Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
Description of key information
The chemical safety assessment according to Annex I of Regulation (EC) No. 1907/2006 does not indicate the need to investigate further the long-term toxicity to fish. Thus, in accordance to Annex IX, column 2 no further long-term toxicity test to fish is proposed.
Key value for chemical safety assessment
Additional information
Experimental data on the long-term toxicity of fatty acids C5-10 esters with dipentaerythritol (CAS 70983-72-1) to fish are not available. The chemical safety assessment according to Annex I of Regulation (EC) No 1907/2006 does not indicate the need to investigate further the long-term toxicity to fish. Consequently, no further long-term toxicity test to fish is proposed, in accordance with Annex VIII, 9.1.3, column 2. According to the Guidance on information requirements and chemical safety assessment Chapter R.7b: Endpoint specific guidance, R.7.8.5.3 (ECHA, 2017), long-term testing of fish should only be conducted if it represents the most sensitive taxonomic group. The Guidance states that if aquatic invertebrates are likely to be more sensitive than fish and algae or the relative sensitivity of invertebrates cannot be predicted, long-term testing on Daphnia sp. should be preferred instead of fish. The available acute toxicity tests indicate no toxic effects to fish. Since fish cannot be identified as the most sensitive organism, a long-term study from a suitable source substance with Daphnia magna was considered as recommended by the Guidance document. This study was conducted according to OECD guideline 211 and indicates no toxic effects of the source substances on the survival and reproduction of Daphnia magna up to the limit of water solubility (NOELR (21 d) ≥ 100 mg/L). Based on the results from the selected structurally related source substances (in accordance with Regulation (EC) No 1907/2006 Annex XI, 1.5), which are characterized by similar ecotoxicological profiles and comparable structure, long-term effects of fatty acids C5-10 esters with dipentaerythritol on fish are not to be expected. Thus, and for animal welfare, long-term testing on fish is not proposed.
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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