Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The following was concluded in the OECD SIDS dossier of 2004: 3-Hydroxy-2-naphthoic acid was judged non- mutagenic in three Ames bacterial tests in Salmonella typhimurium and Escherichia coli strains, but it caused chromosomal damage in V79 hamster cells in vitro (only in the absence, but not in the presence of metabolic activation). No clastogenic activity, and no toxicity was observed in vivo in bone marrow cells of hamsters, dosed with the maximum recommended dose of 2000 mg/kg bw. Only 50 metaphases were examined per animal. Due to the acute systemic toxicity observed in the range of 1000 mg/kg bw in the rat, it can be assumed that the substance had systemic availability.

This information is consistent with the internal genotoxicity data that was not part of the OECD SIDS dossier.


Short description of key information:
BONA was found to be non mutagenic in the Ames test. It did not cause DNA repair activity in a human fibroblast cell line and in primary rat hepatocytes prepared from Arochlor-induced rats. It caused chromosome damage in the absence of metabolic activation in V79 cells. BONA was not genotoxic in a micronucleus study in mice for which only 50 metaphases were examined per animal.

Endpoint Conclusion:

Justification for classification or non-classification