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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2017
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:
2018

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)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Legal entity composition

Test animals / tissue source

Species:
other: three-dimensional human cornea tissue
Strain:
other: Commercially available EpiOcularTM kit.
Details on test animals or tissues and environmental conditions:
The EpiOcularTM tissue consists of normal, human-derived keratinocytes which have been cultured to form a stratified squamous epithelium similar to that found in the human cor-nea. It consists of highly organized basal cells. These cells are not transformed or trans-fected with genes to induce an extended life span. The EpiOcularTM tissues are cultured in specially prepared cell culture inserts with a porous membrane through which nutrients can pass to the cells. 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 microliters to two tissue replicates
Duration of treatment / exposure:
28 minutes
Number of animals or in vitro replicates:
two in vitro replicates
Details on study design:
This study was performed in order to evaluate the potential of Neopentyl Glycol Dipelargonate to evoke eye irritation in a Reconstructed human Cornea-like Epithelium (RhCE) model in an in vitro study.
The EpiOcularTM Eye Irritation Test (EIT) predicts the acute ocular irritation potential of chemicals by measurement of its irreversible tissue damage caused by cytotoxic effects in the human cornea model. Within a testing strategy, the EpiOcularTM EIT is used as a re-placement of the Draize Eye Irritation Test.
It is utilized for the classification and labelling of chemicals concerning their eye irritation potential. The EpiOcularTM EIT is intended to differentiate substances that are “not eye irritant” from those that require labelling as either GHS category 1 or 2 for serious eye damage resp. eye irritation potential.
Eye irritant materials are identified by their ability to produce a decrease in cell viability as determined. The cell viability is measured by dehydrogenase conversion of MTT (3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazoliumbromide), present in cell mitochondria, into a blue formazan salt that is quantitatively measured after extraction from tissues. The per-centage reduction of cell viability in comparison of untreated negative controls is used to predict the eye irritation potential. The formazan production was evaluated by measuring the optical density (OD) of the resulting solution.

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
other: Optical density at 570 nm
Remarks:
Corrected medium value
Run / experiment:
Tissue 1
Value:
2.064
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Irritation parameter:
other: Optical density at 570 nm
Remarks:
Corrected medium value
Run / experiment:
Tissue 2
Value:
2.046
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation

Any other information on results incl. tables

Comparison of Tissue Viability

For the test item and the positive control, the following percentage values of tissue viability were calculated in comparison to the negative control:

Designation

Positive Control

Neopentyl Glycol Dipelargonate

% Viability (Tissue 1)

37.2%

94.8%

% Viability (Tissue 2)

34.2%

94.0%

% Viability Mean

35.7%

94.4%

 


Assessment

Eye irritation is assessed using the criteria given in the following table (source: MatTek Corporation):

% Viability

Assessment

UN GHS classification

> 60 %

Non eye irritant

No category

60 %

At least eye irritant

No prediction can be made (category 1 or 2)

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the test, Neopentyl Glycol Dipelargonate was considered non-eye irritant in the EpiOcularTMEye Irritation Test.