Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

The test substance revealed negative results in a recent Bacterial Reversed Mutation Test with and without metabolic activation. Positive results were found when testing an ancient test sample with a purity of 83.3% and unknown impurities. Because of unproven substance sameness the latter result was not adequate for hazard assessment. Based on that it is concluded that 2-hydroxybenzimidazole caused negative results in the Bacterial Reversed Mutation Test.

Short description of key information:
OECD 471 AMES (KEY_471_2009_HARLAN_1218502): negative
OECD 471 AMES (NON-KEY_471_1991_HOECHST_91.0465): positive

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Findings in genetic toxicity studies i.e. negative results in the AMES Test in the absence and presence of metabolic activation do not meet criteria for classification according to 67/548/EEC (2.2 DSD-DPD) or REGULATION (EC) No 1272/2008 (2.1 GHS). Therefore classification is not warrantable.