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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:
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:
Mutagenic Activity of chemical carcinogens and Related Compounds in the inteaperitoneal Host-Mediated Assay
Author:
Vincent F. Simmon, Herbert S. Rosenkranz, Errol Zeiger, and Lionel A. Poirier
Year:
1979
Bibliographic source:
J NATL CANCER INST, VOL. 62, NO.4, APRIL 1979

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as below
Principles of method if other than guideline:
Acute oral toxicity of 4-Aminoazobenzene in mice
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no

Test material

Constituent 1
Reference substance name:
4-Aminoazobenzene
Cas Number:
60-09-3
Molecular formula:
C12H11N3
IUPAC Name:
4-Aminoazobenzene
Details on test material:
- Name of test material (as cited in study report): 4-Aminoazobenzene
- Molecular formula (if other than submission substance): C12H11N3
- Molecular weight (if other than submission substance): 197.24 g/mole
- Substance type: Organic
Specific details on test material used for the study:
- Name of test material (as cited in study report): 4-Aminoazobenzene
- Molecular formula (if other than submission substance): C12H11N3
- Molecular weight (if other than submission substance): 197.24 g/mole
- Substance type: Organic

Test animals

Species:
mouse
Strain:
Swiss Webster
Sex:
male
Details on test animals or test system and environmental conditions:
- Source: Division of Cancer Treatment, Mammalian Genetics and Animal Production Section, National Cancer Institute
- Age at study initiation:
- Weight at study initiation: 25-30 g.
- Fasting period before study: No data available
- Housing: No data available
- Diet (e.g. ad libitum): Animals were fed laboratory chow ad libitum until they were treated with the test chemicals.
- Water (e.g. ad libitum): No data available
- Acclimation period: No data available

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
No data available
Doses:
2-5,500 mg/kg (generally 125 mg/kg)
No. of animals per sex per dose:
No data available
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 24 hour
- Frequency of observations and weighing: No data available
- Necropsy of survivors performed: No data available
- Other examinations performed: Mortality was observed.
Statistics:
No data available

Results and discussion

Preliminary study:
No data available
Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
483 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 50 % mortality observed
Mortality:
50 % mortality was observed in treated mice
Clinical signs:
No data available
Body weight:
No data available
Gross pathology:
No data available
Other findings:
No data available

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
LD50 was considered to be 483 mg/kg/day when male Swiss-Webster mice were treated with 4-Aminoazobenzene orally.
Executive summary:

In acute toxicity study,male Swiss-Webster mice were treated with 4-Aminoazobenzene in the concentration of 2-5,500 mg/kg (generally 125 mg/kg) orally. 50 % mortality was observed in treated mice. Therefore, LD50 was considered to be 483 mg/kg/day when male Swiss-Webster mice were treated with 4-Aminoazobenzene orally. 

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