Registration Dossier
Registration Dossier
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EC number: 204-844-2 | CAS number: 127-47-9
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Additional information:
The key study for skin sensitisation was performed according to GLP and OECD guideline 406 using Himalayan White spotted guinea pigs (Klecak, 1989). Intradermal induction was performed using 5%, epidermal induction was performed using 30% retinyl acetate in olive oil. Challenge with retinyl acetate (10%) resulted in dermal reactions in the negative control (5/10) and substance-treated group (4/20). At re-challenge with retinyl acetate (10%), none of the animals in the control and treatment group showed any skin reactions. Considering the given information on test substance concentration, i.e. 1.5 mlU/g, as 1500000 IU/g, a concentration of retinyl acetate in the tested substance is assumed to be 516 mg/g or approx 52%.
Respiratory sensitisation
Endpoint conclusion
- 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 67/548/EEC and 1272/2008/EEC, and therefore, a non-classification is warranted.
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