Registration Dossier

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.