CHEMICAL SAFETY REPORT EXECUTIVE SUMMARY

Transcription

1 CHEMICAL SAFETY REPORT EXECUTIVE SUMMARY Substance Name: Potassium methylsilanetriolate EC Number: CAS Number: Registrant s identity: Wacker Chemie AG, Germany 1

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3 CONTENTS 1 IDENTIFIED USES CLASSIFICATION AND LABELLING Classification and labelling according to CLP / GHS Classification and labelling according to DSD / DPD Classification and labelling in Annex I of Directive 67/548/EEC Self classification(s) DERIVATION OF DNEL(S) / DMEL(S) Selection of the critical DNEL(s)/DMELs and/or qualitative/semi-quantitative descriptor for critical health CALCULATION OF PREDICTED NO EFFECT CONCENTRATION (PNEC) SUMMARY AND OVERALL CONCLUSIONS ON PBT OR VPVB PROPERTIES EXPOSURE ASSESSMENT RISK CHARACTERISATION ES1: Production of potassium methylsilanetriolate Human Health Workers Consumers Indirect exposure of humans via the environment Environment Quantitative risk for environmental compartments ES2: Use as a chemical intermediate Human Health Workers Consumers Indirect exposure of humans via the environment Environment Quantitative risk for environmental compartments ES3: Formulation of masonry products Human Health Workers Consumers Indirect exposure of humans via the environment Environment Quantitative risk for environmental compartments ES4: Professional and consumer use of masonry products Human Health Workers Consumers Indirect exposure of humans via the environment Environment Quantitative risk for environmental compartments ES5: Use in non-metal surface treatment and/or mass hydrophobation

4 7.5.1 Human Health Workers Consumers Indirect exposure of humans via the environment Environment Quantitative risk for environmental compartments ES6: Formulation of coatings and paints Human Health Workers Consumers Indirect exposure of humans via the environment Environment Quantitative risk for environmental compartments ES7: Use as a laboratory reagent Human Health Workers Consumers Indirect exposure of humans via the environment Environment Quantitative risk for environmental compartments Other exposure scenarios - environment - critical release rate GUIDANCE ON SAFE USE

5 1 IDENTIFIED USES There are five identified uses of potassium methylsilanetriolate: i) Use as a chemical intermediate ii) Use in masonry iii) Use in non-metal surface treatment and/or mass hydrophobation iv) Use in the coatings and paints v) Use as a laboratory reagent These uses are summarised in terms of the appropriate REACH descriptor codes (ECHA, 2010a) in Table 1.1, and are described in more detail in the following sections. Table 1.1: Description of identified uses Identified use Sector of Use - main user groups (SU) Sector of Use sectors of end-use Product Category (PC) Intermediate SU3 SU8, 9 PC19 Masonry SU 3, 22, 21 SU10,19, n-metal surface treatment PC0 (UCN K35900) Process category (PROC) PROC1, 2, 3, 8b PROC2, 3, 5, 8b, 9, 7, 10, 11, 19 SU3 SU10, 13, PC15, PROC 2, 3,5, 8b, 8a, 9 PROC13, PROC7, Coatings and paints SU10, 3, 22, 21 SU13 PC9a PROC4, 5, 10, 11, 19 Article category (AC) Environmental Release Category (ERC) - ERC6a - ERC2, 6a, 8f - ERC6a, ERC6d, ERC2 - ERC2, 8f Laboratory chemical SU3, 22 SU24 PC21 PROC15 - N/A 2 CLASSIFICATION AND LABELLING 2.1 Classification and labelling according to CLP / GHS Name: Harmonised Reconsile Consortia C&L according to EU-GHS Implementation: EU State/form of the substance: liquid Remarks: substance is only stable in aqueous solution Classification The substance is classified as follows: For physical-chemical properties: 3

6 EC number: RECONSILE potassium methylsilanetriolate CAS number: Explosives: Flammable gases: Flammable aerosols: Oxidising gases: Gases under pressure: Flammable liquids: Flammable solids: Self-reacting substances and mixtures: Pyrophoric liquids: Pyrophoric solids: Self-heating substances and mixtures: Substances and mixtures which in contact with water emits flammable gases: Oxidising liquids: Oxidising solids: Organic peroxides: CSR-PI CHEMICAL SAFETY REPORT 4

7 Corrosive to metals: Reason for no classification: conclusive but not sufficient for classification For health hazards: Acute - oral: Reason for no classification: conclusive but not sufficient for classification Acute - dermal: Acute - inhalation: Skin corrosion/irritation: Skin Corr. 1A (Hazard statement: H314: Causes severe skin burns and eye damage.) Serious damage/eye irritation: Eye Damage 1 (Hazard statement: H318: Causes serious eye damage.) Respiration sensitization: Reason for no classification: data lacking Skin sensitisation: Aspiration hazard: Reproductive Toxicity: Reason for no classification: conclusive but not sufficient for classification Reproductive Toxicity: Effects on or via lactation: Reason for no classification: data lacking Germ cell mutagenicity: Reason for no classification: conclusive but not sufficient for classification Carcinogenicity: Reason for no classification: data lacking 5

8 EC number: RECONSILE potassium methylsilanetriolate CAS number: Specific target organ - single: Reason for no classification: conclusive but not sufficient for classification Specific target organ - repeated: Reason for no classification: conclusive but not sufficient for classification For environmental hazards: Hazards to the aquatic environment: Reason for no classification: conclusive but not sufficient for classification Hazardous to the atmospheric environment: Labelling Signal word: Danger Hazard pictogram: GHS05: corrosion Hazard statements: H314: Causes severe skin burns and eye damage. Precautionary statements: P280: Wear protective gloves/protective clothing/eye protection/face protection. P301+P330+P331: IF SWALLOWED: rinse mouth. Do NOT induce vomiting. P303+P361+P353: IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing. Rinse skin with water/shower. P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing CSR-PI CHEMICAL SAFETY REPORT 6

9 P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a POISON CENTER or doctor/physician. 2.2 Classification and labelling according to DSD / DPD Classification and labelling in Annex I of Directive 67/548/EEC The substance is not classified in Annex I of Directive 67/548/EEC Self classification(s) Chemical name: Harmonised Reconsile Consortia C&L according to DSD Table 1.1 Classification according to Directive 67/548/EEC criteria Endpoints Classification Reason for no classification Justification for (non) classification can be found in section Explosiveness inconclusive 6.1 Oxidising properties inconclusive 6.3 Flammability inconclusive 6.2 Thermal stability Acute Acute - irreversible damage after single exposure Repeated dose Irritation / Corrosion C; R35 Corrosive; Causes severe burns. inconclusive conclusive but not sufficient for classification conclusive but not sufficient for classification conclusive but not sufficient for classification and Sensitisation inconclusive Carcinogenicity data lacking Mutagenicity - Genetic Toxicity Toxicity to reproductionfertility Toxicity to reproductiondevelopment conclusive but not sufficient for classification conclusive but not sufficient for classification conclusive but not sufficient for classification

10 EC number: RECONSILE potassium methylsilanetriolate CAS number: Endpoints Classification Reason for no classification Justification for (non) classification can be found in section Toxicity to reproduction - breastfed babies Environment conclusive but not sufficient for classification conclusive but not sufficient for classification Labelling Indication of danger: C - corrosive R-phrases: R35 - causes severe burns S-phrases: S26 - in case of contact with eyes, rinse immediately with plenty of water and seek medical advice S36/37/39 - wear suitable protective clothing, gloves and eye/face protection S45 - in case of accident or if you feel unwell, seek medical advice immediately (show the label where possible) 3 DERIVATION OF DNEL(S) / DMEL(S) 3.1 Selection of the critical DNEL(s)/DMELs and/or qualitative/semi-quantitative descriptor for critical health The documented DNEL/PNEC are considered adequate for the present REACH risk. They have been calculated using the current ECHA guideline, including the most conservative assessment factors, and are used for the registration under the regulation 1907/2006 dated June 1st 2007 (REACH) only. They should not be used for other regulatory purposes (e.g., OELs) without further consideration and evaluation CSR-PI CHEMICAL SAFETY REPORT 8

11 Table 3.11: DN(M)ELs for workers Exposure pattern Descriptors DNEL/DMEL Most sensitive endpoint Acute - systemic Acute - local Long-term - systemic Long-term local Dermal DNEL 6.6 mg/kg/day Repeated--dose Inhalation DNEL 47 mg/m 3 Repeated--dose Dermal t quantifiable - Corrosion Inhalation t quantifiable - NA Dermal DNEL 6.6 mg/kg/day Repeated--dose Inhalation DNEL 47 mg/m 3 Repeated--dose Dermal t quantifiable - Corrosion Inhalation t quantifiable - NA Table 3.12: DN(M)ELs for consumers Exposure pattern Descriptors DNEL/DMEL Most sensitive endpoint Acute - systemic Acute - local Long-term - systemic Long-term local Dermal DNEL 4.0 mg/kg/day Repeated--dose Inhalation DNEL 10 mg/m 3 Repeated--dose Dermal t quantifiable - Corrosion Inhalation t quantifiable - NA Oral DNEL 0.42 mg/kg/day Repeated--dose Dermal DNEL 4.0 mg/kg/day Repeated--dose Inhalation DNEL 10 mg/m 3 Repeated--dose Dermal t quantifiable - Corrosion Inhalation t quantifiable - NA Discussion In the absence of any significant findings relating to reproductive or developmental endpoints in appropriate screening tests, the critical health effect is considered to be repeated-dose. Potassium methylsilanetriolate is not classified as mutagenic, carcinogenic or sensitising. The DNELs used for risk (workers) are therefore: DNEL (long-term, inhalation): 47 mg/m 3 DNEL (long-term, dermal): 6.6 mg/kg/day The DNELs used for risk (consumers) are: DNEL (long-term, inhalation): 10 mg/m 3 9

12 EC number: RECONSILE potassium methylsilanetriolate CAS number: DNEL (long-term, dermal): 2.9 mg/kg/day DNEL (long-term, oral): 0.42 mg/kg/day Qualitative risk for corrosive following dermal exposure will also be required. 4 CALCULATION OF PREDICTED NO EFFECT CONCENTRATION (PNEC) Potassium methylsilanetriolate is a multi-constituent substance containing methylsilanetriolate, dimers and trimers of methylsilanetriolate and potassium hydroxide. The substance is only stable in aqueous solution at high ph. The of potassium hydroxide on the aquatic environment are limited to ph in unbuffered media and are not relevant for PNEC derivation. Under comparable conditions of concentration and ph methylsilanetriolate is equivalent to the parent acid, methylsilanetriol. The dimers and trimers (and any higher molecular weight oligomers and polymers formed) are expected to be less toxic than the monomer. Table 4.1: PNEC freshwater Value Assessment factor PNEC freshwater (mg/l) See text PNEC marine water (mg/l) PNEC water intermittent releases (mg/l) Table 4.2: PNEC sediment Remarks/justification An additional assessment factor of 10 is applicable for extrapolation from freshwater to marine species A 10-fold reduction in the assessment factor for PNEC freshwater is applicable for acute data from three trophic levels, when releases are intermittent. PNEC sediment (mg/kg wwt) Value Assessment factor Remarks/justification 3.3 n/a sediment data is available. Therefore, PNEC sediment is derived from PNEC freshwater using the equilibrium partitioning method. The Log K OW used in the calculation is Table 4.3: PNEC soil Value Assessment factor Remarks/justification PNEC soil ( mg/kg.wwt) 0.54 n/a soil data is available. Therefore, PNEC soil is derived from PNEC freshwater using the equilibrium partitioning method. The Log K OW used in the calculation is Table 4.4: PNEC sewage treatment plant Value Assessment factor Remarks/justification PNEC stp ( mg/l.) >1 100 An EC50 of >100 mg/l was determined in an ASRI test. An Assessment factor of 100 has been applied CSR-PI CHEMICAL SAFETY REPORT 10

13 Table 4.5: PNEC oral Value Assessment factor Remarks/justification PNEC oral ( mg/kg) A NOEC of 500 mg/kg is obtained from an OECD 422 study in the rat for trimethoxymethylsilane. An assessment factor of 300 is applied. 5 SUMMARY AND OVERALL CONCLUSIONS ON PBT OR VPVB PROPERTIES The substance may persist in the environment and meets the P criteria. However, it does not meet the criteria for B or T. Therefore, the substance does not meet the criteria for PBT or vpvb. 6 EXPOSURE ASSESSMENT Exposure scenarios are presented for production of potassium methylsilanetriolate and the five identified uses described in Section 1. 7 RISK CHARACTERISATION 7.1 ES1: Production of potassium methylsilanetriolate Human Health As discussed in Section 3, the DNELs used for risk are: DNEL (long-term, inhalation): 47 mg/m 3 DNEL (long-term, dermal): 6.6 mg/kg bw/day The documented DNELs are considered adequate for the present REACH risk. They have been calculated using the current ECHA guideline, including conservative assessment factors, and are used for the registration under the regulation 1907/2006 dated June 1st 2007 (REACH) only. They should not be used for other regulatory purposes (e.g., OELs) without further consideration and evaluation. The quantifiable DNEL values for long-term systemic are based on trimethoxy(methyl)silane and therefore cover only systemic but not local corrosive due to ph of the aqueous product (see Section 5.11). Therefore, local due to the corrosive nature of high concentration products must also be taken into account for qualitative risk Workers Table 7.1 shows the quantitative risk for workers. Workers at the production site are routinely involved with the same tasks, therefore it is more appropriate to consider long-term exposure, and short-term exposure is not quantified. It is not possible to quantify risk ratios for local short-term dermal based on corrosion. However, local due to the corrosive nature of high concentration products are taken into account for qualitative risk. 11

14 EC number: RECONSILE potassium methylsilanetriolate CAS number: Table 7.1: Quantitative risk for workers ES1- exposure concentrati ons (EC) Leading toxic end point / Critical effect DNEL/DMEL (appropriate unit) Risk ratio Long-term - systemic Long-term local Dermal (mg/kg bw /day) Inhalation (mg/m 3 ) Combined s Dermal (mg/cm 2 ) Inhalation (mg/m 3 ) Repeat dose 0.55 Repeat dose 6.6 mg/kg bw/day 5.30 x mg/m Corrosion NA NA 0.55 NA NA NA Table 7.2 shows the qualitative risk for workers. Due to the corrosive nature of the aqueous solution of the substance, personal protective equipment is essential and direct skin contact will not occur. Highly controlled conditions applicable for highly reactive chlorosilane substances also handled at production sites is considered applicable to the substance. Workers are required to wear suitable protective gloves or gauntlets, chemically resistant clothing and goggles or face shield to minimise the risk of corrosive. Specific worker training in the use and disposal of protective clothing is provided. It is therefore considered that there is no unacceptable risk to humans from short-term dermal exposure to potassium methylsilanetriolate. Table 7.2: Qualitative risk for workers Acute - local ES1- exposure concentrations (EC) Leading toxic end point / Critical effect Qualitative risk Dermal (mg/cm 2 ) N/A Corrosion Minimal potential for exposure, no unacceptable risk te regarding results from ECETOC TRA Systemic exposure concentrations have been calculated using the ECETOC TRA model, with modifications for use of appropriate gloves. It should be noted that some uses not explicitly discussed in this CSR can also be considered to be safe by comparison to the description given. Therefore, if the new scenario covers the same user group, the same or shorter duration, the same or more complete controls, or more effective PPE, for the same PROC, then a use which might appear to be outside the scope of the CSR could in fact be judged to be safe. This is consistent with REACH guidance to downstream users Consumers There is no exposure of consumers to potassium methylsilanetriolate for this scenario CSR-PI CHEMICAL SAFETY REPORT 12

15 Indirect exposure of humans via the environment Table 7.3 shows the quantitative risk for the exposure of humans via the environment for this scenario. The daily dose exposure concentration in humans through intake via the various routes have been predicted using EUSES Table 7.3: Risk Characterisation for the indirect exposure of humans via the environment Exposure concentration DNEL (oral) mg/kg/day Risk ratio Fish (mg/kg/day) Drinking water (mg/kg/day) Meat (mg/kg/day) Milk (mg/kg/day) 3.09E E E E E E E E Environment Methylsilanetriolate is equivalent to the parent acid, methylsilanetriol, under comparable conditions of concentration and ph (see Section 7). Therefore, all PECs, PNECs and RCRs have been calculated on the basis of the physicochemical properties of methylsilanetriol. The documented PNECs are considered adequate for the present REACH risk. They have been calculated using the current ECHA guideline, including conservative assessment factors, and are used for the registration under the regulation 1907/2006 dated June 1st 2007 (REACH) only. They should not be used for other regulatory purposes (e.g., OELs) without further consideration and evaluation Quantitative risk for environmental compartments The RCRs for the environmental compartments are shown in Table 7.4 and calculated from the PNECs and PECs reported in Sections 7 and 9.1 respectively. They are all <1 and indicate an acceptable risk and no immediate concern for the environment. Table 7.4: ES1 - Quantitative risk for environmental compartments RISK CHARACTERISATION OF [1 "ES 1 PRODUCTION AND ON SITE USES"] [INDUSTRIAL USE] WATER RCR for the local fresh-water compartment 6.96E-04 [-] Intermittent release RCR for the local marine compartment 2.11E-03 [-] SEDIMENT RCR for the local fresh-water sediment compartment 6.96E-04 [-] RCR for the local marine sediment compartment 2.11E-03 [-] 13

16 EC number: RECONSILE potassium methylsilanetriolate CAS number: SOIL RCR for the local soil compartment 9.36E-04 [-] STP RCR for the sewage treatment plant 0.21 [-] PREDATORS RCR for fish-eating birds and mammals (fresh-water) 5.89E-04 [-] RCR for fish-eating birds and mammals (marine) 1.44E-04 [-] RCR for top predators (marine) 4.85E-05 [-] RCR for worm-eating birds and mammals 2.32E-04 [-] 7.2 ES2: Use as a chemical intermediate Human Health As discussed in Section 3, the DNELs used for risk are: DNEL (long-term, inhalation): 47 mg/m 3 DNEL (long-term, dermal): 6.6mg/kg bw/day The documented PNECs/DNELs are considered adequate for the present REACH risk. They have been calculated using the current ECHA guideline, including conservative assessment factors, and are used for the registration under the regulation 1907/2006 dated June 1st 2007 (REACH) only. They should not be used for other regulatory purposes (e.g., OELs) without further consideration and evaluation. The quantifiable DNEL values for long-term systemic are based on trimethoxy(methyl)silane and therefore cover only systemic but not local corrosive due to ph of the aqueous product (see Section 5.11). Therefore, local due to the corrosive nature of high concentration products must also be taken into account for qualitative risk Workers Table 7.5 shows the quantitative risk for workers. Workers at industrial sites are routinely involved with the same tasks, therefore it is more appropriate to consider long-term exposure, and short-term exposure is not quantified. It is not possible to quantify risk ratios for local short-term dermal based on corrosion. However, local due to the corrosive nature of high concentration products are taken into account for qualitative risk CSR-PI CHEMICAL SAFETY REPORT 14

17 Table 7.5: Quantitative risk for workers Long-term - systemic Long-term local Dermal (mg/kg bw /day) Inhalation (mg/m 3 ) Combined s Dermal (mg/cm 2 ) Inhalation (mg/m 3 ) ES2- exposure concentrations (EC) Leading toxic end point / Critical effect 0.07 Repeat dose 0.55 Repeat dose DNEL/DMEL (appropriate unit) 6.6 mg/kg bw/day Risk ratio mg/m Corrosion NA NA 0.55 NA NA NA Table 7.6 shows the qualitative risk for workers. Due to corrosive nature of the aqueous solution of the substance, personal protective equipment is essential and direct skin contact will not occur. Workers are required to wear suitable protective gloves or gauntlets, chemically resistant clothing and goggles or face shield to minimise the risk of corrosive. Specific worker training in the use and disposal of protective clothing is assumed for this type of application as a best practise. It is therefore considered that there is no unacceptable risk to humans from short-term dermal exposure to potassium methylsilanetriolate. Table 7.6: Qualitative risk for workers Acute - local ES2- exposure concentrations (EC) Leading toxic end point / Critical effect Qualitative risk Dermal (mg/cm 2 ) NA Corrosion Minimal potential for exposure, no unacceptable risk te regarding results from ECETOC TRA Systemic exposure concentrations have been calculated using the ECETOC TRA model, with modifications for use of gloves. It should be noted that some uses not explicitly discussed in this CSR can also be considered to be safe by comparison to the description given. Therefore, if the new scenario covers the same user group, the same or shorter duration, the same or more complete controls, or more effective PPE, for the same PROC, then a use which might appear to be outside the scope of the CSR could in fact be judged to be safe. This is consistent with REACH guidance to downstream users Consumers There is no exposure of consumers to potassium methylsilanetriolate for this scenario. 15

18 EC number: RECONSILE potassium methylsilanetriolate CAS number: Indirect exposure of humans via the environment Table 7.7 shows the quantitative risk for the exposure of humans via the environment for this scenario. The daily dose exposure concentration in humans through intake via the various routes have been predicted using EUSES CSR-PI CHEMICAL SAFETY REPORT 16

19 Table 7.7: Risk Characterisation for the indirect exposure of humans via the environment Fish (mg/kg/day) Exposure concentration DNEL (oral) mg/kg/day 0.42 Risk ratio Drinking water (mg/kg/day) Meat (mg/kg/day) 6.24E E-06 Milk (mg/kg/day) 6.24E E Environment Methylsilanetriolate is equivalent to the parent acid, methylsilanetriol, under comparable conditions of concentration and ph (see Section 7). Therefore, all PECs, PNECs and RCRs have been calculated on the basis of the physicochemical properties of methylsilanetriol. The documented PNECs are considered adequate for the present REACH risk. They have been calculated using the current ECHA guideline, including conservative assessment factors, and are used for the registration under the regulation 1907/2006 dated June 1st 2007 (REACH) only. They should not be used for other regulatory purposes (e.g., OELs) without further consideration and evaluation Quantitative risk for environmental compartments The RCRs for the environmental compartments are shown in Table 7.8, calculated from the PNECs and PECs reported in Sections 7 and 9.2 respectively. They are all <1 and indicate an acceptable risk and no immediate concern for the environment. Table 7.8: ES2 - Quantitative risk for environmental compartments RISK CHARACTERISATION OF [2 "ES 2 - INTERMEDIATE"] [INDUSTRIAL USE] WATER RCR for the local fresh-water compartment 6.09E-03 [-] Intermittent release RCR for the local marine compartment [-] SEDIMENT RCR for the local fresh-water sediment compartment 6.09E-03 [-] RCR for the local marine sediment compartment [-] SOIL RCR for the local soil compartment 4.44E-04 [-] 17

20 EC number: RECONSILE potassium methylsilanetriolate CAS number: STP RCR for the sewage treatment plant 0.1 [-] PREDATORS RCR for fish-eating birds and mammals (fresh-water) 3.15E-03 [-] RCR for fish-eating birds and mammals (marine) 1.19E-03 [-] RCR for top predators (marine) 2.57E-04 [-] RCR for worm-eating birds and mammals 1.10E-04 [-] 7.3 ES3: Formulation of masonry products Human Health As discussed in Section 3, the DNELs used for risk are: DNEL (long-term, inhalation): 47 mg/m 3 DNEL (long-term, dermal): 6.6 mg/kg bw/day The documented PNECs/DNELs are considered adequate for the present REACH risk. They have been calculated using the current ECHA guideline, including conservative assessment factors, and are used for the registration under the regulation 1907/2006 dated June 1st 2007 (REACH) only. They should not be used for other regulatory purposes (e.g., OELs) without further consideration and evaluation. The quantifiable DNEL values for long-term systemic are based on trimethoxy(methyl)silane and therefore cover only systemic but not local corrosive due to ph of the aqueous product (see Section 5.11). Therefore, local due to the corrosive nature of high concentration products must also be taken into account for qualitative risk Workers Table 7.9 shows the quantitative risk for workers. Workers at the production site are routinely involved with the same tasks, therefore it is more appropriate to consider long-term exposure, and short-term exposure is not quantified. It is not possible to quantify risk ratios for local short-term dermal based on corrosion. However, local due to the corrosive nature of high concentration products are taken into account for qualitative risk CSR-PI CHEMICAL SAFETY REPORT 18

21 Table 7.9: Quantitative risk for workers Long-term - systemic Long-term local Dermal (mg/kg bw /day) ES3- exposure concentrations (EC) Leading toxic end point / Critical effect 0.82 Repeat dose Inhalation (mg/m 3 ) Repeat dose DNEL/DMEL (appropriate unit) 6.6 mg/kg bw/day Risk ratio mg/m Combined s 0.82 Dermal (mg/cm 2 ) 0.06 Corrosion NA NA Inhalation (mg/m 3 ) NA NA NA Table 7.10 shows the qualitative risk for workers. Due to the corrosive nature of the aqueous solution of the substance, personal protective equipment is essential and direct contacts will not occur. Workers are required to wear suitable protective gloves or gauntlets (butyl or fluorinated rubber types), chemically resistant clothing and goggles or face shield to minimise the risk of corrosive. Specific worker training in the use and disposal of protective clothing is assumed as a best practice. It is therefore considered that there is no unacceptable risk to humans from short-term dermal exposure to potassium methylsilanetriolate. Table 7.10: Qualitative risk for workers Acute - local ES3- exposure concentrations (EC) Leading toxic end point / Critical effect Qualitative risk Dermal (mg/cm 2 ) NA Corrosion Minimal potential for exposure, no unacceptable risk te regarding results from ECETOC TRA Exposure concentrations have been calculated using the ECETOC TRA model, with modifications for use of gloves. It should be noted that some uses not explicitly discussed in this CSR can also be considered to be safe by comparison to the description given. Therefore, if the new scenario covers the same user group, the same or shorter duration, the same or more complete controls, or more effective PPE, for the same PROC, then a use which might appear to be outside the scope of the CSR could in fact be judged to be safe. This is consistent with REACH guidance to downstream users Consumers There is no exposure of consumers to potassium methylsilanetriolate for this scenario Indirect exposure of humans via the environment Table 7.11 shows the quantitative risk for the exposure of humans via the environment for this scenario. The daily dose exposure concentration in humans through intake via the various routes have been predicted using EUSES

22 EC number: RECONSILE potassium methylsilanetriolate CAS number: Table 7.11: Risk Characterisation for the indirect exposure of humans via the environment Exposure concentration DNEL (oral) mg/kg/day Risk ratio Fish (mg/kg/day) Drinking water (mg/kg/day) Meat (mg/kg/day) Milk (mg/kg/day) E E E E Environment Methylsilanetriolate is equivalent to the parent acid, methylsilanetriol, under comparable conditions of concentration and ph (see Section 7). Therefore, all PECs, PNECs and RCRs have been calculated on the basis of the physicochemical properties of methylsilanetriol. The documented PNECs are considered adequate for the present REACH risk. They have been calculated using the current ECHA guideline, including conservative assessment factors, and are used for the registration under the regulation 1907/2006 dated June 1st 2007 (REACH) only. They should not be used for other regulatory purposes (e.g., OELs) without further consideration and evaluation Quantitative risk for environmental compartments The RCRs for the environmental compartments are shown in Fehler! Verweisquelle konnte nicht gefunden werden.and calculated from the PNECs and PECs reported in Sections 7 and 9.2 respectively. They are all <1 and indicate an acceptable risk and no immediate concern for the environment. Table 7.12: ES3 - Quantitative risk for environmental compartments RISK CHARACTERISATION OF [3 "ES 3 - MASONRY FORMULATION"] [INDUSTRIAL USE] WATER RCR for the local fresh-water compartment [-] Intermittent release RCR for the local marine compartment [-] SEDIMENT RCR for the local fresh-water sediment compartment [-] RCR for the local marine sediment compartment [-] SOIL RCR for the local soil compartment 1.11E-03 [-] CSR-PI CHEMICAL SAFETY REPORT 20

23 STP RCR for the sewage treatment plant 0.25 [-] PREDATORS RCR for fish-eating birds and mammals (fresh-water) [-] RCR for fish-eating birds and mammals (marine) 3.65E-03 [-] RCR for top predators (marine) 7.50E-04 [-] RCR for worm-eating birds and mammals 2.74E-04 [-] 7.4 ES4: Professional and consumer use of masonry products Human Health As discussed in Section 3, the DNELs used for risk are: DNEL Professional (long-term, inhalation): 47 mg/m³ DNEL Professional (long-term, dermal): 6.6 mg/kg/day DNEL Consumer (long-term, inhalation): 10 mg/m 3 DNEL Consumer (long-term, dermal): 2.9 mg/kg/day DNEL Consumer (long-term, oral): 0.42 mg/kg/day The documented PNECs/DNELs are considered adequate for the present REACH risk. They have been calculated using the current ECHA guideline, including conservative assessment factors, and are used for the registration under the regulation 1907/2006 dated June 1st 2007 (REACH) only. They should not be used for other regulatory purposes (e.g., OELs) without further consideration and evaluation. The quantifiable DNEL values for long-term systemic are based on trimethoxy(methyl)silane and therefore cover only systemic but not local corrosive due to ph of the aqueous product (see Section 5.11). Therefore, local irritation of low concentration products must also be taken into account for qualitative risk Workers Table7.13 shows the quantitative risk for workers. Professionals using masonry products formulated with the substance are routinely involved with the same tasks, therefore it is more appropriate to consider long-term exposure, and short-term exposure is not quantified. It is not possible to quantify risk ratios for local short-term dermal based on corrosion. However, local due to the corrosive/irritating of the products are taken into account for qualitative risk. 21

24 EC number: RECONSILE potassium methylsilanetriolate CAS number: Table 7.13: Quantitative risk for workers Long-term - systemic Long-term local Dermal (mg/kg bw /day) Inhalation (mg/m 3 ) Combined s Dermal (mg/cm 2 ) Inhalation (mg/m 3 ) ES4- exposure concentrations (EC) Leading toxic end point / Critical effect DNEL/DMEL (appropriate unit) 1.07 Repeat dose 6.6 mg/kg/day Repeat dose 47 mg/m³ Irritation/corrosion NA NA 8.6 NA NA NA Risk ratio 0.34 Table 7.14 shows the qualitative risk for workers. Due to the irritating/corrosive nature of the aqueous solution of the substance/product, personal protective equipment is essential and skin direct contacts will not occur. Workers are required to wear suitable protective gloves or gauntlets and protective clothing, to minimise the risk of irritation. Use of respiratory protective equipment is also required for spray application. Workers training in the use and disposal of personal protective equipment is assumed as a best practise for this type of use. It is therefore considered that there is no unacceptable risk to humans from short-term dermal exposure to potassium methylsilanetriolate. Table 7.14: Qualitative risk for workers Acute - local ES4- exposure concentrations (EC) Leading toxic end point / Critical effect Qualitative risk Dermal (mg/cm 2 ) N/A Irritation/corrosion Minimal potential for exposure, no unacceptable risk te regarding results from ECETOC TRA Exposure concentrations have been calculated using the ECETOC TRA model, with modifications for use of gloves. It should be noted that some uses not explicitly discussed in this CSR can also be considered to be safe by comparison to the description given. Therefore, if the new scenario covers the same user group, the same or shorter duration, the same or more complete controls, or more effective PPE, for the same PROC, then a use which might appear to be outside the scope of the CSR could in fact be judged to be safe. This is consistent with REACH guidance to downstream users Consumers Tables 7.15 and 7.16 show the quantitative risk for short-term and long-term exposures of consumers and the general public for this scenario. As a Tier 1 worst-case approach, CHEMICAL SAFETY CSR-PI REPORT 22

25 the short term exposure concentrations are compared with the long-term DNELs. Since all RCRs are below using this approach, it is not necessary to derive specific short-term DNELs. Due to the irritating/corrosive of the aqueous solution of the substance at low concentration, the supplier must recommend use of safety protective gloves and clothing for consumer use of masonry products containing potassium methylsilanetriolate. Table 7.15: Quantitative risk for consumers application by brushing or rolling (4% limit concentration) Acute - systemic Acute - local Long-term - systemic Long-term local Dermal (mg/kg bw /day) ES4- exposure concentrations (EC) Leading toxic end point / Critical effect 2.22 Repeat dose Inhalation (mg/m 3 ) 0.18 Repeat dose DNEL/DMEL (appropriate unit) 2.9 mg/kg/day mg/m Combined s 0.79 Dermal (mg/cm 2 ) 0.15 NA NA NA Inhalation (mg/m 3 ) 0.18 NA NA NA Dermal (mg/kg bw /day) Repeat dose Inhalation (mg/m 3 ) Repeat dose Risk ratio 2.9 mg/kg/day x mg/m x 10-5 Combined s 2.09 x 10-3 Dermal (mg/cm 2 ) 0.18 Irritation/corrosion NA NA Inhalation (mg/m 3 ) NA NA NA 23

26 EC number: RECONSILE potassium methylsilanetriolate CAS number: Table 7.16: Quantitative risk for consumers application by brushing or rolling (10% concentration) Acute - systemic Acute - local Long-term - systemic Long-term local Dermal (mg/kg bw /day) ES4- exposure concentrations (EC) Leading toxic end point / Critical effect Repeat dose Inhalation (mg/m 3 ) 8.69 Repeat dose DNEL/DMEL (appropriate unit) 2.9 mg/kg/day mg/m Combined s 0.89 Dermal (mg/cm 2 ) 0.22 NA NA NA Inhalation (mg/m 3 ) 8.69 NA NA Dermal (mg/kg bw /day) Repeat dose Inhalation (mg/m 3 ) Repeat dose Risk ratio 2.9 mg/kg/day 6.90 x mg/m x 10-3 Combined s 2.47 x 10-3 Dermal (mg/cm 2 ) 0.22 Irritation/corrosion NA NA Inhalation (mg/m 3 ) NA NA NA Indirect exposure of humans via the environment Table 7.17 shows the quantitative risk for the exposure of humans via the environment for this scenario. The daily dose exposure concentration in humans through intake via the various routes have been predicted using EUSES Table 7.17: Risk Characterisation for the indirect exposure of humans via the environment Fish (mg/kg/day) Exposure concentration 2.77E-03 DNEL (oral) mg/kg/day 0.42 Risk ratio 6.60E-03 Drinking water (mg/kg/day) 1.96E E-03 Meat (mg/kg/day) 8.57E E-07 Milk (mg/kg/day) 8.57E E Environment Methylsilanetriolate is equivalent to the parent acid, methylsilanetriol, under comparable conditions of concentration and ph (see Section 7). Therefore, all PECs, PNECs and RCRs have been calculated on the basis of the physicochemical properties of methylsilanetriol CSR-PI CHEMICAL SAFETY REPORT 24

27 The documented PNECs are considered adequate for the present REACH risk. They have been calculated using the current ECHA guideline, including conservative assessment factors, and are used for the registration under the regulation 1907/2006 dated June 1st 2007 (REACH) only. They should not be used for other regulatory purposes (e.g., OELs) without further consideration and evaluation Quantitative risk for environmental compartments The RCRs for the environmental compartments are shown in Table7.18, calculated from the PNECs and PECs reported in Sections 7 and 9.4 respectively. They are all <1 and indicate an acceptable risk and no immediate concern for the environment. Table 7.18: ES4 - Quantitative risk for environmental compartments RISK CHARACTERISATION OF [4 "ES 4 - MASONRY USE"] [INDUSTRIAL USE] WATER RCR for the local fresh-water compartment 4.67E-04 [-] Intermittent release RCR for the local marine compartment 4.64E-04 [-] SEDIMENT RCR for the local fresh-water sediment compartment 4.67E-04 [-] RCR for the local marine sediment compartment 4.64E-04 [-] SOIL RCR for the local soil compartment 6.16E-06 [-] STP RCR for the sewage treatment plant 1.37E-03 [-] PREDATORS RCR for fish-eating birds and mammals (fresh-water) 5.41E-04 [-] RCR for fish-eating birds and mammals (marine) 5.35E-05 [-] RCR for top predators (marine) 3.03E-05 [-] RCR for worm-eating birds and mammals 1.59E-06 [-] 7.5 ES5: Use in non-metal surface treatment and/or mass hydrophobation Human Health As discussed in Section 3, the DNELs used for risk are: DNEL (long-term, inhalation): 47 mg/m³ 25

28 EC number: RECONSILE potassium methylsilanetriolate CAS number: DNEL (long-term, dermal): 0.69 mg/kg/day The documented PNECs/DNELs are considered adequate for the present REACH risk. They have been calculated using the current ECHA guideline, including conservative assessment factors, and are used for the registration under the regulation 1907/2006 dated June 1st 2007 (REACH) only. They should not be used for other regulatory purposes (e.g., OELs) without further consideration and evaluation. The quantifiable DNEL values for long-term systemic are based on trimethoxy(methyl)silane and therefore cover only systemic but not local corrosive due to ph of the aqueous product (see Section 5.11). Therefore, local due to the corrosive nature of high concentration products must also be taken into account for qualitative risk Workers Table 7.Fehler! Verweisquelle konnte nicht gefunden werden.19 shows the quantitative risk for workers. Workers at industrial sites are routinely involved with the same tasks, therefore it is more appropriate to consider long-term exposure, and short-term exposure is not quantified. It is not possible to quantify risk ratios for local short-term dermal based on corrosion. However, local due to the corrosive nature of high concentration products are taken into account for qualitative risk. Table 7.19: Quantitative risk for workers Long-term - systemic Long-term local Dermal (mg/kg bw /day) ES5- exposure concentrations (EC) Leading toxic end point / Critical effect 0.14 Repeat dose Inhalation (mg/m 3 ) 33 Repeat dose DNEL/DMEL (appropriate unit) 0.69 mg/kg/day mg/m³ 0.70 Combined s 0.27 Dermal (mg/cm 2 ) 0.02 Corrosion NA NA Inhalation (mg/m 3 ) 33 NA NA NA Risk ratio Table 7.Fehler! Verweisquelle konnte nicht gefunden werden.20 shows the qualitative risk for workers. Due to the corrosive of the aqueous solution of the substance, personal protective equipment is essential and exposure will not occur. Workers are required to wear suitable protective gloves or gauntlets, chemically resistant clothing and goggles or shield to minimise the risk of corrosive. Specific worker training in the use and disposal of protective clothing is applicable as a best practise. It is therefore considered that there is no unacceptable risk to humans from short-term exposure to potassium methylsilanetriolate CSR-PI CHEMICAL SAFETY REPORT 26

29 Table 7.20: Qualitative risk for workers Acute - local ES5- exposure concentrations (EC) Leading toxic end point / Critical effect Qualitative risk NA NA Corrosion Minimal potential for exposure, no unacceptable risk te regarding results from ECETOC TRA Exposure concentrations have been calculated using the ECETOC TRA model, with modifications for use of gloves. It should be noted that some uses not explicitly discussed in this CSR can also be considered to be safe by comparison to the description given. Therefore, if the new scenario covers the same user group, the same or shorter duration, the same or more complete controls, or more effective PPE, for the same PROC, then a use which might appear to be outside the scope of the CSR could in fact be judged to be safe. This is consistent with REACH guidance to downstream users Consumers There is no exposure of consumers to potassium methylsilanetriolate Indirect exposure of humans via the environment Table 7.21 shows the quantitative risk for the exposure of humans via the environment for this scenario. The daily dose exposure concentration in humans through intake via the various routes have been predicted using EUSES Table 7.21: Risk Characterisation for the indirect exposure of humans via the environment Fish (mg/kg/day) Exposure concentration DNEL (oral) mg/kg/day 0.42 Risk ratio 0.23 Drinking water (mg/kg/day) Meat (mg/kg/day) 3.02E E-06 Milk (mg/kg/day) 3.02E E Environment Methylsilanetriolate is equivalent to the parent acid, methylsilanetriol, under comparable conditions of concentration and ph (see Section 7). Therefore, all PECs, PNECs and RCRs have been calculated on the basis of the physicochemical properties of methylsilanetriol. The documented PNECs are considered adequate for the present REACH risk. They have been calculated using the current ECHA guideline, including conservative assessment 27

30 EC number: RECONSILE potassium methylsilanetriolate CAS number: factors, and are used for the registration under the regulation 1907/2006 dated June 1st 2007 (REACH) only. They should not be used for other regulatory purposes (e.g., OELs) without further consideration and evaluation Quantitative risk for environmental compartments The RCRs for the environmental compartments are shown in Table 7.22., calculated from the PNECs and PECs reported in Sections 7 and 9.5 respectively. They are all <1 and indicate an acceptable risk and no immediate concern for the environment. Table 7.22: ES5 - Quantitative risk for environmental compartments RISK CHARACTERISATION OF [5 "ES 5 - NMST"] [INDUSTRIAL USE] WATER RCR for the local fresh-water compartment [-] Intermittent release RCR for the local marine compartment [-] SEDIMENT RCR for the local fresh-water sediment compartment [-] RCR for the local marine sediment compartment [-] SOIL RCR for the local soil compartment 4.44E-03 [-] STP RCR for the sewage treatment plant 1 [-] PREDATORS RCR for fish-eating birds and mammals (fresh-water) [-] RCR for fish-eating birds and mammals (marine) 1.48E-03 [-] RCR for top predators (marine) 3.15E-04 [-] RCR for worm-eating birds and mammals 1.10E-03 [-] CSR-PI CHEMICAL SAFETY REPORT 28

31 7.6 ES6: Formulation of coatings and paints Human Health As discussed in Section 3, the DNELs used for risk are: DNEL (long-term, inhalation): 47 mg/m³ DNEL (long-term, dermal): 0.69 mg/kg/day The documented PNECs/DNELs are considered adequate for the present REACH risk. They have been calculated using the current ECHA guideline, including conservative assessment factors, and are used for the registration under the regulation 1907/2006 dated June 1st 2007 (REACH) only. They should not be used for other regulatory purposes (e.g., OELs) without further consideration and evaluation. The quantifiable DNEL values for long-term systemic are based on trimethoxy(methyl)silane and therefore cover only systemic but not local corrosive due to ph of the aqueous product (see Section 5.11). Therefore, local due to the corrosive and irritating nature of high and low concentration products, respectively, must also be taken into account for qualitative risk Workers Table 7.Fehler! Verweisquelle konnte nicht gefunden werden.23 shows the quantitative risk for workers. Workers at industrial sites are routinely involved with the same tasks, therefore it is more appropriate to consider long-term exposure, and short-term exposure is not quantified. It is not possible to quantify risk ratios for local short-term dermal based on corrosion. However, local due to the corrosive nature of high concentration products are taken into account for qualitative risk. Table 7.23: Quantitative risk for workers Long-term - systemic Long-term local Dermal (mg/kg bw /day) ES6- exposure concentrations (EC) Leading toxic end point / Critical effect Repeat dose Inhalation (mg/m 3 ) 1.65 Repeat dose DNEL/DMEL (appropriate unit) 0.69 mg/kg/day mg/m³ Combined s Dermal (mg/cm 2 ) Corrosion NA NA Inhalation (mg/m 3 ) 1.65 NA NA NA Risk ratio Table 7.24 shows the qualitative risk for workers. Due to the corrosive of the substance, personal protective equipment is essential and exposure will not occur. Workers are required to wear suitable protective gloves or gauntlets, chemically resistant clothing and goggles or shield to minimise the risk of corrosive. Specific worker training in the use and disposal of protective clothing is applicable as a best practise. It is therefore considered that there is no unacceptable risk to humans from short-term exposure to potassium methylsilanetriolate. 29

32 EC number: RECONSILE potassium methylsilanetriolate CAS number: Table 7.24: Qualitative risk for workers Acute - local ES6- exposure concentrations (EC) Leading toxic end point / Critical effect Qualitative risk NA NA Corrosion Minimal potential for exposure, no unacceptable risk te regarding results from ECETOC TRA Exposure concentrations have been calculated using the ECETOC TRA model, with modifications for use of gloves. It should be noted that some uses not explicitly discussed in this CSR can also be considered to be safe by comparison to the description given. Therefore, if the new scenario covers the same user group, the same or shorter duration, the same or more complete controls, or more effective PPE, for the same PROC, then a use which might appear to be outside the scope of the CSR could in fact be judged to be safe. This is consistent with REACH guidance to downstream users Consumers There is no exposure of consumers to potassium methylsilanetriolate Indirect exposure of humans via the environment Table 7.25 shows the quantitative risk for the exposure of humans via the environment for this scenario. The daily dose exposure concentration in humans through intake via the various routes have been predicted using EUSES Table 7.25: Risk Characterisation for the indirect exposure of humans via the environment Exposure concentration DNEL (oral) mg/kg/day Risk ratio Fish (mg/kg/day) Drinking water (mg/kg/day) Meat (mg/kg/day) 1.05E E-05 Milk (mg/kg/day) 1.05E E Environment Methylsilanetriolate is equivalent to the parent acid, methylsilanetriol, under comparable conditions of concentration and ph. Therefore, all PECs, PNECs and RCRs have been calculated on the basis of the physicochemical properties of methylsilanetriol. The documented PNECs are considered adequate for the present REACH risk. They have been calculated using the current ECHA guideline, including conservative assessment factors, and are used for the registration under the regulation 1907/2006 dated June 1st CSR-PI CHEMICAL SAFETY REPORT 30