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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Description of key information

According to the weight of evidence approach with available studies (Reed, 1984, Klimisch 2, Human Repeated Insult Patch Test ; Burnett, 1979, Klimisch 4, GPMT ; Chapdelaine, 2000, Klimisch 2 LLNA ) performed in order to assess the potential sensitising effect of the test substance. No adverse effect including sensitising effect was observed during the two studies on volunteersn on guinea pigs or mice. Hence, the registered substance HC Yellow No 2 was not classified.

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Two 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

A Guinea Pigs Maximisation Test was performed (Burnett, 1979, Klimisch 4) :

10 female Guinea pigs were used in this study. On the first day of experiment, three pairs of intradermal injections were performed on each test animal containing 0.1% solution of the test substance, Freunds complete adjuvant. The second induction was performed with topical application of the test item (25% in petrolatum) under occlusive patch for 48 hours. Two weeks later, the animals were challenged with another topical application of the compound under occlusive patch for 24 hours using 3% test item concentration. Observation was performed 24, 48 and 72 hours after removal of the occlusive bandage. Under the experimental conditions of the study, the test substance HC Yellow No. 2 did not induced primary irritation to Guinea Pigs skin after challenge.

A LLNA was performed (Chapdelaine, 2000, Klimisch 2, equivalent to OECD Guideline 429) :

25 μL test preparation applied to dorsal aspect of ear lobe of CBA/Ca mice daily for 3 days. 5 days after the first application, 250 μL of a solution containing 20 μCi/mL 3H-thymidine was injected intravenously. 5 hours later the animals were euthanized and the draining auricular lymph nodes were removed. The compound is not positive (>3) at any concentration and it is not sensitizer in this test. Under the experimental conditions of this study, the test item HC Yellow No. 2 did not induced delayed contact hypersensitivity to mice after skin.

Taken together, the four available studies showed no sensitisation effect on human, guinea pigs and mice. According to the weight of evidence approach, and the negative results at the different available studyes, the registered substance was not classififed for skin irritation.

Justification for classification or non-classification

Taken together, the four available studies showed no sensitisation effect on human, guinea pigs and mice. Based the weight of evidence approach, and the negative results at the different available studyes, the registered substance was not classififed for skin irritation accordingto CLP regulation.