Registration Dossier
Registration Dossier
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EC number: 214-818-2 | CAS number: 1197-18-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 luciferase KeratinoSens™ test method)
- GLP compliance:
- yes
- Type of study:
- ARE-Nrf2 luciferase KeratinoSens™ test method
Test material
- Reference substance name:
- Tranexamic acid
- EC Number:
- 214-818-2
- EC Name:
- Tranexamic acid
- Cas Number:
- 1197-18-8
- Molecular formula:
- C8H15NO2
- IUPAC Name:
- cyclohexanecarboxylic acid
- Test material form:
- solid: crystalline
Constituent 1
In vitro test system
- Details of test system:
- Keratinoses transgenic cell line [442D]
- Vehicle / solvent control:
- DMSO
- Positive control:
- EGDMA (120 M) [442D]
Results and discussion
In vitro / in chemico
Resultsopen allclose all
- Group:
- test chemical
- Run / experiment:
- run/experiment 1
- Parameter:
- Imax [442D]
- Value:
- 1.18 %
- Group:
- test chemical
- Run / experiment:
- run/experiment 2
- Parameter:
- Imax [442D]
- Value:
- 1.32 %
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, Tranexamic Acid is classified as negative (no activation of the antioxidant/electrophile responsive element (ARE)-dependent pathway in keratinocytes) under the experimental conditions described in this report.
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