Skip to main content

Teratology Studies in the Rat

  • Protocol
  • First Online:
Book cover Teratogenicity Testing

Part of the book series: Methods in Molecular Biology ((MIMB,volume 947))

Abstract

The rat is the rodent species of choice for the regulatory safety testing of xenobiotics, such as medicinal products, food additives, and other chemicals. Many decades of experience and extensive data have accumulated for both general and developmental toxicology investigations in this species. The high fertility and large litter size of the rat are advantages for teratogenicity testing. The study designs are well defined in the regulatory guidelines and are relatively standardized between testing laboratories across the world. Teratology studies address maternal- and embryo-toxicity following exposure during the period of organogenesis. This chapter describes the design and conduct of a teratology study in the rat in compliance with the regulatory guidelines. The procedures for the handling and housing of the pregnant animals, the caesarean examinations and the sampling of fetuses for morphological examinations are described. The utility and design of preliminary studies and the inclusion of satellite animals in the main study for toxicokinetic sampling are discussed.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Protocol
USD 49.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 139.00
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 179.00
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD 219.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

References

  1. ICH (2005) Harmonised Tripartite Guideline S5(R2). Detection of toxicity to reproduction for medicinal products & toxicity to male fertility

    Google Scholar 

  2. OECD (2001) Guideline for the testing of chemicals 414. Prenatal Developmental Toxicity Study

    Google Scholar 

  3. FDA (2000) Toxicological principles for the safety of food ingredients IV.C.9.b. Guidelines for Developmental Toxicity Studies (Redbook 2000)

    Google Scholar 

  4. EPA (1998) Health Effects Test Guidelines OPPTS 870.3700. Prenatal Developmental Toxicity Study

    Google Scholar 

  5. ICH (2009) Harmonised Tripartite Guideline M3(R2). Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals

    Google Scholar 

  6. EU (2010) Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes

    Google Scholar 

  7. Tyl RW, Marr MC (1997) In: Hoo RD (ed) Handbook of developmental toxicology, 2nd edn. CRC, Boca Raton, pp 186–192

    Google Scholar 

  8. Barrow P (2000) Reproductive and developmental toxicology safety studies. In: Krinke G (ed) The laboratory rat. Academic, London, pp 199–225

    Chapter  Google Scholar 

  9. US National Research Council (2011). Guide for the care and use of laboratory animals. 8th edn. http://oacu.od.nih.gov/regs/guide/guide.pdf. Accessed 14 Feb 2012

  10. Decree n° 2001-464 regarding the experiments with laboratory animals described in the Journal Officiel de la République Française on 29 May 2001

    Google Scholar 

  11. Decree n° 2001-486 relating to the protection of animals used in scientific experiments described in the Journal Officiel de la République Française on 6 June 2001

    Google Scholar 

  12. European Parliament (2010). Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes

    Google Scholar 

  13. Dainty TC et al (2012) Dried blood spot bioanalysis: an evaluation of techniques and opportunities for reduction and refinement in mouse and juvenile rat toxicokinetic studies. Int J Toxicol 31(1):4–13. doi:10.1177/1091581811429493

    Article  PubMed  CAS  Google Scholar 

  14. Jonsson O et al (2011) Capillary Microsampling (CMS). Collection and analysis of small exact volumes of liquid blood or plasma samples. http://www.diahome.org/productfiles/25852/jonsson%20astrazeneca%20capillary%20microsampling%201compatibility%20mode.pdf. Accessed 11 Feb 2012

  15. Salewski E (1964) Faerbermethode zum Makroskopischen Nachweis von Implantations Stellen am Uterus der Ratte. Naunyn-Schmeidebergs Arch Pharmakol Exp Pathol 247:367

    Article  Google Scholar 

  16. Makris SL, Solomon HM et al (2009) Terminology of developmental abnormalities in common laboratory mammals (version 2). Birth Def Res B Dev Reprod Toxicol 86:227–327

    Article  CAS  Google Scholar 

  17. Paumgartten F et al (2009) Harmonization of terminology in developmental toxicology: the quest for a more precise description and a harmonized classification of fetal observations. Reprod Toxicol 27(1):8–13

    Article  PubMed  CAS  Google Scholar 

  18. Barrow PC (2009) Reproductive toxicity testing for pharmaceuticals under ICH. Reprod Toxicol 28:172–179

    Article  PubMed  CAS  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Mariline Leroy .

Editor information

Editors and Affiliations

Rights and permissions

Reprints and permissions

Copyright information

© 2013 Springer Science+Business Media, LLC

About this protocol

Cite this protocol

Leroy, M., Allais, L. (2013). Teratology Studies in the Rat. In: Barrow, P. (eds) Teratogenicity Testing. Methods in Molecular Biology, vol 947. Humana Press, Totowa, NJ. https://doi.org/10.1007/978-1-62703-131-8_9

Download citation

  • DOI: https://doi.org/10.1007/978-1-62703-131-8_9

  • Published:

  • Publisher Name: Humana Press, Totowa, NJ

  • Print ISBN: 978-1-62703-130-1

  • Online ISBN: 978-1-62703-131-8

  • eBook Packages: Springer Protocols

Publish with us

Policies and ethics