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Toxicological information

Basic toxicokinetics

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Administrative data

Endpoint:
basic toxicokinetics in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable publication which meets basic scientific principles

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
4-Aminoazobenzene. BUA-Stoffbericht 217
Author:
Beratergremium für Altstoffe (BUA)
Year:
1998
Bibliographic source:
BUA der Gesellschaft dt. Chemiker, S. Hirzel Wissenschaftliche Verlagsgesellschaft, Stuttgart
Reference Type:
publication
Title:
Metabolism of some dimethylaminoazobenzene derivatives
Author:
Robinson PJ, Ryan AJ, Wright SE
Year:
1964
Bibliographic source:
J Pharm Pharmacol 16: 80-2T

Materials and methods

Objective of study:
metabolism
Principles of method if other than guideline:
no data
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no data
Radiolabelling:
yes
Remarks:
C14-labeled 4-Aminoazobenzene

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
no data

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
arachis oil
Details on exposure:
no data
Duration and frequency of treatment / exposure:
no data
Doses / concentrations
Remarks:
Doses / Concentrations:
Males: 10 mg/rat Females: 10 mg/rat
No. of animals per sex per dose:
3
Control animals:
not specified
Positive control:
no data
Details on study design:
no data
Details on dosing and sampling:
METABOLITE CHARACTERISATION STUDIES
- Tissues and body fluids sampled: urine
- Time and frequency of sampling: for 3 days
- From how many animals: (samples pooled or not): no data
- Method type(s) for identification:quantified after acid hydrolysis
Statistics:
no data

Results and discussion

Preliminary studies:
no data

Toxicokinetic / pharmacokinetic studies

Details on absorption:
no data
Details on distribution in tissues:
no data
Details on excretion:
urine

Metabolite characterisation studies

Metabolites identified:
yes
Details on metabolites:
p-phenylenediamine (CAS #: 106-50-3)
p-aminophenol (CAS #: 123-30-8)

Any other information on results incl. tables

The excretion of p-aminophenol and p-phenylenediamine was almost completed already after 24 hours. Almost 100 % of the theoretical amount of p-aminophenol were recovered, while only a total of 20- 30% of the p-phenylenediamine was recovered.

Applicant's summary and conclusion