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Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

developmental toxicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is of low toxicological activity (no evidence of toxicity seen in any of the tests available), it can be proven from toxicokinetic data that no systemic absorption occurs via relevant routes of exposure (e.g. plasma/blood concentrations below detection limit using a sensitive method and absence of the substance and of metabolites of the substance in urine, bile or exhaled air) and there is no or no significant human exposure
Justification for type of information:
The Justification information is expanded in the attached document which focuses upom the observation of low toxicological activity and low biopersistence contributing to limited toxicokinetics, which can lead to a conclusion of no significant human exposure.

Data source

Materials and methods

Test animals


Results and discussion

Results (fetuses)

Fetal abnormalities

not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

FMMVF fibres are inorganic and have low biological activity. These fibres do not translocate after intake (ingestion or inhalation). Due to these characteristics it is assessed that exposure of the dams will not result in exposure of foetuses and consequently will not affect the foetuses.