Registration Dossier
Registration Dossier
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EC number: 225-555-8 | CAS number: 4926-55-0
Endpoint summary
Administrative data
Description of key information
According to the key studies (Reed, 1984, Klimisch 2, Human RepeatedInsult Patch Test) performed in order to assess the potential sensitising effect of the test substance, the HC Yellow No. 2 was not classified for sensitisation. Indeed, no adverse effect including sensitising effect was observed during the two studies on volunteers.
Additional information
Two keys studies were available to assess the potential sensitising effect of the test substance : Two Human Repeated Insult Patch Tests were performed (Reed, 1984, Klimisch 2)
The entire study extended over a six weeks period with three phases: induction, rest and challenge. The induction phase consisted of 9 consecutive applications of the test material. The patches were removed 24 hours after application and evaluated each 48 hours. The challenge phase was initiated during the sixth week of the study, with identical patches applied to sites on the opposite arm previously unexposed to the test material. Patches were removed after 24 hours. The sites were grades 24 and 48 hours after removal.
- None of the 104 subjects used in the first study developed sensitization due to treatment with the 3% test item
- None of the 116 subjects used in the second study developed sensitization due to treatment with the 3% test item
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