Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
According to Annex VIII, 8.5.3, column 2, acute dermal toxicity testing is not required if the substance does not meet the criteria for classification for acute toxicity or STOT SE when administered orally and no systemic effects were observed in in vivo tests with dermal administration. The acute oral toxicity studies with the test item as well as with a read-across substance revealed a LD50 above 2000 mg/kg bw. Furthermore, no systemic effects have been observed in in vivo skin irritation and sensitisation studies with the read-across substance. Thus, an acute toxic effect by dermal exposure to the substance is unlikely and acute dermal toxicity testing can be waived.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion

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