Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
5-9 October 2020
1 (reliable without restriction)

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Glycerol tribenzoate
EC Number:
EC Name:
Glycerol tribenzoate
Cas Number:
Molecular formula:
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

In vitro test system

Test system:
human skin model
Source species:
Cell type:
non-transformed keratinocytes
Details on test system:
The test system is a commercially available EpiDermTM-Kit, procured by MatTek.
The EpiDermTM tissue consists of human-derived epidermal keratinocytes which have been cultured to form a multi-layered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers representing main
lipid classes analogous to those found in vivo. The EpiDermTM tissues are cultured on specially prepared cell culture inserts
EpiDermTM tissues were procured from MatTek In Vitro Life Science Laboratories, Bratislava.
Designation of the kit: EPI-218-SIT
Day of delivery: 06. Oct. 2020
Batch no.: 30896
Control samples:
yes, concurrent negative control
yes, concurrent positive control

Results and discussion

In vitro

Irritation / corrosion parameter:
% tissue viability
Negative controls validity:
Positive controls validity:
Remarks on result:
no indication of irritation
Other effects / acceptance of results:
One valid experiment was performed.
The test item Glycerol tribenzoate (GTB) is considered as non-irritant to skin.
After the treatment, the mean value of relative tissue viability was reduced to 94.9%. This value is above the threshold for skin irritation (50%).
The optical density of the negative control was well within the required acceptability criterion of 0.8 ≤ mean OD ≤ 2.8.
The positive control has met the acceptance criterion too, for thus ensuring the validity of the test system.
The variation within replicates was within the accepted range for negative control, positive control and test item (required: ≤ 18%).

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
The test item Glycerol tribenzoate (GTB) is considered as non-irritant to skin.