Toxicologic evaluation of modified gum acacia: mutagenicity, acute and subchronic toxicity. |
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| Authors: | D Schmitt N Tran S Riefler J Jacoby D Merkel P Marone N Naouli |
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| Affiliation: | Exponent Inc, Chemical Regulation and Food Safety Practice, Wood Dale, IL 60191, USA. dschmitt@exponent.com |
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| Abstract: | Modified gum acacia, produced from acacia gum by a process analogous to the production of modified food starch, was tested for mutagenicity in the microbial reverse mutation assay. The assay employed a wide range of dose levels, both with and without metabolic activation. Test results gave no indication that modified gum acacia possessed any mutagenic potential. The acute oral toxicity of modified gum acacia was determined in two studies employing Sprague-Dawley rats, and the LD50 values were found to be >2000 mg/kg. The primary dermal irritation potential of modified gum acacia was evaluated in rabbits by the Draize method. Test results indicated that modified gum acacia was slightly irritating by the Environmental Protection Agency (EPA) classification but not a primary irritant by Consumer Product Safety Commission (CPSC) guidelines. The subchronic toxicity of modified gum acacia was examined in Sprague-Dawley rats fed diets containing 0%, 1%, 2.5%, and 5% modified gum acacia for 13 weeks. No dose-related effects on survival, growth, hematology, blood chemistry, organ weights, or pathologic lesions were observed. Results of these studies indicate that modified gum acacia does not possess mutagenic potential and that animals are not adversely affected by acute or subchronic exposure to modified gum acacia. |
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| Keywords: | 2AA, 2-aminoanthracene 2NF, 2-nitrofluorene ALKP, alkaline phosphatase ALB, albumin ALT, serum alanine aminotransferase ANOVA, analysis of variance APTT, activated partial thromboplastin time AST, serum aspartate aminotransferase BUN, blood urea nitrogen °C, degree Celsius CA, California Ca, calcium CAS, Chemical Abstract Service Cl, chloride cm2, centimeters squared CPSC, Consumer Product Safety Commission CREAT, creatine CHOL, cholesterol DMBA, 9,10,-dimethyl-1,2-benzanthracene E. coli, Escheria coli ENNG, N-ethyl-N-nitro-nitroguanidine EPA OPPTS, United States Environmental Protection Agency Office of Prevention, Pesticides, and Toxic Substances FEMA GRAS, Flavor and Extract Manufacturers Association Generally Recognized as Safe g, grams GLOB, globulin GLUC, glucose Hct, hematocrit Hgb, hemoglobin concentration ICR 191, 1,3-propanediamine, N-(2-chloroethyl)-N′-(6-chloro-2-methoxy-9-acridinyl)-, 1 dihydro IPHS, inorganic phosphorus K, potassium LD50, median lethal dose MCH, mean corpuscular hemoglobin MCHC, mean corpuscular hemoglobin concentration MCV, mean corpuscular volume mg/kg, milligrams per kilogram Na, sodium NAAZ, sodium azide NJ, New Jersey NOAEL, no observed adverse effect level OSA, 1-octenyl succinic anhydride PA, Pennsylvania PDI, primary dermal irritation pH, −log10[H+] ppm, parts per million RBC, erythrocyte count SDH, sorbitol dehydrogenase T-BILI, total bilirubin TP, total protein TRIG, triglycerides μg/plate, micrograms/plate UK, United Kingdom US, United States WBC, white blood cell count w/w, weight per weight |
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