Registration Dossier
Registration Dossier
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EC number: 214-818-2 | CAS number: 1197-18-8
Eye irritation
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
Materials and methods
Test guideline
- 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)
Test material
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- water
- 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
Constituent 1
Constituent 2
Test system
- Vehicle:
- Hank's balanced salt solution
Results and discussion
In vitro
Results
- Irritation parameter:
- cornea opacity score
- Value:
- ca. 0.95
Applicant's summary and conclusion
- 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.
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