3,4-dichloroaniline

Basic toxicokinetics

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

Guideline:

EU Method B.36 (Toxicokinetics)

Deviations:

yes

Remarks:

; animals used in duplicates, just one dose tested

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

3,4-dichloroaniline

EC Number:

202-448-4

EC Name:

3,4-dichloroaniline

Cas Number:

95-76-1

Molecular formula:

C6H5Cl2N

IUPAC Name:

3,4-dichloroaniline

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 or test system 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 / concentration:

2 male rats

Control animals:

no

Positive control reference chemical:

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.