Toxicological review of inorganic phosphates

Inorganic phosphate salts are widely used as food ingredients and in a vari ety of commercial applications. The United States Food and Drug Administrat ion (FDA) considers inorganic phosphates "Generally Recognized,As Safe" (GR AS) (FDA, 1973a, 1979) [FDA: Food and Drug Administration 1973a. GRAS (Gene rally Recognized as Safe) food ingredients-phosphates. NTIS PB-221-224. FDA , Food acid Drug Administration. 1979. Phosphates: Proposed Affirmation of and Deletion From GRAS Status as Direct and Human Food Ingredients. Federal Register 44 (244). 74845-74857, 18 December (1979)] and the European Union (EU) allows inorganic phosphates to be added directly to food (EU Directiv e 95/2/EC as amended by 98/72/EC). In this review, data on the acute, subch ronic and chronic toxicity, genotoxicity, teratogenicity and reproductive t oxicity from the published literature and from unpublished studies by the m anufacturers are reviewed. Based on the toxicity data and similar chemistry , the inorganic phosphates can be separated into four major classes, consis ting of monovalent salts, divalent salts, ammonium salts and aluminum salts . The proposed classification scheme supports the use of toxicity data from one compound to assess the toxicity of another compound in the same class, However, in the case of eye and skin irritation, the proposed classificati on scheme cannot be used because a wide range of responses exists within ea ch class. Therefore, the eye and skin hazards associated with an individual inorganic phosphate should be assessed on a chemical-by-chemical basis. A large amount of toxicity data exists for all four classes of inorganic phos phates. The large and comprehensive database allows an accurate assessment of the toxicity of each class of inorganic phosphate. Overall, all four cla sses of inorganic phosphates exhibit low oral, inhalation and dermal toxici ties. Based on these data, humans are unlikely to experience adverse effect s when the daily phosphorus consumption remains below 70 mg/kg/day (JECFA, 1964, 1982a) [JECFA (Joint FAO/WHO Expert Committee on Food Additives 1964. Specifications for the Identity and Purity of Food Additives and their Tox icological Evaluation) Emulsifiers, Stabilizers, Bleaching, and Maturing Ag ents. Technical Report Series of the World Health Organization 281; ECFA (J oint FAO/WHO Expert Committee on Food Additives 1982a. Phosphoric Acid and Phosphate Salts. ICS/FA/82)]. (C) 2001 Elsevier Science Ltd. All rights res erved.