Registration Dossier
Registration Dossier
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EC number: 477-700-1 | CAS number: 883794-93-2
Endpoint summary
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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