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:

All studies were evaluated for suitability, based on this evaluation, it was established that the studies were conducted according to standard guidelines but not GLP compliant. Based on the results of the evaluation, they were considered to be acceptable for the purposes of classification and labelling and assigned a Klimisch rating of 2.

The conclusion of all studies bar one were that the test material should be considered to be non-sensitising. The result of Kreuzmann J.J. (1991) - report number 91-8080-21 (A) however concluded that the test material should be considered to be a sensitiser. As the quantities of test material used in the above study were smaller than the amounts used in the other four studies this study was considered to be more representative to health and safety assessment as workplace exposure is expected to be nil or negligible. Should exposure occur, it would be expected to be in very small quantities and as such the positive study was considered to be the most relevant. Based on this conclusion Kreuzmann J.J. (1991) - report number 91-8080-21 (A) was assigned as the key study.

Migrated from Short description of key information:
Five skin sensitisation studies were carried out on the test material.
Kreuzmann J.J. (1991) - report number 91-8080-21 (A): The test material, SHOP LIGAND WASTE (SPENT STREAM), was found to be sensitising in Guinea pigs using the concentration 25% in acetone for induction and 5% in acetone for challenge and re-challenge exposures. (KS)

Kreuzmann J.J. (1991) - report number 91-9079-21 (A): The test material, CATALYST 32899 LIGAND (OCTOBER 1990 SHOP LIGAND), was found to be non-sensitising in Guinea pigs using the concentration 50% in acetone for both induction and challenge exposures. (SS)

Kreuzmann J.J. (1991) - report number 91-8081-21 (A): The test material, SHOP LIGAND WASTE (RECYCLED TOLUENE STREAM), was found to be non-sensitising in Guinea pigs using the concentration 50% in acetone for induction and 10% in acetone for challenge exposures. (SS)

Cassidy S.L. (1979) – report number TLGR.79.108: The test material Ligand 32899 is not considered to be a skin sensitizer in guinea-pigs using the concentration 1.0% in acetone for induction and challenge exposures. (SS)

Jud V.A. & Cagen S.Z. (1982) – report number WRC RIR-233: The test material Catalyst 32899 was not considered to be a skin sensitizer in guinea pigs using the concentration 1.0% in absolute ethanol for induction and challenge exposures. (SS)

Justification for classification or non-classification

As the amount of test material used in the key study was smaller than the amounts used in the four supporting studies, the descision was taken to consider the material to be sensitising and as such the material should be classified as a sensitiser to guinea pig skin.