Registration Dossier
Registration Dossier
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EC number: 300-504-3 | CAS number: 93941-05-0
Acute Toxicity: dermal
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
In accordance with column 2 of REACH Annex VIII, an acute dermal toxicity study does not need to be conducted if 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).
Two available acute oral toxicity studies with the substance provide LD50 values of greater than 2000 mg/kg bw. Hence the substance is not classified as hazardous by the oral route. Additionally, no effects were noted in the key in vivo skin irritation or skin sensitisation studies.
It is therefore considered justified to omit the acute dermal toxicity study.
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
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