Registration Dossier
Registration Dossier
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EC number: 411-080-5 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In the GPMT 3 groups of experimental animals were randomly established for the main test: one test substance group consisting of 20 animals (no 21 to 40) and 2 control groups consisting of 10 animals each (no 1 to 10, and 11 to 20). The following test compound concentrations were used in this test: Intradermal induction: 2.5 %; topical induction: 25 %; challenge: 25 %.
The test concentrations were determined in a dose finding assay. An intracutan injection of a 0 - 2.5% solution revealed no effect, whereas with a 5% solution wheals were obvious. With a topical induction and a challenge with a 25% solution no erythema and no edema were evident after 48 and 72 hours.
Neither the test substance animals nor the control animals showed any skin reddening after challenge exposure to the 25% test compound formulation. The test compound was formulated in physiological saline solution (sterile) as a suspension.
Under the conditions of the maximisation test, the test compound has no skin sensitizing potential.
Migrated from Short description of key information:
In a valid study Pigment Yellow was tested in a guinea pig maximisation test (GPMT) as described by Magnusson and Kligman
Respiratory sensitisation
Endpoint conclusion
- Additional information:
no data
Migrated from Short description of key information:
no data
Justification for classification or non-classification
Due to the negative result in the guinea pig maximisation test (GPMT) as decribed by Magnusson and Kligman a classification is not justified
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