Registration Dossier
Registration Dossier
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EC number: 214-818-2 | CAS number: 1197-18-8
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- 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 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
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
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- methylcellulose
- No. of animals per sex per dose:
- 3
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- There was no mortality at the dose level of 2000 mg/kg bw.
- Clinical signs:
- other: The animals were symptom-free during the study
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the acute oral LD50 value of the test item Tranexamic Acid was found to be higher than 2000 mg/kg bw in female Crl:WI rats.
According to the GHS criteria, Tranexamic Acid can be ranked as " Unclassified" for acute oral exposure. (LD50 cut-off of 5000 mg/kg bw).
According to the CLP criteria, Tranexamic Acid can be ranked as "No Category" for acute oral exposure.
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