Registration Dossier
Registration Dossier
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EC number: 939-066-9 | CAS number: -
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:
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
According to the communication number CCH-D-2114328744-46-01/F, and according to ECHA Guidance on information requirements and chemical safety assessment (version 3.0, February 2016), Chapter R7b (Section R.7.8.5., including Figure R.7.8-4), if based on acute aquatic toxicity data neither fish nor invertebrates are shown to be substantially more sensitive, long-term studies may be required on both. In such case, according to the integrated testing strategy, the Daphnia study is to be conducted first. If based on the results of the long-term Daphnia study and the application of a relevant assessment factor, no risks are observed (PEC/PNEC<1), no long-term fish testing may need to be conducted. However, if a risk is indicated, the long-term fish study needs to be conducted.
The long-term Daphnia test concluded that the Test item did not affect the reproduction of Daphnia magna at a loading rate of 1.0 mg a.i./L after 21 days of exposure (saturation concentration), being the NOAEL equal to 1.0 mg a.i./L and EL50 greater than 1.0 mg a.i./L. Based on these results, the substance is not classified for aquatic toxicity according to CLP Regulation and no risk assessment is necessary to be performed according to REACH Regulation. Therefore, it is concluded that the long-term fish testing is not scientifically justified. - Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
Description of key information
Data waiving (study scientifically not necessary): According to the communication number CCH-D-2114328744-46-01/F, and according to ECHA Guidance on information requirements and chemical safety assessment (version 3.0, February 2016), Chapter R7b (Section R.7.8.5., including Figure R.7.8-4), if based on acute aquatic toxicity data neither fish nor invertebrates are shown to be substantially more sensitive, long-term studies may be required on both. In such case, according to the integrated testing strategy, the Daphnia study is to be conducted first. If based on the results of the long-term Daphnia study and the application of a relevant assessment factor, no risks are observed (PEC/PNEC<1), no long-term fish testing may need to be conducted. However, if a risk is indicated, the long-term fish study needs to be conducted.
The long-term Daphnia test concluded that the Test item did not affect the reproduction of Daphnia magna at a loading rate of 1.0 mg a.i./L after 21 days of exposure (saturation concentration), being the NOAEL equal to 1.0 mg a.i./L and EL50 greater than 1.0 mg a.i./L. Based on these results, the substance is not classified for aquatic toxicity according to CLP Regulation and no risk assessment is necessary to be performed according to REACH Regulation. Therefore, it is concluded that the long-term fish testing is not scientifically justified.
Key value for chemical safety assessment
Additional information
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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