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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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in chemico
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25th July 2019 - 14th October 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 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- other: Direct Peptide Reactivity Assay
- Justification for non-LLNA method:
- This assay measures the ability of the test item to cause skin sensitisation. DPRA assay uses synthetic heptapeptides, i.e., Cysteine and Lysine, which are known for their reliability and reproducibility in a direct peptide reactivity assay and are also recommended by the OECD and other regulatory authorities.
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 purity: 99.42%
White powder
pH: 6.75
Batch no: RD/NAG/19/E-006
Stored at 4º C in a tight, light-resistance container
In chemico test system
- Details on the study design:
- Cysteine and lysine containing peptides were incubated with a positive control and the test item for 24 ± 2 hours at 22.5-30 ºC (in dark), separately.
Relative peptide concentration was measured by the high-performance liquid chromatography (HPLC) with gradient elution and UV detection at 220 nm. Cysteine and lysine peptide percent depletion values were calculated and used in a prediction model which allow assigning the test item to one of four reactivity classes used to support the discrimination between sensitisers and non-sensitisers
Results and discussion
- Positive control results:
- Value of the mean percent peptide deletion of the positive control was 73% for cysteine peptide adn 49% for lysine peptide. Relative Coefficient of Variability (RCV) for positie control replicate was 0.43% for percent cysteine depletion and 1.45% for percent lysine depletion.
In vitro / in chemico
Results
- Key result
- Parameter:
- other: Negative
- Value:
- 1
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- A standard calibration curve was generated on each day of HPLC analysis and value of r2 obtained was 0.99999 for Cysteine and 0.99998 for Lysine containing peptides (TABLE 1). This showed that system was suitable for assay.
Any other information on results incl. tables
For a valid experiment, the concentration of Cysteine or Lysine peptide was determined in each sample at 220 nm, by measuring the peak area of the appropriate peak integration and by calculating the concentration of peptide using the linear calibration curve derived from the standard. The percent peptide depletion was determined in each sample by measuring the peak area of the reference control C according to the formula described below:
Percent Peptide Depletion = [ 1- (Peptide oeak area in replicate injection / Mean peptide peak area in reference controls C)] x 100
Cysteine 1:10/Lysine 1:50 prediction model:
Mean of Cysteine and Lysine % Depletion |
Reactivity Class |
Prediction |
0% ≤ Mean % depletion ≤ 6.38% |
Minimal Reactivity |
Negative |
6.38%<Mean % depletion ≤ 22.62% |
Low Reactivity |
Positive |
22.62%<Mean % depletion ≤ 42.47% |
Moderate Reactivity |
Positive |
42.47%<Mean % depletion ≤ 100% |
High Reactivity |
Positive |
Cysteine 1:10 Prediction Model:
Cysteine (Cys) % Depletion |
Reactivity Class |
Prediction |
0%≤Mean % depletion≤13.89% |
Minimal Reactivity |
Negative |
13.89% < Mean % depletion≤23.09% |
Low Reactivity |
Positive |
23.09% < Mean % depletion≤98.24% |
Moderate Reactivity |
Positive |
98.24% < Mean % depletion≤100% |
High Reactivity |
Positive |
Cysteine and lysine peptide percent depletion values were calculated and used in a prediction model which allow assigning the test item to one of four reactivity classes used to support the discrimination between sensitisers and non-sensitisers
Test Item Name |
Actual % Depletion (Cysteine) |
Actual % Depletion (Lysine) |
% Mean Depletion (Cysteine and Lysine) |
Maximum Standard Deviation (Cysteine) |
Maximum Standard Deviation(Lysine) |
DPRA Prediction |
N-Acetyl-D-Glucosamine |
1 |
1 |
1 |
1.05 |
0.44 |
Negative |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- From results of this study, under the specified experimental conditions, N-Acetyl-D-Glucosamine was negative in the DPRA assay.
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