Registration Dossier
Registration Dossier
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EC number: 939-718-2 | CAS number: 1474044-80-8
Endpoint summary
Administrative data
Description of key information
A guinea pig sensitization test (Buehler Method) indicated the test
material is a contact sensitizer in guinea pigs.
Subsequently, a human repeat insult patch test (HRIPT) with 103 human
subjects showed the material is not a sensitizer in humans (Human
Sensitisation Patch Testing .001).
The key study is the human patch test as described in chapter 7.10. The
results of the human patch test in 103 volunteers showed that the
substance is not sensitizing
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In a Buehler test performed the substance was shown to be a skin sensitiser when applied to guinea pig skin. A study with 103 human volunteers showed no sensitisation in any of the subjects. Based on the human findings, the substance is not classified for skin sensitization.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Although a Buelher test with guinea pigs resulted in signs of sensitisation, a well conducted study with 103 human volunteers showed that the substance is not a skin sensitiser. As this study with volunteers was well conducted with a high number of volunteers showing no significant positive reactions, it is concluded that the substance is not skin sensitising to humans. Data on respiratory sensitisation are not available. Thus, the substance is not classifiable for sensitising properties according to CLP (Regulation EC No 1272/2008).
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