Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The AMES tests used five strains of bacteria Salmonella typhimurium: TA 1535, TA 1537, TA 98, TA 100 and TA 97 or TA 1538,

with and without a metabolic activation system, the S9 mix. Different dose levels of the test material were tested on each strain of Salmonella.

AZDN did not induce any significant increase in the number of revertants, in the Salmonella strains used and no toxicity was observed.

In the chromosome aberration test, AZDN did not induce any significant increase in the number of cells with chromosome aberrations, in the number of polyploid cells nor in the number of cells with endoreduplicated chromosomes in the presence or absence of the metabolic activation system, and no toxicity was observed.

The Mouse lymphoma assay showed that AZDN did not induce any significant increase in the mutation frequency and no toxicity was observed

in the presence or absence of the metabolic activation system


Short description of key information:
Four separate AMES studies were used to investigate the potential of the test item 2,2-AZOBIS(ISOBUTYRONITRILE) to induce reverse mutation in Salmonella typhimurium, the studies were run according to or used similar method to OECD 471 guideline.
A chromosome aberration test was run according to OECD Guideline 473 and the Japanese Guideline for screening mutagenicity testing of chemical.
In addition to the above in vitro tests a mouse lymphoma assay was run on AZDN according to OECD Guideline 476.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

According to EU regulation (EC) No 1272/2008 (CLP) and to EU Directive 67/584/EEC, AZDN was unclassified for mutagenicity endpoint.

AZDN was not mutagenic in any of the above in vitro models used : Ames test, mouse lymphoma test, and in mammalian chromosomic aberrations test.