Registration Dossier
Registration Dossier
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EC number: 221-070-0 | CAS number: 2997-92-4
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Bacterial reverse mutagenicity tests are available for 2, 2'-azobis(2-methylpropionamidine) dihydrochloride and one of the decomposition products 3, 3, 4, 4-Tetramethyl-2,5-pyrrolidinedione. The studies k_Oguma_2002 and s_Oguma_2002_pyr do not indicate mutagenic potential. The study d_Kato_1994 is disregarded as it is insufficiently documented and follows no guideline Micronucleus formation was investigated in human lymphocytes and mouse lymphocytes in three studies. k_Andres_2013, s_Scarpato_2011 do not indicate mutagenic potential. The study d_Kato_1994 is disregarded as it is insufficiently documented and follows no guideline. The study s_Damiani_2000 only investigates isolated DNA.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
As no effects were detected in in vitro assays no further testing in vivo is considered.
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Additional information from genetic
toxicity in vitro:
The study s_Damiani_2000 only investigates isolated DNA and gives therefore only hints on mutagenic potential. In the other conducted in vitro studies no hints on genetic toxicity resp. mutagenicity is found.
Justification for selection of
genetic toxicity endpoint
The GLP Study according to the OECD-Guideline 487 is selected as it
is the most reliable study on mammalian cells.
Justification for classification or non-classification
The presented data for genetic toxicity are reliable and adequate guideline studies. The observations within the studies are conclusive but not sufficient for a classification according to Regulation (EC) No. 1272/2008.
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