Registration Dossier
Registration Dossier
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EC number: 223-339-8 | CAS number: 3844-45-9
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- publication
- Title:
- Synthesis of 14C-labelled FD&C Blue No.1 (Brilliant Blue FCF) and its intestinal absorption and metabolic fate in rats
- Author:
- Brown, J.P., Dorsky, A., Enderlin, F.E., Hale, R.L., Wright,V.A., Parkinson, T.M.
- Year:
- 1 980
- Bibliographic source:
- Fd. Cosmet. Toxicol. 18, 1-5 (1980)
Materials and methods
- Objective of study:
- absorption
- excretion
- metabolism
- Principles of method if other than guideline:
- Toxicokinetic study with 14C-labelled substance
Identification of potential metabolites by thin layer chromatography - GLP compliance:
- no
Test material
- Reference substance name:
- Dihydrogen (ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)]amino]-2'-sulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, disodium salt
- EC Number:
- 223-339-8
- EC Name:
- Dihydrogen (ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)]amino]-2'-sulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, disodium salt
- Cas Number:
- 3844-45-9
- Molecular formula:
- C37 H34 N2 Na2 O9 S3
- IUPAC Name:
- disodium 2-({4-[ethyl(3-sulfonatobenzyl)amino]phenyl}{4-[ethyl(3-sulfonatobenzyl)iminio]cyclohexa-2,5-dien-1-ylidene}methyl)benzenesulfonate
- Test material form:
- solid
- Details on test material:
- - purity of 14C test substance: > 99%
- 14C test substance was synthesized by the authors
Constituent 1
- Specific details on test material used for the study:
- - purity of 14C test substance: > 99%
- 14C test substance was synthesized by the authors - Radiolabelling:
- yes
- Remarks:
- 14C
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Duration and frequency of treatment / exposure:
- single
Doses / concentrations
- Dose / conc.:
- 0.27 other: mg (1.74 uCi)
- No. of animals per sex per dose / concentration:
- 13 (8 bile duct ligated)
Results and discussion
Any other information on results incl. tables
Urinary, faecal and pulmonary excretion of radioactivity after oral administration of [14C]FD & C Blue No. 1 to bile-duct ligated rats were 2.02, 97.28 and 0.01% of the administered dose, respectively. Radioactivity recovered from internal organs represented 0.02% of that administered dose. Total recovery of administered radioactivity was 99.38%.
Applicant's summary and conclusion
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