposure and type of effects

Exposure concentration Risk characterisation

Inhalation, local, long-term The predicted 90th percentile long-term exposure is 0.05 µg/m³.

ELR = 2.00E-4

Conclusion on risk characterisation

Based on the a 40 year working life (8h/day, 5 days/week) the ELR for lung cancer mortality is equal to 2.00E-4 (regarding the ELR per µg Cr(VI)/m3 given by the report RAC/27/2013/06 Rev.1).

Remark: as it is explained by the RAC this ELR might be an overestimate. In fact, extrapolating outside the range of observation inevitably introduces uncertainties. As the mechanistic evidence is suggestive of non-linearity, it is acknowledged that the excess risks in the low exposure range might be an overestimate.

9.1.6. Worker contributing scenario 5: Sampling for laboratory analysis and control (PROC 15)

9.1.6.1. Conditions of use Three times per week a sample is taken and analyzed internally in the laboratory. The first step is to collect the sample in a closed flask. The second step is to analyze the sample in the laboratory.

The conditions of this task are described in the below tables.

FIRST STEP: SAMPLING Method

Product (article) characteristics

• Substance product type: liquid ART 1.5

• Concentration of substance in mixture: <1% ART 1.5

• Vapour pressure 0.01 Pa ART 1.5

• Viscosity: low ART 1.5

Amount used (or contained in articles), frequency and duration of use/exposure

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FIRST STEP: SAMPLING Method

• Duration of activity: < 60 minutes ART 1.5

Activity emission potential

• Activity class: Activities with relatively undisturbed surfaces (no aerosol formation)

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

Technical and organisational conditions and measures

• Localised controls – Primary: No localized controls (0.00 % reduction) ART 1.5

• Localised controls – Secondary: No localized controls (0.00 % reduction) ART 1.5

• Local exhaust ventilation: no [Effectiveness Inhal: 0%] ART 1.5

• Occupational Health and Safety Management System: Advanced ART 1.5

• Dispersion: Specialised room ventilation with more than 10 ACH ART 1.5

Conditions and measures related to personal protection, hygiene and health evaluation

• Respiratory Protection: No [Effectiveness Inhal: 0%] ART 1.5

• Gloves (according to EN 374), safety googles (according to EN 166) and protective suite.

ART 1.5

Other conditions affecting workers exposure

• Place of use: Indoor ART 1.5

• Process temperature: Ambient ART 1.5

• Room size: > 3000 m3 ART 1.5

SECOND STEP: ANALYSING Method

Product (article) characteristics

• Substance product type: liquid ART 1.5

• Concentration of substance in mixture: <1% ART 1.5

• Vapour pressure 0.01 Pa ART 1.5

• Viscosity: low ART 1.5

Amount used (or contained in articles), frequency and duration of use/exposure

• Duration of activity: < 60 minutes ART 1.5

Activity emission potential

• Activity class: Activities with relatively undisturbed surfaces (no aerosol formation)

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

Technical and organisational conditions and measures

• Localised controls – Primary: No localized controls (0.00 % reduction) ART 1.5

• Localised controls – Secondary: No localized controls (0.00 % reduction) ART 1.5

• Local exhaust ventilation: no [Effectiveness Inhal: 0%] ART 1.5

• Occupational Health and Safety Management System: Advanced ART 1.5

• Dispersion: Mechanical ventilation giving at least 1 ACH ART 1.5

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SECOND STEP: ANALYSING Method

Conditions and measures related to personal protection, hygiene and health evaluation

• Respiratory Protection: No [Effectiveness Inhal: 0%] ART 1.5

• Gloves (according to EN 374), safety googles (according to EN 166) and protective suite.

ART 1.5

Other conditions affecting workers exposure

• Place of use: Indoor ART 1.5

• Process temperature: Ambient ART 1.5

• Room size: 100 m3 ART 1.5

9.1.6.2. Exposure and risks for workers

For this PROC the company decided to use ART 1.5 method.

The exposure concentrations and risk characterization are reported in the following table.

Table 15. Exposure concentrations and risks for workers

Route of exposure and type of effects

Exposure concentration Risk characterisation

Inhalation, local, long-term The predicted 90th percentile long-term exposure is 0.36 µg/m³.

ELR = 1.44E-3

Conclusion on risk characterisation

Based on the a 40 year working life (8h/day, 5 days/week) the ELR for lung cancer mortality is equal to 1.44E-3 (regarding the ELR per µg Cr(VI)/m3 given by the report RAC/27/2013/06 Rev.1).

Remark: as it is explained by the RAC this ELR might be an overestimate. In fact, extrapolating outside the range of observation inevitably introduces uncertainties. As the mechanistic evidence is suggestive of non-linearity, it is acknowledged that the excess risks in the low exposure range might be an overestimate.

9.2 Conclusions Risks are adequately controlled to a risk level of low concern if the conditions of tasks are used. In fact, the existing data (static and personal sampling) on measured concentrations of chromium trioxide in working place highlighted concentrations below 1 µg/m3 which is the most stringent OEL in Europe (France OEL). The company will continue to make regularly (once a year) such kind of measures in the way to control the performance of their safety measures.

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Photo 4. preparation gloves box connected to a local exhaust ventilation system

Photo 5. personal protective equipment used for the dilution of chromium trioxide

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Photo 6. local lip exhaust ventilation on treating bath

EC number: 215-607-8

Chromium trioxide CAS number: 1333-82-0

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10. RISK CHARACTERISATION RELATED TOCOMBINED EXPOSURE

10.1. Human health

10.1.1. Workers

There is no relevant combinations of exposure scenarios which could result in simultaneous exposure of humans.

10.1.2. Consumer

Not relevant because there is no consumer use.

10.2. Environment (combined for all emission sources)

10.2.1. All uses (regional scale)

10.2.1.1. Total releases

The total releases to the environment from all the exposure scenarios covered are presented in the table below. This is the sum of the releases to the environments from all exposure scenarios addressed.

Table 16. Total releases to the environment per year from all life cycle stages:

Release route Total releases per year

Water 7.9 kg/year

Air 0.79 kg/year

Water 0 kg/year

10.2.1.2. Regional exposure

Environment

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

The PEC regional have been estimated with EUSES.

Table 17. Predicted regional exposure concentrations (Regional PEC)

Protection target Regional PEC RCR

Freshwater 2.73E-7 mg/L Not relevant

Sediment (freshwater) 1.178E-6 mg/kg dw Not relevant

Marine water 2.647E-8 mg/L Not relevant

Sediment (marine water) 1.153E-7 mg/kg dw Not relevant

Air 1.192E-15 mg/m³ Not relevant

Agricultural soil 2.063E-8 mg/kg dw Not relevant

Man via environment

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

EC number: 215-607-8

Chromium trioxide CAS number: 1333-82-0

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Table 18. Regional exposure to man via the environment Route Regional exposure Risk characterisation

Inhalation 1.192E-15 mg/m³ ELR = 3.46E-14

Oral Not relevant (see 9.0.2.2) -

Based on the a 70 year exposure time (24h/day, 7 days/week) the ELR for lung cancer mortality to the Regional PEC exposure man via environment, inhalation (1.192E-15 mg/m3) is equal to 3.46E-14 (regarding the ELR per Cr(VI) µg/m3 given by the report RAC/27/2013/07 Rev.1 for general population). Regarding the below remark, the value of the ELR and the localization of the production site (not near to a town) we consider this exposition as negligible.

Remark: as it is explained by the RAC this ELR might be an overestimate. In fact, extrapolating outside the range of observation inevitably introduces uncertainties. As the mechanistic evidence is suggestive of non-linearity, it is acknowledged that the excess risks in the low exposure range might be an overestimate.

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.