N-acetyl-β-D-glucosamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Justification for type of information:

N-Acetylglucosamine, is a monosaccharide derivative of glucose and is widely distributed worldwide. N-acetyl glucosamine is usually derived from the outer shells of shellfish, but is found in many species including mammals.
In mammals, N-Acetylglucosamine ia a component of glycoproteins, proteoglycans, glycosaminoglycans (GAGs) and other connective tissue building blocks. N-Acetylglucosamine seldom exists in free form, except in human milk (at levels 600–1500 mg/mL) (see review article Chen et al. (2010) Marine Drugs. 2010; 8(9): 2493–2516).
N-acetyl glucosamine is taken orally for osteoarthritis and inflammatory bowel disease (IBD), including ulcerative colitis and Crohn's disease
In a clinical trial in conducted in Japan (Kubomura et al (2017) Exp Ther Med. 2017 Apr; 13(4): 1614–1621) the effect of N-acetylglucosamine administration on cartilage metabolism and safety in healthy subjects was investigated. The treated volunteers were dosed with either 500 or 1000 mg N-Acetylglucosamine /day for up to 16 weeks without signs of adverse effects related to treatment.
The chronic toxicity and carcinogenicity of N-Acetylglucosamine has been assessed in male and female F344 rats. N-Acetylglucosamine was given in the diet at levels of 0%, 1.25%, 2.5% or 5% to groups of 10 rats of each sex for 52 weeks in the chronic toxicity study and 0%, 2.5% or 5% to groups of 50 rats of each sex for 104 weeks in the carcinogenicity study. N-Acetylglucosamine no adverse effects with regard to clinical signs, mortality, hematology, serum biochemistry and histopathological assessment. Slight suppression of body weight gain was observed at more than 2.5 and 5.0%, but this was considered a result of a slight reduction of caloric intake with the high concentration of test compound, rather than any toxicity. Therefore, it was concluded that N-Acetylglucosamine has neither toxic nor carcinogenic effects in F344 rats, the NOAEL estimated from the chronic toxicity study being 5% in both sexes, equivalent to 2323 and 2545 mg/kg bw/day in males and females, respectively (Takahashi et al. (2009) Food Chem Toxicol. 2009 Feb;47(2):462-71.)
Given the above, noting especially the doses used in the chronic toxicity and carcinogenicity study in the rat (Takahashi et al. (2009)) it is considered that the requirement for an acute oral study can be waived.