Registration Dossier
Registration Dossier
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EC number: 948-260-2 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The main constituent 4,8,11-Dodecatrienal 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 acc. to OECD 471 and GLP.
STRAINS: TA 1535, TA 100, TA 1537, TA 98 and E. coli WP2 uvrA
DOSE RANGE: 0.33 μg - 5000 μg/plate (SPT), 0.33 μg - 2500 μg/plate (PIT)
TEST CONDITIONS: Standard plate test (SPT) and preincubation test (PIT) both with and without metabolic activation (liver S9 mix from induced rats).
SOLUBILITY: No precipitation of the test substance was observed with and without S9 mix.
TOXICITY: A bacteriotoxic effect was observed depending on the strain and test conditions at and above 0.33 μg/plate
MUTAGENICITY: 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 chosen the test substance 4,8,11-Dodecatrienal is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay in the absence and the presence of metabolic activation.
The constituent 4,8-Cyclododecadien-1-one was tested for its mutagenic potential in a reverse mutation assay in bacteria acc. to OECD 471 and GLP and did not show a relevant increase in the number of his+ or trp+ revertants either without S9 mix or after the addition of a metabolizing system (BASF 2016, 40M0306/15M064). Accordingly, 4,8-Cyclododecadien-1-one is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay under the experimental conditions chosen.
Justification for classification or non-classification
The present data for genotoxicity of the main constituent 4,8,11-Dodecatrienal do not fulfill the criteria laid down in regulation (EU) 1272/2008. Furthermore, genotoxicity data for the constituent 4,8-Cyclododecadien-1-one do not fulfill the criteria laid down in regulation (EU) 1272/2008. Thus, based on the current data for the these two components (representing 55% to 95% of the reaction mass) a non-classification of the registered substance is warranted.
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