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EC number: 224-924-0 | CAS number: 4553-89-3
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Link to relevant study record(s)
- 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
- 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
- Radiolabelling:
- yes
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- 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 - 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
- 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
- Details on absorption:
- Not applicable
- Details on distribution in tissues:
- Not applicable
- Details on excretion:
- Not applicable
- Metabolites identified:
- yes
- Details on metabolites:
- Naphthionic acid & two unidentified metabolites
- 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.
Reference
Organs exhibiting radioactivity
· Liver
· Kidney
Description of key information
Basic toxicokinetics:
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.
Key value for chemical safety assessment
- Bioaccumulation potential:
- low bioaccumulation potential
Additional information
Basic toxicokinetics:
Based on the available data of basic toxicokinetics for the target substance disodium 4,4'-[[2,4-dihydroxy-5-(hydroxymethyl)-1,3-phenylene]bis(azo)]bisnaphthalene-1-sulphonate following result is summarized:
The absorption, metabolism, tissue distribution and excretion of 14C-labelled Brown HT has been studied in the rat, mouse and guinea-pig. Following administration of a single oral dose of either 50 or 250 mg Brown HT/kg, substantially all of the dose was excreted in the urine and faeces within 72 hr, with the majority (more than 80%) being accounted for in the faeces. A significant difference in urinary excretion of radioactivity was seen between male and female rats, as well as clear species differences at the two dose levels used. In all species studied, 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. The accumulated radioactivity is cleared rapidly from most tissues on cessation of treatment.
Upon oral administration by gavage of the chemical of14C-labelled Brown HT to guinea pigs and rats, from the information available pertaining to absorption, distribution, metabolism and excretion, it can be concluded that the most of the administered chemical which is metabolized as well as the unchanged dye are excreted out of the living system within 72 hours. Thus, the chemical is expected to have low bio-accumulation potential based on study results and weight of evidence approach.
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