Repeated-dose 90-day Oral Toxicity Studies on Whole ... - Europabio

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References • OECD. 1998. Guideline for the Testing of Chemicals – <strong>Repeated</strong> Dose <strong>90</strong>-<strong>day</strong> <strong>Oral</strong> <strong>Toxicity</strong> Study in Rodents, 408. • OECD. 2012. Guidance Document 116 on the Conduct and Design of Chronic <strong>Toxicity</strong> and Carcinogenicity <strong>Studies</strong>, Supporting Test Guidelines 451, 452 and453 2nd Edition. • Rhomberg, L.R., K. Baetcke, J. Blancato, J. Bus, S. Cohen, R. Conolly, R. Dixit, J. Doe, K. Ekelman, P. Fenner-Crisp, P. Harvey, D. Hattis, A. Jacobs, D. Jacobson-Kram, T. Lewandowski, R. Liteplo, O. Pelkonen, J. Rice, D. Somers, A. Turturro, W. West, and S. Olin. 2007. Issues in the design and interpretation of chronic toxicity and carcinogenicity studies in rodents: approaches to <strong>dose</strong> selection. Crit Rev Toxicol 37:729-837. • Sontag, J.M., Page, N.P., and Safiotti, V. 1976. Guidelines for Carcinogen Bioassays in Small Rodents, DHHS Publ. (NIH) 76-801. National Cancer Institute, Bethesda, MD. 53
References • WHO. 2003. GEMS/FOOD Regional Diets: Regional per Capita Consumption Of Raw and Semi-processed Agricultural Commodities. Revision September 2003. 54
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Repeated-d
Page 3 and 4: Existing safety data and the weight
Page 5 and 6: Hazard Identification and multiple
Page 7 and 8: Section summary • EuropaBio Membe
Page 9 and 10: Part 1: Study design and conduct 9
Page 11 and 12: 1. Defining toxicologically relevan
Page 13 and 14: 1. Endpoints and effect sizes Endpo
Page 15 and 16: 1. Toxicological endpoints for powe
Page 17 and 18: 2. Experimental design • EFSA gui
Page 19 and 20: 2. Experimental design (continued)
Page 21 and 22: 2. Section summary/discussion • E
Page 23 and 24: 3. Group or single housing (continu
Page 27 and 28: 4. Endpoints and effect sizes Endpo
Page 29 and 30: 4. Average coefficients of variatio
Page 31 and 32: 4. Analysis details • For the 3-t
Page 33 and 34: 4. Results 1 animal/cage, 3 treatme
Page 35 and 36: 4. Results 2 animals/cage, 3 treatm
Page 37 and 38: 4. Provisos for power analyses •
Page 39 and 40: 4. Should males and females be anal
Page 41 and 42: Part 2: Study analysis and interpre
Page 43 and 44: 1. Toxicological interpretation •
Page 45 and 46: 2. Presentation of results on the s
Page 49 and 50: 3. Summary statistics and raw analy
Page 51 and 52: 3. Section summary/discussion • P
Page 53: References • EFSA. 2011c. Guidanc
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