Registration Dossier

Diss Factsheets

Administrative data

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

Data source

Materials and methods

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

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.