Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Acute Toxicity: oral

Currently viewing:

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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Data is from peer-reviewed journal.

Data source

Reference
Reference Type:
publication
Title:
Acute toxicity:oral
Author:
Not mentioned
Year:
1954
Bibliographic source:
American Review of Tuberculosis. Vol. 70, Pg. 423, 1954.

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: refer below
Principles of method if other than guideline:
The acute toxicity study was conducted to evaluate the toxic effects of administration of Pyrazinamide (CAS No. 98-96-4) in rat by the oral route.
GLP compliance:
not specified
Test type:
other: No data available
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Pyrazine-2-carboxamide
Cas Number:
98-96-4
Molecular formula:
C5H5N3O
IUPAC Name:
Pyrazine-2-carboxamide
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report): Pyrazinamide
- Molecular formula: C5H5N3O
- Molecular weight: 123.1145 g/mol
- Substance type: organic
- Physical state: solid
- Smiles: c1cnc(cn1)C(=O)N
- InChI: 1S/C5H5N3O/c6-5(9)4-3-7-1-2-8-4/h1-3H,(H2,6,9)

Specific details on test material used for the study:
- Name of test material (as cited in study report): Pyrazinamide
- Molecular formula: C5H5N3O
- Molecular weight (if other than submission substance): 123.1145
- Substance type:Organic
- Smiles: c1cnc(cn1)C(=O)N
- InChI: 1S/C5H5N3O/c6-5(9)4-3-7-1-2-8-4/h1-3H,(H2,6,9)

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:
VEHICLE
- Concentration in vehicle: No data available
- Amount of vehicle (if gavage): No data available
- Justification for choice of vehicle: No data available
- Lot/batch no. (if required): No data available
- Purity: No data available

MAXIMUM DOSE VOLUME APPLIED: No data available

DOSAGE PREPARATION (if unusual): No data available

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: No data available
Doses:
No data available
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

Effect levels
Sex:
not specified
Dose descriptor:
LDLo
Effect level:
3 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: non-toxic
Mortality:
No data available
Clinical signs:
other: No data available
Gross pathology:
No data available
Other findings:
No data available

Applicant's summary and conclusion

Interpretation of results:
other: not classified based on CLP criteria
Conclusions:
The acute oral lowest published lethal dose (LDLo) of pyrazinamide in rat was observed to be 3000.0 mg/kg b.wt.
Executive summary:

The acute toxicity study was conducted to evaluate the toxic effects of administration of pyrazinamide (CAS No. 98 -96 -4) in rat by the oral route. The acute oral lowest published lethal dose (LDLo) of pyrazinamide in rat was observed to be 3000.0 mg/kg b.wt. Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that pyrazinamide (CAS No.98 -96 -4) can be classify under non toxic category at the tested dose level of 3000.0 mg/kg body weight.