Module 3 - Strategic case studies in practice

ICH Q3D(R1) Guideline

Taking into account the modifying factors (F1-F5 as discussed in Appendix 1), the inhalation PDE is calculated as:

For continuous dosing =

500 µg/ m 3 x 8 hr/d x 5 d/wk = 119 µg/ m 3 = 0.119 µg/L 24 hr/d x 7 d/wk 1000 L/m 3

Daily dose = 0.119 µg/L x 28800 L = 68.6 µg/kg 50 kg

PDE = 68.6 µg/kg x 50 kg / 1 x 10 x 1 x 1 x 1 = 343 µg/day

R EFERENCES

ATSDR. Toxicological profile for barium and barium compounds. Agency for Toxic Substances and Disease Registry, Public Health Service, U.S. Department of Health and Human Services, Atlanta, GA. 2007. CICAD. Barium and barium compounds. Concise International Chemical Assessment Document 33. World Health Organization, Geneva. 2001. NTP. Technical report on the toxicology and carcinogenesis studies of barium chloride dihydrate (CAS No. 10326-27-9) in F344/N rats and B6C3F1 mice (drinking water studies). National Toxicology Program, Public Health Service, U.S. Department of Health and Human Services, Research Triangle Park, NC. 1994;NTP TR 432. US DoL (OHSA). 29 CRF 1910.1000 Table Z-1. Limits for air contaminants. U.S. Department of Labor. 2013. WHO. Barium in drinking-water: Background document for development of WHO guidelines for drinking-water quality. World Health Organization, Geneva. 2004. WHO/SDE/WSH/03.04/76.

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