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Administrative data

Key value for chemical safety assessment

Additional information

Two Bacterial Mutation assays were perofrmed on FR-522 (98.63%) and FR-522 purified (99.5%). In these Ames test, when tested in dimethylsulfoxide, the test substance shows no evidence of mutagenic activity in the absence or presence of rat S-9 mix. The test substance shows clear evidence of mutagenic activity with strains TA1535 and TA100 in the presence of hamster S-9 mix.

In the chromosome aberration test, the test substance induced chromosomal aberrations in CHO cells, in presence of S9.

In sister chromatid exchange the test substance did not induce sister chromatid exchanges in CHO cells without S9, even at doses that induced toxicity and marked cell cycle delay. Very slight increases in SCEs (sister chromatid exchanges) occurred at toxic levels with S9. The top dose, 1.2 mg/ml, reduced confluence by about 75%.

Short description of key information:
Two in vitro gene mutation study (Ames test), one chromosome aberration, and one sister chromatid exchange study are available for Dibromoneopentyl glycol.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Further to the results of the genetic toxicity tests, Dibroneopentyl glycol does not require classification as mutagenic, in accordance with Directive 67/548/EEC and the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.