2,2-dimethylpropane-1,3-diyl dinonanoate

Eye irritation

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

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. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2,2-dimethylpropane-1,3-diyl dinonanoate

EC Number:

239-938-2

EC Name:

2,2-dimethylpropane-1,3-diyl dinonanoate

Cas Number:

15834-05-6

Molecular formula:

C23H44O4

IUPAC Name:

2,2-dimethyl-3-(nonanoyloxy)propyl nonanoate

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

Results

Results 1

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

Results 2

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.