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 In accordance with Column 2 of REACH Annex X, long-term toxicity testing with sediment organisms (required in Section 9.5.1 of REACH Annex X) is not needed as the chemical safety assessment according to Annex I indicates that this is not necessary. - Due to the moderate rate of hydrolysis of the substance, the chemical safely assessment is based on both the parent substance, (3-chloropropyl)triethoxysilane, and the silanol hydrolysis product (3-chloropropyl)silanetriol.

 

(3-Chloropropyl)triethoxysilane: Testing for toxicity to sediment dwelling organisms is not considered necessary because: PNECsediment has been calculated from the aquatic data using the Equilibrium Partitioning Method. The risk characterisation ratios (RCR) based on the PNECsediment are <1. In accordance with Column 2 of REACH Annex X, there is no need to further investigate the effects of this substance in a sediment toxicity study because, as indicated in guidance R.7.11.6 (ECHA 2016), the quantitative chemical safety assessment (conducted according to Annex I of REACH) indicates that the Risk Characterisation Ratio (RCR) is well below 1, even with due consideration of contributing uncertainties, and therefore the risk is already adequately controlled and further testing is not justifiable. The substance is not readily biodegradable, has some potential for bioaccumulation, some potential for adsorption and has some bioavailability (based on log Kow >3 (3.13) and log Koc 1.7); therefore, (3-chloropropyl)triethoxysilane is expected to partly partition to the sediment compartment. Toxicity of (3-chloropropyl)triethoxysilane was observed in aquatic tests (lowest EC50 was 21.2 mg/l). There is no reason to expect any specific mechanism of toxicity beyond narcosis. Therefore, the occurrence of more severe toxic effects in the sediment compartment that were not expressed in the aquatic studies would be considered unlikely. Additionally, short-term tests conducted with fish and algae (according to OECD 203 and 201, respectively) are ongoing. Once the results of these studies have become available, long-term aquatic testing with the most sensitive trophic level (either Daphnia or fish) will be proposed with the parent substance. PNECsediment values based on the equilibrium partitioning method will be revised once the new aquatic data become available. Overall, it is concluded that the risk characterisation conclusion is sufficiently conservative in respect of any uncertainties and therefore further testing is not considered necessary. Details on how the PNEC and the risk characterisation ratio have been derived can be found in IUCLID Section 6.0 and Chapters 9 and 10 of the Chemical Safety Report, respectively.

 

(3-Chloropropyl)silanetriol: Testing for toxicity to sediment dwelling organisms is not considered necessary because: PNECsediment has been calculated from the aquatic data using the Equilibrium Partitioning Method. The risk characterisation ratios (RCR) based on the PNECsediment are <1. In accordance with Column 2 of REACH Annex X, there is no need to further investigate the effects of this substance in a sediment toxicity study because, as indicated in guidance R.7.11.6 (ECHA 2016), the quantitative chemical safety assessment (conducted according to Annex I of REACH) indicates that the Risk Characterisation Ratio (RCR) is well below 1, even with due consideration of contributing uncertainties, and therefore the risk is already adequately controlled and further testing is not justifiable. The substance is not readily biodegradable but has low potential for bioaccumulation, low potential for adsorption and has low bioavailability (based on log Kow <3 (-1.1) and log Koc 0.45); therefore, partitioning to the sediment compartment is expected to be minimal. Toxicity of (3-chloropropyl)silanetriol was observed in aquatic tests but at concentrations >100 mg/l (lowest EC50 was 685 mg/l). There is no reason to expect any specific mechanism of toxicity beyond narcosis. Therefore, the occurrence of more severe toxic effects in the sediment compartment that were not expressed in the aquatic studies would be considered unlikely. Overall, it is concluded that the risk characterisation conclusion is sufficiently conservative in respect of any uncertainties and therefore further testing is not considered necessary. Details on how the PNEC and the risk characterisation ratio have been derived can be found in IUCLID Section 6.0 and Chapters 9 and 10 of the Chemical Safety Report, respectively.