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Key value for chemical safety assessment

Additional information

Long-term inhalation carcinogenicity toxicity studies with FMMVF fibres are presented in section 7.7 and 7.5.3. Inhalation exposure to FMMVF fibres induced inflammation of the lungs of rats. No pulmonary or mesothelial neoplasms were observed in the animals exposed to FMMVF. The incidence fibrosis was similar to control for FMMVF. Furthermore FMMVF fibres are inorganic fibres, whose physicochemical properties suggest a low potential to cross biological membranes, making it unlikely that a mutagenic effect would be found in bacteria or in mammalian cells. There is sufficient evidence to assess FMMVF fibres as not mutagenic. Thus, mutagenicity studies are waived because they are scientifically unjustified.

Short description of key information:
It is assessed that FMMVF fibres do not possess mutagenic properties, neither in bacteria nor in mammalian cells. FMMVF fibres shall not be classified as mutagenic according to the criteria in Council Directive 67/548/EEC and Regulation (EC) 1272/2008.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Mutagenicity studies in bacteria and mammalian cells are waived. The justification is that long-term inhalation studies show that FMMVF fibres did not show carcinogenic potential neither in the lungs or pleura. Furthermore, the physicochemical properties of FMMVF fibres suggest low potential to cross biological membranes, making it unlikely that a mutagenic effect would be found in bacteria or in mammalian cells. FMMVF fibres are assessed to be non-mutagenic, and shall not be classified as mutagenic according to the criteria in Council Directive 67/548/EEC and Regulation (EC) 1272/2008.

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