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Toward Public Health & Safe Society

생식발생독성시험

Reproductive and Developmental Toxicology

Reproductive generated toxicology test assess the effect of various chemicals to entire reproduction from generation of reproductive cell, pregnancy, birth and growth, and use test animals for the testing of side effects such as teratogenic possibility and fertility disorder.

In the early 1960s, it was confirmed that various chemicals cause environmental risk including the neonatal teratogenicity in accordance with intake of Thalidomide, each countries regulated to investigate the side effect of drugs and medical chemicals on reproductive capability. Considering the birth defects due to drug abuse, drinking of pregnant woman, neurological disease fetus from organomercurial compounds poisoning, the reproductive generated toxicology test is very significant in the field of nonclinical test.

Korea Institute of Toxicology has established various reproductive generated test method since 1990 and is leading the relevant technology by conducting the test on drug, agricultural pesticide and general chemicals.

Field of Test

Segment I, ICH I(Fertility and Early Embryonic Development Study)

  • Inject the test substance to male from 63 or 28 days before the crossbreeding until the end of crossbreeding, and to female from 14 days before the crossbreeding until the point of implantation(6 days of pregnancy), and investigate the influence of test substance to fertility and embryogenesis during early pregnancy, mainly using male and female rat or mouse etc.

Embryo-Fetal Development Study(Segment Ⅱ, ICH Ⅲ)

  • Inject the test substance to organogenic period of pregnant animal, and investigate if the test substance causes deformation, death or growth retardation of fetal, mainly using pregnant rat, mouse, rabbit etc.

Pre-and Postnatal Study(Segment Ⅲ, ICH Ⅱ)

  • Inject the test substance from day 6 of pregnancy to day 20 of rearing, and investigate the influence of test substance to growth, behavioral function and development of reproductive function of next generation animal, mainly using pregnant rat and mouse etc.

Combined Fertility and Development Study

  • Inject the test substance to male from 63 or 28 days before the crossbreeding until the end of crossbreeding, and to female from 14 days before the crossbreeding until the organogenic period after pregnancy to investigate the influence of test substance on fertility and fetal generation, mainly using male and female rat and mouse etc. Especially, in case of expensive test substance such as biomedicine that costs significantly in the production process, it is desirable to use mouse rather than rat for this test.

Multigeneration Study

  • Regarding FO, inject the test substance to male before and during crossbreeding, and to female, inject before crossbreeding, during pregnancy and until ablactation, and investigate the influence of test substance to F1's development and growth, and conduct same method for the next generation animal, mainly using female and male rat.

Other Studies following OECD Test Guideline

  • Conduct various reproductive toxicity test in accordance with test guildline of OECE for agricultural pesticide and general chemicals
    • Test Guideline No. 414. (Prenatal Development Toxicity Study)
    • Test Guideline No. 415. (One - Generation Reproduction Toxicit
    • Test Guideline No. 416. (Two - Generation Reproduction Toxicity Study)
    • Test Guideline No. 421. (Reproduction / Development Toxicity Screening Test)
    • Test Guideline No. 422. (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
    • Test Guideline No. 426. (Developmental Neurotoxicity Study)
    • Test Guideline No. 440. (Uterotrophic Bioassay in Rodents : A short - term Screening Test for Oestrogenic Properties)
    • Test Guideline No. 441. (Hershberger Bioassay in Rats : A short - term Screening Assay for (Anti) Androgen Properties)
    • Test Guideline No. 443. (Extended One - Generation Reproduction Toxicity Study)

최근 업데이트 2021/10/06