Registration Dossier
Registration Dossier
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EC number: 287-484-9 | CAS number: 85536-04-5
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
Description of key information
Since the chemical safety assessment according to Annex I of Regulation (EC) No 1907/2006 does not indicate the need to further investigate the long-term toxicity to fish no further long-term toxicity test to fish is proposed, in accordance with Annex IX, column 2.
Key value for chemical safety assessment
Additional information
There are no experimental studies available, in which the long-term toxicity of the target substanceFatty acids, C16-18, stearyl esters (CAS 85536-04-5) to fish was assessed.
All the available studies for short-term aquatic toxicity to fish, daphnids and algae indicate no potential for acute aquatic toxicity. Furthermore, the short-term toxicity studies provide no indication that aquatic invertebrates are less sensitive than fish. Therefore, a long-term test with fish is not expected to generate significantly different results.
Additional data for long-term aquatic toxicity is not available for aquatic invertebrates. However, a laboratory statement is available for the source substance 2-octyldodecyl isooctadecanoate (CAS 93803-87-3; read-across in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5), according to which a long-term study according to OECD 211 is technically not feasible due to the very low water solubility of the test item and the lack of adequate analytical methods. Therefore, it is considered plausible that a long-term study with fish would face the same technical difficulties.
Moreover, chronic exposure of aquatic organisms is not expected due the ready biodegradability of the substance.
Thus, 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. In accordance with Annex IX, column 2 and for animal welfare reasons, no further long-term toxicity test to fish is therefore 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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