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EC number: 946-959-7 | CAS number: -
The test was performed according to the EU Method B.6, Skin sensitisation. Only one study is available (GLP, Klimish score 1).
The test substance, Acid Black 227, was shown to be a contact allergen in guinea pigs. Based on the available results of the test substance Acid Black 227 is classified as a skin sensitising substance Category 1B (indication of skin sensitising potential) based on GHS criteria.
Table No. 3: Grading of skin reactions
Start of study
End of study
Start of study
♂ – male
♀ – female
The test substance, Acid Black 227, was tested for the assessment of skin allergic effects using albino guinea pigs (strain BFA).
The test was performed according to the EU Method B.6, Skin sensitisation. The method is analogous to the OECD Test Guideline No. 406, Skin Sensitisation.
The Magnusson and Kligman maximization procedure was followed. The pilot experiment was implemented on 3 animals. The main test was performed on 20 treated and 10 control animals.
The experiment proceeded in three phases: two induction phases (intradermal injections and topical application) and the challenge phase. Potential skin reactions were evaluated at the end of experiment.
The evaluation of skin reactions in the exposed group carried out at 48 hours after the start of the challenge phase showed discrete erythema in 6 animal in left flank applied with the test substance. Evaluation at 72 hours after the start of the challenge phase of study showed discrete erythema in next 1 animal in left flanks applied with the test substance and in 3 animals the discrete erythema persisted from the previous day.
The body weight of animals increased through the study and it was not affected by the treatment. The exposed animals showed no other negative clinical symptoms throughout the experiment.
The test substance, Acid Black 227, caused a positive skin reaction in 7 of 20 animals, i.e. in 35 % of animals, which were exposed to the test substance. Therefore the sensitisation response is positive. The test substance, Acid Black 227, was shown to be a contact allergen in guinea pigs.
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