A 28-day oral toxicity study of fermentation-derived cellulose, produced by Acetobacter aceti subspecies xylinum, in F344 rats.
This study was designed to evaluate any adverse effect of fermentation-derived cellulose, produced by Acetobacter aceti subspecies xylinum, when administered to both sexes of F344 rats at dietary levels of 0, 1.25, 2.5, and 5.0% for 28 days. The treatment had no adverse effects on clinical signs, mortality, body weights and food and water consumption, or on urinalysis, ophthalmology, hematology, blood biochemistry, and histopathology findings. At necropsy, slight increased absolute and relative cecum weights, evident in females ingesting 2.5% and 5.0% dietary levels, were considered to be a physiological adaptation to the poorly absorbed fermentation-derived cellulose. The non-observed-adverse-effect level (NOAEL) from the present study was concluded to be 5.0% in the diet (5,331 mg/kg body weights/day for males, and 5,230 mg/kg body weights/day for females).
Hagiwara
Akihiro
A
DIMS Institute of Medical Science, Inc., 64 Goura, Nishiazai, Azai-cho, Ichinomiya, Aichi, Japan. hagiwara@dims.co.jp
Imai
Norio
N
Sano
Masashi
M
Kawabe
Mayumi
M
Tamano
Seiko
S
Kitamura
Satoshi
S
Omoto
Toshio
T
Asai
Iwao
I
Yasuhara
Kazuo
K
Hayashi
Shim-Mo
SM
D000284:Administration, Oral; D000818:Animals; D001835:Body Weight / Q000187:drug effects; D002482:Cellulose / Q000008:administration & dosage / Q000009:adverse effects* / Q000096:biosynthesis* / Q000633:toxicity; D004326:Drinking / Q000187:drug effects; D004435:Eating / Q000187:drug effects; D005260:Female; D005285:Fermentation; D005503:Food Additives; D041822:Gluconacetobacter xylinus / Q000378:metabolism*; D008297:Male; D019055:No-Observed-Adverse-Effect Level; D051381:Rats; D011916:Rats, Inbred F344; D013997:Time Factors; D016482:Urinalysis
D005503:Food Additives; D002482:Cellulose