Registration Dossier
Registration Dossier
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EC number: 926-771-1 | CAS number: -
Endpoint summary
Administrative data
Description of key information
FMMVF fibres are not irritating to human skin or eyes according to the criteria in Council Directive 67/548/EEC and Regulation (EC) 1272/2008.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Albino rabbits have been exposed to 0.5 g FMMVF fibres under a semi-occlusive bandage for 4 hours and subsequently monitored at the intervals of 1, 24, 48, 72 hours and after 7 and 14 days or 2.5x2.5 cm of the test material under a semi-occlusive bandage for 4 hours and subsequently monitored at the intervals of 1, 24, 48, 72 hours and after 7 and 14 days. In both studies the mean score for erythema was 1, and mean score for oedema was 0. It is concluded that FMMVF fibres are not irritating to human skin. Hence, FMMVF fibres shall not be classified as skin irritant according to the criteria in Council Directive 67/548/EEC and Regulation (EC) 1272/2008.
Effects on the outer eye of occupational exposure to mineral wool fibres was investigated in mineral wool workers along with a matched non-exposed control group in a cross-sectional study (Stokholm, 1982). After 4 working days the workers showed a significantly higher frequency of eye symptoms, microepithelial defects on medial bulbar conjunctiva and neutrophil cell count in conjunctival fluid. The effects were reversible. The mechanism was explained as the same foreign body reaction as is seen for skin irritation. The foreign body reaction can be compared to the mechanical abrasive effect from sand particles. The fibres align along the surface of the eye and do not penetrate into the body. It is concluded that FMMVF fibres are not irritating human eyes. Hence, FMMVF fibres shall not be classified as irritant to the eye according to the criteria in Council Directive 67/548/EEC and Regulation (EC) 1272/2008.
Justification for classification or non-classification
Mineral wool causes minor reversible mechanical skin irritation in rabbits. The mean score erythema was 1, and mean score for oedema was 0. Hence, FMMVF fibres shall not be classified as skin irritant according to Council Directive 67/548/EEC and Regulation (EC) 1272/2008.
Mineral wool caused reversible mechanical eye irritation in workers exposed to mineral wool fibres. This effect is not regarded as irritation in the meaning of Council Directive 67/548/EEC and Regulation (EC) 1272/2008. Hence, FMMVF fibres shall not be classified as eye irritant according to 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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