Registration Dossier
Registration Dossier
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EC number: 213-934-0 | CAS number: 1067-53-4
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
Additional information
- In accordance with Column 2 of REACH Annex IX, there is no need to further investigate the effects of this substance in a long-term aquatic toxicity to fish study because, as indicated in guidance R.7.8.4.3 (ECHA 2016), the quantitative chemical safety assessment (conducted according to Annex I of REACH) indicates that further testing is not justified for the following reasons:
- The substances have acute data available for three trophic levels, as well as chronic invertebrate and algal toxicity data. No effects were observed in fish up to the maximum test concentration of 100 mg/l, indicating low toxicity.
- Vinylsilanetriol: an assessment factor of 50 was applied to derive the freshwater PNEC using the long-term invertebrate result. The availability of the long-term result covering the most sensitive species in the aquatic tests, and the application of an appropriate assessment factor, means it is, therefore, unlikely that the aquatic PNEC would be significantly over-estimated. A PNEC has been derived for the purpose of chemical safety assessment and the risk characterisation ratios are below 1.
- 2-Methoxyethanol: no effects were observed in the long-term aquatic invertebrate study and the short-term data recorded effects at concentrations exceeding 1000 mg/l. A PNEC was not derived.
- The substances are highly water-soluble and have low bioavailability based on log Kow<3 (-2.0 and -0.77 for the silanol HP and 2-methoxyethanol, respectively).
- Overall, it is concluded that the risks are adequately assessed using the short-term data and the long-term invertebrate test, and that in vivo testing on vertebrate animals is not considered necessary or justified on ethical grounds
Due to the rapid hydrolysis of the substance, the chemical safely assessment is based on the silanol hydrolysis product vinylsilanetriol and 2-methoxyethanol.
Testing for long-term toxicity to fish is not considered necessary because:
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
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