Registration Dossier

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, acceptable for assessment.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
1979
Reference Type:
secondary source
Title:
Toxicity Profile. Para-Aminoazobenzene
Author:
BIBRA
Year:
1989
Bibliographic source:
BIBRA Information Section, UK.
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
no data
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 4-Aminoazobenzene
- Physical state: solid

Test animals

Species:
mouse
Strain:
Swiss Webster
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Division of Cancer Treatment, Mammalian Genetics and Animal Production Section, National Cancer Institute
- Weight at study initiation: 25 - 30g
- Diet (e.g. ad libitum): ad libitum


Administration / exposure

Route of administration:
other: no data
Vehicle:
not specified
Details on oral exposure:
no data
Doses:
2 - 5500 mg/kg
No. of animals per sex per dose:
no data
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 24 hours

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
483 mg/kg bw
Remarks on result:
other: after 24 hours
Mortality:
no data
Clinical signs:
no data
Body weight:
no data
Gross pathology:
no data
Other findings:
no data

Applicant's summary and conclusion