Registration Dossier
Registration Dossier
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EC number: 223-362-3 | CAS number: 3855-32-1
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
According to REACH Annex XI, 1.2., long-term testing for toxicity to fish is not necessary as there are sufficient available data for risk assessment. There are three reliable acute tests for aquatic toxicity for three trophic levels (fish, Daphnia, algae) available and, in addition, two long-term tests for two trophic levels (Daphnia and algae). Comparing the effect concentrations of the acute tests for the three trophic levels, fish are not the most sensitive species. For acute toxicity the most sensitive species is Daphnia, where an EC50 of 35.4 mg/L was determined. By comparison, in the acute Fish study, a LC50 of 92.5 mg/L was derived. A long-term fish test is not expected to improve the information on aquatic toxicity or provide lower effect concentrations. The available data are adequate for the purpose of classification and labelling and/or risk assessment as hazardous to the environment. Therefore and for animal welfare reasons, further testing on vertebrate animals for that property shall be omitted.
Key value for chemical safety assessment
Additional information
According to REACH Annex XI, 1.2., long-term testing for toxicity to fish is not necessary as there are sufficient available data for risk assessment. There are four reliable tests for aquatic toxicity for three trophic levels (Acute fish, Acute and Long-term Daphnia, acute Algae) available. Comparing the effect concentrations for the three trophic levels, fish are not the most sensitive species. The most sensitive species is Daphnia, where an EC50 of 2.2 mg/L was determined in a long-term study. By comparison, in the acute Fish study, and LC50 of 92.5mg/L was derived. A long-term fish test is not expected to improve the information on aquatic toxicity or provide lower effect concentrations. The available data are adequate for the purpose of classification and labelling and/or risk assessment as hazardous to the environment. Therefore and for animal welfare reasons, further testing on vertebrate animals for that property shall be omitted.
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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