Registration Dossier
Registration Dossier
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EC number: 239-888-1 | CAS number: 15790-07-5 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 15985:1.
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from publication
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- The excretion and metabolism of edible colours
- Author:
- Daniel, J. W.
- Year:
- 1 962
- Bibliographic source:
- Toxicol. appl. Pharmacol., 4, 572-594
- Reference Type:
- secondary source
- Title:
- WHO Food Additive Series 549: Sunset Yellow FCF
- Author:
- WHO
- Year:
- 2 004
- Bibliographic source:
- Sunset Yellow FCF (1964). Available from, as of October 26,
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as below
- Principles of method if other than guideline:
- The excretion and metabolism of edible colours(sunset yellow fcf).
- 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 (5E)-6-oxo-5-[(4-sulfonatophenyl)hydrazinylidene]naphthalene-2-sulfonate
- Details on test material:
- - Name of test material (as cited in study report): sunset yellow
- Molecular formula (if other than submission substance): C16H12N2O7S2.2Na
- Molecular weight (if other than submission substance): 452.37 g/mol
- Substance type: Organic
- Physical state: solid
- Impurities (identity and concentrations): NA
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): sunset yellow
- Molecular formula (if other than submission substance): C16H12N2O7S2.2Na
- Molecular weight (if other than submission substance): 452.37 g/mol
- Substance type: Organic
- Physical state: solid - Radiolabelling:
- not specified
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- Details not available
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on exposure:
- not specified
- Duration and frequency of treatment / exposure:
- Single oral exposure,48 hrs
Doses / concentrations
- Dose / conc.:
- 500 mg/kg bw/day
- No. of animals per sex per dose / concentration:
- not specified
- Control animals:
- not specified
- Positive control reference chemical:
- not specified
- Details on study design:
- not specified
- Details on dosing and sampling:
- not specified
- Statistics:
- not specified
Results and discussion
- Preliminary studies:
- not specified
Main ADME resultsopen allclose all
- Type:
- absorption
- Results:
- The metabolites are then partly absorbed by the intestinal tract of Rabbit.
- Type:
- metabolism
- Results:
- The following metabolites could be identified in 48 hours urine: sunset yellow (2%), sulfanilic acid (54%), p-acetamido benzenesulfonic acid (23%), 1-amino 2-naphthol-6-sulfonic acid (55% in 24 hours)
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- not specified
- Details on distribution in tissues:
- not specified
- Details on excretion:
- not specified
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- Unchanged sunset yellow
sulfanilic acid
p-acetamido benzenesulfonic acid
1-amino 2-naphthol-6-sulfonic acid
Applicant's summary and conclusion
- Conclusions:
- Since the administered dose was rapidly metabolized in 48 hours and other reports with Rat suggests elimination out of the living system in 96 hours; it can be concluded that the chemical is likely to have low bio-accumulation potential.
- Executive summary:
Since the administered dose was rapidly metabolized in 48 hours and other reports with Rat suggests elimination out of the living system in 96 hours;it can be concluded that the chemical is likely to have low bio-accumulation potential.
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