Registration Dossier
Registration Dossier
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EC number: 926-771-1 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Testing of skin sensitization is waived based on the fact that FMMVF fibres are inorganic fibres, whose physicochemical properties suggest a low potential to cross biological membranes and consequently a low potential to penetrate the skin. Skin penetration is prerequisite for the LLNA test. Furthermore, workers have been exposed to man-made vitreous fibres (MMVF) by dermal contact for many years without any indication of induction of skin sensitisation. It is, thus, assessed that FMMVF fibres do induce skin sensitisation in humans.
Migrated from Short description of key information:
FMMVF fibres are assessed not to be a skin sensitiser in humans. FMMVF fibres shall not be classified as a skin sensitiser according to the criteria in Council Directive 67/548/EEC and Regulation (EC) 1272/2008.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Workers have been exposed to man-made vitreous fibres (MMVF) by inhalation for many years without any indication for induction of respiratory sensitisation. Furthermore, FMMVF fibres do not translocate in the body after inhalation. It assessed that FMMVF fibres do not induce respiratory sensitisation in humans.
Migrated from Short description of key information:
FMMVF fibres are assessed not to be a respiratory sensitiser in humans. FMMVF fibres shall not be classified as a respiratory sensitiser according to the criteria in Council Directive 67/548/EEC and Regulation (EC) 1272/2008.
Justification for classification or non-classification
FMMVF fibres are inorganic fibres, whose physicochemical properties suggest a low potential to cross biological membranes, making it unlikely that FMMVF fibres should possess sensitising properties. Furthermore, many years of worker exposure to mineral wool (MMVF) by dermal contact and by inhalation has not in known cases of skin or respiratory sensitisation. It is assessed that FMMVF fibres are not a skin sensitiser or a respiratory sensitiser. FMMVF fibres shall not be classified as a skin or respiratory sensitiser according to the criteria in Council Directive 67/548/EEC and Regulation (EC) 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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