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

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

year of publication: 1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented publication which meets basic scientific principles

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

publication

Title:

Fate of water-insoluble and water-soluble dichlorobenzidine-based pigments in Fischer 344 rats

Author:

Decad GM, Snyder, CD, Mitoma C

Year:

1983

Bibliographic source:

Journal of Toxicology and Environmental Health 11: 455-465

Report date:

1983

Materials and methods

Objective of study:

other: absorption, distribution and excretion

Principles of method if other than guideline:

testing of absorption, distribution and excretion after oral application

GLP compliance:

no

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

IUPAC Name:

2,2'-[(3,3'-dichlorobiphenyl-4,4'-diyl)didiazene-2,1-diyl]bis(3-oxo-N-phenylbutanamide)

Radiolabelling:

yes

Remarks:

14-C labelled, 11 µCi/µmol

Test animals

Species:

rat

Strain:

Fischer 344

Sex:

male

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Emulphor EL-620:ethanol:water (1:1:8, v/v)

Duration and frequency of treatment / exposure:

24 h, single exposure

Doses / concentrations

Remarks:

Doses / Concentrations:
1.11 mg/kg (corresponding to 3.89 µCi/rat or 0.354 µmol/rat)

No. of animals per sex per dose / concentration:

3-6 males

Control animals:

no

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on absorption:

No radioactivity above background levels were detectable in blood.

Details on distribution in tissues:

No radioactivity above background levels were detectable in liver.

Details on excretion:

- No radioactivity above background levels were detectable in urine.
- Radioactivity detected in feces and cecum contents accounted for the entire orally administered dose (recovery: 104% of the administered dose).

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): other: the test item was not absorbed by rats after oral exposure
The test item was not absorbed by rats after oral application.

Executive summary:

Radioactive labelled test item was applied to male Fischer rats by gavage. No test item was detected in blood, urine and liver during 8 hours following exposure. Radioactivity detected in feces accounted for the entire applied dose. These data indicate, that the test item is not absorbed by rats after oral application.