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Diss Factsheets
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4-amino-5-hydroxy-6-(5-{4-chloro-6-[4-(2-sulfonatooxyethanesulfonyl)phenylamino]-1,3,5-triazin-2-ylamino}-2-sulfonatophenylazo)-3-(2-sulfonato-4-(2-sulfonatooxyethanesulfonyl)phenylazo)naphthalene-2,7-disulfonate potassium/sodium;reaction mass of: 4-amino-3-(4-ethenesulfonyl-2-sulfonatophenylazo)-5-hydroxy-6-(5-{4-chloro-6-[4-(2-sulfonatooxyethanesulfonyl)phenylamino]-1,3,5-triazin-2-ylamino}-2-sulfonatophenylazo)naphthalene-2,7-disulfonate potassium/sodium
EC number: 451-440-9 | CAS number: 586372-44-3
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: DIRECTIVE 93/67/EEC
- GLP compliance:
- no
Test material
Constituent 1
Results and discussion
Any other information on results incl. tables
Toxicokinetics, metabolism and distribution
Risk assessment
The data presented in the present dossier only allow for a qualitative assessment of the toxicokinetic behaviour of the test item.
Physico-chemical data:
Blue TZ 4775 is a sodium salt of a reactive dye structure with relatively high molecular weight given into commercial/industrial use in a dedusted and high particle size sales form. For the dedusted sales form therefore generally a particle diameter of > 100 µm
can be assumed. The main component of the mixture has a purity of ca. 64.4 %. More than 400 g Blue TZ 4775 are soluble in water at 20 °C.
Toxicological data:
Blue TZ 4775 was tested for acute toxicity by oral and dermal application, for subacute oral toxicity and for irritant effects on skin and eyes as well as for skin sensitization in a maximisation assay.
In the tests for acute oral and dermal toxicity, Blue TZ 4775 was applied to rats at a single dose level of 2000 mg/kg body weight (oral) and 2000 mg/kg body weight (dermal). Neither mortality nor any substance-related systemic effects or changes on organs
were seen.
On skin irritation testing, Blue TZ 4775 produced a blue staining of the treated skin of rabbits by pigment or colouring of the test article in the area of application. According to EU-criteria the substance is not irritating to skin. The colouring of fur and skin may be
declared as usual/normal for the use of dyestuffs for natural fibres as cotton and/or wool.
On eye irritation testing, Blue TZ 4775 was found to generate irreversible blue stainings of the eyes. Accordingly the dye was classified as irritating to the eye of rabbits.
On skin sensitization testing, Blue TZ 4775 was found not to be a skin sensitizer.
Oral administration of Blue TZ 4775 including following recovery period, did not result in severe adverse effects/ findings. Neither deaths nor treatment related severe clinical signs were observed during the study. Based on the results of this study the "no
observed effect level" was determined with 200 mg per kg-body weight per day. Presumably the substance was relatively well resorbed from the gastrointestinal tract in animal tests without causing toxic effects. No other signs of substance resorption or excretion were seen in any available toxicity study.
Mutagenic effects did not occur in the Ames test and no clastogenic effects in a Chromosome aberration test in vitro with and without metabolic activation. No other indications on the toxicokinetic behaviour of FAT 40815/A (Blue TZ 4775) could be derived from the results of the available studies.
Absorption and metabolism:
With a water solubility of > 400 g/l and a very low log Pow, the substance indicates a low potential for passive absoption by diffusion through cell membranes including dermal absorption and a low bio-accumulation potential.
Distribution and excretion:
The substance and its metabolites are anticipated to be distributed from the portal vein blood into the liver and into the kidneys where the soluble metabolites, including conjugated metabolites, are excreted via urine.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): low bioaccumulation potential based on study results
With a water solubility of > 400 g/l and a very low log Pow, the substance indicates a low potential for passive absoption by diffusion through cell membranes including dermal absorption and a low bio-accumulation potential.
The substance and its metabolites are anticipated to be distributed from the portal vein blood into the liver and into the kidneys where the soluble metabolites, including conjugated metabolites, are excreted via urine.
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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