title: Determination of no-observed-adverse-effect levels and eliciting doses in a representative group of peanut-sensitized children.
abstract: 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."
  
  
  CONCLUSIONS
  The NOAEL in a representative group of children with peanut allergy was 2 mg. Dietary compliance in half of this group was inadequate.
authors.affiliation: Department of Dermatology/Allergology, University Medical Center, Utrecht, The Netherlands. a.e.flinterman@umcutrecht.nl.
authors.forename: Annebeth E
authors.initials: AE
authors.lastname: Flinterman
authors.forename: Suzanne G
authors.initials: SG
authors.lastname: Pasmans
authors.forename: Maarten O
authors.initials: MO
authors.lastname: Hoekstra
authors.forename: Yolanda
authors.initials: Y
authors.lastname: Meijer
authors.forename: Els
authors.initials: E
authors.lastname: van Hoffen
authors.forename: Edward F
authors.initials: EF
authors.lastname: Knol
authors.forename: Susan L
authors.initials: SL
authors.lastname: Hefle
authors.forename: Carla A
authors.initials: CA
authors.lastname: Bruijnzeel-Koomen
authors.forename: André C
authors.initials: AC
authors.lastname: Knulst
mesh_terms: D000293:Adolescent; D010367:Arachis / Q000009:adverse effects* / Q000276:immunology; D002648:Child; D002675:Child, Preschool; D004306:Dose-Response Relationship, Immunologic; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007073:Immunoglobulin E / Q000097:blood; D008297:Male; D019055:No-Observed-Adverse-Effect Level; D021183:Peanut Hypersensitivity / Q000175:diagnosis / Q000276:immunology* / Q000503:physiopathology; D010919:Placebos; D012882:Skin Tests; D011795:Surveys and Questionnaires
chemical_list: D010919:Placebos; D007073:Immunoglobulin E