Reproduction/Developmental Toxicity

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. 

Other types of reproductive toxicity studies, e.g., the prenatal developmental toxicity study, the reproduction/developmental toxicity screening study, and the developmental neurotoxicity study (Section 4.10.3) may give some indications of general toxicological effects arising from repeated exposure over a relatively limited period of the animal s life span as clinical signs of toxicity and... 

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. 

Mitsumori K, Kodama Y, Uchida O, et al Confirmation study, using nitrobenzene, of the combined repeat dose and reproductive/ developmental toxicity test protocol pro-... 

Guideline for Testing of Chemicals. Reproduction/developmental toxicity... 

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... 

There is no requirement for teratology testing at this level, but a screening test for reproductive/developmental toxicity (2) or screening test combined with 28 day toxicity test (3) is required. However, if there is already a prenatal developmental toxicity (teratology) test (4) or a 2-generation study (5) then the screening test is not required. 

Weinbauer GF et al (2008) Reproductive/ developmental toxicity assessment of biopharmaceuticals in nonhiunan primates. In Cavagnaro JA (ed) Preclinical safety evaluation of biopharmaceuticals. A science-based approach to facilitating clinical trials. Wiley, New Jersey, pp 379-397... 

Speilman H (2009) The way forward in reproductive/developmental toxicity testing. Altern Lab Anim 37 641-656... 

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

For reproductive/developmental toxicity, the routes by which the fetus could be exposed are critical and can depend on maternal absorption, distribution, metabolism and placental transfer of the chemical or its metabolite. 

OECD (1996b) Test Guideline 422 Combined repeated dose toxicity with reproduction/ developmental toxicity screening. Paris, Organisation for Economic Co-operation and Development. 

Tri-o-cresyl phosphate, not classified as a pesticide, is the only organophosphate for which testing and a final report were to have been completed in 1986. One of the TOCP studies under the auspices of CDC/NIOSH, and with an A completion priority, was a reproductive/developmental toxicity study. However, it is unclear from the TOCP listings (ref. 172a, Table 23) whether either the reproductive study or one of the neurologic/behavioral studies for TOCP was completed and reported in 1986. 

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