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Reaction mass of 5,5'-[vinylenebis[(3-sulpho-p-phenylene)azo]]bis[3-methylsalicylic] acid, potassium salt, compound with 2,2',2''-nitrilotriethanol and potassium 5-amino-3-{[4-(2-{4-[(7-amino-1-hydroxy-3-sulfo-2-naphthyl)diazenyl]-2-sulfophenyl}vinyl)-3-sulfophenyl]diazenyl}-4-hydroxy-7-sulfonaphthalene-2-sulfonate - 2,2',2''-nitrilotriethanol (1:1) and 3,3'-[vinylenebis[(3-sulpho-p-phenylene)azo]]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonic] acid, potassium salt, compound with 2,2',2''-nitrilotriethanol and 3,3'-[vinylenebis[(3-sulpho-p-phenylene)azo]]bis[6-amino-4-hydroxynaphthalene-2-sulphonic] acid, potassium salt, compound with 2,2',2''-nitrilotriethanol
EC number: 943-311-5 | 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
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
The registered substance is an organic multi-constituent substance and can be characterized by its ionic nature. No experimental data on absorption, metabolism, distribution and excretion are available for the substance. Therefore, the toxicokinetic behavior was evaluated based on the structure and the physico-chemical properties of the substance as well as data from experimental in vivo toxicity studies. In accordance with the low log Pow value of ≤ -4, the components of the registered substance have a high water solubility. No bioaccumulation potential is to be expected based on the physico-chemical properties of the substance. In acute and repeated dose toxicity studies with oral application of the registered substance observations included grey discolorations in several organs. This finding indicates bioavailability and systemic distribution of components of the substance after oral uptake.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
The registered substance is an organic multi-constituent substance and can be characterized by its ionic nature. In accordance with the low log Powvalue, the target chemical is highly hydrophilic. According to the analytical investigations, the substance consists of the following main components:
Table 1: Composition of the target substance
CAS-No. |
Typical concentration |
Concentration range |
85269-31-4 |
Ca. 25.5 % (w/w) |
≥ 15 ≤ 35 % (w/w) |
85283-47-2 |
Ca. 23 % (w/w) |
≥ 15 ≤ 30 % (w/w) |
85269-32-5 |
Ca. 19 % (w/w) |
≥ 10 ≤ 25 % (w/w) |
85269-33-6 |
Ca. 16 % (w/w) |
≥ 10 ≤ 20 % (w/w) |
Description of physico-chemical properties:
- Physical state (20°C): solid
- Colour: black
- Molecular weight: 1081 g/mol
- Relative density (20 °C): 1.369
- Log Pow (23 °C): ≤ - 4
- Water solubility (20 °C): > 100 g to < 200 g/L (estimated)
- Boiling point: the substance decomposes before boiling
Toxicokinetic assessment:
No experimental data on absorption, metabolism, distribution and excretion are available for the substance. Therefore, the toxicokinetic behavior was evaluated based on the structure and the physico-chemical properties of the substance as well as data from experimental in vivo toxicity studies.
Absorption
The molecular weight of 1081 g/mol implies that the substance is less favourable for absorption after oral intake. As the target substance is ionized, it will not readily diffuse across biological membranes. However, according to the low log Powin combination with the high water solubility (> 100 g to < 200 g/L) the substance is considered to be highly soluble in water, i.e. hydrophilic, and will readily dissolve into the gastrointestinal fluids. Due to the large molecule size and the high molecular weight, absorption by passive diffusion may be limited because substances with such properties are normally considered to be too large to cross biological membranes. However, small amounts may be transported into epithelial cells by pinocytosis or persorption. Regarding the structural properties, hydrolysis (e.g. in the stomach) is not expected. In the acute oral toxicity study available for Direct Black 18L NA active dye, a LD50of > 2000 mg/kg bw was deduced. Clinical signs like impaired general state and piloerection were observed. Therefore, it is assumed that absorption has occurred. However, apart from that, no specific data concerning oral absorption of the test substance are available. Therefore, as a worst case an oral absorption of 100 % is assumed.
With regard to absorption after inhalation, the vapour pressure as well as the boiling point are not applicable, because the substance is a solid which decomposes before boiling and without melting, indicating that inhalation as a vapour will be negligible. If the substance reaches the respiratory tract, passive diffusion could occur due to the low log Pow. Because of its good water solubility, the substance is likely to dissolve in the mucus of the upper respiratory tract, and consequently will at least partly be removed before reaching the lower respiratory tract. However, no specific data concerning absorption after inhalation are available.
The physical state of the substance is solid, therefore the substance will have to dissolve into the surface moisture of the skin before uptake can begin. Due to the high water solubility and low log Powthe substance may be too hydrophilic to cross the lipid rich environment of the stratum corneum, therefore dermal absorption is likely to be low. Hence, dermal uptake for this substance is also suggested to be low. However, no specific data concerning dermal absorption of the test substance are available.
Distribution and Accumulative potential
Direct Black 18L NA active dye consists of a large molecules and therefore wide distribution of the systemically available part is not to be expected. Due to the high water solubility rapid diffusion through aqueous channels and pores is likely to occur and also limits its distribution. In an acute oral toxicity study as well as in an oral repeated dose toxicity study, observations included grey discolorations in several organs like e.g. forestomach, jejunum, colon, liver, mesenteric lymph nodes and kidneys. This finding gives evidence of the substances distribution. However, it does not provide any information on the amount of substance that has distributed. A bioaccumulation potential is not expected considering the physico-chemical properties of the substance. The estimated low log Powvalue of equal to or less than – 4 (at 23 °C) confirms this assumption.
Metabolism and Excretion
Direct Black 18L NA active dye is assumed to be mainly excreted via feces as seen in both an acute toxicity study and a repeated dose toxicity study with oral application of the test material. Clinical signs included black discoloration of the feces of all animals, respectively, indicating that this discoloration is caused by the color of the substance.
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