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

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Hypothesis of safety and study justification • In such cases, EuropaBio Members believe there is no specific hypothesis to test in the <strong>90</strong>-<strong>day</strong> study and thus no justification for them. – EFSA published opinion appears to agree with this position. • EFSA Panel on Genetically Modified Organisms (GMO). Scientific opinion- Guidance for risk assessment of food and feed from genetically modified plants. EFSA Journal 2011; 9(5):2150 • However, if potential indications of toxicity are present in the existing data, then EuropaBio Members believe the principles of Hazard Identification should be followed to maximise the possibility of detecting toxic effects of the test diet. 4
Hazard Identification and multiple <strong>dose</strong> levels • For Hazard Identification purposes, administering a <strong>dose</strong> lower than the highest possible (which maintains nutritional balance) is of disputable value. • Testing at the highest possible concentration maximises exposure and thus the potential to detect unanticipated adverse effects. – Consistent with the limit <strong>dose</strong> approach detailed in OECD TG 408 (1998). – Requirement of nutritional balance limits concentration in diet. – EuropaBio Members estimate the highest possible concentration of soybean and maize will typically exceed human intake in the EU 10X to 100X (WHO, 2003; EFSA 2011c). • It is difficult to scientifically justify the inclusion of the low <strong>dose</strong> group if regulating on the basis of Hazard Identification. – A “clean” low <strong>dose</strong> level would then likely be irrelevant if the high <strong>dose</strong> is adverse. 5
Page 1 and 2: Repeated-d
Page 3: Existing safety data and the weight
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 and 54: References • EFSA. 2011c. Guidanc
Page 55 and 56:
References • WHO. 2003. GEMS/FOOD
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Repeated-dose 90-day Oral Toxicity Studies on Whole ... - Europabio

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