Registration Dossier
Registration Dossier
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EC number: 203-813-0 | CAS number: 110-89-4
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
Description of key information
No data on long-term toxcity to fish are available
Key value for chemical safety assessment
Additional information
In Annex XI, Section 3, it is laid down that testing in accordance with Annex IX may be omitted, based on the exposure scenario(s) developed in the Chemical Safety Report (“Substance-Tailored Exposure-Driven Testing”). In accordance with Annex XI Section 3, it can be demonstrated in the risk assessment that the manufacture and the use of the substance do not pose an unacceptable risk for all environmental compartments as the risk characterization ratios (RCRs) of the chemical safety assessment are well below 1 for all compartments (see Chemical Safety Report Ch. 10). Therefore, it is concluded that piperidine does not pose a risk to the environment.
Additionally, according to ECHA Guidance on information requirements and chemical safety assessment Chapter R.10: Characterisation of dose [concentration]-response for environment R.10.3.1.2, it may sometimes be possible to determine with high probability that the most sensitive species has been examined, i.e. that a further long-term result from a different taxonomic group would not be lower than the data already available. Acute data for all three trophic levels demonstrated that aquatic invertebrates were by far the most sensitive species towards the test substance with an EC50 (48h) of 19 mg/L (BASF SE 50E0108/09X103, 2013). Acute studies on fish and algae revealed LC50/EC50-values exceeding 100 mg/L (BASF SE 60E0108/09X102, 2013 and BASF AG 10F0180/875094, 1987).
Based on the information provided above, a long-term aquatic toxicity study would not provide any substantial information gain in the Chemical Safety Assessment of the substance. Furthermore, such a study would not contribute to a significant revision of the existing Risk assessment of the registration item, or change its current conclusions. Accordingly, long-term toxicity testing on fish is not deemed necessary for piperidine. Therefore, and for reasons of animal welfare, a long-term toxicity test on fish is not provided.
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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