Registration Dossier
Registration Dossier
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EC number: 207-431-5 | CAS number: 470-82-6
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
The results of the in vitro gene mutation studies in bacteria and in vitro chromosome aberration study in mammalian cells concluded that the test substance was not genotoxic.
An in vitro sister chromatid exchange assay indicated that the test material was positive without metabolic activation but negative with metabolic activation, however the results were positive only without activation at doses that induced cell cycle delay. No aberration induction was detected.
Finally, an in vivo mouse micronucleus study was conducted according to OECD guideline 474 on a structural analogue. Since the test substance did not cause any substantial increase in the incidence of micronucleated polychromatic erythrocytes, it is concluded that the test substance did not show any evidence of causing chromosome damage when administered orally in an in vivo test.
Justification for selection of genetic toxicity endpoint
The results of an in vivo mouse micronucleus conducted according to OECD guideline 474 on a structural analogue did not show any evidence of causing chromosome damage when administered orally.
Short description of key information:
In vitro gene mutation studies in bacteria concluded that the test substance was not genotoxic under the conditions of the studies either with or without metabolic activation.
An in vitro chromosome aberration study in mammalian cells concluded that the test substance was not genotoxic under the conditions of the study as the results were negative both with and without metabolic activation.
In a sister chromatid exchange assay, however, the test material was positive without metabolic activation but negative with metabolic activation in a test for genotoxicity. The results were positive only without activation at doses that induced cell cycle delay. No aberration induction was detected.
Finally, the results of an in vivo mouse micronucleus conducted according to OECD guideline 474 on a structural analogue did not show any evidence of causing chromosome damage when administered orally.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
The results of an in vivo mouse micronucleus conducted according to OECD guideline 474 on a structural analogue did not show any evidence of causing chromosome damage when administered orally.
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