Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 239-415-9 | CAS number: 15396-00-6
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- fish early-life stage toxicity
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Description of key information
Key value for chemical safety assessment
Additional information
Due to the rapid hydrolysis of the registration substance, the chemical safely assessment is based on the silanol hydrolysis product 3-aminopropylsilanetriol.
Testing for long-term toxicity to fish is not considered necessary because:
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 substance has acute data available for three trophic levels, as well as chronic invertebrate and algal toxicity data, either measured or read across from appropriate structural analogues. Based on this available aquatic data the most sensitive trophic level in the short-term tests was invertebrates, but the most sensitive trophic level in the long-term tests was for algae. Furthermore, no effects were observed in the short-term toxicity to fish test when the substance was tested at nominal concentrations of 100 mg/l.
An assessment factor of 50 was applied to derive the freshwater PNEC using the long-term algae 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.
The registered substance is highly water-soluble and has low bioavailability based on log Kow <3 (-4.0).
Overall it is concluded that the risk is 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.
Details on how the PNEC and the risk characterisation ratio have been derived can be found in IUCLID Section 6.0 and Chapters 7, 9 and 10 of the Chemical Safety Report, respectively.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
