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Clinical observations in patients with intolerance reactions suggest that most patients are
sensitive to multiple substances. An extensive search of the medical database provided only
a small number of published clinical studies on the potential role of erythrosine in intolerance
reactions. The studies investigated the effect of erythrosine on a number of clinical patients
with various symptoms. The patients were challenged with various doses of erythrosine,
from 1 mg up to 30 mg. In some of the studies, symptoms were reported with the higher
doses, which at 30 mg for an average adult of 60 kg, is five times higher than the current ADI
for erythrosine (0.1 mg/Kg body weight). It is not possible to estimate, based on the
available evidence, the prevalence of intolerance reactions to erythrosine in the general
population but it is unlikely to be common. It is noteworthy that erythrosine is poorly
absorbed from the gastrointestinal tract, which further reduces the exposure resulting from
the small amounts of erythrosine that would be expected in a normal diet