Scientific evaluation of the safety factor for the acceptable daily intake (ADI). Case study: Butylated hydroxyanisole (BHA)

Abstract

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.

Keywords:

• acceptable daily intake
• ADI
• safety factors
• food additives
• butylated hydroxyanisole
• BHA