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Key value for chemical safety assessment

Additional information

DEGDN was not mutagenic for Salmonella in a mammalian microsome mutagenicity assay using strains TA97, TA98, TA100 or TA102 in the presence and absence of S9 metabolic activation over a 1000-fold DEGDN concentration range. However, in a forward mutation assay using the point mutation at the thymidine kinase locus in the mouse lymphoma cell (L5178Y TK=/-), DEGDN was shown to be a weak mutagen independent of S9 metabolic activation.

There were no apparent TNG-induced mutagenic effects in the cytogenetic analyses of cells from dogs and rats and in the dominant lethal mutation study in rats for the substance TNG.


Short description of key information:
Two in vitro mutagenicity studies were found for DEGDN:
- gene mutation study in bacteria
- gene mutation study in mammalian cells

No reference to in vitro cytogenicity study in mammalian cells or in vitro micronucleus was found. Due to the results of in vitro and in vivo mutagenicity studies were used for read-across.
One reference to in vitro chromosome abberation test in chinese hamster chromosomes was found, but only in form the summary in document Summary of SIDS results for TNG. The series of cytogenic studies in dogs and rats in the chronic study were conducted for TNG. In addition, dominant lethal mutation studies were also conducted.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification