Registration Dossier
Registration Dossier
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EC number: 208-736-6 | CAS number: 540-10-3
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
The chemical safety assessment carried out according to Annex I of Regulation (EC) No 1907/2006 does not raise the need to further investigate the long-term toxicity to fish.
Key value for chemical safety assessment
Additional information
There are no studies available assessing the long-term toxicity of hexadecyl palmitate (CAS 540-10-3) on fish. The available aquatic studies for the acute toxicity to all three trophic levels (fish, aquatic invertebrates and algae) as well as the available aquatic studies for the chronic toxicity to two trophic levels (aquatic invertebrates and algae) indicate no effects up to the limit of water solubility. Furthermore, there is no indication in the short-term tests that aquatic invertebrates may be less sensitive than fish. Based on the available data, a long-term test with fish is not expected to generate significantly different results from the available long-term study with aquatic invertebrates. Moreover, due to the ready biodegradability of the substance, exposure of aquatic organisms to the substance is unlikely in surface waters.
Therefore, the chemical safety assessment carried out according to Annex I of Regulation (EC) No 1907/2006 does not raise the need for the further investigation of the long-term toxicity to fish. Thus, in accordance with Annex VIII, column 2 no long-term toxicity test to fish is proposed to avoid unnecessary testing of vertebrates in favor of animal welfare.
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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