Registration Dossier
Registration Dossier
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EC number: 271-347-5 | CAS number: 68541-50-4
Toxicity to microorganisms
Administrative data
Link to relevant study record(s)
Description of key information
EC (3 h)> 1000 mg/L (OECD 209)
Key value for chemical safety assessment
Additional information
Studies investigating the toxicity of 2-ethyl-2-(((1-oxoisooctadecyl)oxy)methyl)-1,3-propanediyl bis (isooctadecanoate) (CAS 68541-50-4) to microorganisms are not available. The evaluation therefore refers to the structural analogue category member 2-ethyl-2-[[(1-oxooleyl)oxy]methyl]-1,3-propanediyl dioleate (CAS-No. 57675-44-2) as part of a read across approach. The read across is suitable due to the similar fatty acid chain length of both substances. This is in accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5. Grouping of substance and read across approach. Further justification is given within the endpoint summary 6.1 and within the analogue justification section 13. The toxicity of 2-ethyl-2-[[(1-oxooleyl)oxy]methyl]-1,3-propanediyl dioleate (CAS-No. 57675-44-2) was tested in a GLP guideline study following OECD 209. The respiration rate of domestic activated sludge was observed at a substance concentration of 10000 mg/L. The test was terminated after 3 hours of incubation. An inhibition of the respiration rate was not observed. Thus an EC10 > 10000 mg/L (nominal) was reported.
The results obtained for the structurally related read-across substance (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) being characterised by an equal ecotoxicological profile, indicated that 2-ethyl-2-(((1-oxoisooctadecyl)oxy)methyl)-1,3-propanediyl bis (isooctadecanoate) (CAS 68541-50-4) will not affect the respiration rate of microorganisms. As it can be seen in the data matrix of the category justification in section 13 and the overall endpoint summary IUCLID 6.1, all reliable data in the category support the hazard assessment of each category member by showing a consistent pattern of results, i.e. no microbial inhibition and no toxic effects were observed to aquatic organisms up to the limit of water solubility.
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