Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Negative results were reported in in vitro assay for gene mutation (EMEA1) in Salmonella typhimurium and Escherichia coli, as well as negative results reported in the in vitro assay for forward point mutation on HPRT lucus (EMEA2).Controversial results were obtained in the in vitro chromosomal aberration assay (EMEA3).

The in vivo reported assay (EMEA4) on micronucleus test was considered as negative result from the source of data.

Finally, the reported in silico method, performed with DEREK and MC4PC software, showed to give negative resuls about the genotoxicity of Betamethasone.

Short description of key information:
Experimental, both in vitro and in vivo, as well as in silico results were reported. Some data remain controversial, but evidence of negative results were reported in very reliable source of data.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

In accordance to Directive 67/548/EEC and Regulation 1272/2008/EC, classification is not necessary for genetic toxicity based on the available data.