Registration Dossier
Registration Dossier
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EC number: 203-569-5 | CAS number: 108-29-2
Endpoint summary
Administrative data
Description of key information
A maximization test was carried out with 25 human volunteers. The material was tested at a concentration of 10% in diethyl phthalate and produced no sensitization reactions (see section 7.10.4).
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin sensitisation in vivo, RL 2 (please refer to section 7.10.4)
A maximization study was conducted with 25 adult human volunteers. The test item was applied to the same site on the volar aspect of the forearms for five 48 hour periods. Following a ten day rest period, the subjects were challenged with a patch applied to a previously untreated site for 48 hours using an occlusive dressing. There were no sensitization responses in any of the subjects (Opdyke 1962-1980, origial study by Kligman (1966), Kliman & Epstein (1975) and Kligman (1978)).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Classification, Labeling, 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 test item was found to be not sensitising to skin in a human test, thus, the test item is not considered to be classified for skin sensitisation under Regulation (EC) No 1272/2008, as amended for the fifteenth time in Regulation (EU) No 2020/217.
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