Threshold dose for peanut: Risk characterization based upon published results from challenges of peanut-allergic individuals

Steve L. Taylor, Rene W.R. Crevel, David Sheffield, Jamie Kabourek, Joseph Baumert

Research output: Contribution to journalArticle

89 Scopus citations

Abstract

Population thresholds for peanut are unknown. However, lowest- and no-observed adverse effect levels (LOAELs and NOAELs) are published for an unknown number of peanut-allergic individuals. Publications were screened for LOAELs and NOAELs from blinded, low-dose oral challenges. Data were obtained from 185 peanut-allergic individuals (12 publications). Data were analyzed by interval-censoring survival analysis and three probability distribution models fitted to it (Log-Normal, Log-Logistic, and Weibull) to estimate the ED10. All three models described the data well and provided ED10's in close agreement: 17.6, 17.0, and 14.6 mg of whole peanut for the Log-Normal, Log-Logistic, and Weibull models, respectively. The 95% lower confidence intervals for the ED10's were 9.2, 8.1, and 6.0 mg of whole peanut for the Log-Normal, Log-Logistic, and Weibull models, respectively. The modeling of individual NOAELs and LOAELs identified from three different types of published studies - diagnostic series, threshold studies, and immunotherapy trials - yielded significantly different whole peanut ED10's of 11.9 mg for threshold studies, 18.0 mg for diagnostic series and 65.5 mg for immunotherapy trials; patient selection and other biases may have influenced the estimates. These data and risk assessment models provide the type of information that is necessary to establish regulatory thresholds for peanut.

Original languageEnglish (US)
Pages (from-to)1198-1204
Number of pages7
JournalFood and Chemical Toxicology
Volume47
Issue number6
DOIs
StatePublished - Jun 1 2009

Keywords

  • Allergy
  • Modeling
  • Peanut
  • Threshold

ASJC Scopus subject areas

  • Food Science
  • Toxicology

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