Determination of no-observed-adverse-effect levels and eliciting doses in a representative group of peanut-sensitized children

A.E. Flinterman, S.G.M.A. Pasmans, M.O. Hoekstra, Y. Meijer, E. van Hoffen, E.F. Knol, S.L. Hefle, C.A.F.M. Bruijnzeel - Koomen, A.C. Knulst

Research output: Contribution to journalArticleAcademicpeer-review


BACKGROUND: Current labeling practices for allergenic foods like peanut can be inadequate. For future regulatory and industry guidelines, information on no-observed-adverse-effect levels (NOAELs) and eliciting doses (EDs) for allergenic foods is necessary.

OBJECTIVE: To determine NOAEL and ED in a representative group of peanut-sensitized children, relate these data to history and sensitization, and evaluate the outcome of dietary management.

METHODS: From an overall eligible group of 96 peanut-sensitized children, a representative group of 27 was evaluated by questionnaires, skin prick test, determination of specific IgE, and double-blind placebo-controlled food challenge (DBPCFC) with peanut according to the international consensus protocol, with 9 doses ranging from 10 microg to 3 g peanut flour. Dietary management was evaluated over a 12-month period.

RESULTS: Twenty-two children (81%) had a positive DBPCFC. The NOAEL in this group was 1 mg peanut flour, corresponding to 2 mg whole peanut. The ED for subjective symptoms (10 mg to 3 g) was significantly lower than for objective symptoms (100 mg to 3 g; P = .002). Severe reactions occurred only at high doses. EDs were not correlated to previous reactions by history, skin prick test, or specific IgE levels. All patients with a positive DBPCFC were advised to follow a strict diet. During the follow-up period, 10 patients had a less strict diet likely containing traces of peanut. In 3 cases, a mild reaction occurred with food products labeled "may contain peanut."

CONCLUSION: The NOAEL in a representative group of children with peanut allergy was 2 mg. Dietary compliance in half of this group was inadequate.

Original languageEnglish
Pages (from-to)448-454
Number of pages7
JournalJournal of Allergy and Clinical Immunology
Issue number2
Publication statusPublished - Feb 2006


  • Adolescent
  • Arachis
  • Child
  • Child, Preschool
  • Dose-Response Relationship, Immunologic
  • Double-Blind Method
  • Female
  • Humans
  • Immunoglobulin E
  • Male
  • No-Observed-Adverse-Effect Level
  • Peanut Hypersensitivity
  • Placebos
  • Skin Tests
  • Surveys and Questionnaires


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