Man-made vitreous (silicate) fibres with random orientation with alkaline oxide and alkali earth oxide (Na2O+K2O+CaO+MgO+BaO) content greater than 18 % by weight

Repeated dose toxicity: oral

Administrative data

Endpoint:

sub-chronic toxicity: oral

Data waiving:

exposure considerations

Justification for data waiving:

a sub-chronic toxicity study (90 days) by the oral route does not need to be conducted because an appropriate inhalation study is available and inhalation is the most appropriate route of administration as based on the provided thorough and rigorous exposure assessment

other:

Results and discussion

Target system / organ toxicity

Critical effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

Testing of repeated dose oral toxicity 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 for absorption through the gastrointestinal tract. FMMVF fibres are assessed not to possess toxic properties by repeated ingestion.