Registration Dossier
Registration Dossier
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EC number: 276-771-4 | CAS number: 72705-26-1
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Bacterial Reverse Mutation Assay (Ames test)
The test substance did not induce gene mutations in the S. typhimurium strains. .
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Bacterial reverse mutation test (Ames
test)
The test substance was tested for mutagenicity with the strains TA 98, TA 100, TA 1535 and TA 1537 Salmonella typhimurium (Ames Test). The mutagenicity studies were conducted in the absence and in the presence of a metabolizing system derived from rat liver homogenate. A dose range up to 12500 µg/plate was used in the pre-test. No inhibition was observed at any of the concentrations of the test substance employed in this test and the main mutation study was set up using test substance at concentrations in the range 20 to 12500 µg/plate. The test substance did not show in these bacterial test systems either with or without exogenous metabolic activation at the dose levels investigated a dose dependent increase in the number of revertants in any of the bacterial strains. All counts of revertant colonies were similar to those recorded for the negative control plates and were within the range expected for spontaneous reversion for each strain. The positive controls showed the expected results and the activity of the S9 fraction was found to be satisfactory. Based on these results it can be stated that the test substance is not mutagenic in these bacterial test systems.
According to the results of the present study, the test substance is not mutagenic in the Ames test under the experimental conditions chosen here.
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation EC (No) 1272/2008. Based on the available in vitro genetic toxicity study (Ames test), the test substance is not considered to be classified for mutagenicity under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776
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