Registration Dossier
Registration Dossier
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EC number: 255-485-3 | CAS number: 41669-30-1
Toxicity to microorganisms
Administrative data
Link to relevant study record(s)
Description of key information
NOEC (14 d): ≥ 14.2 mg/L for activated sludge microorganisms (OECD 301B)
Key value for chemical safety assessment
Additional information
Since no studies investigating the toxicity of isooctadecyl isooctadecanoate (CAS 41669-30-1) to activated sludge microorganisms are available, in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5a read-across to the structurally related source substance 2-octyldodecyl isooctadecanoate (CAS 93803-87-3) was conducted. The source substance is representative to evaluate the toxicity of isooctadecyl isooctadecanoate to activated sludge microorganisms. 2-octyldodecyl isooctadecanoate is characterized by the same fatty acid chain length (isooctadecanoic acid) and a similar branched alcohol component (2-octyldodecanol compared to isohexadecanol/isooctadecanol for the target substance). This read-across is justified in detail in the overall summary (IUCLID Section 6.1) and within the analogue justification in IUCLID Section 13. In this case of read-across, the best suited (highest degree of structural similarity, nearest physico-chemical properties) read-across substance was used for the assessment.
Since no studies on the toxicity to activated sludge microorganisms are available for the source substance 2-octyldodecyl isooctadecanoate a ready biodegradability study is used to derive a NOEC for the toxicity to aquatic microorganisms. If a compound degrades well in a ready biodegradability test, or does not inhibit the degradation of a positive control at a certain concentration, this concentration can be used as a NOEC value. This approach is in accordance with the Guidance on information requirements and chemical safety assessment (Chapter R.7b: Endpoint specific guidance, ECHA, 2012). A substance can be assumed to be not inhibitory to aquatic microorganisms, if in the toxicity control of a ready biodegradation test, more than 25% degradation based on CO2 evolution occurred within 14 days (OECD guideline 301). For 2-octyldodecyl isooctadecanoate (CAS 93803-87-3) a biodegradation test conducted according to OECD guideline 301B is available (Desmares-Koopmans, 1998). The test includes a toxicity control, which contains 14.2 mg/L of the test substance and 39.85 mg/L of the reference material. The toxicity control attained 78.1% degradation after 14 days of incubation. Hence, the substance is not toxic to aquatic microorganisms and a NOEC of ≥ 14.2 mg/L was derived. Based on the available result from one structurally related source substance (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which is characterized by a similar ecotoxicological profile and comparable structure, it can be concluded that isooctadecyl isooctadecanoate will not exhibit effects to activated sludge microorganisms.
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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