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Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data is from NTP Technical Report

Data source

Reference
Reference Type:
publication
Title:
Toxicology and carcinogenesis studies of Triamterene (CAS no 396-01-0) In F344/N rats and B6C3F1 mice (Feed Studies)
Author:
NTP Technical Report
Year:
1993
Bibliographic source:
NTP TR 420, U.S. Department of Health and Human Services, 1993

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Acute oral toxicity study of Triamterene in rats
GLP compliance:
not specified
Test type:
other: No data
Limit test:
no

Test material

Constituent 1
Reference substance name:
Triamterene
EC Number:
206-904-3
EC Name:
Triamterene
Cas Number:
396-01-0
IUPAC Name:
6-phenylpteridine-2,4,7-triamine
Test material form:
solid: crystalline
Details on test material:
- Name of test material (as cited in study report): Triamterene
- Molecular formula (if other than submission substance): C12H11N7
- Molecular weight (if other than submission substance): 253.26 g/mole
- Substance type: Organic
- Physical state: Crystalline powder
Specific details on test material used for the study:
- Name of test material (as cited in study report): Triamterene
- Molecular formula (if other than submission substance): C12H11N7
- Molecular weight (if other than submission substance): 253.26 g/mole
- Substance type: Organic
- Physical state: Crystalline powder

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
No data available

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
No data available
Doses:
400 mg/kg bw
No. of animals per sex per dose:
No data available
Control animals:
not specified
Details on study design:
No data available
Statistics:
No data available

Results and discussion

Preliminary study:
No data available
Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
400 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 50 % mortality observed
Mortality:
50 % mortality observed in treated rats at 400 mg/kg bw
Clinical signs:
other: No data available
Gross pathology:
No data available
Other findings:
No data available

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category V
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 was considered to be 400 mg/kg bw when rat were treated with Triamterene orally.
Executive summary:

In a acute oral toxicity study, rat were treated with Triamterene in the concentration of 400 mg/kg bw orally. 50 % mortality observed in treated rats at 400 mg/kg bw. Therefore, LD50 was considered to be 400 mg/kg bw when rat were treated withTriamterene orally.