Reproduction/Developmental Toxicity Screening Test

Combined repeated dose toxicity study with the reproduction/developmental toxicity screening test OECD... 

Reproduction/Developmental Toxicity Screening Test (Original Guideline, adopted 27 July 1995)... 

Reproduction/developmental toxicity screening test (July 2000)... 

Combined repeated dose toxicity smdy with the reproduction/developmental toxicity screening test (July 2000) 870.3700 Prenatal developmental toxicity smdy (August 1998)... 

The combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG 422) is, for the repeated dose toxicity part, concordant with the standard 28-day oral toxicity study (OECD TG 407) except for use of pregnant females and longer exposure duration (about 6 weeks for males and approximately 54 days for females) in the combined study compared to the standard 28-day study. 

The reproductive/developmental toxicity screening test can provide initial information on possible effects on reproduction and/or development and may make it possible to identify a substance as being toxic to reproduction, i.e., the test gives a clear positive result. However, this test offers only limited means of detecting postnatal manifestations of prenatal exposure or effects that may be induced during postnatal exposure. In addition, because of the study design (e.g., relatively small numbers of animals per dose level, relatively short smdy duration), the test will not provide evidence for definite claims of no effects. 

OECD (1996) Test Guideline 422. OECD Guideline for Testing of Chemicals. Combine repeated dose toxicity study with the reproduction/developmental toxicity screening test, http // WWW.oecd-ilibrary.org/ environment/ test-no-422-combined-repeated-dose-toxicity-study-with-the-reproduction-developmental-toxicity-screening-test 9789264070981-en. Accessed 12 Feb 2012... 

OECD (1995) Test No. 421 Reproduction/ developmental toxicity screening test. OECD, Paris. doi 10.1787/9789264070967-en... 

OECD TG 421 and TG 422 Reproduction/ Developmental Toxicity Screening Test (with or without the Combined Repeat Dose Toxicity Study) From 2 weeks prior to mating until at least day 4 postnatally 3 dose levels plus control n = 8-10 pregnant females Fertility Pregnancy length and birth Fetal and pup growth and survival until day 3 + short-term test - limited exposure period - limited number of end-points - limited sensitivity due to number of animals... 

III.G.7.5.2 The Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test 422. 848... 

OECD (Organization for Economic Cooperation and Development). 1995. OECD Guidelines for Testing of Chemicals. Reproduction/Developmental Toxicity Screening Test. TG No. 421. Organization for Economic Cooperation and Development, Paris, France. 

OECD 421. OECD guideline for testing of chemicals. Test No. 421 Reproduction/ Developmental Toxicity Screening Test. Available at www.oecd.org. 2000. 

Nagao, T. (2006) Combined repeat dose and reproductive/developmental toxicity screening test of thiophene by oral administration in rats. Kanagawa, Japan, Hatano Research Institute, Food and Drug Safety Center. 

A.7.2.5.2 Results obtained from screening tests (e.g., OECD Guidelines 421—Reproduction/Developmental Toxicity Screening Test, and 422—Combined Repeated Dose Toxicity Study with Reproduction/Development Toxicity Screening Test) can also be used to justify classification, although the quality of this evidence is less reliable than that obtained through full studies. 

Prenatal Developmental Toxicity" test (OPPTS 870.3700 oral route, one species), OECD 421 ("Reproduction/Developmental Toxicity Screening Test") or OECD 422 (combined OECD 407 (28-day study) and OECD 421). 

Repeated exposures via the oral route in rats showed changes in organ weights, clinical chemistry, hematology, and histopa-thology at 650 mg/kg-bw/day with a NOAEL of 184 mg/kg-bw/day for systemic toxicity. A combined raal reproductive/ developmental toxicity screening test in rats showed decreased numbers of spermatocytes and spermatids in the testes at 3[Pg.306]

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