N,N-diethyl-p-(phenylazo)aniline

Acute Toxicity: oral

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

Test material information

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:

other: 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.