Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information
These fibres produced clear unequivocal negative results in bacterial mutation and in-vitro micronucleus test.
Link to relevant study records
in vitro gene mutation study in mammalian cells
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

In most studies mineral fibres have been reported to be negative for genetic toxicological effects; this even applies to those fibres accepted as carcinogens. There are sporadic positive published reports on the genetic toxictiy of mineral fibres, but these have never been reproducible.

The studies undertaken on the substance under consideration in this dossier confirm that it is not genotoxic.

Justification for classification or non-classification

These fibres produced clear and unequivocally negative results for in vitro testing, there is no evidence of genetic toxicity in any long term study carried out and as such these fibres are not classified.