Registration Dossier

Toxicological information

Basic toxicokinetics

Currently viewing:

Administrative data

Endpoint:
basic toxicokinetics in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
year of publication: 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Metabolism Studies of an Azo Dye and Pigment in the Hamster Based on Analysis of the Urine for Potentially Carcinogenic Aromatic Amine Metabolites
Author:
Nony CR, Bowman MC, Cairns T, Lowry LK, Tolos WP
Year:
1980
Bibliographic source:
Journal of Analytical Toxicology 4: 132-140
Report Date:
1980

Materials and methods

Objective of study:
metabolism
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
investigation of metabolism after single oral application
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Radiolabelling:
no

Test animals

Species:
hamster
Strain:
other: Syrian Golden
Sex:
male

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: trioctanoin
Duration and frequency of treatment / exposure:
192 hrs, single exposure
Doses / concentrations
Dose / conc.:
100 mg/kg bw/day (actual dose received)
Remarks:
Doses / Concentrations:
100 mg/kg
No. of animals per sex per dose:
3 males
Control animals:
no

Results and discussion

Main ADME results
Type:
excretion
Results:
no 3,3'-dichlorobenzidine, monoacetyldichlorobenzidine, diacetyldichlorobenzidine or alkali hydrolyzable conjugates detectable

Toxicokinetic / pharmacokinetic studies

Toxicokinetic parameters
Key result
Test no.:
#1
Toxicokinetic parameters:
other: no 3,3'-dichlorobenzidine, monoacetyldichlorobenzidine, diacetyldichlorobenzidine or alkali hydrolyzable conjugates were detectable in urine

Metabolite characterisation studies

Metabolites identified:
no
Details on metabolites:
None of the possible metabolites analysed for (3,3'-dichlorobenzidine, monoacetyldichlorobenzidine, diacetyldichlorobenzidine and alkali hydrolyzable conjugates) were detected in any of the urine samples.

Bioaccessibility

Bioaccessibility testing results:
no detected

Applicant's summary and conclusion

Conclusions:
Hamsters treated orally with the test item did not excrete 3,3'-dichlorobenzidine, monoacetyldichlorobenzidine, diacetyldichlorobenzidine or alkali hydrolyzable conjugates in the urine collected up to 192 hours after the end of the exposure period.
Executive summary:

Male Syrian Golden Hamsters were applied a single dose of 100 mg test item per kg bw by gavage and urine was collected for up to 192 hours after exposure. No metabolites (3,3'-dichlorobenzidine, monoacetyldichlorobenzidine, diacetyldichlorobenzidine or alkali hydrolyzable conjugates) were detectable in urine by HPLC or EC-GC. Fecal analysis was not performed.