Registration Dossier
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EC number: 219-764-3 | CAS number: 2526-62-7
Long-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- long-term toxicity to aquatic invertebrates
- 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
Testing for long-term toxicity to invertebrates is not considered necessary because:
The substance hydrolyses rapidly therefore the chemical safety assessment is based on the silicon containing hydrolysis product 3-(trihydroxysilyl)propiononitrile.
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 aquatic invertebrates 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 the Risk Characterisation Ratio 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 highly water-soluble, has low potential for bioaccumulation (based on log Kow <3 (-2.9)) and there is no reason to expect any specific mechanism of toxicity beyond narcosis. Therefore, the occurrence of toxic effects that were expressed in the existing short-term aquatic studies (conducted at concentrations up to 120 mg/l of parent substance) would be considered unlikely.
Based on the acute aquatic data, read across from a structural analogue, no short-term effects were seen in any trophic level, although a chronic endpoint NOEC of 60 mg/l was reported in the algal test. Thus, toxicity of 3-(trihydroxysilyl)propiononitrile to invertebrate species is not expected.
A PNEC has been derived for the purpose of chemical safety assessment. An assessment factor of 1000 was applied to derive the freshwater PNEC. This high assessment factor to derive the predicted no-effect level already reflects the typically higher value of a short-term EC50 compared to a long-term NOEC/EC10. For a narcotic chemical without a specific mode of toxic action, it is unlikely that the aquatic PNEC would be significantly over-estimated using this method.
Overall it is concluded that the risk characterisation conclusion is sufficiently conservative in respect of any uncertainties and therefore further in vivo 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.
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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