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A 90-day ad libitum administration toxicity study of oligoglucosamine in F344 rats.
Food Chem Toxicol. 2007 Sep; 45(9):1575-87.FC

Abstract

A 90-day ad libitum administration toxicity study of oligoglucosamine (OG) was carried out using F344 rats of both sexes. The animals were divided into four groups of 20 animals each, 10 of each sex, and fed a diet containing 0, 0.04, 0.2 or 1.0 (w/w)% OG. During the administration period, no animals of either sex died or exhibited abnormal signs in the 0.04% OG and 0.2% OG groups. In the 1% OG group, in both sexes, erythema and swelling of the snout and forelimbs and loss of fur in the forelimbs were observed. On macroscopic observation, emaciation, swelling of the snout, auricles and forelimbs and alopecia of the forelimbs were also observed in 2-3 males of the 1% OG group. It was suggested that these topical abnormalities might be due to dermal responses to OG adhering to the skin and fur, which are easily soiled with saliva during grooming. In the animals of the 1% OG group, food consumption decreased, resulting in body weight gain being suppressed. This was found concomitantly with the abnormal findings mentioned above. Thus, feeding difficulties due to the topical lesions on the snout and forelimbs were thought to affect body weight. In hematology, platelet count, lymphocyte count and differential neutrophil count increased in males of the 1% OG group. These changes might be related to the dermal inflammation. Abnormalities in urinalysis and blood chemistry, as well as a small thymus, small spleen, dark spots or areas on the glandular stomach mucosa, pale Harderian glands and small testes in histopathology, were also observed in males in the 1% OG group. Whether or not all these changes were related only to the malnutrition remains to be elucidated. From these results, OG gave rise to no adverse effects in rats up to the dose level of 0.2 (w/w)%. Thus, the no observed adverse effect level was determined to be 0.2 (w/w)% for rats of either sex (124.0mg/kg/day in males, 142.0mg/kg/day in females).

Authors+Show Affiliations

Safety Testing Laboratory, Hatano Research Institute, Food and Drug Safety Center, Ochiai 729-5, Hadano, Kanagawa 257-8523, Japan.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17418928

Citation

Naito, Yukiko, et al. "A 90-day Ad Libitum Administration Toxicity Study of Oligoglucosamine in F344 Rats." Food and Chemical Toxicology : an International Journal Published for the British Industrial Biological Research Association, vol. 45, no. 9, 2007, pp. 1575-87.
Naito Y, Tago K, Nagata T, et al. A 90-day ad libitum administration toxicity study of oligoglucosamine in F344 rats. Food Chem Toxicol. 2007;45(9):1575-87.
Naito, Y., Tago, K., Nagata, T., Furuya, M., Seki, T., Kato, H., Morimura, T., & Ohara, N. (2007). A 90-day ad libitum administration toxicity study of oligoglucosamine in F344 rats. Food and Chemical Toxicology : an International Journal Published for the British Industrial Biological Research Association, 45(9), 1575-87.
Naito Y, et al. A 90-day Ad Libitum Administration Toxicity Study of Oligoglucosamine in F344 Rats. Food Chem Toxicol. 2007;45(9):1575-87. PubMed PMID: 17418928.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A 90-day ad libitum administration toxicity study of oligoglucosamine in F344 rats. AU - Naito,Yukiko, AU - Tago,Kazumi, AU - Nagata,Tomoko, AU - Furuya,Mami, AU - Seki,Takayuki, AU - Kato,Hiroyasu, AU - Morimura,Tomomi, AU - Ohara,Naoki, Y1 - 2007/02/21/ PY - 2006/05/22/received PY - 2007/02/07/revised PY - 2007/02/13/accepted PY - 2007/4/10/pubmed PY - 2007/10/4/medline PY - 2007/4/10/entrez SP - 1575 EP - 87 JF - Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association JO - Food Chem Toxicol VL - 45 IS - 9 N2 - A 90-day ad libitum administration toxicity study of oligoglucosamine (OG) was carried out using F344 rats of both sexes. The animals were divided into four groups of 20 animals each, 10 of each sex, and fed a diet containing 0, 0.04, 0.2 or 1.0 (w/w)% OG. During the administration period, no animals of either sex died or exhibited abnormal signs in the 0.04% OG and 0.2% OG groups. In the 1% OG group, in both sexes, erythema and swelling of the snout and forelimbs and loss of fur in the forelimbs were observed. On macroscopic observation, emaciation, swelling of the snout, auricles and forelimbs and alopecia of the forelimbs were also observed in 2-3 males of the 1% OG group. It was suggested that these topical abnormalities might be due to dermal responses to OG adhering to the skin and fur, which are easily soiled with saliva during grooming. In the animals of the 1% OG group, food consumption decreased, resulting in body weight gain being suppressed. This was found concomitantly with the abnormal findings mentioned above. Thus, feeding difficulties due to the topical lesions on the snout and forelimbs were thought to affect body weight. In hematology, platelet count, lymphocyte count and differential neutrophil count increased in males of the 1% OG group. These changes might be related to the dermal inflammation. Abnormalities in urinalysis and blood chemistry, as well as a small thymus, small spleen, dark spots or areas on the glandular stomach mucosa, pale Harderian glands and small testes in histopathology, were also observed in males in the 1% OG group. Whether or not all these changes were related only to the malnutrition remains to be elucidated. From these results, OG gave rise to no adverse effects in rats up to the dose level of 0.2 (w/w)%. Thus, the no observed adverse effect level was determined to be 0.2 (w/w)% for rats of either sex (124.0mg/kg/day in males, 142.0mg/kg/day in females). SN - 0278-6915 UR - https://www.unboundmedicine.com/medline/citation/17418928/A_90_day_ad_libitum_administration_toxicity_study_of_oligoglucosamine_in_F344_rats_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0278-6915(07)00075-0 DB - PRIME DP - Unbound Medicine ER -