Safety evaluation of lipase G from Penicillium camembertii.
Lipase G, a partial glycerides eliminating enzyme produced by Penicillium camembertii, was subjected to safety evaluation studies to establish its safety when used as a processing aid in the food industry. The toxicological studies on the enzyme included a 90-day gavage study with rats, a mutagenicity study using bacteria, and a pathogenicity study using mice. The no-adverse-effect level from the 90-day gavage toxicity study was 2000 mg/kg body weight/day for rats. There was no evidence of mutagenic potential. The micro-organism was evaluated for pathogenicity using mice and classified as a non-pathogen. Results indicate that the production and use of lipase G may be regarded as safe for the enzyme production worker and the consumer.
Kondo
M
M
Pharmacology Department, Central Research Laboratories, Amano Pharmaceutical Co. Ltd, Aichi-ken, Japan.
Ogawa
T
T
Matsubara
Y
Y
Mizutani
A
A
Murata
S
S
Kitagawa
M
M
D000818:Animals; D005260:Female; D005525:Food-Processing Industry; D008049:Lipase / Q000493:pharmacokinetics / Q000633:toxicity*; D008297:Male; D051379:Mice; D008813:Mice, Inbred ICR; D009152:Mutagenicity Tests; D009929:Organ Size / Q000187:drug effects; D010407:Penicillium / Q000201:enzymology*; D051381:Rats; D017207:Rats, Sprague-Dawley; D012964:Sodium / Q000097:blood / Q000652:urine; D014018:Tissue Distribution
D012964:Sodium; D008049:Lipase