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Toxicological information

Basic toxicokinetics

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Administrative data

Endpoint:
basic toxicokinetics
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: acceptable, well-documented publication which meets basic scientific principles

Data source

Reference
Reference Type:
publication
Title:
Preliminary studies on the bioavailability and disposition of bioincurred carrot residues of [14C] linuron and [14C] 3,4-dichloroaniline in rats
Author:
Worobey, BL and Shields, JB
Year:
1991
Bibliographic source:
Food additives and contaminants 8(2): 193-200

Materials and methods

Objective of study:
excretion
Test guideline
Qualifier:
equivalent or similar to
Guideline:
EU Method B.36 (Toxicokinetics)
Deviations:
yes
Remarks:
; animals used in duplicates, just one dose tested
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 3,4-dichloroaniline (DCA)
- Analytical purity: >=98.5 %
- Radiochemical purity: >=98.5 %
- Specific activity : radioactive DCA was fortified with non-radioactibve DCA to yield specific activity of 3831 dpm
- Locations of the label: Benzene ring


spiked carrot tissue: macerating fresh control carrot tubers with [14C]-3,4-dichloroaniline
Radiolabelling:
yes
Remarks:
3,4-[ring-U-14C]-dichloroaniline (1.443 MBq/mmol)

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 270-330 g
- Fasting period before study: 18 h
- Individual metabolism cages: yes
- Diet: ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: aqueous solution
Details on exposure:
no data
Duration and frequency of treatment / exposure:
single treatment, termination after 72 h
Doses / concentrations
Remarks:
Doses / Concentrations:
4,1400 dpm (5.04 µg) [14C]-3,4-DCA/ animal
4,6900 dpm (5.71 µg) [14C]-3,4-DCA in 100g carrot tuber macerate / animal
No. of animals per sex per dose:
2 male rats
Control animals:
no
Positive control:
not applicable
Details on study design:
no data
Details on dosing and sampling:
no data
Statistics:
no data

Results and discussion

Preliminary studies:
no data

Toxicokinetic / pharmacokinetic studies

Details on absorption:
no data
Details on distribution in tissues:
[14C]-residue disposition was unremarkable in terms of tissue bioaccumulation. Tissues like liver, kidney, muscle and blood containes <= 1 % of the radioactivity, others like adrenals, thyroid and spleen <= 0.1 %
Details on excretion:
pure test material: elimination of radioactivity within 72 h: Urine 81 % (plateau reached after 24 h) , faeces 26 % of administered radioactivity;
carrot tubers macerate: elimination of radioactivity within 72 h: Urine 20 % (plateau reached after 24 h) , faeces 63 % of administered radioactivity;

Metabolite characterisation studies

Metabolites identified:
no

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): no bioaccumulation potential based on study results
Executive summary:

Worobey, B.L. and Shields, J.B., 1991

In two male wistar rats that were treated with 4.14 x 104 dpm (5.04 µg) radiolabeled 3,4-dichloroaniline by oral gavage [14C]-residue disposition was unremarkable in terms of tissue bioaccumulation. The radioactivty was excreted mainly via urine (81 %) within the first 24 h after exposure. Only 26 % were excreted via faeces within 72 h. If the test material was given to the rats in combination with carrot tuber maccerate most of the radioactivity was excreted via faeces (63 %) and only 20 % via urine indicating an influence of the carrot tubers on gastrointestinal absorption.