Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2021
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Remarks:
This is an in-vitro test which adheres to generally accepted in-vitro validity criteria

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2021
Report date:
2021

Materials and methods

Test guideline
Qualifier:
no guideline required
Principles of method if other than guideline:
The detailed method followed, is described in XCellR8 SOP L0064 "Neutral Red Uptake (NRU) Cytoxicity Test Using Human Dermal Fibroblasts in Xeno-Free Culture Conditions"
GLP compliance:
no
Test type:
other: In-vitro: Neutral Red Uptake (NRU) Cytoxicity Test Using Human Dermal Fibroblasts in Xeno-Free Culture Conditions

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: 20118
Purity: 98.1%
Expiry: 24 months from 07/2020

Test animals

Species:
other: Human Dermal Fibroblast Cells
Strain:
other: Neonatal human dermal fibroblast cultures
Sex:
not specified

Administration / exposure

Route of administration:
other: A single application of 8 concentratons of the test item (n=6) was applied in cell culture medium with 1% DMSO (dilution factor of 2 in the range-finder, 1.3 in the main test).

Results and discussion

Preliminary study:
Cell viability did not reduce to below 50% at 200 ug/mL.
Effect levels
Key result
Sex:
not specified
Dose descriptor:
other: IC50
Effect level:
> 500 other: ug/mL
Based on:
test mat.
Remarks on result:
other: Based on cell viability

Applicant's summary and conclusion

Conclusions:
Glycerol tribenzoate was classified as Category 4 or Category 5 or Unclassified (Classification, IC50>500 ug/mL)