4,4'-bis[4-[bis(2-hydroxyethyl)amino]-6-anilino-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonic acid

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented report which meets basic scientific principles.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1972

Report date:

1972

Reference 2

Reference Type:

publication

Title:

Metabolic Behaviour of Water-Soluble Fluorescent Whitening Agents in the Rat and Bean Plant

Author:

W. Muecke et al.

Year:

1975

Bibliographic source:

Environmental Quality and Safety, Supplement, vol. 4, 174-179

Materials and methods

Objective of study:

metabolism

Principles of method if other than guideline:

Absorption, Distribution and Excretion study

GLP compliance:

no

Remarks:

pre-GLP study

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 4,4'-bis[(4-anilino-6-morpholino-1,3,5-triazin-2-yl)amino]stilbene-2,2'-disulphonate

EC Number:

240-245-2

EC Name:

Disodium 4,4'-bis[(4-anilino-6-morpholino-1,3,5-triazin-2-yl)amino]stilbene-2,2'-disulphonate

Cas Number:

16090-02-1

IUPAC Name:

disodium 2,2'-ethene-1,2-diylbis{5-[(4-anilino-6-morpholin-4-yl-1,3,5-triazin-2-yl)amino]benzenesulfonate}

Details on test material:

- Name of test material (as cited in study report): 4,4'-bis-(2-anilino-4-morpholino-1,3,5- triazine-6-yl-amino)-stilben-2,2'-disulphonic acid disodium salt
- Specific activity (if radiolabelling): 8.7 µCi/mg

Radiolabelling:

yes

Remarks:

14C

Test animals

Species:

rat

Strain:

other: SIV 50

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ivanovas, Kisslegg, Germany
- Weight at study initiation: approximately 200 g

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Duration and frequency of treatment / exposure:

single application

Doses / concentrations

Remarks:

Doses / Concentrations:
6.1 ± 0.1 mg/kg for females and 5.9 ± 0.2 mg/kg for males (mean ± SEM)

No. of animals per sex per dose / concentration:

4

Control animals:

no

Details on dosing and sampling:

METABOLITE CHARACTERISATION STUDIES
- Tissues and body fluids sampled: urine, faeces, tissues,
- Time and frequency of sampling: 16 or 24, 40 or 48, 64 or 72 hours after application
- Method type(s) for identification: Liquid scintillation counting
- Limits of detection and quantification: 0.01 ppm

Results and discussion

Metabolite characterisation studies

Metabolites identified:

not measured

Any other information on results incl. tables

Following an oral dose of 14C-labeled test substance in water to rats of both sexes, rapid and complete excretion of radioactive material was observed, with an excretion half life ranging from 7-13 hours. About 90% of the applied radioactivity was eliminated in faeces within 24 hours of dosing, indicating, in combination with the short half life times, that no significant amounts of test substance were absorbed from the gastro-intestinal tract. No sex differences were observed. Radioactivity found in urine was at the limit of detection (0.02%. of applied dose). No radioactivity was found in the expired air (< 0.01%). No radioactivity was found in blood, liver kidney, brain, muscle, or fat 96 hours after dosing (limit of quantification 0.005 - 0.01 ppm FWA equivalents). The total recovery of radioactivity was 97.5% and 95.2% of the orally applied dose for males and females, respectively.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): no bioaccumulation potential based on study results
The substance is rapidely excreted via feces.