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Summary
Erythrosine (FD & C Red No. 3), a food colorant, affects the thyroid. Establishing an Acceptable Daily Intake (ADI) using data-derived safety factors suggests human studies provide the most appropriate ADI value.
Area of Science:
- Food toxicology
- Risk assessment
- Endocrinology
Background:
- Erythrosine (FD & C Red No. 3) is an iodine-containing food colorant.
- Its thyroid effects and mechanism are central to establishing an Acceptable Daily Intake (ADI).
- Evaluations by JECFA and SCF considered erythrosine as a secondary tumorigenic agent.
Purpose of the Study:
- To apply a proposed approach of data-derived safety factors for determining the ADI of erythrosine.
- To evaluate different methods for establishing an ADI based on toxicological data.
Main Methods:
- A decision tree scheme was used, examining three possibilities for ADI calculation.
- These included approaches based on long-term rat data, rat hormone data, and human hormonal changes (NOEL).
Main Results:
- Three different ADI values were derived: 0.25, 0.3, and 0.1 mg/kg body weight.
- The ADI derived from human studies (NOEL for hormonal changes) was deemed most appropriate.
Conclusions:
- The ADI based on human NOEL data is the most suitable.
- Further human pharmacokinetic studies are recommended to reduce uncertainty regarding default values.