Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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 purpose of this skin sensitizing study was to assess the possible allergenic potential of the test item when administered topically to albino guinea pigs. For this purpose the study was conducted with the non-adjuvant Buehler test according to the OECD Guideline 406. 20 female animals of the test group were treated topically with the test item applied with a concentration of 50% in mineral oil once a week for a 3 week induction phase. Two weeks after the final induction application the animals were challenged with the same test item at the concentration of 50 % and 20 % in mineral oil. Two weeks after the first challenge application the animals of the test group were rechallenged with the same test item at the concentrations of 50 % and 25 % in bi-distilled water. The ten animals of the control group were not treated during the induction. They were only treated as the test animals at the challenge. No cutaneous irritation reactions were observed in the control and test animals. The vehicle alone did not cause any cutaneous reaction, either. Therefore the test item is considered non-sensitising to the skin.


Migrated from Short description of key information:
The test item is not sensitising to the skin of Hartley Guinea Pigs.

Justification for classification or non-classification

No classification and labelling is required according to Regulation No (EC) 1272/2008 (CLP) or Directive 67/548/EEC (DSD) criteria.