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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

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.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Species:
rat
Strain:
Wistar
Sex:
female
Route of administration:
oral: gavage
Vehicle:
methylcellulose
No. of animals per sex per dose:
3
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
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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
> 2 000 mg/kg bw

Additional information

Justification for classification or non-classification

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.