Glycerol tribenzoate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October - December 2020

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2020

Report date:

2020

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)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Glycerol tribenzoate

EC Number:

210-379-6

EC Name:

Glycerol tribenzoate

Cas Number:

614-33-5

Molecular formula:

C24H20O6

IUPAC Name:

1,3-bis(benzoyloxy)propan-2-yl benzoate

Test material form:

solid: flakes

Details on test material:

room temperature: off-white coloured flakes or granulate; > 80 °C: colourless to yellowish liquid
Batch no. 20118
CAS no. 614-33-5
Production date 28. Jul. 2020
Expiry date 15. Aug. 2022

Specific details on test material used for the study:

Batch no. 20118
Purity 98.1%
Expiry date 15. Aug. 2022

Test animals / tissue source

Species:

human

Strain:

not specified

Details on test animals or tissues and environmental conditions:

Commercially available EpiOcularTM kit.
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 cul-tured 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.

EpiOcularTM tissues were procured from MatTek In Vitro Life Science Laboratories, Mlynské Nivy 73, 82105 Bratislava, Slovakia.
Designation of the kit: OCL-200-EACH
Day of delivery: 10. Nov. 2020
Batch no.: 30684

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

Replicate Amount
Tissue 1 50.2 mg
Tissue 2 51.0 mg

Results and discussion

In vitro

Results

Irritation parameter:

other: Tissue viability

Remarks:

%

Run / experiment:

1b

Value:

84.7

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: % Viability

Applicant's summary and conclusion

Conclusions:

Under the conditions of the test, Glycerol tribenzoate (GTB) is considered non-eye irritant in the EpiOcularTM Eye Irritation Test.
After treatment with the test item, the mean value of relative tissue viability was reduced to 84.7%. This value is 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 1.8 (> 0.8 and < 2.8).
The positive control induced a decrease in tissue viability as compared to the negative control to 22.3%.
The 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:

Glycerol tribenzoate (GTB)is considered non-eye irritant in the EpiOcular^TMEye Irritation Test.