Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Non-human data:

The test substance phenazone was investigated for genotoxic effects in three in vitro studies.

In a reverse gene mutation assay in bacteria, strains TA100, TA1535, TA98, TA1537, TA1538 of S. typhimurium and Escherichia coli Wp2 uvrA trp- were exposed to phenazone at concentrations of 0, 4, 20, 100, 500, 2500, 5000, 10000 ug/plate in the presence and absence of mammalian metabolic activation (S9 mix). The test chemical did not induce mutations in the S. typhimurium and E. coli strains, with and without metabolic activation.

In a micronucleus assay study [OECD 474] phenazone was administered by gavage at doses of 0, 63, 200 and 630 mg/kg bw/day in NMRI mice (Horstmann et al., 1984). In this assay phenazone did not induce significant micronuclei in polychromatic erythrocytes.

A study to investigate chromosome aberrations in rats after oral administration of phenazone (5300 ppm) for 117 weeks did not detect increased aberrations in peripheral blood lymphocytes (after stimulation with PHA).

 

Human data:

No data available.


Short description of key information:
The test substance phenazone was investigated for genotoxic effects in three different in vitro studies. Phenazone was not considered mutagenic in the Ames test with and without metabolic activation (S9). A micronucleus test with NMRI-mice revealed no mutagenic effects. A study to investigate chromosome aberrations in rats could not detect increased aberrations in peripheral blood lymphocytes.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on results of three genetic toxicity studies, phenazone was not classified and labelled as genotoxic according to Directive 67/548/EEC (DSD) and to Regulation 1272/2008/EC (CLP).