title: Subchronic and reproductive/developmental (screening level) toxicity of complexation products of iron trichloride and sodium tartrate (FemTA).
abstract: A complexation/reaction product, termed FemTA, of sodium tartrate [D(-)- and L(+)-tartaric acid and mesotartaric acid], sodium hydroxide, and iron trichloride may have use as an anticaking agent in salt preparations. FemTA is composed of about 4% sodium tartrate, approximately 10% mesotartaric acid, approximately 7% chloride, approximately 4% iron, approximately 7% sodium, approximately 0.3% sodium oxalate, and approximately 65% water. FemTA was tested in a 90-d oral toxicity study, which included a screening level reproductive/developmental toxicity phase, in Harlan Wistar rats. FemTA was administered by oral gavage at 500, 1000, and 2000 mg/kg body weight/d prior to and during mating, or about 20, 40, or 80 mg of iron/kg body weight/d, such that males received 90/91 d of treatment and females 104 to 109 d. Treatment was associated with inflammatory lesions of the lower GI tract at the mid- and high-dose levels, increased liver and kidney weights, increased serum bile acids and blood urea nitrogen, decreased chloride, and changes to hematological parameters consistent with inflammation. The effects were considered the result of iron overload. There were no effects on reproductive/developmental toxicity parameters. The no-observed-adverse-effect level (NOAEL), based on gastrointestinal tract effects was 500 mg/kg body weight/d. The NOAEL for reproductive/developmental toxicity was 2000 mg/kg body weight/d, the highest dose tested.
authors.affiliation: Intertek Cantox, 2233 Argentia Rd., Suite 308, Mississauga, ON, Canada, L5N 2X7.
authors.forename: Barry
authors.initials: B
authors.lastname: Lynch
authors.forename: Harry
authors.initials: H
authors.lastname: Emmen
authors.forename: Francois
authors.initials: F
authors.lastname: van Otterdijk
authors.forename: Annette
authors.initials: A
authors.lastname: Lau
mesh_terms: D000284:Administration, Oral; D000818:Animals; D001835:Body Weight / Q000187:drug effects; D002712:Chlorides / Q000008:administration & dosage / Q000633:toxicity*; D004305:Dose-Response Relationship, Drug; D005260:Female; D005503:Food Additives / Q000633:toxicity; D058085:Iron Compounds / Q000008:administration & dosage / Q000633:toxicity*; D007668:Kidney / Q000187:drug effects / Q000378:metabolism; D008099:Liver / Q000187:drug effects / Q000378:metabolism; D008297:Male; D019055:No-Observed-Adverse-Effect Level; D051381:Rats; D017208:Rats, Wistar; D012098:Reproduction / Q000187:drug effects; D013644:Tartrates / Q000008:administration & dosage / Q000633:toxicity*; D018675:Toxicity Tests
chemical_list: D002712:Chlorides; D005503:Food Additives; D058085:Iron Compounds; D013644:Tartrates; C029768:tartaric acid
keywords: iron trichloride; safety; tartaric acid