100-fold margin of safety¶
Lehman, A. J., & Fitzhugh, O. G. (1954). 100-fold margin of safety. Quarterly Bulletin of the Association of Food and Drug Officials of the United States, 18(1), 33-35.
Cited by¶
1 citation across 1 artifact.
Each citation links to the sentence it supports in the citing article.
Primes¶
- Dose-Response Relationship
- A dose-response curve is fitted to the data, the NOAEL (no-observed-adverse-effect level—the highest dose with no statistically significant effect) and LOAEL (lowest-observed-adverse-effect level) are identified, and a reference dose (RfD) is calculated as NOAEL / uncertainty factor (typically 10 for intraspecies variability, 10 for interspecies extrapolation, and additional factors for data quality)—a 100-fold composite safety factor whose food-additive lineage Lehman and Fitzhugh (1954) introduced and which has propagated essentially unchanged into modern chemical risk assessment.
This sourceOriginal articulation of the 100-fold composite uncertainty factor (10x interspecies x 10x intraspecies) for translating animal NOAEL to human acceptable intake; supports D47-030 (the food-additive lineage of the RfD uncertainty-factor approach).
- A dose-response curve is fitted to the data, the NOAEL (no-observed-adverse-effect level—the highest dose with no statistically significant effect) and LOAEL (lowest-observed-adverse-effect level) are identified, and a reference dose (RfD) is calculated as NOAEL / uncertainty factor (typically 10 for intraspecies variability, 10 for interspecies extrapolation, and additional factors for data quality)—a 100-fold composite safety factor whose food-additive lineage Lehman and Fitzhugh (1954) introduced and which has propagated essentially unchanged into modern chemical risk assessment.
Verification¶
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