Acute Oral Toxicity single dose test with a 14-day observation period endpoints: mortality and gross necropsy does not provide information on the dose-response relationship Sensitisation is caused by long-term changes in the immune system and could not be detected by acute toxicity testing.
US, FDA Redbook Subchronic >= 90 days >= 3 treated group >= 20 animals/gender/grou p Chronic >= 12 months >= 3 treated group >= 20 animals/gender/grou p
Subchronic and Chronic rodent oral toxicity studies Gross necropsy and tissue collection organ weights: adrenals, kidneys and liver Histopathology: 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
In Vitro Studies heat/process stability in vitro digestability in gastic fluid ELISA or RAST to identify the presence of food-specific IgE within serum
General Aspects All 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.