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Descriptions of NTP Study Types
Descriptions of NTP Study Types
Home » Testing Information » Descriptions of NTP Study Types » Reproductive » Abstracts » Abstract for RACB20103, RACB20104, RACB20105, RACB20106, and RACB20203
The purpose of this study was to examine the sensitivity of the pubertal assay to an estrogen (Methoxychlor), anti-androgen (Vinclozolin and Flutamide), and a thyroid-active agent (Phenobarbital) in intact juvenile/peripubertal male and female rats. Fifty-five time-mated female (F0) Sprague Dawley Rats were received from Charles River Laboratories and allowed to litter at TherImmune. After weaning on Postnatal Day (PND) 21, 135 F1 males and 135 F1 females were assigned to male and female cohort studies, respectively. The F1 males were dosed with corn oil (0 mg/kg), or the test articles: Phenobarbital (25, 50, and 100 mg/kg/day), Vinclozolin (10, 30, and 100 mg/kg/day), or Flutamide (25 and 50 mg/kg/day), once daily via oral gavage from PND 23-53/54. The F1 females were dosed with corn oil (0 mg/kg), or the test articles: Ethinyl Estradiol (0.0025 and 0.0050 mg/kg/day), Methoxychlor (12.5, 25, and 50 mg/kg/day), or Phenobarbital (25, 50 and 100 mg/kg/day), once daily via oral gavage from PND 22-42/43.
Parameters evaluated include mortality and clinical observations, body weights, day of preputial separation, day of vaginal opening, estrous cyclicity, gross pathology, organ weights and histopathology.
The following parameters were affected by treatment:
Males | |||||
---|---|---|---|---|---|
Test Article | Concentration
(mg/kg/day) |
Body Weight |
Age of Preputial Separation | Organ Weights | Histology |
Phenobarbital | 25 | - | - | ↑liver | - |
50 | - | - | ↑liver | - | |
100 | ↓ | ↑ | ↑liver ↓pituitary | - | |
Vinclozolin | 10 | - | ↑ | - | - |
30 | - | ↑ | ↓repro. organs ↑ testis, | - | |
100 | - | ↑ | ↓repro. organs ↑ testis | - | |
Flutamide | 25 | - | ↑ | ↓repro. organs ↑ testis, ↓ kidneys |
- |
50 | - | ↑ | ↓repro. organs ↑ testis, ↓ kidneys, ↑adrenal glands |
testis lesions |
Females | |||||
---|---|---|---|---|---|
Test Article | Concentration
(mg/kg/day) |
Age at Vaginal Opening |
Age at First Estrus | Irregular Estrous Cycles | Organ Weights |
Phenobarbital | 25 | - | - | - | ↑liver ↑ adrenal |
50 | - | - | - | ↑ liver ↑ adrenal | |
100 | ↑ | - | - | ↑ liver ↑ adrenal ↓ thyroid | |
Methoxychlor | 12.5 | ↓ | ↓ | - | - |
25 | ↓ | ↓ | X | - | |
50 | ↓ | ↓ | X | ↓ liver ↓ ovary ↓ pituitary | |
Ethinyl Estradiol | 0.0025 | - | - | - | ↑adrenal |
0.005 | ↓ | ↓ | X | ↑adrenal |
The lowest observable effect level (LOEL) for an endocrine effect was 25 mg/kg/day for Flutamide, 10 mg/kg/day for Vinclozolin, 100 mg/kg/day for Phenobarbital, 12.5 mg/kg/day for Methoxychlor, and 0.005 mg/kg/day for Ethinyl Estradiol.
Report Date: May 2004
Web page last updated on September 13, 2007
The National Institute of Environmental Health Sciences is one of the National Institutes of Health within the U.S. Department of Health and Human Services. The National Toxicology Program is headquartered on the NIEHS campus in Research Triangle Park, NC.