Registration Dossier

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:
Acute oral and dermal toxicity studies in rats: in the limit test at a fixed dose of 2000 mg/kg no significant treatment related effects were seen. In such studies LD50 was higher than 2000 mg/kg. The repeated administration in the 13-week toxicity combined with reproductive endpoint study in rodents by oral did not showed any adverse systemic effects. The lack of general effects and of the target organ toxicity does not lead to conclude that the test item is adsorbed and distributed systemically. Skin and eye irritation studies did not show any local or systemic toxicity.
Furthermore not significant exposure to the substance is foreseen for humans and environment during all steps of life cycle under the operational conditions and the risk management measures implemented and recomended (see Chemical Safety Report).

Data source

Materials and methods

Results and discussion

Results (fetuses)

Fetal abnormalities

not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion