Registration Dossier
Registration Dossier
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EC number: 239-622-4 | CAS number: 15571-58-1
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
Description of key information
According to the REACh Annex XI, Section 1, a test on long-term toxicity towards fish does not need to be conducted as it is scientifically not necessary. Vertebrate-animal testing can be avoided as fish are assumed to be not the most sensitive aquatic species.
Information gained through ecotoxicological testing is commonly used in the scope of classification and labeling (C&L), the PBT assessment as well as the chemical safety assessment. As C&L is solely based on the results of acute aquatic tests as well as results of biodegradation and / or bioaccumulation tests, a long-term test on toxicity of DOTE towards fish would not influence the outcome of the classification and labeling of DOTE.
Key value for chemical safety assessment
Additional information
In the scope of the PBT-assessment, a substance will fulfil the T-criterion in cases where chronic effect values are below a concentration of 0.01 mg/L. As effective concentrations of the available long-term studies (algae and daphnia) are above that threshold value, a chronic fish test is not necessary to refine the PBT-assessment considering that (i) very often fish is not the most sensitive species compared to aquatic plants or invertebrates (assumption already supported by the results of the acute tests carried out) and (ii) DOTE escape PBT classification based on the results of a bioaccumulation test demonstrating that DOTE is not bioaccumulative. To draw conclusions on the chemical safety assessment of DOTE, standard testing data on short-term toxicity for three trophic levels and on two long-term tests covering two trophic levels is available. Algae and Daphnia are with an EC50 of 0.17 mg/L the most sensitive aquatic species when regarding acute effects. As acute effective concentrations towards fish are about a factor of 150 lower than effective concentrations covering acute adverse effects towards algae it can be safely assumed that fish are not the most sensitive fresh water species. Concluding, as the fish values are likely to be at least a factor of about 100 less sensitive than algae regarding acute as well as chronic effects, there are no further requirements for fish testing (Guidance Document R.7b, p51, ECHA, 2008). The risk of the test substance towards aquatic species is sufficiently described based on the available data avoiding unnecessary vertebrate testing as no additional information would be obtained on the basis of new long-term fish tests.
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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