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Reviews of Environmental Contamination and Toxicology pp 1–78Cite as

Teratologic Testing: Status and Issues After Two Decades of Evolution

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Part of the book series: Reviews of Environmental Contamination and Toxicology ((RECT,volume 102))

Abstract

It goes without saying that the thalidomide tragedy of 1961 triggered teratologic testing of drugs and chemicals on an unprecedented international scale. Prior to this time, safety testing was limited to a few chemicals most likely to be consumed by man, and the tests themselves were incapable of fully demonstrating toxic manifestations of the embryo.

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References

  • Adams J, Buelke-Sam J, Kimmel CA, Nelson CJ, Miller DR (1985a) Collaborative Behavioral Teratology Study: preliminary research. Neurobehav Toxicol Teratol 7:555–578.

    PubMed  CAS  Google Scholar 

  • Adams J, Buelke-Sam J, Kimmel CA, Nelson CJ, Reiter LW, Sobotka TJ, Tilson HA, Nelson BK (1985b) Collaborative Behavioral Teratology Study: protocol design and testing procedures. Neurobehav Toxicol Teratol 7:579–586.

    PubMed  CAS  Google Scholar 

  • Adams J, Oglesby M, Ozemek H, Rath J, Kimmel CA, Buelke-Sam J (1985c) Collaborative Behavioral Teratology Study: programmed data entry and automated test systems. Neurobehav Toxicol Teratol 7:547–554.

    PubMed  CAS  Google Scholar 

  • Alder S, Janton C, Zbinden G (1981) Preclinical Safety Requirements in 1980. Inst Toxicol, Swiss Fed Inst Technol, Univ. Zurich.

    Google Scholar 

  • Baeder C, Wickramaratne GAS, Hummler H, Merkle J, Schon H, Tuchmann-Duplessis H (1985) Identification and assessment of the effects of chemicals on reproduction and development (reproductive toxicology). Food Chem Toxicol 23:377–388.

    Article  PubMed  CAS  Google Scholar 

  • Barrow MV, Taylor WJ (1969) A rapid method for detecting malformations in rat fetuses. J Morphol 127:291–305.

    Article  PubMed  CAS  Google Scholar 

  • Bass R, Neubert D (1980) Testing for embryotoxicity. Arch Toxicol (Suppl 4):256–266.

    CAS  Google Scholar 

  • Bazzoli AS, Manson J, Scott WJ, Wilson JG (1977) The effects of thalidomide and two analogues on the regenerating forelimb of the newt. J Embryol Exp Morphol 41:125–135.

    PubMed  CAS  Google Scholar 

  • Beck F (1977) Evaluation of organs (gross organ pathology). In: Neubert D, Merker H-J, Kwashigrouch TE (eds) Methods in Prenatal Toxicology. Evaluation of Embryotoxic Effects in Experimental Animals. Teratology Workshop, Berlin, 1977, George Thieme Publ., Stuttgart, pp 103–112.

    Google Scholar 

  • Berry CL, Germain J (1972) The assessment of a polygenically inherited anomaly in the mouse as a teratological screening system. J Pathol. 107 Pxi (Abst.).

    Google Scholar 

  • Berry CL, Nickols CD (1979) The effects of aspirin on the development of the mouse third molar. A potential screening system for weak teratogens. Arch Toxicol 42:185–190.

    Article  PubMed  CAS  Google Scholar 

  • Best JB, Morita M (1982) Planarians as a model system for in vitro teratogenesis studies. Teratog Carcinog Mutag 2:277–291.

    Article  CAS  Google Scholar 

  • Birge WJ, Black JA, Westerman AG, Ramley BA (1983) Fish and amphibian embryos—a model system for evaluating teratogenicity. Fund Appl Toxicol 3:237–242.

    Article  CAS  Google Scholar 

  • Black DL, Marks TA (1986) Inconsistent use of terminology in animal developmental toxicology studies: a discussion. Teratology 33:333–338.

    Article  PubMed  CAS  Google Scholar 

  • Blake DA (1980) In vivo teratogenicity tests. Proc Workshop Method Assess Reprod Hazards Workplace, pp 219–225.

    Google Scholar 

  • Bornschein RL (1980) The role of behavioral assessment in standard in vivo teratogenicity testing. Proc Workshop Method Assess Reprod Hazards Workplace, pp 227–245.

    Google Scholar 

  • Bournias-Vardiabasis N, Teplitz RL, Chernoff GF, Seecof RL (1983) Detection of teratogens in the Drosophila embryonic cell culture test: assay of 100 chemicals. Teratology 28:109–122.

    Article  PubMed  CAS  Google Scholar 

  • Braun AG, Nichinson BB, Horowicz PB (1982) Inhibition of tumor cell attachment to concanavalin A-coated surfaces as an assay for teratogenic agents: approaches to validation. Teratog Carcinog Mutag 2:343–354.

    Article  CAS  Google Scholar 

  • Brent RL (1964) Drug testing in animals for teratogenic effects: thalidomide in the pregnant rat. J Pediatr 64:762–770.

    Article  PubMed  CAS  Google Scholar 

  • Brent RL (1972) Protecting the public from teratogenic and mutagenic hazards. J Clin Pharmacol 12:61–70.

    CAS  Google Scholar 

  • Brent RL (1982) Drugs and pregnancy: are the insert warnings too dire? Contemporary OB/GYN 20:42–49.

    Google Scholar 

  • Brent RL (1983) The Bendectin saga: another American tragedy (Brent, ’80). Teratology 27:283–286.

    Article  PubMed  CAS  Google Scholar 

  • Brent RL (1984) Ethical and legal implications of drug use in pregnancy. In Stern L (ed) Drug Use in Pregnancy, ADIS Health Science Press, Balgowlah, Australia, pp 1–11.

    Google Scholar 

  • Brent RL (1985) Methods for evaluating the alleged teratogenicity of environmental agents. Prog Clin Biol Res 163C: 191–195.

    PubMed  CAS  Google Scholar 

  • Brent RL (1986) Editorial comment: definition of a teratogen and the relationship of teratogenicity to carcinogencity. Teratology 34:359–360.

    Article  PubMed  CAS  Google Scholar 

  • Brown NA, Fabro S (1981) Quantitation of rat embryonic development in vitro: a morphological scoring system. Teratology 24:65–78.

    Article  PubMed  CAS  Google Scholar 

  • Brown NA, Fabro S (1983) The value of animal teratogenicity testing for predicting human risk. Clin Obstet Gynecol 26:467–477.

    Article  PubMed  CAS  Google Scholar 

  • Brown NA, Freeman SJ (1984) Alternative tests for teratogenicity. ATLA-Alternat. Lab Anim 12:7–23.

    Google Scholar 

  • Buelke-Sam J, Kimmel CA (1979) Development and standardization of screening methods for behavioral teratology. Teratology 20:17–30.

    Article  PubMed  CAS  Google Scholar 

  • Buelke-Sam J, Kimmel CA, Adams J, Nelson CJ, Vorhees CV, Wright DC, St. Omer V, Korol BA, Butcher RE, Geyer MA, Holson JF, Kutscher CL, Wayner MJ (1985). Collaborative Behavioral Teratology Study: results. Neurobehav Toxicol Teratol 7:591–624.

    PubMed  CAS  Google Scholar 

  • Butcher RE, Hoar RM, Nolen GA, Vorhees CV (1979) Interlaboratory comparison of behavior testing. J Assoc Offic Anal Chem 62:840–843.

    CAS  Google Scholar 

  • Butcher RE, Wootten V, Vorhees CV (1980) Standards in behavioral teratology testing: test variability and sensitivity. Teratog Carcinog Mutag 1:49–61.

    Article  CAS  Google Scholar 

  • Cahen RL (1964) Evaluation of the teratogenicity of drugs. Clin Pharmacol Ther 5:480–514.

    PubMed  CAS  Google Scholar 

  • Cameron IL, Lawrence WC, Lum JB (1985) Medaka eggs as a model system for screening potential teratogens. Prog Clin Biol Res 163C: 239–240.

    PubMed  CAS  Google Scholar 

  • Chernoff N, Kavlock RJ (1982) An in vivo teratology screen utilizing pregnant mice. J Toxicol Environ Hlth 10:541–550.

    Article  CAS  Google Scholar 

  • Chester A, Hallesy D, Andrew F (1985) Behavioral methods in reproductive and developmental toxicology. Neurobehav Toxicol Teratol 7:745–752.

    PubMed  CAS  Google Scholar 

  • Christian MS, Hoberman AM (1985) Current in vivo reproductive toxicity and teratology methods. In Homburger F (ed) Safety Evaluation and Regulation of Chemicals 2, 2nd Int. Conf., Cambridge, Mass. 1983, Karger, Basel, pp 78–88.

    Google Scholar 

  • Christian MS, Voytek PE (1983) In vivo reproductive and mutagenicity tests. In Hornberger F, Hayes JA, Pelikan EW (eds) A Guide to General Toxicology, Karger, Basel, pp 294–325.

    Google Scholar 

  • Collins TFX (1978) Reproduction and teratological guidelines: review of deliberations by the National Toxicology Advisory Committee’s Reproduction Panel. J Environ Pathol Toxicol 2:141–147.

    PubMed  CAS  Google Scholar 

  • Collins TFX, Collins EV (1976) Current methodology in teratology research. In Mehlman MA, Shapiro RE, Blumenthal H (eds) New Concepts in Safety Evaluation, Hemisphere Publ. Corp., Washington, pp 155–175.

    Google Scholar 

  • D’Aguanno W (1973) Guidelines for Reproduction Studies for Safety Evaluation of Drugs for Human Use. In: FDA Introduction to Total Drug Quality, DHEW Publ. #/(FDA) 74–3006, DHEW/PHS/FDA, November.

    Google Scholar 

  • Dawson AB (1926) A note on the staining of the skeleton of cleared specimens with Alizarin red S. Stain Technol 1:123–124.

    Google Scholar 

  • Department of Health & Social Security (1979) Notes for Guidance on Reproductive Studies, MAIL 23, England.

    Google Scholar 

  • Dumont JN, Epier RG (1984) Validation studies on the FETAX teratogenesis assay (frog embryos). Teratology 29:27A (Abst).

    Google Scholar 

  • ECETOC (1986) Technical Report No. 21. A Guide to the Classification of Carcinogens, Mutagens and Teratogens Under the Sixth Amendment. European Chemical Industry Ecology & Toxicology Centre (ECETOC), Brussels, Belgium, Feb. 11 (ISSN 0773–8072).

    Google Scholar 

  • Ellenhorn MJ (1964) The FDA and the prevention of drug embryopathy. J New Drugs 4:12–20.

    Google Scholar 

  • EPA (1978a) Proposed Guidelines for Registering Pesticides in the U.S.; Hazard Evaluation: Humans and Domestic Animals. Federal Register 43(163): 37336–37403.

    Google Scholar 

  • EPA (1978b) Toxic Substances Control Act. Statement of Interpretation and Enforcement Policy; Notification of Substantial Risk (under Section 8(e). Federal Register 3(52): 11110–11116.

    Google Scholar 

  • EPA (1982) Pesticide Assessment Guidelines (FIFRA). Subdivision F. Hazard Evaluation: Human and Domestic Animals. Office of Pesticide Programs, EPA Wash. DC, EPA 540/9–82–025.

    Google Scholar 

  • EPA (1984) 40 CFR Part 158. Data Requirements for Pesticide Registration; Final Rule. Federal Register 49(207): 42856–42905.

    Google Scholar 

  • EPA (1986a) Developmental Neurotoxicity Screen. Federal Register 51 (94): 17890–17894.

    Google Scholar 

  • EPA (1986b) Guidelines for the Health Assessment of Suspect Developmental Toxicants. Federal Register 51(185): 34028–34040.

    Google Scholar 

  • EPA SEP (1985) Standard Evaluation Procedure. Teratology Studies. Chitlik LD, Bui QQ, Burin GJ, and Dapson SC. Hazard Evaluation Division, Office of Pesticide Programs, EPA, Wash. DC, EPA 540/9–85–018.

    Google Scholar 

  • Fabro S, Shull G, Brown NA (1982) The relative teratogenic index and teratogenic potency. Proposed components of developmental toxicity risk assessment. Teratog Carcinog Mutag 2:61 – 76.

    Article  CAS  Google Scholar 

  • Faherty JF, Jackson BA, Greene MF (1972) Surface staining of 1 mm (Wilson) slices of fetuses for internal visceral examination. Stain Technol 47:53–58.

    PubMed  CAS  Google Scholar 

  • FDA (1966) Guidelines for Reproduction Studies for Safety Evaluation of Drugs for Human Use. Drug Review Branch, Division of Toxicological Evaluation, Bureau of Science, FDA, Wash DC.

    Google Scholar 

  • FDA (1979) Pregnancy categories. Federal Register 44(124): 37464–37465.

    Google Scholar 

  • FDA (1982) Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food. Bureau of Foods, FDA, Wash. DC.

    Google Scholar 

  • Final Report (1977) Committee on Postnatal Evaluation of Animals Subjected to Insult During Development. 21 pp.

    Google Scholar 

  • Flint OP, Orton TC, Ferguson RA (1984) Differentiation of rat embryo cells in culture: response following acute maternal exposure to teratogens and nonteratogens. J Appl Toxicol. 4:109–116.

    Article  PubMed  CAS  Google Scholar 

  • Fraser FC (1963) Report. In Conference on Prenatal Effects of Drugs, Commission on Drug Safety, Chicago, pp 11–18.

    Google Scholar 

  • Freeman MM, Finkel MJ (1980) Drugs and other hazards to the fetus and newborn. In Schwarz RH, Yaffe SJ (eds) Drug and Chemical Risks to the Fetus and Newborn, AR Liss, New York, pp 67–72.

    Google Scholar 

  • Generoso WM, Rutledge JC, Cain KT, Hughes LA, Braden PW (1987) Exposure of female mice to ethylene oxide within hours of mating leads to fetal malformation and death. Mutat Res 176:269–274.

    PubMed  CAS  Google Scholar 

  • Gillman J, Gilbert C, Gillman T, Spence I (1948) A preliminary report on hydrocephalus, Spina bifida and other congenital anomalies in the rat produced by trypan blue. South Afr J Med Sci 13:47–90.

    CAS  Google Scholar 

  • Goldstein L, Murphy DP (1929) Etiology of ill health in children born after maternal pelvic irradiation: defective children born after post-conception pelvic irradiation. Am J Roentgenol 22:322–331.

    Google Scholar 

  • Greenberg JH (1982) Detection of teratogens by differentiating embryonic cells in culture: evaluation as a screening system. Teratog Carcinog Mutag 2:319–323.

    Article  CAS  Google Scholar 

  • Gregg NM (1941) Congenital cataract following German measles in the mother. Trans Ophthalmol Soc Aus 3:35–46.

    Google Scholar 

  • Guidance Document (1985). On Requirements of Section 4(f) of the Toxic Substances Control Act. Risk Analysis Branch, Existing Chemical Assessment Division, Office of Toxic Substances, EPA, Wash DC.

    Google Scholar 

  • Hale F (1935) Relation of vitamin A to anophthalmos in pigs. Am J Ophthalmol 18:1087–1093.

    CAS  Google Scholar 

  • Hamilton HC, Harned BK (1944) The effect of the administration of sodium bromide to pregnant rats on the learning ability of the offspring. III. Threetable test. J Psychol 18:183–195.

    Google Scholar 

  • Hardin BD, Becker RA, Kavlock RJ, Seidenberg JM, Chernoff N (1987) Overview and summary: Workshop on the Chernoff/Kavlock preliminary developmental toxicity test. Teratog Carcinog Mutag 7:119–127.

    Article  CAS  Google Scholar 

  • Haskin D (1948) Some effects of nitrogen mustard on the development of external body form in the fetal rat. Anat Rec 102:493–511.

    Article  PubMed  CAS  Google Scholar 

  • Hassell JR, Horigan EA (1982) Chondrogenesis: a model developmental system for measuring teratogenic potential of compounds. Teratog Carcinog Mutag 2:325–331.

    Article  CAS  Google Scholar 

  • Hays DP (1981) Teratogenesis: a review of the basic principles with a discussion of selected agents. Part I. Drug Intell Clin Pharm 15:444–458.

    CAS  Google Scholar 

  • Health and Welfare (1973) The Testing of Chemicals for Carcinogenicity, Mutagenicity, and Teratogenicity, Canada, pp 135–183.

    Google Scholar 

  • Health and Welfare (1981a) Preclinical Toxicologic Guidelines, Bureau of Human Prescription Drugs, Health Protection Branch, Canada.

    Google Scholar 

  • Health and Welfare (1981b) Guidelines for Pesticide Toxicology Data Requirements, Health Protection Branch, Canada.

    Google Scholar 

  • Healy MJR (1972) Animal litters as experimental units. Appl Statistics 21:155–159.

    Article  Google Scholar 

  • Hill R (1983) Model systems and their predictive value in assessing teratogens. Fund Appl Toxicol 3:229–232.

    Article  CAS  Google Scholar 

  • Insight Team (1979) (of Sunday Times of London) Suffer the Children: The Story of Thalidomide. Viking Press, New York.

    Google Scholar 

  • IRLG (1981) Recommended Guideline for Teratogenicity Studies in the Rat, Mouse, Hamster, or Rabbit. Testing Standards and Guidelines Work Group, Wash DC.

    Google Scholar 

  • IRLG (1986) Workshop on Reproductive Toxicity Risk Assessment. Environ Health Perspect 66:193–221.

    Google Scholar 

  • Jelinek R (1982) Use of chick embryo in screening for embryotoxicity. Teratog Carcinog Mutag 2:255–261.

    Article  CAS  Google Scholar 

  • Jensh RP (1983) Behavioral testing procedures: a review. In Johnson EM, Kochhar DM (eds) Teratogenesis and Reproductive Toxicology, Springer-Verlag, Berlin, pp 171–200.

    Google Scholar 

  • Johnson EM (1980) A subvertebrate system for rapid determination of potential teratogenic hazards. J Environ Pathol Toxicol 4:153–156.

    PubMed  CAS  Google Scholar 

  • Johnson EM (1981) Screening for teratogenic hazards: nature of the problem. Ann Rev Pharmacol Toxicol 21:417–429.

    Article  CAS  Google Scholar 

  • Johnson EM (1984) A prioritization and biological decision tree for developmental toxicity safety evaluations. J Am Coll Toxicol 3:141–147.

    Google Scholar 

  • Johnson EM (1986) False positives/false negatives in developmental toxicology and teratology. Teratology 34:361–362.

    Article  PubMed  CAS  Google Scholar 

  • Johnson EM, Christian, MS (1984) When is a teratology study not an evaluation of teratogenicity? J Am Coll Toxicol 3:431–434.

    Google Scholar 

  • Johnson EM, Gabel BEG (1983) An artificial ‘embryo’ for detection of abnormal developmental biology. Fund Appl Toxicol 3:243–249.

    Article  CAS  Google Scholar 

  • Johnson EM, Christian MS, Dansky L, Gabel BEG (1987) Use of the adult developmental relationship in prescreening for developmental hazards. Teratog Carcinog Mutag 7:273–285.

    Article  CAS  Google Scholar 

  • Karnofsky DA (1965) Drugs as teratogens in animals and man. Ann Rev Pharmacol 5:447–472.

    Article  CAS  Google Scholar 

  • Karnofsky DA, Basch RS (1960) Effects of 5-fluorodeoxyuridine and related halogenated pyrimidines on the sanddollar embryo. J Biophys Biochem Cytol 7:61–71.

    Article  PubMed  CAS  Google Scholar 

  • Keller SJ, Smith M (1982) Animal virus screens for potential teratogens: poxvirus morphogenesis. Teratog Carcinog Mutag 2:361–374.

    Article  CAS  Google Scholar 

  • Kelsey FO (1965) Problems raised for the FDA by the occurrence of thalidomide embryopathy in Germany, 1960–1961. Am J Pub Hlth 55:703–707.

    Article  CAS  Google Scholar 

  • Kelsey FO (1980) The importance of epidemiology in identifying drugs which may cause malformations—with particular reference to drugs containing sex hormones. Acta Morphol Acad Sci Hung 28:189–195.

    PubMed  CAS  Google Scholar 

  • Kelsey FO (1985) Drug labeling for teratogenicity: requirements of the U.S. Food and Drug Administration. Prog Clin Biol Res 163C: 155–159.

    PubMed  CAS  Google Scholar 

  • Kenel MF, Schardein, JL, Terry RD, Miller LG (1984) Developmental variations as markers of maternal and embryotoxicity. Teratology 29:40A–41A (Abst).

    Google Scholar 

  • Khera KS (1981) Common fetal aberrations and their teratologic significance. Fund Appl Toxicol 1:13–18.

    CAS  Google Scholar 

  • Khera KS (1985) Maternal toxicity: a possible etiological factor in embryo-fetal deaths and fetal malformations of rodent-rabbit species. Teratology 31:129–153.

    Article  PubMed  CAS  Google Scholar 

  • Kimmel CA (1981) A profile of developmental toxicity. In Kimmel CA, Buelke-Sam J (eds) Developmental Toxicology, Raven Press, New York, pp 321–331.

    Google Scholar 

  • Kimmel CA, Buelke-Sam J (1985) Collaborative Behavioral Teratology Study: background and review. Neurobehav Toxicol Teratol 7:541–545.

    PubMed  CAS  Google Scholar 

  • Kimmel CA, Wilson JG (1973) Skeletal deviations in rats: malformations or variations? Teratology 8:309–316.

    Article  PubMed  CAS  Google Scholar 

  • Kimmel CA, Buelke-Sam J, Adams J, Reiter LW, Sobotka TJ, Tilson HA (1982a) Design considerations in the evaluation of standardized methods in a behavioral teratology protocol. Teratology 25:54a (Abst).

    Google Scholar 

  • Kimmel CA, Buelke-Sam J, Adams J (1985) Collaborative Behavioral Teratology Study: implications, current applications and future directions. Neurobehav Toxicol Teratol 7:669–673.

    PubMed  CAS  Google Scholar 

  • Kimmel GL, Smith K, Kochhar DM, Pratt RM (1982b) Overview of in vitro teratogenicity testing: aspects of validation and application to screening. Teratog Carcinog Mutag 2:221–229.

    Article  CAS  Google Scholar 

  • Kitamura S, Hirano Y, Noguchi Y, Kojima T, Kakita T, Kuwaki H (1959) The epidemiological survey on Minamata disease. (No. 2). J Kumamoto Med Soc 33 (Suppl 3): 569–571.

    Google Scholar 

  • Kochhar DM (1982) Embryonic limb bud organ culture in assessment of teratogenicity of environmental agents. Teratog Carcinog Mutag 2:303–312.

    Article  CAS  Google Scholar 

  • Kopf R, Lorenz D, Salweski E (1964) Der Einfluss von Thalidomide auf die Fertilitat von Ratten in Generationversuch uber zwei Generationen. Naunyn Schmiedebergs Arch exp Path Pharmakol 247:121–135.

    Article  CAS  Google Scholar 

  • Kotzin BL, Baker RF (1972) Selective inhibition of genetic transcription in sea urchin embryos. J Cell Biol 55:74–81.

    Article  PubMed  CAS  Google Scholar 

  • Kunz W, Keller H, Muckter H (1956) N-Phthalyl-glutaminsaureimid. Arzneim Forsch 6:426–430.

    CAS  Google Scholar 

  • Lamar JK (1968) Consideration of the effects of drugs on reproduction. J New Drugs 8:9–14.

    CAS  Google Scholar 

  • Larsson KS, Elwin CE, Gabrielsson J, Paalzow L, Wachtmeister CA (1982) Do teratogenicity tests serve their objectives? Lancet 2:439.

    Article  PubMed  CAS  Google Scholar 

  • Lehman AJ (1965) (Staff, Division of Pharmacology, Food and Drug Administration, Department of Health, Education and Welfare) Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. The Association of Food and Drug Officials of the United States, pp 43–44.

    Google Scholar 

  • Lenz W (1961) Kindliche Missbildungen nach Medikament-Einnahme wahrend der Graviditat? Deut Med Wochenschr 86:2555–2556.

    Google Scholar 

  • Life Sciences Research Office (1986) Predicting Neurotoxicity and Behavior Dysfunction from Preclinical Toxicologic Data. In Leukroth RW (ed.) FASEB Report for Center for Food Safety and Applied Nutrition, FDA, and Dept of Health and Human Services, Bethesda, MD.

    Google Scholar 

  • Machemer L, Stenger EG (1971) [Examination of fetuses in teratological experiments. Modification of “Wilson Technique”]. Arzneim Forsch 21:144–145.

    CAS  Google Scholar 

  • MAFF (1985) Guidance on Toxicology Study Data for Application of Agricultural Chemical Registration. Ministry of Agriculture, Forestry and Fisheries, Director General, Agricultural Production Bureau, 59 NohSan No 4200, pp 45–49.

    Google Scholar 

  • Manson JM, Zenick H, Costlow RD (1982) Teratology test methods for laboratory animals. In Hayes AW (ed) Principles and Methods of Toxicology, Raven Press, New York, pp 141–184.

    Google Scholar 

  • Marks TA (1985) Animal tests employed to assess the effects of drugs and chemicals on reproduction. In Lobl TJ, Hafez ESE (eds) Male Fertility and Its Regulation, MTP Press Ltd. Boston, pp 245–267.

    Google Scholar 

  • McBride WG (1961) Thalidomide and congenital abnormalities. Lancet 2:1358

    Article  Google Scholar 

  • Ministry of Health and Welfare (1984) Guidelines of Toxicity Studies. Notification No. 118 of the Pharmaceutical Affairs Bureau. Yakugyo Jiho Co. Ltd. Tokyo, Japan, pp 21–35.

    Google Scholar 

  • Monie IW, Kho KG, Morgan J (1965) Dissection procedure for rat fetuses permitting Alizarin red staining of skeleton and histological study of viscera. In: Supplement to Teratology Workshop Manual. A Collection of Lectures and Demonstrations from the 2nd Workshop in Teratology, Berkeley, 1965, PMA, Wash. DC, pp 163–173.

    Google Scholar 

  • Mummery CL, Van den Brink CE, Van der Saag PT, De Laat SW (1984) A short-term screening test for teratogens using differentiating neuroblastoma cells in vitro. Teratology 29:271–279.

    Article  PubMed  CAS  Google Scholar 

  • Murphy ML (1959) A comparison of the teratogenic effects of five polyfunctional alkylating agents on the rat fetus. Pediatrics 23:231–244.

    PubMed  CAS  Google Scholar 

  • NAS (1977) Principles and Procedures for Evaluating the Toxicity of Household Substances. A report prepared by the Committee for the Revision of NAS Publication 1138, Committee on Toxicology, National Research Council, Wash. DC, pp 99–110.

    Google Scholar 

  • Nau H, Zierer R, Spielmann H, Neubert D, Gansau C (1981) A new model for embryotoxicity testing: teratogenicity and pharmacokinetics of valproic acid following constant rate administration. Life Sci 29:2803–2813.

    Article  PubMed  CAS  Google Scholar 

  • Nelson CJ, Felton RP, Kimmel CA, Buelke-Sam J, Adams J (1985) Collaborative Behavioral Teratology Study: statistical approach. Neurobehav Toxicol Teratol 7:587–590.

    PubMed  CAS  Google Scholar 

  • Nisbet ICT, Karch NJ (1983) Chemical Hazards to Human Reproduction, Noyes Data Corp. Park Ridge, NJ.

    Google Scholar 

  • Nolen GA (1985) An industrial developmental toxicologist’s view of behavioral teratology and possible guidelines. Neurobehav Toxicol Teratol 7:653–657.

    PubMed  CAS  Google Scholar 

  • OECD (1981) Guidelines for Testing of Chemicals. Director of Information, OECD, Paris, France.

    Google Scholar 

  • Palmer AK (1974) Problems associated with the screening of drugs for possible teratogenic activity. Exp Embryol Teratol 1:16–33.

    PubMed  CAS  Google Scholar 

  • Palmer AK (1976) Assessment of current test procedures. Environ. Health Perspect. 18:97–104.

    Article  PubMed  CAS  Google Scholar 

  • Palmer AK (1981) Regulatory requirements for reproductive toxicology: theory and practice. In Kimmel CA, Buelke-Sam J (eds) Developmental Toxicology, Raven Press, New York, pp 259–287.

    Google Scholar 

  • Palmer AK, Cozens DD (1980) Comments on the history of teratology testing. Teratology 21:260 (letter).

    Article  PubMed  CAS  Google Scholar 

  • Panel on Reproduction (1970). Food and Drug Administration Advisory Committee on Protocols for Safety Evaluations: Report on Reproduction Studies in the Safety Evaluation of Food Additives and Pesticide Residues. Toxicol Appl Pharmacol 16:264–296.

    Article  Google Scholar 

  • Peck HM (1963) Preclinical evaluation of drugs for evidence of teratogenic activity. J Pharm Sci 52:1115–1120.

    Article  PubMed  CAS  Google Scholar 

  • Pesticides Safety Precautions Scheme (1982) Working Document B8, England.

    Google Scholar 

  • PMA (1977) Preclinical Guidelines for the Assessment of Drug and Medical Device Safety in Animals. PMA Drug Safety Subsection, pp 45–54.

    Google Scholar 

  • Powell JG, Cochrane RL (1978) The effects of the administration of fenoprofen or indomethacin to rat dams during late pregnancy, with special reference to the ductus arteriosus of the fetuses and neonates. Toxicol Appl Pharmacol 45:783–796.

    Article  PubMed  CAS  Google Scholar 

  • Pratt RM, Willis WD (1985) In vitro screening assay for teratogens using growth inhibition of human embryonic cells. Proc Nat Acad Sci USA 82:5791–5794.

    Article  PubMed  CAS  Google Scholar 

  • Raynaud A (1937) Intersexualite provoquee chez la souris femelle par injection d’hormone male a la mere en gestation. C. R. Soc. Biol. (Paris) 126:866–868.

    CAS  Google Scholar 

  • Report (1963) Conference on Prenatal Effects of Drugs, Chicago. Commission on Drug Safety.

    Google Scholar 

  • Robson JM, Sullivan RM (1968) Teratology. In Boyland E, Goulding R (eds) Modern Trends in Toxicology, Appleton-Century-Crofts, New York, pp 86–106.

    Google Scholar 

  • Schardein JL (1983) Teratogenic risk assessment. Past, present, and future. In Kalter H (ed) Issues and Reviews in Teratology, Vol. 1, Plenum, New York, pp 181–214.

    Google Scholar 

  • Schardein JL (1985) Chemically Induced Birth Defects. Marcel Dekker, New York.

    Google Scholar 

  • Schardein JL (1987) Approaches to defining the relationship of maternal and developmental toxicity. Teratog Carcinog Mutag 7:255–271.

    Article  CAS  Google Scholar 

  • Schardein JL, Schwetz BA, Kenel MF (1985) Species sensitivities and prediction of teratogenic potential. Environ Hlth Perspect 61:55–67.

    CAS  Google Scholar 

  • Scholer HFL, deWachter AM (1961) Evaluation of androgenic properties of progestational compounds in the rat by the female foetal masculinization test. Acta Endocrinol (Kbh.) 38:128–136.

    CAS  Google Scholar 

  • Schuler RL, Radike MA, Hardin BD, Niemeier RW (1985) Pattern of response of intact Drosophila to known teratogens. J Am Coll Toxicol 4:291–303.

    CAS  Google Scholar 

  • Schwetz BA (1981) Monitoring problems in teratology. In Gralla EJ (ed) Scientific Considerations in Monitoring and Evaluating Toxicological Research, Hemisphere Publ Corp Wash. DC, pp 179–192.

    Google Scholar 

  • Secretary’s Commission (1969) Report on Pesticides and Their Relationship to Environmental Health. U.S. Dept. of Health, Education and Welfare.

    Google Scholar 

  • Shepard TH (1983) Teratology—information useful in advising health personnel and at-risk individuals. Develop Pharmacol 135:343–349.

    CAS  Google Scholar 

  • Sher SP, Bokelman DL, Ditzler WD (1980) Preclinical toxicity requirements for human drugs. Drug Info J 14:82–97.

    Google Scholar 

  • Sjostrom H, Nilsson R (1972) Thalidomide and the Power of the Drug Companies. Penguin, Great Britain.

    Google Scholar 

  • Sleet RB, Brendel K (1985) Homogenous populations of Artemia nauplii and their potential use for in vitro testing in developmental toxicology. Teratog. Carcinog Mutag 5:41–54.

    Article  CAS  Google Scholar 

  • Smith MK, Kimmel GL, Kochhar DM, Shepard TH, Spielberg SP, Wilson JG (1983) A selection of candidate compounds for in vitro teratogenesis test validation. Teratog Carcinog Mutag 3:461–480.

    Article  CAS  Google Scholar 

  • Somers GF (1962) Thalidomide and congential abnormalities. Lancet 1:912–913.

    Article  PubMed  CAS  Google Scholar 

  • Staples RE (1974) Detection of visceral alterations in mammalian fetuses. Teratology 9:A37–38(Abst).

    Article  Google Scholar 

  • Staples RE (1975) Definition of teratogenesis and teratogen. In Shepard TH, Miller JR, Marois M (eds) Method for Detection of Environmental Agents That Produce Congenital Defects, North Holland Publ. Co. Amsterdam, pp 25–26.

    Google Scholar 

  • State of California (1984) Food and Agriculture Code. Article 14. Birth Defect Prevention (S. B. 950), pp 13121–13130.

    Google Scholar 

  • Sterz H (1977) Routine examination of rat and rabbit fetuses for malformation of internal organ combination of Barrow’s and Wilson’s methods. In: Neubert D, Merker H-J, Kwashigrouch TE (eds) Methods in Prenatal Toxicology. Evaluation of Embryonic Effects in Experimental Animals. Teratology Workshop, Berlin, 1977, Georg Thieme Publ., Stuttgart, pp 113–122.

    Google Scholar 

  • Sterz H, Lehmann H (1985) A critical comparison of the freehand razor-blade dissection method according to Wilson with an in situ sectioning method for rat fetuses. Teratog Carcinog Mutag 5:347–354.

    Article  CAS  Google Scholar 

  • Stuckhardt JL, Poppe SM (1984) Fresh visceral examination of rat and rabbit fetuses used in teratogenicity testing. Teratog Carcinog Mutag 4:181–188.

    Article  CAS  Google Scholar 

  • Tanimura T (1985a) Guidelines for developmental toxicity testing of chemicals in Japan. Neurobehav Toxicol Teratol 7:647–652.

    PubMed  CAS  Google Scholar 

  • Tanimura T (1985b) Twenty-five years’ history of the Japanese Teratology Society. Cong Anom 25:261 – 281.

    Article  Google Scholar 

  • Thiersch JB (1952) Therapeutic abortions with a folic acid antagonist 4-aminopteroyl-glutamic acid administered by the oral route. Am J Obstet Gynecol 63:1298–1304.

    PubMed  CAS  Google Scholar 

  • Tousey S (1905) Discussion of paper by Edw. C. Titus. J Adv Therap 23:650.

    Google Scholar 

  • TSCA (1979) Subpart F—Teratogenic/Reproductive Health Effects. Federal Register 44 (145): 44087–44089.

    Google Scholar 

  • TSCA (1985) Part 798—Health Effects Testing Guidelines. Federal Register 50 (188): 39397–39471.

    Google Scholar 

  • Tuchmann-Duplessis H (1965) Design and interpretation of teratogenic tests. In Robson JM, Sullivan FM, Smith RL (eds) Embryopathic Activity of Drugs, Little Brown & Co. Boston, pp 56–93.

    Google Scholar 

  • Tuchmann-Duplessis H (1972) Teratogenic drug screening. Present procedures and requirements. Teratology 5:271–286.

    Article  PubMed  CAS  Google Scholar 

  • Tuchmann-Duplessis H (1980) The experimental approach to teratogenicity. Ecotoxicol Environ Safety 4:422–433.

    Article  PubMed  CAS  Google Scholar 

  • van Julsingha EB, Bennett CG (1977) A dissecting procedure for the detection of anomalies in the rabbit foetal head. In: Neubert D, Merker H-J, Kwashigrouch TE (eds) Methods in Prenatal Toxicology. Evaluation of Embryotoxic Effects in Experimental Animals. Teratology Workshop, Berlin, 1977, Georg Thieme Publ., Stuttgart, pp 126–144.

    Google Scholar 

  • Vorhees CV (1983) Behavioral teratogenicity testing as a method of screening for hazards to human health: a methodological approach. Neurobehav Toxicol Teratol 5:469–474.

    PubMed  CAS  Google Scholar 

  • Vorhees CV (1985) Comparison of the Collaborative Behavioral Teratology and the Cincinnati Behavioral Teratology test batteries. Neurobehav Toxicol Teratol 7:625–633.

    PubMed  CAS  Google Scholar 

  • Vorhees CV, Butcher RE (1982) Behavioral teratogenicity. In Snell K (ed) Developmental Toxicology, Croom Helm Press, London, pp 247–298.

    Google Scholar 

  • Vorhees CV, Brunner RL, Butcher RE (1979) Psychotropic drugs as behavioral teratogens. Science 205:1220–1225.

    Article  PubMed  CAS  Google Scholar 

  • Vorhees CV, Butcher RE, Brunner RL (1984) Developmental toxicity and psycho toxicity of potassium iodide in rats: a case for the inclusion of behavior in toxicological assessment. Food Chem Toxicol 22:963–970.

    Article  PubMed  CAS  Google Scholar 

  • Warkany J (1965) Development of experimental mammalian teratology. In: Wilson JG, Warkany J (eds) Teratology. Principles and Techniques, U. of Chicago Press, Chicago, pp 1–11.

    Google Scholar 

  • Weil CS (1970) Selection of the valid number of sampling units and a consideration of their combination in toxicological studies involving reproduction, teratogenesis or carcinogenesis. Food Cosmet Toxicol 8:177–182.

    Article  PubMed  CAS  Google Scholar 

  • Weil CS (1972) Statistics vs. safety factors and scientific judgment in the evaluation of safety for man. Toxicol Appl Pharmacol 21:454–463.

    Article  PubMed  CAS  Google Scholar 

  • Welsch F, Stedman DB (1984) Inhibition of metabolic cooperation between Chinese hamster V79 cells by structurally diverse teratogens. Teratog Carcinog Mutag 4:285–302.

    Article  CAS  Google Scholar 

  • Wendler D (1980) The state and future requirements of teratogenic testing. Arch Toxicol (Suppl 4): 274–283.

    CAS  Google Scholar 

  • Werboff J, Gottlieb JS (1963) Drugs in pregnancy: behavioral teratology. Obstet Gynecol Surv 18:420–423.

    Article  Google Scholar 

  • W.H.O. (1967) Principles for the Testing of Drugs for Teratogenicity. Report of a WHO Scientific Group. WHO Tech Rep Ser No 364, pp 5–18.

    Google Scholar 

  • W.H.O (1975) Guidelines for Evaluation of Drugs for Use in Man. Report of a WHO Scientific Group. WHO Tech Rep Ser No 563, pp 25–29.

    Google Scholar 

  • Wickramaratne GA deS (1985) The Chernoff-Kavlock in vivo teratogenicity screen adapted for use in rats. Teratology 31:69A (Abst).

    Google Scholar 

  • Wickramaratne GA deS (1987) The Chernoff-Kavlock assay: its validation and application in rats. Teratog Carcinog Mutag 7:73–83.

    Article  CAS  Google Scholar 

  • Wilk AL, Greenberg JH, Horigan EA, Pratt RM, Martin GR (1980) Detection of teratogenic compounds using differentiating embryonic cells in culture. In Vitro 16:269–276.

    Article  PubMed  CAS  Google Scholar 

  • Wilson JG (1959) Experimental studies on congenital malformations. J Chronic Dis 10:111–130.

    Article  PubMed  CAS  Google Scholar 

  • Wilson JG (1965) Methods for administering agents and detecting malformations in experimental animals. In: Wilson JG, Warkany J (eds) Teratology. Principles and Techniques, Univ. of Chicago Press, Chicago, pp 263–277.

    Google Scholar 

  • Wilson JG (1968) Introduction: problems of teratogenic testing. In: Fink BR (ed) Toxicity of Anesthetics, Williams & Wilkins, Baltimore, pp 259–268.

    Google Scholar 

  • Wilson JG (1973) Environment and Birth Defects. Academic Press, New York.

    Google Scholar 

  • Wilson JG (1975) Reproduction and teratogenesis: current methods and suggested improvements. J Assoc Offic Anal Chem 58:657–667.

    CAS  Google Scholar 

  • Wilson JG (1977) Teratogenic effects of environmental chemicals. Fed Proc 36:1698–1703.

    PubMed  CAS  Google Scholar 

  • Wilson JG (1978) Review of in vitro systems with potential for use in teratogenicity screening. J Environ Pathol Toxicol 2:149–167.

    PubMed  CAS  Google Scholar 

  • Wilson JG (1979) The evolution of teratological testing. Teratology 20:205–212.

    Article  PubMed  CAS  Google Scholar 

  • Wilson JG, Warkany J (eds) (1965) Teratology. Principles and Techniques. University of Chicago Press, Chicago.

    Google Scholar 

  • Wilson JG, Warkany J (1985) The history of organized teratology in North America. Teratology 31:285–296.

    Article  PubMed  CAS  Google Scholar 

  • Wolkowski-Tyl R (1981) Reproductive and teratogenic effects: no more thalidomides. ACS Symp Ser Pestic Mod Toxicol pp 115–155.

    Google Scholar 

  • Woo DC, Hoar RM (1972) “Apparent, hydronephrosis” as a normal aspect of renal development in late gestation in rats: the effect of methyl salicylate. Teratology 6:191–196.

    Article  PubMed  CAS  Google Scholar 

  • Zbinden G (1981) Experimental methods in behavioral teratology. Arch Toxicol 48:69–88.

    Article  PubMed  CAS  Google Scholar 

  • Zilva SS, Golding J, Drummond JC, Coward KH (1921) The relation of the fatsoluable factor to rickets and growth in pigs. Biochem J 15:427–437.

    PubMed  CAS  Google Scholar 

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  1. International Research and Development Corporation, Mattawan, Michigan, 49071, USA

    James L. Schardein

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  1. College of Agriculture, University of Arizona, Tucson, Arizona, 85721, USA

    George W. Ware

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Schardein, J.L. (1988). Teratologic Testing: Status and Issues After Two Decades of Evolution. In: Ware, G.W. (eds) Reviews of Environmental Contamination and Toxicology. Reviews of Environmental Contamination and Toxicology, vol 102. Springer, New York, NY. https://doi.org/10.1007/978-1-4612-3810-2_1

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