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

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