Registration Dossier
Registration Dossier
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EC number: 224-924-0 | CAS number: 4553-89-3
Basic toxicokinetics
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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Data is from peer reviewed journal
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- The aim of this study is to describe the absorption, distribution and excretion of ~4C-labelled Brown HT in the rat, mouse and guinea-pig following oral administration at low (50-70mg/kg) and high (250 mg/kg) dose levels.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Disodium 4,4'-[[2,4-dihydroxy-5-(hydroxymethyl)-1,3-phenylene]bis(azo)]bisnaphthalene-1-sulphonate
- EC Number:
- 224-924-0
- EC Name:
- Disodium 4,4'-[[2,4-dihydroxy-5-(hydroxymethyl)-1,3-phenylene]bis(azo)]bisnaphthalene-1-sulphonate
- Cas Number:
- 4553-89-3
- Molecular formula:
- C27H20N4O9S2.2Na
- IUPAC Name:
- disodium 4,4'-[[2,4-dihydroxy-5-(hydroxymethyl)-1,3-phenylene]bis(azo)]bisnaphthalene-1-sulphonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Disodium 4,4’-(2,4-dihydroxy-5- hydroxymethyl-1,3-phenylene bis-azo) di- (naphthalene-1-sulfonate)
- Molecular formula: C27H20N4O9S2.2Na
- Molecular weight: 654.58 g/mol
- Substance type: Organic
- Physical state: Solid
Constituent 1
- Radiolabelling:
- yes
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- The labelled colouring, diluted with unlabelled colouring, was administered as an aqueous solution at a volume (5 ml/kg body weight) that provided a dose level of 50-70 or 250mg Brown HT/kg body weight
- Duration and frequency of treatment / exposure:
- single dose of 14C-labelled Brown HT
Study duration 3 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
50-70 (low dose) or 250mg Brown HT/kg body weight (high dose)
- No. of animals per sex per dose / concentration:
- 3 animals (male)
- Control animals:
- not specified
- Positive control reference chemical:
- Not Available
- Details on study design:
- Not Available
- Details on dosing and sampling:
- Not Available
- Statistics:
- Not Available
Results and discussion
Main ADME resultsopen allclose all
- Type:
- absorption
- Results:
- There is no direct evidence for absorption of unchanged Brown HT from the gastro-intestinal tract.
- Type:
- distribution
- Results:
- Major part of the distribution is in the gastro-intestinal tract, liver and kidneys.
- Type:
- metabolism
- Results:
- Naphthionic acid was the major urinary metabolite, whereas in the faeces naphthionic acid, trace quantities of unchanged dye and at least two unidentified metabolites were found.
- Type:
- metabolism
- Results:
- Recovery of administered radioactivity (%) in Guinea pig in the low dose (50 mg/kg bw and high dose 250 mg/kg bw was found to be 99.3 and 95.7 respectively. Guinea-pigs excreted a greater proportion of the higher dose in the urine
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:
- Naphthionic acid & two unidentified metabolites
Any other information on results incl. tables
Organs exhibiting radioactivity
· Liver
· Kidney
Applicant's summary and conclusion
- Conclusions:
- In vivo study upon oral administration of the chemical Brown HT [IUPAC name: disodium 4,4'-[[2,4-dihydroxy-5-(hydroxymethyl)-1,3-phenylene]bis(azo)]bisnaphthalene-1-sulphonate] to male guinea pig indicates that the chemical is expected to have low bio-accumulation potential since most of the administered radioactivity was eliminated in the faeces after 72 hours.
- Executive summary:
From the available data on absorption, distribution, metabolism and excretion in an in vivo study upon oral administration of the chemicalBrown HT [IUPAC name: disodium 4,4'-[[2,4-dihydroxy-5-(hydroxymethyl)-1,3-phenylene]bis(azo)]bisnaphthalene-1-sulphonate] to male guinea pig there are indications that the chemical is expected to have low bio-accumulation potential since most of the administered radioactivity was eliminated in the faeces after 72 hours.
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