Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
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

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1972
Report Date:
1972
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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
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.