Registration Dossier
Registration Dossier
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EC number: 214-818-2 | CAS number: 1197-18-8
Endpoint summary
Administrative data
Description of key information
In vitro EpiSkinTM (SM) model test with Tranexamic Acid indicates that the test item is non-irritant to skin. The calculated In Vitro lrritancy Score of Tranexamic acid (ViaDerm TXA / SpecWhite TA) 20% in Water is 0.95; therefore, the test article is considered a mild irritant according to Gautheron et al.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- 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 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes
- Test system:
- human skin model
- Source species:
- human
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- ca. 106.3
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, in this in vitro EpiSkinTM (SM) model test with Tranexamic Acid, the results indicate that the test item is non-irritant to skin.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- GLP compliance:
- yes (incl. QA statement)
- Vehicle:
- Hank's balanced salt solution
- Irritation parameter:
- cornea opacity score
- Value:
- ca. 0.95
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The calculated In Vitro lrritancy Score of Tranexamic acid (ViaDerm TXA / SpecWhite TA) 20% in Water is 0.95; therefore, the test article is considered a mild irritant according to Gautheron et al. No category can be assigned regarding the UN GHS Category, as per the OECD Test Guideline No. 437.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Justification for classification or non-classification
No category can be assigned regarding the UN GHS Category.
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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