Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The skin sensitising properties of the registered substance were tested in a Buehler Test conducted according to OECD test guideline 406 and in compliance with GLP. In a preliminary range finding test a test item concentration of 60% (w/w) in vehicle (mixture of sesame oil and acetone (4:1 w/w)) was concluded to be suitable for the main study. In the main study, female Dunkin-Hartley guinea pigs (20/group) received 3 topical applications of the test material on the left flanks for 6 h. Induction exposures were conducted within 2 weeks on days 0, 7 and 14. Animals of the negative control group (6/group) received the vehicle alone. For challenge exposure, all animals (test and control group) received topical test item applications (60% (w/w)) on the right flanks for 6 h on test day 28. Animals were observed for skin reactions 24 and 48 h after patch removal. There were no animals with skin reactions noted in test and negative control groups at any reading time point. The sensitivity of the strain was proven with the positive control substance 2-Mercaptobenzothiazole. Thus, the test item can be regarded as non-sensitising under the conditions of this test (Evonik Stockhausen GmbH, 2008).

Migrated from Short description of key information:
Skin sensitisation (OECD 406, Buehler Test): not sensitising

Justification for selection of skin sensitisation endpoint:
The available key study was selected for assessment. The study was conducted according to OECD test guideline 406 (Buehler Test) and in compliance with GLP.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:
Justification for selection of respiratory sensitisation endpoint:
Study not required according to Annex VII-X of Regulation (EC) No 1907/2006.

Justification for classification or non-classification

The available information on the registered substance is reliable and suitable for classification. The data do not meet the criteria for classification for skin sensitisation according to Regulation (EC) No 1272/2008 or Directive 67/548/EEC.