Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Additional information:

In the key study according to OECD TG 406 and GLP, retinol (approx 50% in Polysorbate 20) has been tested in guinea pigs according to Buehler (BASF 32H0097/992038).

Induction was performed with 3 weekly topical (occlusive) applications of 25% test substance in Lutrol E 400. Three challenges were performed 14, 21 and 56 days after the last induction.

After the 1st challenge with a 10% preparation of the test substance in Lutrol E 400, dermal reactions were observed in 17/20 test group animals and 3/10 challenge controls.

Due to skin reactions in control animals, a 2nd challenge was performed with 5% and 10% test substance preparations in Lutrol E 400. After the 2nd challenge dermal reactions were noted in 9/10 animals (control group 1), 5/10 animals (control group 2) and 19/20 animals (test group) after application of 10% test substance. Application of 5% test substance resulted in dermal reactions in 6/10 animals (control group 1), 2/10 animals (control group 2) and 16/20 animals (test group).

In order to rule out, whether the dermal effects could be attributed to one of the two main test substance ingredients, a 3rd challenge with separate applications of 2.5% retinol (in Miglyol 812) or 2.5% Polysorbat 20 (in Lutrol E 400) was performed. Application of 2.5% retinol (in Miglyol 812) resulted in dermal reactions in 3/10 animals (control group 1), 2/10 animals (control group 2), 0/10 animals (control group 3) and 19/20 animals (test group), whereas the application of 2.5% Polysorbat 20 did not result in any dermal reaction.

No skin reactions were observed after application of the vehicles alone in all three challenge applications.

Taken together, the test substance has a sensitizing effect on the skin of the guinea pig in the BUEHLER test under the test conditions chosen. The ingredient of the test substance considered to be responsible for the sensitizing effect is retinol.

In the supporting study, i.e. open epicutaneous test in guinea pigs, retinol (approx 50% in Polysorbate 20)

showed a sensitizing effect (induction by 13 open topical applications of 0.2%, 0.4%, 0.75%, 2%, 5% test substance; BASF 31H0097/992149). The induction threshold concentration under this conditions was 0.4% . No skin sensitization could be induced by a test substance preparation of 0.2% in Lutrol E 400.


Migrated from Short description of key information:
Buehler test in guinea pigs (OECD TG 406): sensitizing

Respiratory sensitisation

Endpoint conclusion
Additional information:

No data available

Justification for classification or non-classification

The present data on dermal sensitization fulfill the criteria laid down in 67/548/EEC and 1272/2008/EEC, and therefore, a classification with R43 and "Skin sensitisation" (Category 1) is warranted.