Module 3 - Strategic case studies in practice

ICH Q3D(R1) Guideline

Table A.1.1: Values Used in the Calculations in this Document Rat body weight 425 g

Mouse respiratory volume Rabbit respiratory volume Guinea pig respiratory volume Human respiratory volume Dog respiratory volume Monkey respiratory volume Mouse water consumption

43 L/day 1440 L/day 430 L/day 28,800 L/day 9,000 L/day 1,150 L/day 5 mL/day

Pregnant rat body weight Mouse body weight Pregnant mouse body weight Guinea pig body weight Rhesus monkey body weight Rabbit body weight (pregnant or not) Beagle dog body weight Rat respiratory volume

330 g 28 g 30 g 500 g 2.5 kg 4 kg

11.5 kg

Rat water consumption

30 mL/day 30 g/day

290 L/day Rat food consumption

References 1. United States Pharmacopeial Convention, Pharmacopeial Forum, Nov-Dec 1989. 2. IPCS. Assessing Human Health Risks of Chemicals: Derivation of Guidance Values for Health-based Exposure Limits, Environmental Health Criteria 170. International Programme on Chemical Safety. World Health Organization, Geneva. 1994. 3. US FDA, Guidance for Industry and Other Stakeholders: Toxicological Principles for the Safety Assessment of Food Ingredients (Redbook 2000), available at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInfor mation/IngredientsAdditivesGRASPackaging/ucm2006826.htm. 4. Tvermoes BE, Unice KM, Paustenbach DJ, Finley BL, Otani JM, Galbraith DA. Effects and blood concentrations of cobalt after ingestion of 1 mg/d by human volunteers for 90 d. Am J Clin Nutr 2014;99:632-46.

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