Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 8th 2019 - November 9th 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- Bacterial Reverse Mutation Test - Salmonella typhimurium
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N-acetyl-β-D-glucosamine
- EC Number:
- 231-368-2
- EC Name:
- N-acetyl-β-D-glucosamine
- Cas Number:
- 7512-17-6
- Molecular formula:
- C8H15NO6
- IUPAC Name:
- N-acetyl-β-D-glucosamine
- Test material form:
- solid
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- The S9 fraction is buffered and supplemented with the essential co-factors β-NADP and Glucose-6-phosphate to form the “S9 mix”. This mix is added to the top agar in this activated assay. The S9 fraction procured from M/S G.P. Meshram, Nagpur, and (Lot N ° MWR/ARI/S9F/ 01/18, APPENDIX 7) was used in the study.
Co-factor Mix
D- Glucose –6- phosphate: 0.80 g
beta-Nicotinamide adenine dinucleotide Phosphate (beta-NADP): 1.75 g
Magnesium chloride: 0.90 g
Potassium chloride: 1.35 g
Sodium phosphate, dibasic: 6.40 g
Sodium phosphate, monobasic: 1.40 g
Distilled water: 450 mL
Constituent 5% v/v S9 mix (10 mL) 10% v/v S9 mix (10 mL)
Co-factor mix 9.5 mL 9.0 mL
S9 fraction 0.5 mL 1.0 mL
- Test concentrations with justification for top dose:
- An initial toxicity test was performed and showed no increase in the number of revertant colonies observed at 5000 µg N-acetyl-D-glucosamine /plate with and without S9 activation at 5% v/v S9 mix. Based on these results six concentrations 156.25, 312.5, 625, 1250, 2500 and 5000 µg N-acetyl-D-glucosamine /plate, in the absence and presence of the metabolic activation system (10% v/v S9 mix) for TA1537, TA1535, TA98, TA100, and TA102, was selected for the confirmatory mutation test.
- Vehicle / solvent:
- Distilled water
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- mitomycin C
- Details on test system and experimental conditions:
- Tester strains TA1537, TA1535, TA98, TA100, and TA102 were exposed to test concentrations of 156.25, 312.5, 625, 1250, 2500, and 5000 µg/plate of N-acetyl-D-glucosamine both in the absence and presence of metabolic activation (10 % v/v S9 mix). Plates were maintained in triplicates for each test concentration of test item, negative and positive controls. The numbers of revertant colonies were recorded after 48 h incubation period at 37 ± 1 ºC.
- Rationale for test conditions:
- Treatment with 2-aminoanthracene in the absence of the metabolic activation system was also performed for tester strain TA100 in both the initial toxicity-mutation test and the confirmatory mutation test to verify the efficiency of the S9 fraction used in the study. Since 2-aminoanthracene should not be used as the sole indicator of S9 mix, by testing this control in the absence of S9 it demonstrates that the chemical requires metabolic activation by S9 in order to be mutagenic in this test system.
- Evaluation criteria:
- A result is considered positive if concentration-related increase over the range tested and/or a reproducible increase at one or more concentrations in the number of revertant colonies per plate in at least one strain with or without metabolic activation system. Biological relevance of the result was considered first.
Strains TA1535, TA1537
Data sets were judged positive if the increase in mean revertants at the peak of the dose response was equal to or greater than 3.0 times the mean negative control value.
Strains TA98, TA100 and TA102
Data sets were judged positive, if the increase in mean revertants at the peak of the dose response was equal to or greater than 2.0 times the mean negative control value.
Statistical analysis was used as an aid in the evaluation of dose response.
A response that did not meet all three of the above criteria (magnitude, concentration-responsiveness, reproducibility) was not evaluated as positive.
Negative results obtained in the initial toxicity-mutation test were confirmed by a second experiment, using the same method as specified above, with an alteration in concentration spacing and S9 concentration. - Statistics:
- Simple linear regression analysis was performed for TA1537, TA1535, TA98, TA100 and TA102, separately, to assess the dose dependent nature of revertant colonies.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks:
- 9-Aminoacridine Hydrochloride Monohydrate (75 µg/plate)
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks:
- Sodium Azide (0.5 µg/plate)
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks:
- 2-Nitrofluorene (7.5 µg/plate)
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks:
- Sodium Azide (5 µg/plate)
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks:
- Mitomycin-C (0.5 µg/plate)
- Additional information on results:
- All values determined in the negative control tests were within historical controls for their respective strains. An increase in revertants was not observed in tester strain TA100 (in both the initial and confirmatory mutation test) when treated with 2-aminoanthracene in the absence of the metabolic activation but a clear increase in revertant numbers was observed in the presence of the metabolic activation. This demonstrated the efficiency of the S9, fraction used in this assay. All positive controls exhibited clear increases in the number of revertant colonies when compared with the negative controls thus are considered valid. Cytotoxicity was not observed as the background bacterial lawn and numbers of revertant colonies showed no treatment related effects for the test item up to 5000 µg/plate. No significant increase in revertant colonies was observed for any test strain with or without metabolic activation when treated with the test item up to 5000 µg/plate when compared to the concurrent negative controls and all results were within the historical control ranges.
Applicant's summary and conclusion
- Conclusions:
- A normal bacterial background lawn, without reduction in number of revertant colonies was observed up to 5000 µg/plate in TA1537, TA1535, TA98, TA100 and TA102, in the absence and presence of the metabolic activation system (10% v/v S9 mix). From results of this study, it is concluded that N-acetyl-D-glucosamine is non-mutagenic to any strain of Salmonella typhimurium, viz., TA1537, TA1535, TA98, TA100, and TA102, when tested under specified experimental conditions.
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.