Registration Dossier
Registration Dossier
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EC number: 425-950-7 | CAS number: 187393-00-6
Endpoint summary
Administrative data
Description of key information
Not skin sensitizing in guinea pigs (OECD TG 406; RCC, 1997).
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In the key study for skin sensitization, i.e. a guinea pig maximization test (RCC 651453, 1997, OECD 406, GLP) 10 male Himalayan guinea pigs were treated via intradermal induction using 3 % Bemotrizinol dilution in PEG 400. The epicutaneous induction was conducted under occlusion with Bemotrizinol at 30 % in PEG 400. Two weeks after the epicutaneous induction application the challenge was completed by epicutaneous application of Bemotrizinol at 30 % in PEG 400 under occlusive dressing. Cutaneous reactions, i.e. erythema and eschar, as well as oedema formation were evaluated at 24 and 48 hours after removal of the dressing. No toxic symptoms were evident in the guinea pigs. No deaths occurred. In this study 0 % of the animals were observed with positive skin reactions after treatment with Bemotrizinol. Overall, Bemotrizinol was not a skin sensitizer in guinea pigs under the chosen testing conditions.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
No data available.
Justification for classification or non-classification
The present data on dermal sensitization do not fulfill the criteria laid down in regulation (EU) 1272/2008, and therefore, a non-classification is warranted.
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