Registration Dossier
Registration Dossier
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EC number: 202-615-1 | CAS number: 97-88-1
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
Description of key information
For n-BMA, based on the acute data, fish appears to be the most sensitive trophic level. In the risk assessment this has been compensated by an additional assessment factor of 10 (default assessment factor with three trophic levels: 10, with two trophic levels not using the most sensitive trophic level: 100). This way the current approach provides a sufficient and even more conservative margin of safety in comparison to the default approach with a third chronic (fish) test. This way there is no scientific justification for the chronic fish test because it will not provide a higher level of protection.
Key value for chemical safety assessment
Additional information
For this member of the category no chronic fish data are available. In this case the risk assessment has been performed based on the two other available NOECs in the other trophic levels. In an ECHA communication the necessity of a chronic fish test has been raised. Since the fish test is a vertebrate study it should only be performed if the same level of confidence cannot be achieved in other ways. It is necessary to answer two questions: What is most likely the most sensitive trophic level and can the difference in sensitivity be predicted with any certainty?
For n-BMA, based on the acute data, fish appears to be the most sensitive trophic level. There is a Japanese 14 day extended acute fish study which seems to indicate the same thing with a NOEC even below the 21d daphnia NOEC. The likely difference is in an order of magnitude of three-to fourfold. In the risk assessment this has been compensated by an additional assessment factor of 10 (default assessment factor with three trophic levels: 10, with two trophic levels not using the most sensitive trophic level: 100). This way the current approach provides a sufficient and even more conservative margin of safety in comparison to the default approach with a third chronic (fish) test. This way there is no scientific justification for the chronic fish test because it will not provide a higher level of protection.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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