Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
The full waiving argumentation is detailled in the document "Skin sensitization: waiving argumentation" in the box below.
The studies mentionned as weight of evidence are detailled in the endpoints of the section 7.10.4 (sensitisation data, human) - the pdf printed version of these endpoints is also enclosed in the box below.

No data for the target substance (Note Q man-made vitreous fibres) are available. Thus, data from appropriate read-across substances (mineral wool fibres and fibreglass) were used to assess the potential for skin sensitisation. An in vitro or in vivo skin sensitisation study does not need to be conducted because historical human data on skin sensitisation from 4 studies are available (see IUCLID sections 7.10.4) and were assessed in a weight-of-evidence approach. Human data provide evidence to indicate no concern of skin sensitising potential of mineral wool fibres and fibreglass after exposure. In particular, the study from Jolanki et al., (2002) reported only a very low incidence of allergic contact dermatitis possibly attributable to occupational exposure to stone/rock wool in Finnish workers (2 out of 11,532 cases with occupational dermatoses recorded during 1990-1999), which was considered not statistically significant. The other 3 studies showed that the reported skin effects (e.g. after patch test performance) by mineral wool fibres and fibreglass were of mechanical and not of allergic nature (Björnberg & Löwhagen, 1977; Possick et al., 1970; Wang et al., 1993), which supports the conclusion that mineral wool fibres and fibreglass do not act as skin sensitisers.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The testing for skin sensitisation is waived, because MMVF note Q 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 in the LLNA test. It is evaluated that MMVF note Q fibres will not give any response in the LNNA test. Furthermore, many years of workers exposure has not revealed cases of skin sensitisation. It is assessed that MMVF note Q fibres are not a skin sensitiser in humans.