Abstract
The rat is the routine species of choice as the rodent model for regulatory safety testing of xenobiotics such as medicinal products, food additives, and other chemicals. However, the rat is not always suitable for pharmacological, toxicological, immunogenic, pharmacokinetic, or even practical reasons. Under such circumstances, the mouse offers an alternative for finding a suitable rodent model acceptable to the regulatory authorities. Since all essential routes of administration are possible, the short reproductive cycle and large litter size of the mouse make it a species well adapted for use in teratology studies. Given that good quality animals, including virgin mated females, can be acquired relatively easily and inexpensively, the mouse has been used in reproductive toxicity studies for decades and study protocols are well established.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
Mouse Genome Sequencing Consortium (2002) Initial sequencing and comparative analysis of the mouse genome. Nature 420:520–562
ICH (2005) Harmonised tripartite guideline S5(R2). Detection of toxicity to reproduction for medicinal products & toxicity to male fertility
ICH (2011) Addendum to ICH S6: preclinical safety evaluation of biotechnology-derived pharmaceuticals
FDA (2006) Guidance for industry: considerations for developmental toxicity studies for preventive and therapeutic vaccines for infectious disease indications
OECD (2001) Guideline for the testing of chemicals 414. Prenatal developmental toxicity study
EPA (1998) Health effects test guidelines OPPTS 870.3700. Prenatal developmental toxicity study
FDA (Redbook 2000) Toxicological principles for the safety of food ingredients IV.C.9.b. Guidelines for developmental toxicity studies
European Community (EC) (2004) Commission directive 2004/73/EC, Part B, methods for the determination of toxicology, B.31: “Prenatal developmental toxicity study”, EC Publication No. L152
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
ILAR (1996) Commission on life sciences, National Research Council, Guide for the Care and Use of Laboratory Animals, National Academy Press
ICH (2009) Harmonised tripartite guideline M3(R2). Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals
Hood RD (1997) Handbook of developmental toxicology. In: Wilson (ed), CRC, Boca Raton, pp. 207–209
Hoff J (2000) Methods of blood collection in the mouse. Lab Anim 29(10):47–53
Hem A, Smith AJ, Solberg P (1998) Saphenous vein puncture for blood sampling of the mouse, rat, hamster, gerbil, guinea pig, ferret and mink. Lab Anim 32(4):364–368
Salewski E (1964) Faerbermethode zum makroskopischen nachweis von implantations stellen am uterus der ratte. Naunyn-Schmeidebergs Arch Pharmakol Exp Pathol 247:367
Makris SL et al (2009) Terminology of developmental abnormalities in common laboratory mammals (version 2). Birth Defects Res B Dev Reprod Toxicol 86:227–327
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
Barrow P (2000) Reproductive and developmental toxicology safety studies. In: Krinke G (ed) The laboratory rat. Academic, London, pp 199–225
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2013 Springer Science+Business Media, LLC
About this protocol
Cite this protocol
Marsden, E., Leroy, M. (2013). Teratology Studies in the Mouse. 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_10
Download citation
DOI: https://doi.org/10.1007/978-1-62703-131-8_10
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