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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
2019
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

Constituent 1
Chemical structure
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
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