Pentatriacontan-18-one

Eye irritation

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:

2019

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:

Pentatriacontan-18-one

EC Number:

207-993-1

EC Name:

Pentatriacontan-18-one

Cas Number:

504-53-0

Molecular formula:

C35H70O

IUPAC Name:

pentatriacontan-18-one

Test material form:

solid

Test animals / tissue source

Species:

human

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 cornea. It consists of highly organized basal cells. These cells are not transformed or transfected 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:

Replicate Amount
Tissue 1 50.0 mg
Tissue 2 50.3 mg

Duration of treatment / exposure:

6 hours

Duration of post- treatment incubation (in vitro):

18 hours

Number of animals or in vitro replicates:

2

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Run / experiment:

% Viability Mean

Value:

101.3

Vehicle controls validity:

not examined

Negative controls validity:

valid

Positive controls validity:

valid

Any other information on results incl. tables

Designation	Positive Control	Stearone
% Viability (Tissue 1)	39.3%	101.7%
% Viability (Tissue 2)	37.9%	100.9%
% Viability Mean	38.6%	101.3%

Criterion	Demanded	Found
Mean OD of negative control	>0.8 and < 2.5	1.6
% mean relative viability of positive control	< 50% of negative control	38.6%
Variation within replicates	< 20%	1.2% (negative control) 1.4% (positive control) 0.8% (test item)

 

Values for negative control and for positive control were within the range of historical data of the test facility .

 

Therefore, the experiment is considered valid.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the test, Stearone is considered non-eye irritant in the EpiOcular Eye Irritation Test.
After treatment with the test item, the mean value of relative tissue viability was 101.3%.
This value is well above the threshold for eye irritation potential (≤ 60%).
All validity criteria were met. The criterion for optical density of the negative control was fulfilled: The OD value was 1.6 (> 0.8 and < 2.5).
The positive control induced a decrease in tissue viability as compared to the negative control to 38.6%. Variation within the replicates of the controls and the test item was acceptable (< 20%).
For these reasons, the result of the test is considered valid

Executive summary:

One valid experiment was performed.

The test item Stearone was applied to a three-dimensional human cornea tissue model in duplicate for an exposure time of 6 hours.

 

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 positive 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 1.6. The positive control showed clear eye irritating effects, the mean value of the relative tissue viability was 38.6% (< 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 101.3%. 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, Stearone is considered non- eye irritant in the EpiOcular^TMEye Irritation Test.