Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 260-906-9 | CAS number: 57693-14-8
- 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:
- other: expert statement
- Adequacy of study:
- key study
- Study period:
- 2013
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Information is derived from existing toxicological studies.
Data source
Materials and methods
Test material
- Reference substance name:
- Trisodium bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(3-)
- EC Number:
- 260-906-9
- EC Name:
- Trisodium bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(3-)
- Cas Number:
- 57693-14-8
- Molecular formula:
- C40H20CrN6O14S2.3Na
- IUPAC Name:
- trisodium bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(3-)
Constituent 1
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Based on the subacute (28-day) oral toxicity study absorption of toxicologically significant amounts of the substance via the gastrointestinal tract has to be assumed since obvious discoloration of inner organs was observed throughout the body.
The skin sensitisation studies indicate some local dermal bioavailability. However, systemic availability seems to be negligible after dermal exposure since no systemic signs of intoxication were seen after occlusive administration of 2000 mg test item per kg body weight in rats in the acute dermal toxicity study. Indications of a significant dermal absorptive potential were also not revealed by testing for primary irritation in rabbits. - Details on distribution in tissues:
- Based on the results of the subacute oral toxicity study, discolorations were observed in liver, kidney, lymph nodes, reproductive organs, thymus and salivary glands. Thus it can be concluded, that test item is absorbed through the gastrointestinal tract and systemically available within the organism. Histopathological findings indicate a deposition of the dye mainly in interstitial macrophages of the affected tissues.
There were no signs of bioaccumulation of the test material although the dose-response-relationship of the macroscopic as well as the microscopic discolorations after dosing in the subacute toxicity study indicates some retention of the dye. This view is supported by the physical-chemical properties (solubility in water) and the molecular structure.
- Details on excretion:
- Taking into account the physico-chemical properties and the molecular structure of the dye it can be assumed that the main route of excretion will be the kidney. This notion is confirmed by the discoloration of kidneys observed in the subacute study.
Metabolite characterisation studies
- Metabolites identified:
- no
- Details on metabolites:
- Test substance proved to be weakly active in the Ames-test with and without exogenous metabolic activation. This indicates that it does not need metabolic activation. It was not genotoxic in the HPRT in vitro and the micronucleus assay in vivo. Thus metabolites, if any are formed, are not more toxic than the parent compound.
In the skin sensitisation test positive reactions were seen, which indicate some reactivity e. g. protein binding.
No effects were seen in the subacute study except for a discoloration of tissues histologically allocated to tissue macrophages. No functional or structural impairments were detected. Therefore, the substance is considered to just pass through the organism without significant metabolism. The only interaction being some binding to bio-molecules giving rise to the hypersensitivity reactions and the accumulation observed in macrophages. Depending on the dose, the capacity of the excretion mechanisms may become exhausted leading to deposition of the dye in tissue macrophages.
Applicant's summary and conclusion
- Conclusions:
- Based on all available data, test substance does not exhibit conspicuous toxicokinetic behaviour in the sense of accumulative and/or delayed effects with regard to the individual parameters absorption, distribution, metabolism and excretion.
The results from studies with dermal exposure indicate that it has a small but definite dermal absorptive potential. It is absorbed from the gastrointestinal tract in significant amounts and distributed throughout the body.
Indications of an intense metabolism or a bio-accumulative potential do not exist as no delayed toxicity occurred. Additionally no increase in severity of systemic effects was observed in the subacute oral toxicity study, which also points to no bio-accumulation potential as well as to excretion. - Executive summary:
Absorption:
Based on the subacute (28-day) oral toxicity study absorption of toxicologically significant amounts of test substance via the gastrointestinal tract has to be assumed since obvious discoloration of inner organs was observed throughout the body.
The skin sensitisation studies indicate some local dermal bioavailability. However, systemic availability seems to be negligible after dermal exposure since no systemic signs of intoxication were seen after occlusive administration of 2000 mg test substance per kg body weight in rats in the acute dermal toxicity study. Indications of a significant dermal absorptive potential were also not revealed by testing for primary irritation in rabbits.
Distribution:
Based on the results of the subacute oral toxicity study discolorations were observed in liver, kidney, lymph nodes, reproductive organs, thymus and salivary glands. Thus it can be concluded, that test substance is absorbed through the gastrointestinal tract and systemically available within the organism. Histopathological findings indicate a deposition of the dye mainly in interstitial macrophages of the affected tissues.
There were no signs of bioaccumulation of the test material although the dose-response-relationship of the macroscopic as well as the microscopic discolorations after dosing in the subacute toxicity study indicates some retention of the dye. This view is supported by the physical-chemical properties (solubility in water) and the molecular structure.
Metabolism:
Test substance proved to be weakly active in the Ames-test with and without exogenous metabolic activation. This indicates that it does not need metabolic activation. It was not genotoxic in the HPRT in vitro and the micronucleus assay in vivo. Thus metabolites, if any are formed, are not more toxic than the parent compound.
In the skin sensitisation test positive reactions were seen, which indicate some reactivity e. g. protein binding.
No effects were seen in the subacute study except for a discoloration of tissues histologically allocated to tissue macrophages. No functional or structural impairments were detected. Therefore, it is considered to just pass through the organism without significant metabolism. The only interaction being some binding to bio-molecules giving rise to the hypersensitivity reactions and the accumulation observed in macrophages. Depending on the dose the capacity of the excretion mechanisms may become exhausted leading to deposition of the dye in tissue macrophages.
Excretion:
Taking into account the physico-chemical properties and the molecular structure of the dye it can be assumed that the main route of excretion will be the kidney. This notion is confirmed by the discoloration of kidneys observed in the subacute study.
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.