Registration Dossier

Toxicological information

Basic toxicokinetics

Currently viewing:

Administrative data

Endpoint:
basic toxicokinetics in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
publication
Title:
Metabolic behaviour of water-soluble fluorescent whitening agents in the rat and bean plant
Author:
Muecke W, Dupuis G, Esser HO
Year:
1975
Bibliographic source:
Environmental Quality and Safety. Supplement [1975, 4:174-179]

Materials and methods

Objective of study:
toxicokinetics
Test guideline
Qualifier:
according to
Guideline:
other:
Principles of method if other than guideline:
Transformation and fate of the chemical after entry into the body of living organisms to decide its bioaccumulation potential.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material: disodium4,4'-bis[(4-anilino-6-morpholino-1,3,5-triazin-2-yl)amino]stilbene-2,2'-disulphonate
- Molecular formula: C40-H40-N12-O8-S2.2Na
- Molecular weight: 925
- Substance type: Organic
- Physical state: Solid
Radiolabelling:
yes

Test animals

Species:
rat
Strain:
SIV 50
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on exposure:
The behaviour of water-soluble fluorescent whitening agents (FWA) was studied in rats and bean plants using 14C-labelled compounds.
Duration and frequency of treatment / exposure:
96 hours
Doses / concentrations
Remarks:
Doses / Concentrations:
5 mg/kg
No. of animals per sex per dose:
4
Control animals:
not specified

Results and discussion

Main ADME resultsopen allclose all
Type:
absorption
Results:
No significant amounts of whitener were absorbed from the digestive tract of the rats.
Type:
distribution
Results:
No radioactive residues were found in blood, liver, kidney, brain, muscle, or fat 96 hours after dosing with the chemical.
Type:
metabolism
Results:
Details not available.
Type:
excretion
Results:
Following oral doses of 5 mg/kg of each of theFWAs to rats, rapid and complete excretion of radioactive material was observed, with an excretion half-life ranging from 7-13 hours.
Type:
excretion
Results:
Faeces were practically the only route of excretion, indicating, in combination with the short half life times, that no significant amounts of whitener were absorbed from the digestive tract.

Toxicokinetic / pharmacokinetic studies

Details on absorption:
Not applicable since the chemical does not have pharma application.

Metabolite characterisation studies

Metabolites identified:
no

Any other information on results incl. tables

Organs exhibiting radioactivity: No radioactive residues were found in blood, liver, kidney, brain, muscle, or fat.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): low bioaccumulation potential based on study results
From the available information on absorption, distribution and excretion of the chemical Disodium 4,4'-bis[(4-anilino-6-morpholino-1,3,5-triazin-2-yl)amino]- stilbene-2,2'-disulfonate [14C-labelled Fluorescent whitening agent (FWA)] shall have low bio-accumulation potential.
Executive summary:

From the available information on absorption, distribution and excretion of the chemicalDisodium 4,4'-bis[(4-anilino-6-morpholino-1,3,5-triazin-2-yl)amino]- stilbene-2,2'-disulfonate [14C-labelled Fluorescent whitening agent (FWA)]shall have low bio-accumulation potential.