2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-N-phenylbutyramide]

Basic toxicokinetics

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Administrative data

Endpoint:

basic toxicokinetics in vivo

Type of information:

experimental study

Adequacy of study:

key 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

Test material information

Constituent 1

Reference substance name:

2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-N-phenylbutyramide]

EC Number:

228-787-8

EC Name:

2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-N-phenylbutyramide]

Cas Number:

6358-85-6

Molecular formula:

C32H26Cl2N6O4

IUPAC Name:

2-[2-(3,3'-dichloro-4'-{2-[2-oxo-1-(phenylcarbamoyl)propyl]diazen-1-yl}-[1,1'-biphenyl]-4-yl)diazen-1-yl]-3-oxo-N-phenylbutanamide

Test material form:

not specified

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 / concentration:

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 (or Bioavailability)

Bioaccessibility (or Bioavailability) 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.