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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
basic toxicokinetics in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from abstract of peer reviewed publication.

Data source

Reference
Reference Type:
publication
Title:
Metabolic disposition of [14C]-metanil yellow in rats
Author:
Singh, R. L
Year:
1989
Bibliographic source:
Biochemistry International (1989), 19(5), 1109-16

Materials and methods

Objective of study:
absorption
distribution
excretion
metabolism
Test guideline
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
The absorption, metab. and excretion of [14C]metanil yellow was studied in rats.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 3-(p-anilinophenylazo)benzenesulphonate
EC Number:
209-608-2
EC Name:
Sodium 3-(p-anilinophenylazo)benzenesulphonate
Cas Number:
587-98-4
Molecular formula:
C18H14N3O3S.Na
IUPAC Name:
sodium 3-(p-anilinophenylazo)benzenesulphonate
Test material form:
solid
Details on test material:
- Name of test material: Ext. D&C Yellow No. 1
- IUPAC name: sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate
- Molecular formula: C18H15N3O3SNa
- Molecular weight: 375.383 g/mol
- Substance type: organic
- Physical state: solid
- Purity: No data available
- Impurities (identity and concentrations): no data available
Specific details on test material used for the study:
- Name of test material : sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate
- Molecular formula : C18H14N3O3S.Na
- Molecular weight: 375.383 g/mol
- Smiles notation : c1(Nc2ccccc2)ccc(\N=N\c2cc(ccc2)S(=O)(=O)[O-])cc1.[Na+]
- InChl : 1S/C18H15N3O3S.Na/c22-25(23,24)18-8-4-7-17(13-18)21-20-16-11-9-15(10-12-16)19-14-5-2-1-3-6-14;/h1-13,19H,(H,22,23,24);/q;+1/p-1/b21-20+;
- Substance type: Organic
- Physical state: Solid
Radiolabelling:
yes

Test animals

Species:
rat
Strain:
not specified
Details on species / strain selection:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
not specified

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Details on exposure:
single oral dose of 5 mg/kg
Duration and frequency of treatment / exposure:
single dose
Doses / concentrations
Dose / conc.:
5 mg/kg diet
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:
single dose of 5 mg/kg was administered orally
Type:
distribution
Results:
Liver, kidney, spleen, and testis retained no count whereas 13.6% of the radioactivity was retained by gastrointestinal tract.
Type:
metabolism
Results:
Metabolites of metanil yellow which were characterized by TLC and IR, NMR, and mass spectroscopic studies as metanilic acid and p-aminodiphenylamine.
Type:
excretion
Results:
80.5% of the dose was excreted in the urine and feces within 96 h, with the majority being accounted for in the feces.

Metabolite characterisation studies

Metabolites identified:
yes
Details on metabolites:
Analaysis of urine and feces detected two azo-reduction metabolites of metanil yellow which were characterized by TLC and IR, NMR, and mass spectroscopic studies as metanilic acid and p-aminodiphenylamine.

Bioaccessibility (or Bioavailability)

Bioaccessibility (or Bioavailability) testing results:
not specified

Applicant's summary and conclusion

Conclusions:
The substance sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate was determined to be readily absorbed, metabolised and rapidly excreted in the urine and feces within 96 h, with the majority being accounted for in the feces (80.5% in 96 hrs). Hence the substance is assumed to possess no bio-accumulation potential based on study results.
Executive summary:

The absorption, metabolism and excretion of [14C] metanil yellow was studied in rats. Following administration of a single oral dose of 5 mg dye (7.6mCi)/kg, 80.5% of the dose was excreted in the urine and feces within 96 h, with the majority being accounted for in the feces. Liver, kidney, spleen, and testis retained no count whereas 13.6% of the radioactivity was retained by gastrointestinal tract. Analaysis of urine and feces detected two azo reduction metabolites of metanil yellow which were characterized by TLC and IR, NMR, and mass spectroscopic studies as metanilic acid and p-aminodiphenylamine. Hence the substance is assumed to possess no bio-accumulation potential based on study results.