9 Acute Oral Toxicity single dose test with a 14-day observation period endpoints: mortality and gross necropsydoes not provide information on the dose-response relationshipSensitisation is caused by long-term changes in the immune system and could not be detected by acute toxicity testing.
10 US, FDA Redbook Subchronic >= 90 days >= 3 treated group >= 20 animals/gender/groupChronic>= 12 months>= 3 treated group>= 20 animals/gender/group
11 Subchronic and Chronic rodent oral toxicity studies Gross necropsy and tissue collectionorgan weights: adrenals, kidneys and liverHistopathology: target tissues and gross lesions for all animals, all tissues for all high-dose, control animals and all animal killed or died on study and selected tissues for all intermediate-dose animals
12 In Vitro Studies heat/process stability in vitro digestability in gastic fluidELISA or RAST to identify the presence of food-specific IgE within serum
15 General AspectsAll safety testing should be performed according to GLP (Good Laboratory Practice).Only validated and generally accepted methods should be applied.A detailed description of material and methods should be provided for each analysis.Measurement errors and limits of measurements should be specified.