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In September 2003, a new revision of the draft guideline (Organization for Economic Co-operation and Development [OECD] Guideline for the Testing of Chemicals, Proposal for a New Guideline 426, Developmental Neurotoxicity Study) was distributed. The draft guideline consists of 51 paragraphs and an appendix. The National Coordinators were requested to arrange national expert reviews of the guideline proposal in their member countries. The member of the Behavioral Teratology (BT) Committee of the Japanese Teratology Society (JTS) reviewed, discussed and commented on the draft Test Guideline proposal. The BT Committee of the JTS also commented that the International Collaborative Study to validate this protocol should be definitely performed. These comments were sent to the OECD Secretariat. The BT Committee of the JTS expects that the comments are useful for further discussion.
A computer simulation experiment which attempted to examine the effect of sample size on reproducibility of the effect of treatment was performed on the basis of actual data obtained from the Collaborative Behavioral Teratology Study of the National Center for Toxicological Research. The degree of the treatment effect was assessed in terms of the strength of the association (eta square). The results indicate that sample size has a large effect on the reproducibility of results which are assessed with the magnitude of SD for eta squares obtained from replication experiments. Suitable sample sizes to obtain relatively consistent results across studies were discussed, pointing out that not enough attention has been paid to the effect of sample size in the issue of reproducibility of results in some behavioral teratology studies.
Medical records of 1179 pregnant women counselled at the Department of Medical Genetics Klimentska during the period 1990-1995 because of exposure to medicaments during the preconception period and in the first trimester were analyzed. Women exposed to antimicrobial agents prevailed (48 per cent). Most frequent was treatment with Doxycycline, Co-trimoxazole and Metronidazole. 23 per cent of women were exposed to sex hormones, most frequently to oral contraceptives and norethisterone. The average gestational age at exposure to antimicrobial agents was 21.5 days and 30 days at exposure to sex hormones. Specific features of clinical-teratological counselling and the role of the Czech Teratologic Information Service are described.
This report refers to the actual opinions on epidemiology, pathogenesis and prevention of congenital malformations presented during the 41st Annual Meeting of Teratology Society, held on the 23rd-28th June 2001 at Montreal in Canada.
2-Methylresorcinol (2-MR) was administered to groups of 40 male and 35 female Sprague-Dawley rats by admixture with the diets at levels of 0.1, 0.4, and 1.5% (see Part I; T.H. Re, R.F. Loehr, S.C. Rodriguez, C.E. Gilmore, and C.M. Burnett, 1986, Fundam. Appl. Toxicol. 7, 287-292). Following 90 days of exposure, 25 randomly selected females in each group were mated to untreated males in a teratology study in which exposure to 2-MR continued throughout the gestation period. After 20 weeks of exposure to 2-MR, 20 males per group were removed from the test diets containing 2-MR and were mated to untreated females in a dominant lethal study. Feeding 2-MR at levels of 0.4 and 1.5% in the diet was associated with a significant reduction in body weight gain. 2-MR was not teratogenic nor did it induce a dominant lethal effect under the conditions of this study.
Comparison is made of the NCTR Collaborative Behavioral Teratology Study (CBTS) test battery with tests of the Cincinnati test battery using rat offspring derived from the same samples and sub-divided and evaluated in parallel. It was noted that in the two experiments, one using prenatal d-amphetamine and one prenatal methylmercury exposure, both test batteries were in general agreement, viz., d-amphetamine was largely negative with no major findings observed and methylmercury was positive with several major findings. The results obtained from the two test batteries differed, however, in the methylmercury experiments, undoubtedly as a reflection of the different tests used. Whereas the CBTS battery detected in each laboratory methylmercury-induced auditory startle facilitation, increased adult activity, and in all laboratories combined decreased correct responding and intertrial responding in operant conditioning, the Cincinnati battery found delayed righting and swimming ontogeny, decreased adolescent activity, and impaired complex water maze performance. It was noted that the CBTS battery emphasized startle and activity testing, while the Cincinnati battery emphasized reflex ontogeny. The CBTS battery convincingly demonstrated its detection sensitivity, intralaboratory and interlaboratory reliability, but since few positive control agents were evaluated relatively few data on criterion validity were obtained. The Cincinnati battery has relatively little data on its interlaboratory reliability, but a large amount of data on intralaboratory reliability, sensitivity, and through the use of many positive control agents in the past, considerable data establishing its criterion validity. All tests need all three characteristics, but validation is the most crucial task for future research on these and other test batteries.(ABSTRACT TRUNCATED AT 250 WORDS)
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