Mast cell degranulation assay suitable to distinguish allergenicity of hydrolysates.
Intra- and inter-laboratory validation supports suitability of degranulation assay.
Mast cell degranulation assay may contribute to replacement animal testing.
Humanized mouse antibodies allow wider use to mast cell degranulation assay.
Note: same lot no. for human IgE and anti-human IgE are used in the ring trial.