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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

Constituent 1
Chemical structure
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 EpiOcularTMEye Irritation Test.