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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:
1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented study report which meets basic scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Objective of study:
other: bioavailability of hypothetical cleavage products
Principles of method if other than guideline:
investigation of urinary excretion of a hypothetical cleavage product of the test item after oral application
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Radiolabelling:
no

Test animals

Species:
rat
Strain:
other: Tif:RAI f (SPF)
Sex:
male

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: oil (no further information)
Duration and frequency of treatment / exposure:
single exposure
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 40, 400 mg/kg
No. of animals per sex per dose:
The test was performed with 30 male rats, not indicated how many animals were investigated per substance and dose group
Control animals:
yes
Positive control:
3,3'-dichlorobenzidine

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on excretion:
- No 3,3'-dichlorobenzidine metabolites were detected in the urine collected after administration of the test item.

Any other information on results incl. tables

- animals receiving 3,3'-dichlorobenzidine excreted 2-4% of the administered dose within 24 hours and additional 0.2-1% between 24 and 48 hours after application

- limit of detection: 5 µg/l urine

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): other: no indication for a metabolic spllitting of the pigment into 3,3'-dichlorobenzidine
No 3,3'-dichlorobenzidine was detectable in the urine of rats after oral application, which indicates that the test item is not splitted into 3,3'-dichlorobenzidine after oral application.
Executive summary:

Single oral application of 40 or 400 mg test item/kg bw to male rats did not result in the excretion of 3,3'-dichlorobenzidine in the urine during 48 hours after exposure. After application of 3,3'-dichlorobenzidine about 2 -4% of the applied dose was detected in the urine excreted within 24 hours after application.