Registration Dossier

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.