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Diss Factsheets
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EC number: 231-368-2 | CAS number: 7512-17-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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.
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.