Registration Dossier
Registration Dossier
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EC number: 202-440-0 | CAS number: 95-68-1
Carcinogenicity
Administrative data
Description of key information
NOEL (feeding study, 18 months, male rat): 4000 mg/kg diet (highest dose tested)
NOEL (feeding study, 18 months, male mouse): 250 mg/kg diet (highest dose tested)
NOEL (feeding study, 18 months, female mouse): 125 mg/kg diet
Key value for chemical safety assessment
Justification for classification or non-classification
Based on the limited amount and quality of existing data no statement on classification/non-classification of 2,4 -Xylidine with reference to carcinogenicity can be made according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
Additional information
One carcinogenicity study was performed with 2,4 -Xylidine:
Mice (males/females) and rats (males), 25/dose level/sex, were held on the basal diet of Purina laboratory chow for two weeks before grouping for the feeding study. 2,4-Xylidine was fed at two levels - the higher being the maximum tolerated dose, the lower one half that level. The animals were given the 2,4-Xylidine containing diets for a period of 18 months. Mice were held 3 months longer and rats 6 months longer on control diet before termination of the study. The following observations were made:
- 2,4-xylidine was not carcinogenic in male rats or male mice
- in female mice pulmonary tumors were significantly increased at the high dose level (250 mg/kg diet) only
Differences in detoxication pathways may possibly account for this reversal in effect.
From literature the susceptibility of CD-1 mice to spontaneous and chemically induced lung tumorigenesis is known. Therefore, the relevance of this study result for humans is questionable.
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