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EC number: 214-818-2 | CAS number: 1197-18-8
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Tranexamic acid was negative in the DPRA and was classified in the “no or minimal reactivity class” when using the Cysteine 1:10 / Lysine 1:50 prediction model.
Tranexamic Acid is classified as negative (no activation of the antioxidant/electrophile responsive element (ARE)-dependent pathway in keratinocytes).
DEREK NEXUS version 6.1.1 did not yield any alerts for skin sensitization of Tranexamic acid. Additionally, the query structure does not contain any unclassified or misclassified features and is consequently predicted to be a non-sensitizer.
Based on the concordant negative results of the 2o3 DA test methods, as described in OECD TG 497, the overall 2o3 prediction is considered negative and Tranexamic acid is concluded to be a non-sensitizer.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation, other
- Remarks:
- Assessment of the Skin Sensitization potential of Tranexamic acid
- Type of information:
- not specified
- Remarks:
- Using the "2 out of 3" (2o3) defined approach mentioned in OECD TG 497 to determine whether the substance causes skin sensitization. The DPRA and the KeratinoSensTM assay, were used as the individual information sources.
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 497
- Type of study:
- other: "2 out of 3" (2o3) defined approach mentioned in OECD TG 497
- Remarks on result:
- not measured/tested
- Remarks:
- No data were available that would preclude performance of the studies to determine the potential for skin sensitization. Therefore the DPRA (Charles River project no 203298595), and the KeratinoSensTM assay (Charles River project no 203298606) were performed and used as the individual information sources for the 2o3 DA. The DEREK nexus prediction (Charles River project no 203298607) was performed to provide supporting information on skin sensitization.
- Outcome of the prediction model:
- negative [in vitro/in chemico]
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, based on the concordant negative results of the 2o3 DA test methods, as described in OECD TG 497, the overall 2o3 prediction is considered negative and Tranexamic acid is concluded to be a non-sensitizer. Therefore, Tranexamic acid does not need to be classified for skin sensitization according to Regulation (EC) No 1272/2008 (CLP).
- Endpoint:
- skin sensitisation, other
- Type of information:
- (Q)SAR
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
- Qualifier:
- no guideline followed
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- DEREK NEXUS version 6.1.1 did not yield any alerts for skin sensitization of Tranexamic
acid. Additionally, the query structure does not contain any unclassified or misclassified
features and is consequently predicted to be a non-sensitizer.
Tranexamic acid is predicted to be not sensitizing to the skin. - 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
- 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
- Details of test system:
- Keratinoses transgenic cell line [442D]
- Vehicle / solvent control:
- DMSO
- Positive control:
- EGDMA (120 M) [442D]
- 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 %
- 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.
- Endpoint:
- skin sensitisation: in chemico
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
- GLP compliance:
- yes
- Type of study:
- direct peptide reactivity assay (DPRA)
- Details of test system:
- cysteine peptide, (Ac-RFAACAA-COOH)
- lysine peptide (Ac-RFAAKAACOOH)
- Vehicle / solvent:
- water
- Positive control:
- cinnamic aldehyde
- Group:
- test chemical
- Run / experiment:
- mean
- Parameter:
- mean lysine depletion
- Value:
- 0.5 %
- Group:
- test chemical
- Run / experiment:
- mean
- Parameter:
- mean cystein depletion
- Value:
- 2.3 %
- Outcome of the prediction model:
- no or minimal reactivity [in chemico]
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, this DPRA test is valid. Tranexamic acid was negative in the DPRA and was
classified in the “no or minimal reactivity class” when using the Cysteine 1:10 / Lysine 1:50
prediction model.
Referenceopen allclose all
Type of Evidence / Source Name - Reference | Relevance | Reliability | Prediction model assay | Prediction model 2o3 DA (Annex 1) |
OECD TG 442C | Study appropriate for investigation of Key event 1 and the 2o3 DA. | Klimisch score 1 | Negative | Negative (nonborderline) |
OECD TG 442D | Study appropriate for investigation of Key event 2 and the 2o3 DA. | Klimisch score 1 | Negative | Negative (nonborderline) |
Derek Nexus prediction | Supporting information on skin sensitisation. | Klimisch score 2 | Negative | - |
A valid DPRA was performed in accordance with OECD TG 442C and in accordance with GLP principles. The substance was dissolved in Milli-Q water at 100 mM and formed a clear solution (as judged by visual inspection). Upon preparation as well as after incubation of the test item with synthetic peptides containing either cysteine (SPCC) or lysine (SPCL) no precipitate or phase separation was observed. In the cysteine reactivity assay the test item showed 2.3% SPCC depletion while in the lysine reactivity assay the test item showed 0.5% SPCL depletion. The mean of the SPCC and SPCL depletion was 1.4% and as a result the test item was considered to be negative in the DPRA and classified in the “no or minimal reactivity class” when using the Cysteine 1:10 / Lysine 1:50 prediction model.
These values resulted in a negative outcome (non-borderline) according to the adapted prediction model for use within the 2o3 DA as described in OECD TG 497 (refer to Annex 1, Figure 1.1)
A valid KeratinoSensTM assay was performed according to OECD 442D and in accordance with GLP principles. The test item was dissolved in dimethyl sulfoxide at 200 mM. From this stock, 11 spike solutions in DMSO were prepared. The stock and spike solutions were diluted 100-fold in the assay resulting in test concentrations of 0.98 – 2000 μM (2-fold dilution series). The highest test concentration was the highest dose required in the current guideline. No precipitate was observed at any dose level tested. Two independent experiments were performed. Both experiments passed the acceptance criteria. Overall it was concluded that the test conditions were adequate and that the test system functioned properly. The test item showed no toxicity (no IC30 and IC50 value) and no biologically relevant induction of the luciferase activity (no EC1.5 value) was measured at any of the test concentrations in both experiments. The maximum luciferase activity induction (Imax) was 1.18-fold and 1.32-fold in experiment 1 and 2 respectively. The test item is classified as negative in the KeratinoSensTM assay since negative results (<1.5-fold induction) were observed at test concentrations up to 2000 μM.
These values resulted in a negative outcome (non-borderline) according to the adapted prediction model for use within the 2o3 DA as described in OECD TG 497 (refer to Annex 1, Figure 1.2)
Derek Nexus version 6.1.1 yielded no alert for skin sensitization of Tranexamic acid and predicted the substance to be a non-sensitizer. The structure did not contain misclassified or unclassified features.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
Tranexamic acid does not need to be classified for skin sensitization according to Regulation (EC) No 1272/2008 (CLP).
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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