Current developments in reproductive toxicity testing of pesticides

Reproductive Toxicology

Volumn 28, Issue 2, 2009, Pages 180-187

  Cooper, Ralph L ^a  

^a U S ENVIRONMENTAL PROTECTION AGENCY   (United States)

Author keywords

Immunotoxicology; Multigenerational testing; Neurotoxicology; Reproductive toxicology; Risk assessment

Indexed keywords

PESTICIDE;

ARTICLE; CROP PROTECTION; DECISION MAKING; DEVELOPMENTAL DISORDER; ENVIRONMENTAL EXPOSURE; HEALTH HAZARD; IMMUNOTOXICITY; MATING; METHODOLOGY; NEUROTOXICITY; NONHUMAN; PRACTICE GUIDELINE; PROGENY; REPRODUCTIVE TOXICITY; RISK ASSESSMENT; SAFETY; SCREENING TEST; TOXICOKINETICS; UNITED STATES;

ANIMALS; CONSENSUS DEVELOPMENT CONFERENCES AS TOPIC; ENDPOINT DETERMINATION; FEMALE; GUIDELINES AS TOPIC; IMMUNE SYSTEM; MALE; NERVOUS SYSTEM; PESTICIDES; RATS; REPRODUCTION; RISK ASSESSMENT; TOXICITY TESTS;

ANIMALIA; RATTUS;

EID: 67651002633     PISSN: 08906238     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.reprotox.2009.04.014     Document Type: Article

References (34)

1. ICH International Conference on Harmonisation; Guideline on Detection of Toxicity to Reproduction for Medicinal Products 1994; Fed. Reg., September 22, 1994; 59, 48746.
2. OECD Test Guideline 414. OECD Guideline for Testing of Chemicals. Prenatal Developmental Toxicity Study. Organisation for Economic Co-operation and Development, Paris, France; 2001. Available at http://caliban.sourceoecd.org/vl=8257865/cl=11/nw=1/rpsv/ij/oecdjournals /1607310x/v1n4/s15/p1.
3. OECD Test Guideline 416. OECD Guideline for Testing of Chemicals. Two-generation Reproduction Toxicity Study. Organisation for Economic Co-operation and Development, Paris, France; 2001. Available at http://caliban.sourceoecd.org/vl=8257865/cl=11/nw=1/rpsv/ij/oecdjournals /1607310x/v1n4/s17/p1.
4. US EPA Health Effects Test Guidelines, OPPTS 870.3700, Prenatal Developmental Toxicity Study, EPA 712-C-98-207. Office of Prevention, Pesticides, and Toxic Substances, US Environmental Protection Agency, Washington, DC; 1998. Available at http://www.epa.gov/opptsfrs/publications/OPPTS_Harmonized/870_Health_Eff ects_Test_Guidelines/Series/.
5. US EPA Health Effects Test Guidelines, OPPTS 870.3800, Reproduction and Fertility Effects, EPA 712-C-98-208. Office of Prevention, Pesticides, and Toxic Substances, US Environmental Protection Agency, Washington, DC; 1998. Available at http://www.epa.gov/opptsfrs/publications/OPPTS_Harmonized/870_Health_Eff ects_Test_Guidelines/Series/.
6. US FDA Toxicological Principles for the Safety of Food Ingredients, Redbook 2000. IV.C.9.a. Guidelines for Reproduction Studies. Center for Food Safety and Applied Nutrition, US Food and Drug Administration, Washington, DC; 2000. p. 80-117. Available at http://www.cfsan.fda.gov/∼redbook/red-toca.html.
7. US FDA Toxicological Principles for the Safety of Food Ingredients, Redbook 2000, IV.C.9.b. Guidelines for Developmental Toxicity Studies. Center for Food Safety and Applied Nutrition, US Food and Drug Administration, Washington, DC; 2000. p. 123-34. Available at http://www.cfsan.fda.gov/∼redbook/red-toca.html.
8. Carmichael N.G., Barton H., Boobis A.R., Cooper R.L., Dellarco V.L., Doerrer N.G., et al. Agricultural chemical safety assessment: a multi-sector approach to the modernization of human safety requirements. Crit Rev Toxicol 36 (2006) 1-7
9. Barton H.A., Pastoor T.P., Baetcke K., Chambers J.E., Diliberto J., Doerrer N.G., et al. The acquisition and application of absorption, distribution, metabolism, and excretion (ADME) data in agricultural chemical safety assessments. Crit Rev Toxicol 36 (2006) 9-35
10. Doe J.E., Boobis A.R., Blacker A., Dellarco V.L., Doerrer N.G., Franklin C., et al. A tiered approach to systemic toxicity testing for agricultural chemical safety assessment. Crit Rev Toxicol 36 (2006) 37-68
11. Cooper R.L., Lamb J.C., Barlow S.M., Bentley K., Brady A.M., Doerrer N.G., et al. Technical Committee on Agricultural Chemical Safety Assessment (ACSA) Life Stages Task Force White Paper. Crit Rev Toxicol 36 (2006) 69-90
12. Spielmann H, Vogel R. The extended 1-generation study (OECD 415), as a replacement of the mammalian 2-generation study (OECD 416). In: Proceedings of the 6th World Congress on Alternatives & Animal Use in the Life Sciences, August 21-25, 2007, Tokyo, Japan.
13. Sakai T., Takahashi M., Mitsumori K., Yasuhara K., Kawashima K., Mayahara H., et al. Collaborative work to evaluate toxicity on male reproductive organs by repeated dose studies in rats-overview of the studies. Toxicol Sci (2000) Spec. No, 1-21
14. OECD Test Guideline 415. OECD Guideline for Testing of Chemicals. One-Generation Reproduction Toxicity Study. Organisation for Economic Co-operation and Development, Paris, France; 1983. Available at http://caliban.sourceoecd.org/vl=8257865/cl=11/nw=1/rpsv/ij/oecdjournals /1607310x/v1n4/s16/p1.
15. Hotchkiss A.K., Rider C.V., Blystone C.R., Wilson V.S., Hartig P.C., Ankley G.T., et al. Fifteen years after "Wingspread"-environmental endocrine disrupters and human and wildlife health: where we are today and where we need to go. Toxicol Sci 105 2 (2008) 235-259
16. Ulbrich B., and Palmer A.K. Detection of effects on male reproduction - a literature survey. J Am Coll Toxicol 14 4 (1995) 293-327
17. Makris S., Kimmel C., James L., Mendez E., and Piersma A. Reproductive toxicity studies: one generation versus two generations. The Toxicologist 47 (2008) 129
18. Reaves M.E., Cooper R., Dellarco V., Dix D., Martin M., Mendez E., et al. Retrospective analysis of multigeneration reproduction toxicity studies: what is the impact of the second generation in hazard assessment for pesticides. The Toxicologist 47 (2008) 244
19. Janer G., Hakkert B.C., Slob W., Vermeire T., and Piersma A.H. A retrospective analysis of the two-generation study: what is the added value of the second generation?. Reprod Toxicol 24 (2007) 97-102
20. Myers D.P., Willoughby C.R., Bottomley A.M., and Buschmann J. An analysis of the results from Two-Generation Reproduction Toxicity Studies to assess the value of the second generation for the detection of adverse treatment-related effects on reproductive performance. Reprod Toxicol 26 (2008) 47-50
21. US EPA Health Effects Test Guidelines, OPPTS 870.6300, Developmental Neurotoxicity Study, EPA 712-C-98-239. Office of Prevention, Pesticides, and Toxic Substances, US Environmental Protection Agency, Washington, DC; 1998. Available at http://www.epa.gov/opptsfrs/publications/OPPTS_Harmonized/870_Health_Eff ects_Test_Guidelines/Series/870-6300.pdf.
22. OECD Test Guideline 426. OECD Guideline for Testing of Chemicals. Developmental Neurotoxicity Study. Organisation for Economic Co-operation and Development, Paris, France; 2007. Available at http://www.oecdbookshop.org/oecd/display.asp?K=5L4FG25MNKXS&lang=EN &sort=sort_date%2Fd&sf1=Title&st1=neurotoxicity&sf3=Subje ctCode&st4=not+E4+or+E5+or+P5&sf4=SubVersionCode&ds=neurotox icity%3B+All+Subjects%3B+&m=1&dc=4&plang=en.
23. Makris S.L., Raffaele L., Allen S., Bowers W.J., Hass U., Alleva E., et al. A retrospective performance assessment of the developmental neurotoxicity study in support of OECD test guideline 426. Environ Health Perspect 117 1 (2009) 17-25
24. Holsapple P. Developmental immunotoxicity testing: a review. Toxicology 185 (2003) 193-203
25. Luebke R.W., Chen D.H., Dietert R., Yang Y., King M., and Luster M.I. The comparative immunotoxicity of five selected compounds following developmental or adult exposure. J Toxicol Environ Health B Crit Rev 9 (2006) 1-26
26. Dietert R.R., and Piepenbrink M.S. Perinatal immunotoxicity: why adult exposure assessment fails to predict risk. Environ Health Perspect 114 (2006) 477-483
27. Luster M.I., Portier C., Pait D.G., Rosenthal G.J., Germolec D.R., Corsini E., et al. Risk assessment in immunotoxicology. II. Relationships between immune and host resistance tests. Fundam Appl Toxicol 21 (1993) 71-82
28. ECETOC (Triggering and Waiving Criteria for the Extended One-Generation Reproduction Toxicity Study). Document No. 45, Brussels, Belgium, 2008, 51 pp. Available at: http://www.ecetoc.org/technical-documents.
29. Vogel R, Seidle T, Spielmann H. A modular one-generation reproduction study as a flexible testing system for regulatory safety assessment. J Reprod Toxicol, in press.
30. Moore N, Bremer S, Carmichael N, Datson G, Dent M, Gaua-Chapelle W, et al. A Modular Approach to the Extended One-Generation Reproduction Toxicity Study: Outcome of an ECETOC Task Force and International ECETOC/ECVAM Workshop. Alternatives to laboratory Animals; 2009.
31. OECD Test Guideline 421. OECD Guideline for Testing of Chemicals. Reproduction/Developmental Toxicity Screening Test. Organisation for Economic Co-operation and Development, Paris, France; 1995. Available at http://caliban.sourceoecd.org/vl=8257865/cl=11/nw=1/rpsv/ij/oecdjournals /1607310x/v1n4/s22/p1.
32. US EPA Health Effects Test Guidelines, OPPTS 870.3550, Reproduction/Developmental Toxicity Screening Test, EPA 712-C-00-367. Office of Prevention, Pesticides, and Toxic Substances, US Environmental Protection Agency, Washington, DC; 2000. Available at http://www.epa.gov/opptsfrs/publications/OPPTS_Harmonized/870_Health_Eff ects_Test_Guidelines/Series/870-3550.pdf.
33. OECD Test Guideline 422. OECD Guideline for Testing of Chemicals. combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test. Organisation for Economic Co-operation and Development, Paris, France; 1996. Available at http://caliban.sourceoecd.org/vl=8257865/cl=11/nw=1/rpsv/ij/oecdjournals /1607310x/v1n4/s23/p1.
34. US EPA Health Effects Test Guidelines, OPPTS 870.3650, Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test. EPA 712-C-00-368. Office of Prevention, Pesticides, and Toxic Substances, US Environmental Protection Agency, Washington, DC; 2000. Available at http://www.epa.gov/opptsfrs/publications/OPPTS_Harmonized/870_Health_Eff ects_Test_Guidelines/Series/870-3650.pdf.