Registration Dossier
Registration Dossier
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EC number: 948-946-1 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Available data with test substance:
Ames: negative (OECD 471)
Additional information
The test substance Reaction mass of Hexanedioic acid, 1-cyclohexyl 6-(2-ethylhexyl) ester, Hexanedioic acid, 1,6-dicyclohexyl ester and Hexanedioic acid, 1,6-bis(2 -ethylhexyl) ester was tested for its mutagenic potential based on the ability to induce point mutations in selected loci of several bacterial strains, i.e. Salmonella typhimurium and Escherichia coli, in a reverse mutation assay. Test strains are TA 1535, TA 100, TA 1537, TA 98 and E. coli WP2 uvrA. The dose range was 33 μg - 5000 μg/plate (SPT) and 33 μg - 5000 μg/plate (PIT). Standard plate test (SPT) and preincubation test (PIT) both with and without metabolic activation (liver S9 mix from induced rats). Precipitation of the test substance was found at 5000 μg/plate with and without S9 mix. A weak bacteriotoxic effect was only observed in the standard plate test using tester strain E.coli with S9 mix at a concentration 5000 μg/plate. A relevant increase in the number of his+ or trp+ revertants (factor ≥ 2: TA 100, TA 98 and E.coli WP2 uvrA or factor ≥ 3: TA 1535 and TA 1537) was not observed in the standard plate test or in the preincubation test without S9 mix or after the addition of a metabolizing system. Under the experimental conditions of this study, the test substance Reaction mass of Hexanedioic acid, 1-cyclohexyl 6-(2-ethylhexyl) ester, Hexanedioic acid, 1,6 -dicyclohexyl ester and Hexanedioic acid, 1,6-bis(2-ethylhexyl) ester is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay in the absence and the presence of metabolic activation.
Justification for classification or non-classification
Based on the results of the genetic toxicity testing, the test item was not classified and labelled accordingto Regulation (EC) No 1272/2008 (CLP).
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