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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: 1978
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Carcinogenicity studies on different diarylide yellow pigments in mice and rats
Author:
Leuschner F
Year:
1978
Bibliographic source:
Toxicology Letters 2: 253-260
Report Date:
1978

Materials and methods

Objective of study:
other: excretion of possible metabolites
Principles of method if other than guideline:
investigation of excretion of possible metabolites in the urine
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Radiolabelling:
no

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female

Administration / exposure

Route of administration:
oral: feed
Vehicle:
unchanged (no vehicle)
Duration and frequency of treatment / exposure:
23 month
Doses / concentrations
Dose / conc.:
9 000 ppm
Remarks:
Doses / Concentrations:
9000 ppm in diet
No. of animals per sex per dose:
10
Control animals:
yes, plain diet
Details on dosing and sampling:
- 2-h urine samples were collected (no further information)

Results and discussion

Main ADME results
Type:
excretion
Results:
no 3,3'-dichlorobenzidine was detected in the urine

Toxicokinetic / pharmacokinetic studies

Details on excretion:
- no 3,3'-dichlorobenzidine was detected in the urine
Toxicokinetic parameters
Key result
Test no.:
#1
Toxicokinetic parameters:
other: no 3,3'-dichlorobenzidine was detected in the urine

Applicant's summary and conclusion

Conclusions:
The test item is not absorbed after oral application and there is no evidence for a metabolic splitting of the test item to 3,3'-dichlorobenzidine
The test item seems not to be absorbed after oral application and there is no evidence for a metabolic splitting of the test item to 3,3'-dichlorobenzidine.
Executive summary:

Rat were exposed to 9000 ppm test item in diet for two years. Two-hour urine samples were collected after 6 and 23 months from 10 male and female rats and were analysed by thin layer chromatography for the presence of the hypothetical cleavage product 3,3'-dichlorobenzidine. No 3,3'-dichlorobenzidine was detectable in urine of treated and control animals.