Registration Dossier
Registration Dossier
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EC number: 244-971-0 | CAS number: 22413-03-2
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. Since the substance is expected to be poorly soluble in water the study does not need to be conducted.
Key value for chemical safety assessment
Additional information
There are no experimental studies available, in which the long-term toxicity of the target substance Docosyl stearate (CAS 22413-03-2) to fish was assessed.
All the available studies for short-term aquatic toxicity to fish and algae indicate no potential for acute aquatic toxicity. Therefore, a long-term test with fish is not expected to generate significantly different results.
Additional data for long-term aquatic toxicity is available for aquatic invertebrates. Experimental data are available for the suitable source substance 9-Octadecenoic acid (Z)-, 9-octadecenyl ester, (Z)- (CAS 3687-45-4) and dodecyl oleate (CAS 36078-10-1). No effects on reproduction and mortality were recorded after 21 d resulting in a NOELR (21 d) of ≥ 100 mg/L. Additionally 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. These technical deficiencies are also likely to be problematic in a chronic study with fish.
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 VIII, column 2 and for animal welfare reasons, no further long-term toxicity test to fish is therefore proposed.
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