Establishing the upper end of the range of adequate and safe intakes for amino acids: a toxicologist's viewpoint
Establishing the upper end of the range of adequate and safe intakes for amino acids: a toxicologist's viewpoint
The safety assessment of high intake levels of individual amino acids cannot be based on data from nutritional studies with proteins. Routine toxicity tests designed to investigate a wide range of possible effects should be undertaken for hazard identification and characterization using studies selected to mirror the predicted pattern and duration of human exposure. The approach used to establish an acceptable daily intake level for additives and pesticides, based on defining a "no observed adverse effect" level in the experimental study and dividing by uncertainty factors that allow for species differences and human variability, has a long history of use for foreign compounds and would provide a suitable basis for determining health-based guidance values for single amino acids. The usual default uncertainty factors for toxicokinetics and toxicodynamics should be replaced by compound-specific values if suitable data are available. In addition, the usual uncertainty factors should be modified to more relevant default values based on species differences and human variability in the biodisposition of amino acids in general or of groups of metabolically interrelated amino acids. There would be no significant health concerns if the human intake levels were below a health-based guidance value developed using this approach. A population-distribution approach could be used to define the magnitude of any risk at intake levels above the guidance value.
amino acid, safety assessment, dose response, risk characterization, uncertainty factors, human variability
1617S-1624S
Renwick, Andrew G.
3a210ca8-de23-4dae-aa6c-c853a1651d19
2004
Renwick, Andrew G.
3a210ca8-de23-4dae-aa6c-c853a1651d19
Renwick, Andrew G.
(2004)
Establishing the upper end of the range of adequate and safe intakes for amino acids: a toxicologist's viewpoint.
Journal of Nutrition, 134 (6 sup), .
Abstract
The safety assessment of high intake levels of individual amino acids cannot be based on data from nutritional studies with proteins. Routine toxicity tests designed to investigate a wide range of possible effects should be undertaken for hazard identification and characterization using studies selected to mirror the predicted pattern and duration of human exposure. The approach used to establish an acceptable daily intake level for additives and pesticides, based on defining a "no observed adverse effect" level in the experimental study and dividing by uncertainty factors that allow for species differences and human variability, has a long history of use for foreign compounds and would provide a suitable basis for determining health-based guidance values for single amino acids. The usual default uncertainty factors for toxicokinetics and toxicodynamics should be replaced by compound-specific values if suitable data are available. In addition, the usual uncertainty factors should be modified to more relevant default values based on species differences and human variability in the biodisposition of amino acids in general or of groups of metabolically interrelated amino acids. There would be no significant health concerns if the human intake levels were below a health-based guidance value developed using this approach. A population-distribution approach could be used to define the magnitude of any risk at intake levels above the guidance value.
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Published date: 2004
Additional Information:
Supplement: 3rd Amino Acid Workshop
Keywords:
amino acid, safety assessment, dose response, risk characterization, uncertainty factors, human variability
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Local EPrints ID: 27357
URI: http://eprints.soton.ac.uk/id/eprint/27357
ISSN: 0022-3166
PURE UUID: 95b967e2-9e00-44d9-8707-33db1c60c6d8
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Date deposited: 28 Apr 2006
Last modified: 22 Jul 2022 20:37
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Author:
Andrew G. Renwick
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