Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2019

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals / tissue source

Species:
human
Details on test animals or tissues and environmental conditions:
Commercially available EpiOcularTM kit. EpiOcularTM tissues were procured from MatTek In Vitro Life Science Laboratories, Mylnské Nivy 73, 82105 Bratislava, Slovakia.
Designation of the kit: OCL-200-EIT
Day of delivery: 16. Oct. 2018
Batch no.: 27075
The tissue surface is 0.6 cm2

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
50 µl/Tissue
Duration of treatment / exposure:
28 min.
Duration of post- treatment incubation (in vitro):
120 min at 37 ± 1 °C
Number of animals or in vitro replicates:
2

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
other: Optical Density (570 nm)
Run / experiment:
Tissue 1
Value:
1.903 - 1.962
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Irritation parameter:
other: Optical Density (570 nm)
Run / experiment:
Tissue 2
Value:
1.863 - 1.866
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The eye irritation and corrosion potential of the test item was examined according to OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage). Under the conditions of the test, 3,3'-Oxybis-1-propanol is considered non-eye irritant in the EpiOcularTM Eye Irritation Test.
Executive summary:

One valid experiment was performed.

The test item 3,3'-Oxybis-1-propanol was applied to a three-dimensional human cornea tissue model in duplicate for an exposure time of 28 minutes.

50 μL of the liquid test item was applied to two tissue replicates.

After treatment, the respective substance was rinsed from the tissue; then, cell viability of the tissues was evaluated by addition of MTT, which can be reduced to formazan. The formazan production was evaluated by measuring the optical density (OD) of the resulting solution.

Demineralised water was used as negative control and methyl acetate was used as posi-tive control.

The controls showed the following results: After treatment with the negative control, the absorbance values were within the required acceptability criterion of mean OD > 0.8 and < 2.5, OD was 1.9. The positive control showed clear eye irritating effects, the mean value of the relative tissue viability was 31.2 % (< 50%).

Variation within tissue replicates of the controls and the test item was acceptable (< 20%).

After treatment with the test item, the mean value of relative tissue viability was 97.7%.

This value is well above the threshold for eye irritation potential (≤ 60%). Test items that induce values above the threshold are considered non-eye irritant.

Under the conditions of the test, 3,3'-Oxybis-1-propanol is considered non-eye irritant in the EpiOcularTM Eye Irritation Test.