title: Comparative assessment of gastrointestinal irritant potency in man of tin(II) chloride and tin migrated from packaging.
abstract: Tin is present in low concentrations in most canned foods and beverages, the highest levels being found in products packaged in unlacquered or partially lacquered tinplate cans. A limited number of case-reports of acute gastrointestinal disorders after consumption of food containing 100-500 mg/kg tin have been reported, but these reports suffer many insufficiencies. Controlled clinical studies on acute effects of tin migrated from packaging suggest a threshold concentration for adverse effects (AEs) of >730 mg/kg. Two separate randomised, single-centre, double-blind, crossover studies, enabling comparison of the tolerability of tin added as tin(II) chloride at concentrations of <0.5, 161, 264 and 529 mg/kg in 250 ml tomato juice in 20 volunteers (Study 1) and tin migrated from packaging at concentrations of <0.5, 201 and 267 mg/kg in 250 ml tomato soup in 24 volunteers (Study 2) were carried out. Distribution studies were conducted to get insight in the acute AEs of low molecular weight (<1000 Da) tin species in the soluble fraction of food products. Results show that the chemical form of tin and not the elemental concentration per se determines the severity of AEs. A clear dose-response relationship was only observed when tin was added as tin(II) chloride in tomato juice. No clinically significant AEs were reported in Study 2 and comparison of the incidence of tin-related AEs showed no difference between the dose levels (including control). Tin species of low molecular weight in supernatant represented 31-32% of total tin in canned tomato soup versus 56-61% in juice freshly spiked with tin(II) chloride. Differences in the incidence of AEs following administration of tomato juice with 161 and 264 mg of tin per kg and tomato soup with 201 and 267 mg of tin per kg likely results from differences in the concentration of low molecular weight tin species and in the nature of tin complexes formed. The results of this work demonstrate that tin levels up to 267 mg/kg in canned food cause no AEs in healthy adults and support the currently proposed tin levels of 200 mg/kg and 250 mg/kg for canned beverages and canned foods, respectively, as safe levels for adults in the general population.
authors.affiliation: Shell Health Services, Shell International BV, PO Box 162, 2501 AN The Hague, The Netherlands. peter.boogaard@shell.com
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Boogaard
authors.forename: Michel
authors.initials: M
authors.lastname: Boisset
authors.forename: Steve
authors.initials: S
authors.lastname: Blunden
authors.forename: Scot
authors.initials: S
authors.lastname: Davies
authors.forename: Teng Jin
authors.initials: TJ
authors.lastname: Ong
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Taverne
mesh_terms: D000293:Adolescent; D000328:Adult; D001628:Beverages / Q000009:adverse effects / Q000032:analysis; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D018857:Food Packaging; D005519:Food Preservation; D005767:Gastrointestinal Diseases / Q000139:chemically induced*; D006801:Humans; D007509:Irritants; D018551:Solanum lycopersicum; D008297:Male; D008452:Maximum Allowable Concentration; D017971:Tin Compounds / Q000009:adverse effects*
chemical_list: D007509:Irritants; D017971:Tin Compounds; C023599:stannous chloride