Registration Dossier
Registration Dossier
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EC number: 203-910-8 | CAS number: 111-81-9
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Two in vitro studies were performed on Methyl-10-undecenoate in the years 1995 and 2002, respectively. Both the bacterial reverse mutation rate test (Ames Test) and a mammalian chromosomal aberration test revealed negative results. Concerning the mammalian cell gene mutation tests a read across with undecylenic acid is being proposed (also negative study outcome). No in-vivo studies needed to be carried out yet for methyl 10-undecenoate.
The Ames test was achieved on Salmonella typhimurium strains: TA 1535, TA 1537, TA 98, TA 100 and TA 102, with and without metabolic activation. Test item concentrations up to 5000 µg/plate were tested. Methyl undecylenate did not reveal any mutagenic activity, despite its toxicity to bacteria.
This lack of mutagenic properties was confirmed by a chromosomal aberrations test carried out on human lymphocytes. Those cells were exposed with and without metabolic activation at the following doses : 1.25, 2.5, 5 and 10 mM. No significant chromosomal aberrations were noticed. In-vivo studies were not required for this substance.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
As indicated above, the available in vitro studies on genetic toxicity gave negative results, thus no classification of methyl 10 -undecenoate is warranted for genotoxicity according to EU regulation (EC) No. 1272/2008 (CLP) and to EU 67/548/ECC classification system.
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