Evaluations of the Joint FAO/WHO Expert Committee on Food Additives (JECFA)

PROPYL p-HYDROXYBENZOATE

General Information

Synonyms: PROPYL p-OXYBENZOATE, PROPYLPARABEN
Chemical Names: PROPYL p-HYDROXYBENZOATE; n-PROPYL ESTER OF p-HYDROXYBENZOIC ACID
CAS number: 94-13-3
INS: 216
Functional Class:
  • Food Additives
    • PRESERVATIVE

Evaluations

Evaluation year: 2006
ADI: WITHDRAWN (2006)
Comments: In view of the adverse effects in male rats, propyl paraben (propyl p-hydroxybenzoate) should be excluded from the group ADI for the parabens used in food. This conclusion was reached on the grounds that the group ADI was originally set on a NOEL of 1000 mg/kg bw per day for a different toxicological end-point?growth depression?taken from the range of studies then available for the methyl, ethyl and propyl parabens. Propyl paraben has shown adverse effects in tissues of reproductive organs in male rats at dietary doses of down to 10 mg/kg bw per day, which is within the range of the group ADI (0?10 mg/kg bw), with no NOEL yet identified.
Meeting: 17
Specs Code: R (1995)
Report: TRS 940-JECFA 67/30
Tox Monograph: FAS 58-JECFA 67
Specification: WITHDRAWN (2006); see FAO JECFA Monographs 3-JECFA 67/61
Previous Years: 1998, COMPENDIUM ADDENDUM 6/FNP 52 Add.6/129. R; FAO JECFA Monographs 1 vol.3/185
1995, COMPENDIUM ADDENDUM 3/FNP 52 Add.3/165. R
1973, NMRS 53/TRS 539-JECFA 17/17, FNP 4-JECFA 17/156; COMPENDIUM/1215, FAS 5/NMRS 53A-JECFA 17/81. 0-10 (Group ADI as the