Registration Dossier
Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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EC number: 443-940-0 | 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
- Type of information:
- calculation (if not (Q)SAR)
- Remarks:
- Migrated phrase: estimated by calculation
- Adequacy of study:
- key study
- Study period:
- 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Evaluation and assessment of the toxicokinetic properties based on the results obtained for the toxicological end-points with simultaneous reference to physico-chemical data such as solubility in various solvents and log Pow
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- other: Expert statement
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
- Objective of study:
- toxicokinetics
Test guideline
- Qualifier:
- no guideline followed
- Deviations:
- not applicable
- Principles of method if other than guideline:
- Assessment of the toxicokinetic properties based on the results obtained for the toxicological end-points with simultaneous reference to physico-chemical data such as solubility in various solvents and log Pow
- GLP compliance:
- no
Test material
- Details on test material:
- - Name of test material (as cited in study report): Reaktiv-Scharlach F01-0467
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- other: Not applicable
- Strain:
- other: Not applicable
- Details on test animals or test system and environmental conditions:
- Not applicable
Administration / exposure
- Route of administration:
- other: Not applicable
- Vehicle:
- other: Not applicable
- Details on exposure:
- Not applicable
- Duration and frequency of treatment / exposure:
- Not applicable
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Not applicable
- No. of animals per sex per dose / concentration:
- Not applicable
- Control animals:
- other: Not applicable
- Positive control reference chemical:
- Not applicable
- Details on study design:
- Not applicable
- Details on dosing and sampling:
- Not applicable
- Statistics:
- Not applicable
Results and discussion
- Preliminary studies:
- None
Main ADME resultsopen allclose all
- Type:
- absorption
- Results:
- Dermal absorption is unlikely due to the negative log Pow and the acidic character of test substance. However, after oral gavage test substance is at least partially absorbed.
- Type:
- metabolism
- Results:
- Partial metabolic cleavage by bacterial azoreductases in the intestine resulting in more hydrophilic amines seems to be likely.
- Type:
- other: accumulation
- Results:
- Accumulation of the test substance in the fatty tissues of the body is unlikely. Correspondingly, organ discolorations largely disappeared after the 14-wk recovery period.
- Type:
- excretion
- Results:
- via kidneys and additionally via feces is likely
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- No data
- Details on distribution in tissues:
- No data
- Details on excretion:
- No data
Metabolite characterisation studies
- Metabolites identified:
- not measured
- Details on metabolites:
- Not applicable
Any other information on results incl. tables
Evaluation and Assessment:
Due to the negative log Pow and the acidic character of test substance a dermal absorption is unlikely. This is in accordance with the data obtained in the acute dermal toxicity and dermal irritation study.
An oral resorption of test substance is also restricted due to the low log Pow of -5.1 since most substances with a log Pow <0.5 are only marginally resorbed. However, after oral gavage test substance is at least partially absorbed.
As test substance is an azo dye, partial metabolic cleavage by bacterial azoreductases in the intestine resulting in more hydrophilic amines seems to be likely
Due to the physico-chemical properties of the test substance a major accumulation of the chemical in the body is unlikely. Test substance is excreted via kidneys. An additional elimination via feces is likely, since the molecular weight of the substance is >300.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): other: does not show any toxicokinetic peculiarity
Based on the physico-chemical properties of test substance and the results obtained in various toxicological examinations, it can be concluded that the test substance does not show any toxicokinetic peculiarity - Executive summary:
Evaluation and assessment of the toxicokinetic properties of the test substance was carried out based on the results obtained for the toxicological end-points with simultaneous reference to physico-chemical data such as solubility in various solvents and logPow.
Based on the physico-chemical properties of test substance and the results obtained in various toxicological examinations, it can be concluded that the test substance does not show any toxicokinetic peculiarity.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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