Registration Dossier
Registration Dossier
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EC number: 305-897-5 | CAS number: 95193-83-2
Carcinogenicity
Administrative data
Description of key information
Not carcinogenic.
Key value for chemical safety assessment
Justification for classification or non-classification
The susbtance shall not be classified for carcinogenicity according to the CLP Regulation (EC) No. 1272/2008.
Additional information
EFSA Panel on Food Additives and Nutrient Sources added to Food describes some studies on the carcinogenicity potential of the substance:
In the chronic toxicity study performed on mice four groups of mice (65 per sex in the exposed groups; 105 per sex in the control group) were fed daily diets containing the substance at the dose of 150, 400, or 1500 mg/kg bw/day. On day 21 after parturition, animals were selected from the litters of the appropriate treatment groups to provide groups of 100 animals of each sex (controls) or 50 animals of each sex (test groups). These F1 animals received the same diet for 21 months (males) or 23 months (females).
The number of animals bearing palpable masses remained low (approximately 10 %) and the incidence and time of onset was similar in all groups. Histological observation of a wide range of tissues (including the thyroid) at termination or when aberrant tissues were suspected showed no treatment-related toxic effects. There was no marked difference in the tumour types observed between groups or in the overall incidence of the tumours.
In the chronic toxicity study performed on rats, the P0 generation rats were administered the substance in the diet at the dose levels of 15, 50, 250, 1000 or 2500 mg/kg bw/day for two months before mating. After parturition and weaning the F1 animals were maintained on diets containing the same levels of the substance as the parental generation for up to 30 months. No tissues damage and no evidence of a carcinogenic potential of the test item was observed.
In another study in mice, groups of animals (60 per sex) were fed dietary levels of up to 7500 mg/kg bw/day of the substance for 23-24 months. No evidence of carcinogenicity was noted.
EFSA, 2009, Scientific Opinion on the re-evaluation of Quinoline Yellow (E 104) as a food additive.
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