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Administrative data

Key value for chemical safety assessment

Additional information

Short description of key information:
An in vitro study on bacteria was carried out according to EU method B.13/14 and OECD guideline 471. The test item was examined for mutagenic activity in five histidine-dependent auxotrophs of Salmonella typhimurium, strains TA 98, TA 1538, TA 100, TA 1535 and TA 1537, using pour-plate assays. It was concluded that the test item was devoid of mutagenic activity under the conditions of the test.
An in vivo micronucleus test was carried out in NMRI mice according to OECD guideline 474. Five animals were administered doses of 300, 600 1200 mg/kg bw by single intraperitoneal application with exposure periods of 24 and 48 hours. Negative controls were run concurrently. Positive controls received 20 mg/kg bw cyclophosphamide (2 male and 3 female) and 0.15 mg/kg bw vincristine (3 male and 2 female). All controls were valid. No clastogenic effects of test item administration were observed.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the data available the substance is not classified or labeled according to Directive 67/548/EEC (DSD) or Regulation 1272/2008/EC (CLP).