Registration Dossier
Registration Dossier
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EC number: 926-771-1 | CAS number: -
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:
Data source
Materials and methods
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.
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