Registration Dossier
Registration Dossier
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EC number: 221-066-9 | CAS number: 2996-92-1
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- fish early-life stage toxicity
- Data waiving:
- exposure considerations
- Justification for data waiving:
- other:
- Justification for type of information:
- For detailed information on this adaptation based on Annex XI (Section 3), please refer to the CSR attached in Section 13.
Reference
Description of key information
A long-term toxicity study on fish is not necessary as
- exposure considerations in accordance with Annex XI, Section 3, indicate that exposure of aquatic organisms to trimethoxyphenylsilane is absent or not significant
and
- the substance has a low hazard potential based on the available toxicity data.
Key value for chemical safety assessment
Additional information
In accordance with Annex XI, Section 3, exposure of aquatic organisms to trimethoxyphenylsilane (CAS No. 2996-92-1) is absent or not significant.
The environmental hazard assessment, PNEC derivation and risk characterization is based on the silanol hydrolysis product, phenylsilanetriol, as the substance hydrolyses rapidly. The other hydrolysis product, methanol, is known for its absence of environmental toxicity.
The hazard assessment showed no short-term aquatic hazard to all three trophic levels (all acute effect values > 100 mg/L). Consequently, no PNECs aqua (freshwater/marine water) were derived. The silanol hydrolysis product is well soluble. Significant deviations from this overall ecotoxicity profile are not expected and greater long-term toxicity in an additional test with fish is considered unlikely.
However, for the purpose of exposure-based adaptation as in the present endpoint, PNECs were derived in the Chemical Safety Report (CSR, Chapters 9 and 10) for the required risk characterization even though no hazard was identified in the available aquatic toxicity studies. The PNECs aqua (freshwater/marine water) were derived using a worst-case threshold value of 100 mg/L in combination with the standard assessment factors of 1000 and 10000, respectively, as outlined in ECHA guidance R.10 (2008).
The risk characterization for the silanol hydrolysis product of the substance indicated no risk to the aquatic environment (RCR < < 1).
For detailed information on the risk assessment please refer to the attached documentation in Section 13.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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