Registration Dossier
Registration Dossier
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EC number: 210-379-6 | CAS number: 614-33-5
Acute Toxicity: oral
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:
- 2 021
- 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
- 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
Constituent 1
- 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)
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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