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Diss Factsheets

Administrative data

Description of key information

Mineral wool fibres (made of glass, stone/rock or slag) were used as read-across substances for Note Q MMVFs due to their similarities in the chemical components. For short term exposure (hours to few days) the difference in persistence between Note Q and non-Note Q fibres is not considered relevant. As mineral wool fibres and Note Q MMVFs have nearly identical chemical components, mineral wool fibres are deemed as suitable read-across substances for Note Q MMVFs.

Animal data of the 5 studies on mineral wool fibres provide evidence to indicate no concern of skin irritation after exposure. In these studies conducted according to OECD guideline 404 "Acute Irritation/ Corrosion" mean scores for erythema and oedema were either 0 or clearly below relevant thresholds with regards to classification as skin irritant.

Human data of the 2 epidemiological studies (see IUCLID section 7.10.2) on mineral wool fibres related to skin irritation conclude that the skin irritating potential of all mineral wool test materials was highly significantly lower than for the control 20% sodium dodecyl sulphate (Dengler, 2000) and that no striking skin irritations or eczematous skin changes were observed in a dermatologically controlled application study (Diepgen, 2001) on mineral wools (however, some persons reported low-degree and temporary itching).

One human study (Stokholm et al., 1982) investigating the effect of mineral wool fibres on the human eye concluded that observed symptoms and cellular changes can be explained by the assumption that man-made mineral fibres have the same mechanical and reversible effect on the eye as on the skin (see IUCLID section 7.10.2).

In accordance with Section 1 of REACH Annex XI, additional skin and eye irritation studies do not need to be conducted. Taking a weight-of-evidence approach, no classification for irritation/corrosion of the eye or skin is warranted under CLP Regulation.

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 MMVF note Q 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 MMVF note Q fibres are not irritating to human skin. Hence, MMVF note Q 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 MMVF note Q fibres are not irritating human eyes. Hence, MMVF note Q 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, MMVF note Q 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, MMVF note Q fibres shall not be classified as eye irritant according to Council Directive 67/548/EEC and Regulation (EC) 1272/2008.

Animal data of the 5 studies (performed according to OECD guideline 404) on mineral wool fibres (suitable read-across substance for Note Q MMVFs) provide evidence to indicate no concern of skin irritation after exposure. Human data on mineral wool fibres related to skin irritation conclude that the skin irritating potential of all mineral wool test materials was highly significantly lower than for the control 20% sodium dodecyl sulphate and that no striking skin irritations or eczematous skin changes were observed in a dermatologically controlled application study on mineral wools. One human study investigating the effect of mineral wool fibres on the human eye also concluded that observed symptoms and cellular changes can be explained by the assumption that man-made mineral fibres have the same mechanical and reversible effect on the eye as on the skin.

In accordance with Section 1 of REACH Annex XI, additional skin and eye irritation studies do not need to be conducted. The existing animal and human data have demonstrated that the reversible effects on the eye and skin are of mechanical nature and not related to the chemical composition of the fibres. Thus, taking a weight-of-evidence approach, no classification for irritation/corrosion of the eye or skin is warranted under CLP Regulation.