Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

In a key study performed to OECD Guideline 406, a test group of 6 male and 6 female Hartley albino guinea pigs was dosed topically with the test material (100%) one time per week for three weeks for a total of three induction exposures. The duration of the exposures was 6 hours. Two weeks after the last induction exposure Test group animals were challenge dosed for detection of sensitisation by topical application of a known non-irritating concentration of the test material (50% in acetone) to previously unexposed areas of the skin. One week after challenge dosing, the Test Group animals were rechallenged to confirm the initial challenge results.

There were no deaths, clinical findings or remarkable body weight changes.

The positive control material, dinitrochlorobenzene, was demonstrated to be an extreme sensitizing agent in albino guinea pigs under the conditions of this study based on the Sensitization Incidence Index of 83%, thereby demonstrating the reliability of the test system.

There was one reaction in the Test Group that exceeded the highest reaction in the Naive Control Group I, following dosing with 50% w/v concentration of OS#89776 in acetone. The Sensitization Incidence Index was calculated to be 8% for the Test Group following challenge dosing. There were two sensitization reactions (2/12) in the Test Group following rechallenge dosing with a 50% w/v concentration of OS#89776 in acetone.

The Sensitization Incidence Index was calculated to be 17% for the Test Group following rechallenge dosing.

In accordance with CLP Regulation (EC) No 1272/2008 the test material is classified for skin sensitisation


Migrated from Short description of key information:
After rechallenge with 50% test material in acetone 2/12 animals showed a sensitisation reaction (17% sensisation). The substance is a skin sensitiser.

Justification for classification or non-classification

The skin Sensitization Incidence Index was calculated to be 17% for the Test Group following rechallenge dosing.

In accordance with CLP Regulation (EC) No 1272/2008 the test material is classified for skin sensitisation