• Title/Summary/Keyword: Reproductive and developmental toxicology

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Uterotrophic Assays of Pyrethroid Insecticides in Immature Rats

  • Kim, Soon-Sun;Rhee, Gyu-Seek;Lee, Rhee-Da;Kwack, Seung-Jun;Lim, Kwon-Jo;Yhun, Hyo-Jung;Park, Kwang-Sik;Park, Kui-Lea
    • Proceedings of the Korean Society of Toxicology Conference
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    • 2003.10b
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    • pp.149-149
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    • 2003

  • It is well known that many pesticides possess hormonal activity, and thus have been classified as endocrine disruptors. Currently, pyrethroid insecticides are in worldwide use to control in door pests, providing potential for environmental exposure. A few studies of hormonal activities of these pyrethroid insecticides, however, have been reported, and are controversial between studies.(omitted)

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Assessing systemic, developmental, and reproductive toxicity and estrogenicity of Korean red ginseng extract G1899 in juvenile Sprague-Dawley Rats

  • Sangyun Kim;Ji-Seong Jeong;Woojin Kim;Onju Ham;Yixian Quah;Soontag Jung;Dong-Ju Park;Min Jae Kim;Byung-Cheol Han;Eunji Kim;Seung-Jin Lee;Wook-Joon Yu
    • Journal of Ginseng Research
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    • v.48 no.3
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    • pp.333-340
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    • 2024

  • Background: Korean red ginseng (KRG) is a product from ginseng roots, which is enriched with ginsenosides and has been utilized for a long time as an adaptogen to alleviate various physiological or disease conditions. While KRG is generally considered safe, conducting a thorough toxicological assessment of the spray-dried powder G1899 during the juvenile period is essential to establish its safety profile. This study aimed to assess the safety of G1899 during the juvenile period using Sprague-Dawley rats. Methods: Two studies were conducted separately: a juvenile toxicity study and a uterotrophic bioassay. To assess the potential toxicity at systemic, postnatal developmental, and reproductive levels, G1899 was orally gavaged once a day in post-weaning juvenile Sprague-Dawley (SD) rats at 0, 1250, 2500, or 5000 mg/kg/day. Estrogenicity was assessed by orally gavaging G1899 in immature female SD rats at 0, 2500, or 5000 mg/kg/day on postnatal days (PND) 19-21, followed by a uterotrophic bioassay. These studies were conducted in accordance with the Good Laboratory Practice (GLP) regulations and regulatory test guidelines. Results: Regarding juvenile toxicity, no abnormalities related to the G1899 treatment were observed in any group during the experiment. Moreover, no uterotrophic responses were observed in the dosed female group. Based on these results, the no observed adverse effect level (NOAEL) of G1899 was determined to be at least 5000 mg/kg/day for general systemic function, developmental/reproductive function, and estrogenic activity. Conclusion: Our results suggest that G1899 is not toxic to juveniles at doses of up to 5000 mg/kg/day.

  • https://doi.org/10.1016/j.jgr.2024.01.002 인용 PDF

The Recommended Approaches and Recent Trends in Reproductive and Developmental Toxicology (생식 · 발생독성시험의 방법적 고찰과 최신 연구 동향)

  • Kwack, Seung-Jun;Cho, Dae-Hyun
    • Toxicological Research
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    • v.21 no.4
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    • pp.271-278
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    • 2005

  • Reproductive and developmental toxicology is concerned with various physical or chemical agents interfering with fertility in both gender or normal growth of offsprings. Reproductive and developmental toxicology is rather a complex science, with many fields, i.e., various endpoints are involved and many different mechanisms of action. For that reason, diverse aspects must be considered when attempting to assess possible adverse health effects in the area of reproductive and developmental toxicology. The thalidomide tragedy made it clear to regulatory authorities around the world that systematic, comprehensive evaluation of the reproductive cycle was needed to adequately evaluate the potential of medicinal drugs to impair the process of reproduction or the development of embryos, fetuses, and children. International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) and U.S. Food and Drug Administration (FDA) developed a guideline to assess the reproductive and developmental toxicity. Also these guidelines have since been applied to the detection and regulation of environmental toxicants, food additives, and so on. Although it was hoped that testing procedures of guideline would be updated constantly to reflect the current state of the science in reproductive and developmental toxicology, it was not until this decade that regulatory guidelines and testing methods have been altered in a significant way. In this paper, we would like to present the recommended approaches and recent trends for improvement of testing guidelines or experimental methods in reproductive and developmental toxicology.

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