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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 473-160-6 | 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
No experimental data on absorption, distribution, metabolism and excretion are available for the substance. This toxicokinetic assessment is based on the physico-chemical properties and existing toxicological data. Based on these, limited oral and inhalation absorption and negligible dermal absorption are expected.Metabolism via hydrolysis is not expected. Bioaccumulation of the substance is not expected after repeated exposure. The substance is expected to be predominantly excreted via faeces.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
No experimental data on absorption, distribution, metabolism and excretion are available for the source and target substance. The toxicokinetic assessment is based on their physicochemical properties and existing toxicological data.
Absorption
Generally, oral absorption is favoured for molecular weights below 500 g/mol, while molecular weights above 1000 g/mol do no longer favour absorption. Blue MGi 1037-Na shows good water solubility (37.85 g/L) which enables its dissolution in the gastrointestinal fluids. The hydrophilic properties are also demonstrated by the low log Pow value (< -4.06) . Due to the high molecular weight (777 g/mol) the substance is considered to be unable to pass through aqueous pores and the transport through the epithelial barrier by bulk passage of water can be excluded. On the other hand, small amounts may be transported into epithelial cells by endocytosis or persorption. These characteristics indicate that absorption following oral exposure will be very limited. This assumption is confirmed by the results of the acute oral toxicity study where only coloured faeces/diarrhea was observed after treatment with the substance and high dosing did not lead to any mortalities.
Decomposition of the compound at high temperatures (280 °C) and the low vapor pressure indicate that the substance will not be available for inhalation as a vapor under standard environmental conditions. The substance is a powder and inhalation of dust might occur. Generally, particles with an aerodynamic diameter below 100 µm have the potential to be inspired, particles below 50 µm may reach the thoracic region and those below 15 µm are able to pass into the alveolar region of the respiratory tract. Since 50 % (by mass) of the particles are smaller than 23.6 µm and 10 % smaller than 9.4 µm a significant amount of the substance is expected to reach the thoracic region and alveolar region upon exposure to dust. The potential for adsorption directly across the respiratory tract epithelium is negligible based on the very low Pow and high molecular weight. However, still a small amount may be taken up by endocytosis or persorption and transported to the blood via the lymphatic system.
Dermal absorption is also considered to take place to a very limited amount. The powdered substance will readily dissolve in moisture of the skin surface due to their water solubility. The high water solubility, the molecular weight and the negative Pow indicate a very low uptake of the substance into the stratum corneum. The source substance Blue MGi 1037 was not found to be irritating to the rabbit skin. Slight erythema was observed in a single animal one hour after treatment, but showing complete reversibility after 24 hours. No skin effects were observed in the Guinea pig maximization test with the source substance. However, in the acute dermal toxicity study slight focal erythema was observed after treatment with Blue MGi 1037 in some of the animals, but was found to be reversible after a few days. The LD50 was determined to be > 2000 mg/kg bw. Therefore, only minimal damage to enhance the penetration of the stratum corneum is expected upon exposure to the target substance.
Distribution
As mentioned above the physicochemical properties of the substance favour a limited systemic absorption following oral, inhalative and dermal uptake. The high molecular weight will limit the entry of the molecules via aqueous pores and only small amounts may enter the systemic circulation by endocytosis or persorption. After being absorbed into the body, the substance is likely not distributed into the interior part of the cells due to their hydrophilic properties (negative Pow) and in turn the extracellular concentration may be higher than the intracellular concentration.
The low Pow indicates no bioaccumulation potential for the target and source substance. All values are well below 3 and therefore both substances are not considered to be bioaccumulative. This has been confirmed in fish bioaccumulation study with Blue MGi 1037, where the BCF was below 1.
Metabolism
For the source substance Blue MGi 1037 the chromosomal aberration study in vitro indicates a difference in genotoxic effects with regard to the use of a metabolic activation system in the test. In the Ames test no mutagenicity was observed after treatment with Blue MGi 1037 with and without metabolic activation. However, the chromosomal aberration assay shows a clastogenic outcome only in the experimental parts applying a continuous treatment without a metabolic activation system, suggesting a direct way of interference with cellular macromolecules and a sufficient detoxification of the substance and/or repair of DNA damage in the experimental parts with pulse treatment in the absence and presence of metabolic activation. Based on the results obtained in the hydrolysis study performed with Blue MGi 1037 the source and target substance can be considered as hydrolytically stable at physiological pH (no degradation observed) and also at acidic and alkaline pH values (half life times of several days at pH 4 and 9 and 50°C). Thus, metabolism via hydrolysis is not expected.
Excretion
Substances with high water solubility are prone to excretion via urine, but the molecular weight above 300 g/mol limits this pathway. The high molecular weight favours excretion via bile and faeces. Excretion via faeces has been confirmed by the results of the acute oral toxicity study (Blue MGi 1037 Na) and repeated dose toxicity study (Blue MGi 1037) where coloured faeces/diarrhea was observed after treatment with the substance.
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.