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EC number: 218-827-2
CAS number: 2244-16-8
Table 1. Survival of mice in the two year gavage studies of d-carvone
Animals initially in study
Animals surviving until study termination
Mean survival (days)
Survival P values
Table: Number of mice with lesions of the nasal cavity in the two year gavage studies of d-carvone
Multifocal acute inflammation
**P<0.01 vs. vehicle controls
Chronic toxicity study was performed for d- carvone using B6C3F1 mice. The test chemical was mixed with corn oil and dosed by the gavage route of exposure to male and female at dose levels of 0, 375 or 750 mg/kg. During the study period, the animals were observed for clinical signs, body weight changes, organ weight changes and histopathalogy.The survival of both 375 mg/Kg (after week 101) and 750 mg/Kg (after week 92) groups of female mice was significantly greater than that of the vehicle controIs. No significant differences were observed between any groups of male mice. No compound-related clinical signs were observed. Mean body weights of dosed and vehicle control male mice were similar throughout most of the studies; mean body weights of dosed female mice were within 7% of those of vehicle controls throughout most of the studies. No increase in neoplastic lesions was observed in dosed mice. No increases in tumor incidences were observed in mice administered d-carvone. In the current study, only nine primary neoplasms were seen in female vehicle control mice, each in a different animal. This low number may be related to the early deaths of female vehicle control mice. However, the incidences of male mice with primary neoplasms (vehicle control, 27/50; low dose, 15/50; high dose, 16/50) and the total numbers of primary neoplasms (vehicle control, 38; low dose, 18; high dose, 20) were significantly lower in dosed groups than in vehicle controls. It is not known if the low tumor yields are related to d-carvone administration. The only lesions considered possibly related to d-carvone in the 2-year studies in mice were atrophy of the olfactory epithelium and hyperplasia of the underlying Bowman's glands. These mayhave been related to reflux of d-carvone into the nose after the gavage needle was withdrawn, because inflammatory exudate and "foreign material" were often found in the nasal passage of dosed animals. Based on these considerations, the No observed Adverse Effect level (NOAEL) for d-carvone using male and female mice in 103 weeks study is considered to be 750 mg/kg/day.
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