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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30th 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 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- 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 purity: 99.42%
White Powder
pH: 6.75
Date of manufacture: May 2019, Date of expiry: April 2022
Batch no.: RD/NAG/19/E-006
Stored at 2 - 8 ºC in a closed, light-resistance container
Test animals / tissue source
- Species:
- cattle
- Details on test animals or tissues and environmental conditions:
- Sourced form Deonar Abattoir slaughter house, Mumbai, Maharashtra.
Bovine age is 1-5 yeras determined by teeth count, horm ring count, horizontal diameter of corneas and central corneal thickness.
Test system
- Vehicle:
- other: Sodium Chloride I.P.
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- N-Acetyl-D-Glucosamine
VEHICLE
-Sodium Chloride I.P.
- Batch no.: 20690173 - Duration of treatment / exposure:
- Corneas were exposed for 4 h ± 5 minutes at 32 ± 1 °C.
- Duration of post- treatment incubation (in vitro):
- 90 ± 5 min
- Number of animals or in vitro replicates:
- Three sets of three corneas.
- Details on study design:
- Groups of 3 corneas were tested.
One group was treated with 750 μL of NADG (20% w/v in saline solution)
The positive control group was treated with 750 μL of 20% (w/v) concentration of imidazole in normal (physiological) saline
The negative control group was treated with 750 μL of normal (physiological) saline.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- 0.42
- Positive controls validity:
- valid
- Remarks:
- The mean IVIS of imidazole (20% w/v) (positive control) was within the range of two standard deviations of the mean of historical control data
Any other information on results incl. tables
The mean In-vitro Irritancy Score (IVIS) of normal (physiological) saline (control) and imidazole (20% w/v) (positive control) treated corneas, was found to be 0.70 and 105.42, respectivley.
The mean IVIS score for corneas treated with 750 μL n-acetyl-d-glucosamine (solution) at 20% (w/v) concentration in (normal (physiological) saline) was 0.42.
Applicant's summary and conclusion
- Conclusions:
- The IVIS score for corneas treated with 750 μL n-acetyl-d-glucosamine (solution) at 20% (w/v) concentration in (normal (physiological) saline) was 0.42.
Based on results of this study, the classification for n-acetyl-d-glucosamine is as follows:
Classification (OECD 437 UN GHS): No Category
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