Developmental neurotoxicity guideline study: Issues with methodology, evaluation and regulation

Congenital Anomalies

Volumn 52, Issue 3, 2012, Pages 122-128

  Tsuji, Ryozo ^a   Crofton, Kevin M ^b  

^a SUMITOMO CHEMICAL CO LTD   (Japan)

^b U S ENVIRONMENTAL PROTECTION AGENCY   (United States)

Author keywords

Developmental neurotoxicity; Environmental Protection Agency; Guideline study; Organisation for Economic Co operation and Development; Regulation

Indexed keywords

COST; DEVELOPMENTAL NEUROTOXICITY; EVALUATION; EXPOSURE; FEEDING; HUMAN; LEARNING; MEMORY; METHODOLOGY; NEUROPATHOLOGY; NEUROTOXICITY; NONHUMAN; PRACTICE GUIDELINE; PRIORITY JOURNAL; PROGENY; REVIEW;

ANIMALS; ENVIRONMENTAL POLLUTANTS; GUIDELINES AS TOPIC; HUMANS; NEUROTOXICITY SYNDROMES; RATS; RISK ASSESSMENT; TOXICITY TESTS; UNITED STATES; UNITED STATES ENVIRONMENTAL PROTECTION AGENCY;

ANIMALIA; RATTUS;

EID: 84865552179     PISSN: 09143505     EISSN: 17414520     Source Type: Journal    
DOI: 10.1111/j.1741-4520.2012.00374.x     Document Type: Review

References (45)

1. Bolon B, Garman R, Jensen K etal. Ad Hoc Working Group of the STP Scientific and Regulatory Policy Committee. 2006. A 'best practices' approach to neuropathologic assessment in developmental neurotoxicity testing - for today. Toxicol Pathol 34:296-313.
2. Bolon B, Garman RH, Gundersen HJ etal. 2011. Continuing education course #3: current practices and future trends in neuropathology assessment for developmental neurotoxicity testing. Toxicol Pathol 39:289-293.
3. Chakrabarti S, Fombonne E. 2005. Pervasive developmental disorders in preschool children: confirmation of high prevalence. Am J Psychiatry 162:1133-1141.
4. Clancy B, Finlay BL, Darlington RB etal. 2007. Extrapolating brain development from experimental species to humans. Neurotoxicology 28:931-937.
5. Coecke S, Goldberg AM, Allen S etal. 2007. Workgroup report: incorporating in vitro alternative methods for developmental neurotoxicity into international hazard and risk assessment strategies. Environ Health Perspect 115:929-931.
6. Cooper RL. 2009. Current developments in reproductive toxicity testing of pesticides. Reprod Toxicol 28:180-187.
7. Crofton KM, Foss JA, Hass U etal. 2008. Undertaking positive control studies as part of developmental neurotoxicity testing: a report from the ILSI Research Foundation/Risk Science Institute expert working group on neurodevelopmental endpoints. Neurotoxicol Teratol 30:266-287.
8. Crofton KM, Makris SL, Sette WF etal. 2004. A qualitative retrospective analysis of positive control data in developmental neurotoxicity studies. Neurotoxicol Teratol 26:345-352.
9. Crofton KM, Mundy WR, Lein PJ etal. 2011. Developmental neurotoxicity testing: recommendations for developing alternative methods for the screening and prioritization of chemicals. ALTEX 28:9-15.
10. Dobbing J. 1974. The later growth of the brain and its vulnerability. Pediatrics 53:2-6.
11. Dobbing J, Sand J. 1979. Comparative aspects of the brain growth spurt. Early Hum Dev 3:79-83.
12. Ema M, Fukui Y, Aoyama H etal. 2007. Comments from the Developmental Neurotoxicology Committee of the Japanese Teratology Society on the OECD Guideline for the Testing of Chemicals, Proposal for a New Guideline 426, Developmental Neurotoxicity Study, Draft Document (October 2006 version), and on the Draft Document of the Retrospective Performance Assessment of the Draft Test Guideline 426 on developmental neurotoxicity. Congenit Anom (Kyoto) 47:74-76.
13. GAO. 2005. Chemical regulation: options exist to improve EPA's ability to assess health risks and manage its chemical review program. GAO-05-458. U.S. Government Accounting Office. Washington, D.C. http://www.gao.gov/products/GAO-05-458[Accessed January 31, 2012].
14. Grandjean P, Landrigan PL. 2006. Developmental neurotoxicity of industrial chemicals. Lancet 368:2167-2178.
15. Harada T. 2009. Research report of gathering information about methods for evaluations of developmental neurotoxicity induced by chemicals. http://www.fsc.go.jp/fsciis/survey/show/cho20090140001[ Accessed January 31, 2012].
16. Howdeshell KL. 2002. A model of the development of the brain as a construct of the thyroid system. Environ Health Perspect 110(Suppl 3):337-348.
17. Judson R, Richard A, Dix DJ etal. 2009. The toxicity data landscape for environmental chemicals. Environ Health Perspect 117:685-695.
18. Kawamoto T, Tsukamoto N, Tanto M etal. 2011. Japan environment and children's study. Epidemiology 22:157-158.
19. Landrigan PJ, Kimmel CA, Correa A etal. 2004. Children's health and the environment: public health issues and challenges for risk assessment. Environ Health Perspect 112:257-265.
20. Landrigan PJ, Schechter CB, Lipton JM etal. 2002. Environmental pollutants and disease in American children: estimates of morbidity, mortality, and costs for lead poisoning, asthma, cancer, and developmental disabilities. Environ Health Perspect 156:877-883.
21. Lein P, Locke P, Goldberg A. 2007. Meeting report: alternatives for developmental neurotoxicity testing. Environ Health Perspect 115:764-768.
22. Makris SL, Raffaele K, Allen S etal. 2009. A retrospective performance assessment of the developmental neurotoxicity study in support of OECD test guideline 426. Environ Health Perspect 117:17-25.
23. May M. 2000. Distributing behavior: neurotoxic effects in children. Environ Health Perspect 108:A262-A267.
24. McDonald ME, Paul JF. 2010. Timing of increased autistic disorder cumulative incidence. Environ Sci Technol 44:2112-2118.
25. MEXT Japan. 1999. Present state of escalation of violence, bullying and refusal to attend school. Japanese Government Policies in Education, Science and Culture 1999. http://www.mext.go.jp/b_menu/hakusho/html/hpad199901/hpad199901_2_052.html[Accessed January 31, 2012].
26. Mileson BE, Fernc SA. 2001. Methods to identify and characterize developmental neurotoxicity for human risk assessment: overview. Environ Health Perspect 109(Suppl 1):77-78.
27. Mizutani M. 1985. Collaborative studies on behavioral teratology by 46 laboratories: effects of behavioral teratogenicity chemicals on the learning behavior of the rat. Congenit Anom 25:197.
28. Nishimura T, Iwase T, Hasimoto Y etal. 2001. Evaluation of a core battery of tests for detecting behavioral dysfunction of rat offspring induced by retinoic acid: collaborative work II of the Japanese Behavioral Teratology Committee. Congenit Anom 41:156-168.
29. NRC. 1984. Toxicity testing: strategies to determine needs and priorities. Washington DC: National Research Council, National Academy Press. ISBN 0-3-0-03433-7.
30. NRC. 2004. Appendix A: values and limitations of animal toxicity data, intentional human dosing studies for EPA regulatory purposes - scientific and ethical issues. Washington DC: National Research Council, The National Academies Press. ISBN 0-309-09172-1.
31. NRC. 2007. Toxicity testing in the 21st century: a vision and a strategy. Washington, DC: National Research Council The National Academies Press. ISBN 0-309-15173-2.
32. OECD. 2007. OECD guidelines for the testing of chemicals/section 4: health effects. Test No. 426: developmental neurotoxicity study. http://www.oecd.org/dataoecd/20/52/37622194.pdf[Accessed January 31, 2012].
33. Okazaki S, Takashima H, Yamaguchi M etal. 2003. Neurobehavioral toxicity of acrylamide and IDPN (3, 3′-iminodipropionitrile) in rats by 28-day oral administration - problems encountered in collaborative study and a commentary on conducting neurobehavioral testing. J Toxicol Sci 28(Suppl 1):1-14.
34. Raffaele KC, Rowland J, May B etal. 2010. The use of developmental neurotoxicity data in pesticide risk assessments. Neurotoxicol Teratol 32:563-572.
35. Rice D, Barone S Jr. 2000. Critical periods of vulnerability for the developing nervous system: evidence from humans and animal models. Environ Health Perspect 108(Suppl 3):511-533.
36. Satoh H, Tsukamoto N, Kawamoto T etal. 2010. Inauguration of JECS: Ministry of the Environment; Japan Environment and Children's Study. IGAKU NO AYUMI 235:1081-1132. (In Japanese).
37. Tachibana T, Terada Y, Fukunishi K etal. 1996. Estimated magnitude of behavioral effects of phenytoin in rats and its reproducibility: a collaborative behavioral teratology study in Japan. Physiol Behav 60:941-952.
38. Tanimura T. 1986. Collaborative studies on behavioral teratology in Japan. Neurotoxicology 7:35-45.
39. Trasande L, Landrigan PJ, Schechter C. 2005. Public health and economic consequences of methyl mercury toxicity to the developing brain. Environ Health Perspect 113:590-596.
40. Tyl RW, Crofton K, Moretto A etal. 2008. Identification and interpretation of developmental neurotoxicity effects: a report from the ILSI Research Foundation/Risk Science Institute expert working group on neurodevelopmental endpoints. Neurotoxicol Teratol 30:349-381.
41. USEPA. 1998a. Guidelines for neurotoxicity risk assessment. Fed Regist 63:26926-26954. http://www.epa.gov/raf/publications/pdfs/NEUROTOX.PDF[Accessed January 31, 2012].
42. USEPA. 1998b. Health effects guidelines OPPTS 870.6300 developmental neurotoxicity study. EPA 712-C-98-239. http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0156-0042[Accessed January 31, 2012].
43. USEPA. 2002. Organophosphate pesticides: revised cumulative risk assessment. http://www.epa.gov/opp00001/cumulative/rra-op/[Accessed January 31, 2012].
44. WHO. 2001. Neurotoxicity risk assessment for human health: principles and approaches. Environmental Health Criteria 223. http://www.inchem.org/documents/ehc/ehc/ehc223.htm[Accessed January 31, 2012].
45. Zhao Q, Dourson M, Gadagbui B. 2006. A review of the reference dose for chlorpyrifos. Regul Toxicol Pharmacol 44:111-124.