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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Endpoint summary

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Administrative data

Description of key information

The test item has a skin sensitizing potential as shown in animal studies.

Key value for chemical safety assessment

Skin sensitisation

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

A guinea pig maximization study according to OECD guideline 406 was performed to evaluate the sensitization potential of the test substance. The test was conducted with 30 female Dunkin-Hartley guinea pigs (20 animals as test group, and 10 animals as control group). During the induction procedure the test group was exposed to 1% test substance via intradermal injections and 100% test substance via topical application. The control group was exposed to vehicle only during this procedure. All animals were challenged with 25% and 50% test item and vehicle, respectively. When challenged with 50% test substance, 9/10 (90%) positive responses were noted in the test groups after 24 h and 10/10 (100%) positive response after 48 hours. Following treatment with 25% test substance, 9/10 animals showed erythema reactions at both 24 and 48 hour time points. Control animals did not show any reactions. In conclusion, the test material produced a 100% (10/10) sensitization rate and was classified as an strong sensitizer to guinea pig skin under the conditions of this study.

In a supporting study performed similarly to OECD Guideline 406, test animals were induced intradermally (5 %) and epicutaneously (100%) with the test article. Epidermal challenge of 5 male and 5 female guinea pigs (test groups) with 50% test material in vaseline resulted in positive responses in 5 guinea pigs (2 males and 3 females) after 24 hours and in 2 guinea pigs (1 male and 1 female) after 48 hours, corresponding to a sensitization rate of 50%. The test material was graded as a moderate sensitizer according to the Magnusson and Kligman maximization scale. Overall, based on the results of the presented studies, the test article is considered as a strong sensitizer and requires classification.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. The epicutaneous sensitisation study indicates a potential for skin sensitisation. As a result the substance is considered to be classified as skin sensitizer category 1A (H317: "May cause an allergic skin reaction") under Regulation (EC) No 1272/2008, as amended for the eighth time in Regulation (EU) No 2016/218.