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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Link to relevant study record(s)

Reference
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.
Objective of study:
absorption
distribution
excretion
metabolism
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
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
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
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
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
Preliminary studies:
not specified
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.
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) testing results:
not specified
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.

Description of key information

Basic toxicokinetics:

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.

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential

Additional information

Basic toxicokinetics:

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.