Teratological testing

Christian, M.S. and Hoberman, A.M. (1989). Current in vivo reproductive toxicity and developmental toxicity (teratology) test methods. In A Guide to General Toxicology, 2nd ed. (Marquis, J.A. and Hayes, A.W., Eds.). S. Karger, Basel, Switzerland, pp. 91-100. 

Schardein, J. (1988). Teratologic testing Status and issues after two decades of evolution. Rev. Environ. Contam. Toxicol. 102 1-78. 

Chernoff N, Kavlock RJ. 1983. A teratology test system which utilizes postnatal growth and viability in the mouse. Environ Sci Res 27 Short-Term Bioassays Anal Complex Environ Mixtures (3) 417-427. 

REACH guidelines may require teratology testing for new and existing chemicals. This chapter discusses procedures to assess the need for teratology testing and the conduct and interpretation of teratology tests where required. 

There is no requirement for teratology testing at this level. 

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. 

A 2-generation reproduction study is also indicated for consideration at this level, but this is outside the scope of this chapter. However, if a 2-generation study, or a 1-generation study (6), has already been conducted, its findings may provide information which avoids the need for teratology testing. 

Teratology testing is only listed as a requirement at 100 tonnes or more (Annexes IX and X), although where there are serious concerns about the potential for adverse effects on development a teratology study may be proposed for substances at 10 tonnes or more. 

The quote attributed to Andrew Lang he uses statistics as a drunken man uses a lamp post, for support rather than illumination is very appropriate to teratology testing, and particularly to fetal abnormalities. 

Sample Volume <100 L, High Concentration Factors. Lyophiliza-tion is a feasible process for concentrating limited numbers of 50-100-L samples to relatively high degrees of concentration (e.g., 3000-fold to dryness). Thus, it is one method of choice for the preparation of samples for in vivo tests (including teratology tests). 

Figure 21.4 Abbreviated protocol for a teratology test and for a perinatal/postnatal toxicity test in rats.

Animals used in teratology testing of the chemical Mutagenicity assays in which the chemical was tested EPA Gene-Tox review information... 

R.E. Butcher and C.J. Nelson, Design and analysis issues in behavioral teratology testing, Neurobehav. Toxicol. Teratol. 7(6) (1985) 659. 

Heine W. Thalidomidembryopathie im Tierversuch. 111. Teratologische Testung von Thalidomidabbauprodukten. [Thalidomide embryopathy in animal experiments. 3. Teratologic tests of thalidomide catabolic products.] Z Kinderheilkd 1966 96(2) 141-6. 

Teratological Testing. Following the reports of the effects of thalidomide on fetuses exposed during the first trimester which appeared in 1961-1965, (, 75), the United States Food and... 

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