Title
The application of in vitro data in the derivation of the acceptable daily intake of food additives
Author
Walton, K.
Walker, R.
van de Sandt, J.J.M.
Castell, J.V.
Knapp, A.G.A.A.
Kozianowski, G.
Roberfroid, M.
Schilter, B.
Centraal Instituut voor Voedingsonderzoek TNO TNO Voeding
Publication year
1999
Abstract
The acceptable daily intake (ADI) for food additives is commonly derived from the NOAEL (no-observed-adverse-effect level) in long-term animal in vivo studies. To derive an ADI a safety or uncertainty factor (commonly 100) is applied to the NOAEL in the most sensitive test species. The 100-fold safety factor is considered to be the product of both species and inter-individual differences in toxicokinetics and toxicodynamics. Although in vitro data have previously been considered during the risk assessment of food additives, they have generally had no direct influence on the calculation of ADI values. In this review 18 food additives are evaluated for the availability of in vitro toxicity data which might be used for the derivation of a specific data-derived uncertainty factor. For the majority of the food additives reviewed, additional in vitro tests have been conducted which supplement and support the short- and long-term in vivo toxicity studies. However, it was recognized that these in vitro studies could not be used in isolation to derive an ADI; only when sufficient in vivo mechanistic data are available can such information be used in a regulatory context. Additional short-term studies are proposed for the food additives which, if conducted, would provide data that could then be used for the calculation of data-derived uncertainty factors. Copyright (C) 2000 Elsevier Science B.V.
Subject
Nutrition
Acceptable daily intake
Food additives
In vitro
Metabolism
Toxicodynamics and uncertainty factor
Toxicokinetics
2 hydroxybiphenyl
Aluminum
Aspartame
Biphenyl
Brilliant blue
Butylcresol
Curcumin
Cyclamate sodium
Cyclohexylamine
Dodecyl gallate
Erythrosine
Ferrocyanide
Food additive
Gallic acid
Gallic acid propyl ester
Nitrate
Nitrite
Tartrazine
Tiabendazole
Dietary intake
Food safety
Human
Nonhuman
Review
Risk assessment
Species difference
Toxicity testing
Toxicokinetics
Animals
Food Additives
Humans
No-Observed-Adverse-Effect Level
Toxicity Tests
Animalia
To reference this document use:
http://resolver.tudelft.nl/uuid:92b85618-23c3-4006-81d4-0b25d4a0b080
DOI
https://doi.org/10.1016/s0278-6915(99)00107-6
TNO identifier
235341
ISSN
0278-6915
Source
Food and Chemical Toxicology, 37 (12), 1175-1197
Document type
article