Registration Dossier
Registration Dossier
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EC number: 202-940-9 | CAS number: 101-41-7
Endpoint summary
Administrative data
Description of key information
The skin sensitizing potential of the test substance was determined in an open epicutaneous test with guinea pigs. No skin sensitizing effects were observed. This result is in-line with the result of an human maximization test. No skin sensitizing effects were observed in 25 healthy adult volunteers examined. In conclusion it can be stated that the test substance is not skin sensitizing.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The endpoint Sensitisation is covered with an Weight of Evidence Approach, as two studies are availabe:
Klecak 1985
To assess the potential of several substances including the test substance to cause skin irritation and to compare these results with human test results, an open epicutaneous test was performed on male and female guinea pigs. Therefore, after a range finding test to identify the minimal irritating and the maximal nonirritating concentrations, 0.1 mL of the test material (undiluted and diluted) was applied to the clipped flanks to groups of 6 animals per concentration for induction at concentrations of 100 %, 30 %, 10 %, 3 %, 1 % and 0.3 %. During induction, the test substance was applied daily for 20 days. The minimal irritating concentration was applied two times in the challenge phase (day 21 and 35). The skin reactions were read after 24, 48 and/or 72 hours. On the basis of these results, the test substance was considered to be non sensitising. This result is supported by results of skin sensitization tests on humans, as described in this publication.
Kligman (1971)
In an human sensitization study a Maximization Test was conducted on 25 healthy male humans to determine the contact sensitizing potential of the test item, applied in diluted form of 2 %. The test substance was applied under occlusion to the volar forearms for five alternate-day 48 hour periods. The challenge sites were read on removal of the patch and 24 hours thereafter. As no skin reactions were observed, the Maximization test results did not indicate a sensitizing effect of the test substance to the skin. The details of the study are shown in 7.10.4.
Conclusion: The skin sensitizing potential of the test substance was determined in an open epicutaneous test with guinea pigs. No skin sensitizing effects were observed. This result is in-line with the result of an human maximization test. No skin sensitizing effects were observed in 25 healthy adult volunteers examined. In conclusion it can be stated that the test substance is not skin sensitizing.
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. As a result the substance is not considered to be classified for skin sensitisation under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.
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