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[Peri- and postnatal study on halopredone acetate in rats]
The Journal of Toxicological Sciences
|August 1, 1985
Summary
Halopredone acetate (THS-201) did not affect rat dams or their offspring (F1 and F2 generations) in peri- and postnatal development studies. The highest tested dose of 25.6 mg/kg/day showed no adverse reproductive or developmental effects.
Area of Science:
- Reproductive toxicology
- Developmental toxicology
- Pharmacology
Context:
- Peri- and postnatal studies are crucial for assessing the safety of pharmaceutical compounds.
- Synthetic corticosteroids require thorough evaluation for potential reproductive and developmental risks.
- Jcl: Wistar rats are a standard model for toxicological assessments.
Purpose:
- To evaluate the reproductive and developmental toxicity of halopredone acetate (THS-201) in rats.
- To determine the non-effect level of THS-201 during gestation, delivery, lactation, and offspring development.
- To assess the impact of THS-201 on F1 and F2 generations' viability, development, and reproductive performance.
Summary:
- Pregnant rats received subcutaneous halopredone acetate (THS-201) at doses of 0.05, 0.4, 3.2, and 25.6 mg/kg/day from day 17 of gestation to day 21 postpartum.
- No adverse effects were observed on maternal parameters including gestation, delivery, and lactation.
- THS-201 did not influence the viability, development, reflex responses, learning abilities, or reproductive performance of the F1 generation, nor the development of the F2 generation.
Impact:
- Establishes a high no-observed-adverse-effect level (NOAEL) for THS-201 in reproductive and developmental toxicity.
- Provides critical safety data for the use of halopredone acetate in contexts where pregnant or lactating individuals might be exposed.
- Supports the safety profile of THS-201, indicating a low risk for reproductive and developmental toxicity in mammalian models.