Registration Dossier
Registration Dossier
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EC number: 239-593-8 | CAS number: 15545-97-8
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Three studies on the endpoint genetic toxicity in vitro available:
- in vitro gene mutation in bacteria assay
- in vitro gene mutation in mammalian cells assay
- in vitro micronucleus in mammalian cells assay
Therefore the information requirements by (EC) No 1907/2006, Annex VII and VIII, column 2 are fulfilled.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (positive)
Genetic toxicity in vivo
Description of key information
A positive result in the in vitro micronucleus in mammalian cells assay was observed.
Therefore further testing shall be considered according to (EC) No 1907/2006, Annex VIII, column 2.
To meet this request an in vivo study on genetic toxicity is proposed.
Endpoint conclusion
- Endpoint conclusion:
- no study available (further information necessary)
Mode of Action Analysis / Human Relevance Framework
Based on the results of the available in vitro studies, a genotoxic mechanism on the level of single nucleobases seems not to be present.
Due to the findings in the in vitro micronucleus assay, effects on the whole genom (e.g. strand breaks) may be the leading mode of action.
Additional information
Justification for classification or non-classification
The available data is not completely conclusive. A positive finding in one in vitro assay is present. The present Azo moiety in general is an alert for genotoxic hazard however structural related substances (2,2'-dimethyl-2,2'-azodipropiononitrile, EC 201-132-3; 2,2’-[azobis(1-methylethylidene)]bis[4,5-dihydro-1H-imidazole dihydrochloride, EC 248-655-3) are not classified for genotoxicity. In conclusion, the available data is not sufficient for classification.
In order to conclude on this hazard, an in vivo genetic toxicity study is proposed.
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