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EC number: 203-308-5
CAS number: 105-55-5
Key study for DNEL
calculation / Long-term exposure (systemic effects)
A 2-year carcinogenicity study on rats and mice is available on
DETU by oral route (NCI 1978).
Study was performed to determine whether DETU have the capacity to
produce cancer in animals. DETU was administered in diet for 103 weeks
at concentrations of 125 and 250 ppm (6.25 and 12.50 mg/kg bw/d,
respectively) to rats and 250 and 500 ppm (12.5 and 25 mg/kg bw/d,
respectively) to mice.
No mortality, no clinical signs were observed on rats and mice. No
change of body weight gain were observed on rats, but a decrease of body
weight gain was observed at both doses in mice.
Based upon statistical results, the administration of DETU was
associated with the increased incidence of thyroid follicular-cell
carcinomas in male rats and thyroid follicular-cell neoplams in female
rats (at 125 and 250 ppm).
In mice (in both sexes), the neoplasms observed were similar in
type and distribution in dosed and control mice (ex:
alveolar/bronchiolar adenoma, hepatocellular adenoma and carcinoma,
leukemia or malignant lymphoma...). None of statistical tests for any
site revealed a significant positive association between administration
of compound and increased tumor incidence.
Under the conditions of the bioassay, DETU was carcinogenic in
Fischer 344 rats, inducing thyroid neoplasms and hyperplasia. However,
DETU was considered as not carcinogenic in B6C3F1 mice.
The LOAEL for toxicity is 125 ppm (6.25 mg/kg bw/d), based on
thyroid toxicity in rats at this dose.
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