Registration Dossier
Registration Dossier
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EC number: 309-832-1 | CAS number: 101227-09-2
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
Description of key information
The chemical safety assessment carried out according to Annex I of Regulation (EC) No 1907/2006 does not indicate the need to investigate further the long-term toxicity to fish.
Key value for chemical safety assessment
Additional information
There are no long-term fish studies available for fatty acids, C16-18, 2-hexyldecyl esters (CAS 101227-09-2). Available short-term studies for fish, daphnia and algae, all indicate no potential for aquatic toxicity. Additional long-term toxicity data are not available for aquatic invertebrates. However, a statement from the laboratory is available for the read-across substance 2-octyldodecyl isooctadecanoate (CAS 93803-87-3; in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5) stating that a study according to OECD 211 is technically not feasible due to the lack of analytical methods and the very low water solubility. Therefore, it is considered justified that a long-term study with fish would result in the same technical difficulties. Nevertheless, available chronic results throughout the category did not result in any chronic effects on Daphnia magna up to the limit of water solubility. As there was no sign that invertebrates are less sensitive than fish in the short-term tests, it cannot be expected that a long-term test with fish will generate different results then the ongoing long-term test with aquatic invertebrates. Due to its ready biodegradability it is not likely that aquatic organisms are exposed to the test substance since it will be ultimately degraded in sewage treatment plants. Hence due to animal welfare reasons and to avoid unnecessary vertebrate tests, no further long-term test with fish was proposed. 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.
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