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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:
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:
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

Reference
Name:
Unnamed
Type:
Constituent
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:
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.