Registration Dossier
Registration Dossier
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EC number: 220-491-7 | CAS number: 2783-94-0
Basic toxicokinetics
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:
- Intestinal absorption of polymeric derivatives of the food dyes sunset yellow and tartrazine in rats
- Author:
- Honohan, T. et al.
- Year:
- 1 977
- Bibliographic source:
- Xenobiotica, 7, 765-774
Materials and methods
- Objective of study:
- absorption
- distribution
- excretion
- metabolism
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate
- EC Number:
- 220-491-7
- EC Name:
- Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate
- Cas Number:
- 2783-94-0
- Molecular formula:
- C16H12N2O7S2.2Na
- IUPAC Name:
- disodium 6-hydroxy-5-[(4-sulfonatophenyl)diazenyl]naphthalene-2-sulfonate
- Details on test material:
- - Name of test material (as cited in study report):Sunset Yellow FCF
- Substance type:Organic
- Physical state:solid
- Impurities (identity and concentrations):NA
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- water
- Details on exposure:
- Female Sprague Dawley rats were dosed orally with 1 ml of aq. soln. containing 2-25 mg of sunset yellow
- Duration and frequency of treatment / exposure:
- 72 hrs
Doses / concentrations
- Remarks:
- Doses / Concentrations:
2-25 mg of sunset yellow
- No. of animals per sex per dose / concentration:
- Not specified
- Control animals:
- not specified
Results and discussion
Main ADME resultsopen allclose all
- Type:
- absorption
- Results:
- Some absoprtion is reported to take place
- Type:
- distribution
- Results:
- Takes place in the bile
- Type:
- metabolism
- Results:
- sulphanilic acid is reported to be one of the metabolite
- Type:
- excretion
- Results:
- Rats dosed with sunset yellow excreted 0.3 and 1.5% of the administered dye in urine and bile, resp.& 37% of the sulphanilic acid equivalents in the urine. Dye was visible in bile within 15 min after dosing and the colour disappeared within 2-3 h.
- Type:
- excretion
- Results:
- Urinary excretion of sunset yellow also was maximal soon after dosing, Within the range of 2-25 mg, dosage had no effect on the percentage excretion of dye or metabolite in urine or bile.
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Not applicable
- Details on distribution in tissues:
- Not applicable
- Details on excretion:
- Not applicable
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- Sulfanilic acid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): low bioaccumulation potential based on study results
Since the urinary excretion of sunset yellow was maximal soon after dosing, it can be concluded that the chemical shall have low bio-accumulation potential. - Executive summary:
Since the urinary excretion of sunset yellow was maximal soon after dosing, it can be concluded that the chemical shall have low bio-accumulation potential.
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