Scientific evaluation of the safety factor for the acceptable daily intake (ADI). Case study: butylated hydroxyanisole (BHA).
The principles of 'data-derived safety factors' are applied to toxicological and biochemical information on butylated hydroxyanisole (BHA). The calculated safety factor for an ADI is, by this method, comparable to the existing internationally recognized safety evaluations. Relevance for humans of forestomach tumours in rodents is discussed. The method provides a basis for organizing data in a way that permits an explicit assessment of its relevance.
Würtzen
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Coca-Cola International, Glostrup, Denmark.
D000818:Animals; D002083:Butylated Hydroxyanisole / Q000493:pharmacokinetics / Q000633:toxicity*; D005503:Food Additives / Q000008:administration & dosage / Q000633:toxicity*; D006801:Humans; D008452:Maximum Allowable Concentration; D013045:Species Specificity; D013274:Stomach Neoplasms / Q000139:chemically induced
D005503:Food Additives; D002083:Butylated Hydroxyanisole