Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Cross-reference
Reason / purpose for cross-reference:
reference to other study

Data source

Materials and methods

Results and discussion

Any other information on results incl. tables

The long-term inhalation studies described in details in endpoint sections 7.5.3 and 7.7 show that FMMVF fibres induced minimal collagen deposition in the lungs of rats comparable to what is observed for any biologically inert dust at the same exposure levels. Furthermore, FMMVF fibres induce fibrosis, but no significant neoplastic changes in the lungs or in the pleura of rats. The mortality rate in the exposed animals was the same as for the control animals. From these studies it is concluded that FMMVF fibres have no acute toxicity by inhalation.

Applicant's summary and conclusion

Interpretation of results:
relatively harmless
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Testing of acute inhalation toxicity is waived because results from long-term inhalation toxicity studies are available. These studies showed that inhalation of FMMVF fibres caused minimal collagen deposition and induced fibrosis, but no significant neoplastic changes in the lungs or pleura. The mortality rate in the exposed animals was the same as for the control animals. Based on these long-term inhalation studies FMMVF fibres are evaluated to have no acute toxicity by inhalation.

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