Registration Dossier
Registration Dossier
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EC number: 204-411-8 | CAS number: 120-61-6
Carcinogenicity
Administrative data
Description of key information
Dimethyl terephthalic acid was not carcinogenic to rats and mice fed diets containing 2500 or 5000 ppm for 2 years.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 250 mg/kg bw/day
Justification for classification or non-classification
There was no definitive evidence that dimethyl terephthalate is carcinogenic to rats and mice, when fed in the diet for 2 years. Therefore the classification according to Regulation (EC) No. 1272/2008 is not required.
Additional information
The carcinogenicity of DMT has been investigated in two high qualtiy studies in F344 rats and B6C3F1 mice (National Cancer Institute, 1979).
Groups of 50 animals per species per sex were administered dimethyl terephthalate at doses of 2500 or 5000 ppm for 103 weeks, then observed for an additional 2 weeks. Matched controls consisted of 50 untreated animals per species per sex. No clinical behaviour was observed which was related to the treatment. Survival at the end of the study was not affected by the test material. A variety of tumors were observed in both control and dosed rats. However, there was no difference in the type or number of lesions in the dosed or control group. In mice of each sex, no tumors occurred at incidences that clearly were related to administration of the test chemical. The occurrence of lung tumours in male mice was considered equivocal, based on an unusually low occurrence of this type of tumour in control mice. It was concluded that under the conditions of the study, dimethyl terephthalate was not carcinogenic for F344 rats and B6C3F1 mice.
Dose levels are calculated using default factors to be equivalent to 125 and 250 mg/kg bw/d (rat); 375 and 750 mg/kg bw/d in the mouse.
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