Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Although a bacterial test showed clear mutagenic effects these results could not be confirmed in two mammalian in vitro test systems. Test systems based on mammalian cells are considered to more closely represent the situation in man.


Short description of key information:
Mutagenic effects were deterined in vitro in bacteria and mammalian cells using the methodology of the Ames test, the HGPRT test, and chromosomal aberration. Although the Ames test showed clear mutagenic effects in all tester strains in the presence of metabolic activation, this result could not be confirmed in the HGPRT mutation assay and in a chromosomal aberration assay in mammalian cells (V79).

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

No mutagenic effects in any of the studies in mammalian cells outweigh the effects seen in the bacterial assay, which is designed for maximum sensitivity tolerating a high rate of false positive results.