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Administrative data

Key value for chemical safety assessment

Additional information

DMDMH gave mainly negative results with in vitro bacterial mutation assays though one of the four available assays was positive. It gave positive results with in vitro cytogenetics, in vitro mammalian gene mutation and in vitro UDS assays. However it gave negative results with an in vivo micronucleus assay and an alkaline elution assay.

DMH gave negative results in all the in vitro studies performed (bacterial mutation, cytogenetics, mammalian gene mutation and UDS).

Justification for selection of genetic toxicity endpoint
There are 12 in vitro studies available on DMDMH and DMH. Some of the studies on DMDMH are positive however there are 2 in vivo studies available both of which are negative. Therefore no study was selected.

Short description of key information:
DMDMH readily undergoes hydrolysis to DMH and therefore data is provided for both substances. DMDMH gave positive results in a number of different in vitro assays however gave negative results in two in vivo assays. DMH gave negative results in a number of different in vitro assays.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

DMDMH gave negative results in two in vivo assays and therefore there is no requirement for classification.