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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25th July 2019 - 23rd December 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 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
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
- Specific details on test material used for the study:
- Analysed concentration 99.42%
Manufactured by R. N. Laboratories Pvt. Ltd.
Appearance: White powder
Date of manufacture: May 2019, Date of expiry: April 2022
Batch No.: RD/NAG/19/E-006
pH 6.75 (limit: 6.0 - 8.0)
Stored at 4°C in a light resistance container
In vitro test system
- Test system:
- artificial membrane barrier model
- Source species:
- other: Reconstructed human epidermis (SkinEthic™ RHE).
- Cell type:
- other: normal human keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- Reconstructed human epidermis (SkinEthic(TM) RHE). Normal human keratinocytes cultured for 17-days on a 0.5 cm^2 polycarbonate filter insert at the air-liquid interface in a chemically defined growth medium. The cells form a multi-layered, highly differentiated and stratified epidermis model of the human epidermis that consists of a main basal, supra basal, spinous and granular layers and a functional stratum corneum
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- NADG
-16 ± 2 mg of test item/0.5 cm2
NEGATIVE CONTROL
- Dulbecco’s Phosphate Buffered Saline (DPBS)
- 16 µL/0.5 cm2
POSITIVE CONTROL
- 5% Sodium dodecyl sulfate, 5% aqueous
- 16 µL/0.5 cm2 - Duration of treatment / exposure:
- 42 minutes
- Duration of post-treatment incubation (if applicable):
- Tissues were incubated in 6-well plates containing 2mL growth medium at 37 ± 1°C in 5 ± 1% CO2 in a humidified incubator for 42 hours.
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- mean percent viability
- Value:
- 95.5
- Positive controls validity:
- valid
- Remarks:
- A reduction in the cell viability of 1.2 %
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
There was a significant difference observed in the absorbance for colour interference between Isopropanol (negative control) and the test item:
Treatment |
Optical Density (nm) |
Interaction |
Negative Control (Isopropanol) |
0.042 |
No |
0.048 |
||
N-Acetyl-D-Glucosamine |
0.049 |
No |
0.061 |
NADG did not cause direct MTT reduction compared to the concurrent negative control (maintainence medium):
Treatment |
Interaction |
Negative Control (Maintenance Medium) |
No |
N-Acetyl-D-Glucosamine |
No |
N-Acetyl-D-Glucosamine is classified as "No Category (Non Skin Irritant)" according to the results of this study.
Data Summary of Percent Viability
Treatment |
Tissue Replicate |
OD at 570 nm |
Blank Corrected OD |
Mean of Corrected OD |
Mean OD of Three Tissues |
% Viability/ Tissue |
Mean % Viability |
SD of % Viability |
CV of % Viability |
Corrosivity Class |
Negative Control (Dulbecco’s Phosphate Buffered Saline (DPBS)) |
1 |
1.679 |
1.636 |
1.548 |
1.644 |
100 |
100 |
0.084 |
5.11 |
NA |
1.737 |
1.694 |
|||||||||
1.356 |
1.313 |
|||||||||
2 |
1.876 |
1.833 |
1.703 |
|||||||
1.728 |
1.685 |
|||||||||
1.633 |
1.590 |
|||||||||
3 |
1.722 |
1.679 |
1.681 |
|||||||
1.720 |
1.677 |
|||||||||
1.730 |
1.687 |
|||||||||
N-Acetyl-D-Glucosamine |
1 |
1.680 |
1.633 |
1.571 |
1.570 |
95.6 |
95.5 |
1.852 |
1.94 |
No Category |
1.596 |
1.549 |
|||||||||
1.579 |
1.532 |
|||||||||
2 |
1.596 |
1.549 |
1.538 |
93.6 |
||||||
1.545 |
1.498 |
|||||||||
1.614 |
1.567 |
|||||||||
3 |
1.654 |
1.607 |
1.600 |
97.3 |
||||||
1.646 |
1.599 |
|||||||||
1.642 |
1.595 |
|||||||||
Positive control (Sodium dodecyl sulphate (5% aq.)) |
1 |
0.062 |
0.019 |
0.02 |
0.020 |
1.2 |
1.2 |
0.058 |
4.83 |
Category 2 |
0.063 |
0.020 |
|||||||||
0.063 |
0.020 |
|||||||||
2 |
0.064 |
0.021 |
0.02 |
1.2 |
||||||
0.063 |
0.020 |
|||||||||
0.063 |
0.020 |
|||||||||
3 |
0.062 |
0.019 |
0.021 |
1.3 |
||||||
0.064 |
0.021 |
|||||||||
0.065 |
0.022 |
Results of the negative control met the OECD guideline 439 acceptance range for the prediction model SkinEthicTM RHE. The positive control also met the acceptance criteria of the OECD guideline 439.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on results of this study, the classification for N-Acetyl-D-Glucosamine is No Category (Non Skin Irritant).
- Executive summary:
Tissues were exposed to the negative control (Dulbecco’s Phosphate Buffered Saline (DPBS)), positive control (sodium dodecyl sulfate, 5% aqueous (SDS)) and the test item, N-Acetyl-D-Glucosamine in triplicate for 42 minutes, at the room temperature.
The mean cell viability in tissues treated with the test item was 95.5% after, 42 minutes’ exposure. No significant reduction in the percent cell viability was observed in treated tissues, when compared with that of the concurrent negative control. All criteria for a valid study were met.
Based on results of this study, the classification for N-Acetyl-D-Glucosamine is No Category (Non Skin Irritant).
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