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Diss Factsheets
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EC number: 443-090-0 | CAS number: -
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics, other
- Type of information:
- other: Based on available physico-chemical properties and toxicological data of the substance
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Assessment based on physico-chemical properties and toxicological data of the substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
- Objective of study:
- other: Toxicokinetic assessment
- Principles of method if other than guideline:
- An expert assessment was made based on physical chemical properties and all toxicity data available.
Test material
- Reference substance name:
- -
- EC Number:
- 443-090-0
- EC Name:
- -
- Cas Number:
- 477795-15-6
- Molecular formula:
- C26H24FN8Na3O14S4
- IUPAC Name:
- Trisodium 2-{2-[1-ethyl-2-hydroxy-4-methyl-6-oxo-5-(sulfonatomethyl)-1,6-dihydropyridin-3-yl]diazen-1-yl}-4-{[4-fluoro-6-({4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}amino)-1,3,5-triazin-2-yl]amino}benzene-1-sulfonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Reaktivgelb F-97494
Constituent 1
Administration / exposure
- Details on study design:
- A toxicokinetic assessment has been performed based on available physico-chemical properties and toxicological data (i.e., acute oral toxicity, acute dermal toxicity skin irritation eye irritation skin sensitization subacute (28 d) oral toxicity, bacterial reverse mutation test, in vitro chromosome aberration test and in vivo micronucleus test) of the test substance.
Results and discussion
Any other information on results incl. tables
Evaluation and assessment:
The data of the acute dermal toxicity, dermal irritation and skin sensitization test indicate little or no dermal absorption, owing to the fact that no irritating or sensitizing effects were observed. This is in accordance with the physico-chemical properties of test substance. Oral absorption of test substance is probably also restricted due to the low log Ko/w of <-4.9 since most substances with a log Ko/w <0.5 are only marginally absorbed. However, after oral gavage test substance is at least partially absorbed. This can be concluded from the data obtained in the acute oral toxicity study with females, in which yellowish discolorations of the urine between 1-2 and 4-8 h after administration were observed. As test substance is an azo dye, partial metabolic cleavage by bacterial azo reductases in the intestine resulting in more hydrophilic amines seems to be likely. Due to the physico-chemical properties of test substance an accumulation of the test substance in the fatty tissues of the body is unlikely. Likewise, distribution or accumulation in other organs was not observed after oral administration. The elimination of the absorbed test substance fraction seems to be very efficient, as urine discoloration disappeared 24 h after administration. It can be assumed that the test substance is also eliminated via faeces, as substances with a molecular weight above 300 g/mol are preferentially excreted via the faeces in rats.
In summary, based on the high water solubility, low log Ko/w, and the results obtained in various toxicological examinations it can be concluded that test substance does not show any toxicokinetic peculiarity.
Applicant's summary and conclusion
- Conclusions:
- The test substance is not expected to be absorbed to a high extent via the oral or dermal exposure routes. Based on its physico-chemical properties, accumulation of the test substance in the fatty tissues of the body is unlikely. Elimination of the absorbed test substance fraction seems to be very efficient.
- Executive summary:
A toxicokinetic assessment was conducted based on available physico-chemical properties and toxicological data of the test substance.
Based on physico-chemical properties of test substance, oral absorption is probably restricted due to the low log Kow of <-4.9. Most substances with a log Kow <0.5 are only marginally absorbed. Likewise, the data of the acute dermal toxicity, dermal irritation and skin sensitization tests indicates little or no dermal absorption, owing to the fact that no irritating or sensitizing effects were observed. However, an acute oral toxicity study with females in which yellowish discolorations of the urine between 1-2 and 4-8 h after administration were observed suggests that the test substance is at least partially absorbed after oral (gavage) exposure. As the test substance is an azo dye, it may undergo partial metabolic cleavage by bacterial azo-reductases in the intestine, resulting in more hydrophilic amines.
Based on its physico-chemical properties, accumulation of the test substance in the fatty tissues of the body is unlikely. Distribution or accumulation in other organs was not observed after oral administration. The elimination of the absorbed test substance fraction seems to be very efficient, as urine discoloration disappeared 24 h after administration. It can be assumed that the test substance is also eliminated via feces, as substances with a molecular weight above 300 g/mol are preferentially excreted via the feces in rats.
In light of available information, it can be concluded that test substance does not show any toxicokinetic peculiarity.
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