Toxicologic evaluation of modified gum acacia: mutagenicity, acute and subchronic toxicity.
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.
Schmitt
D
D
Exponent Inc, Chemical Regulation and Food Safety Practice, Wood Dale, IL 60191, USA. dschmitt@exponent.com
Tran
N
N
Riefler
S
S
Jacoby
J
J
Merkel
D
D
Marone
P
P
Naouli
N
N
D000818:Animals; D001835:Body Weight / Q000187:drug effects; D005247:Feeding Behavior / Q000187:drug effects; D005260:Female; D006170:Gum Arabic / Q000633:toxicity*; D007509:Irritants / Q000633:toxicity; D008297:Male; D009152:Mutagenicity Tests; D011817:Rabbits; D051381:Rats; D017207:Rats, Sprague-Dawley; D012867:Skin / Q000187:drug effects
D007509:Irritants; D006170:Gum Arabic