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Diss Factsheets
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EC number: 207-837-2 | CAS number: 497-18-7
- 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 available information suggests that absorption of the test substance from the gastrointestinal tract can take place. Some absorption may also potentially take place via the skin. Once absorbed, the substance would be distributed in the serum and urine is likely to be the significant route of excretion. There is limited evidence suggesting that the test substance may be metabolised, however no studies have been conducted to identify potential metabolites.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
TOXICOKINETIC BEHAVIOUR:
The substance is composed as listed in IUCLID section 1.2. It is a white solid with a molecular weight of 90.08 g/mol. The low vapour pressure value (7.2 x 10-5 Pa at 25ºC) and predicted negative explosive and oxidising properties shows that the substance is non volatile therefore inhalation is not a significant route of exposure.
The test item has a low log octanol/water partition coefficient (log10Pow -2.94) and high water solubility (234 g/l at 20.0°C). The available acute dermal studies and repeated dose reproductive screening study showed limited evidence of absorption however the repeated dose reproductive screening study did not show evidence of metabolism or excretion. The test item is classified as a moderate skin sensitiser and although mild dermal irritation was evident it is not classified as a dermal irritant and therefore skin penetration may be limited. The available repeated dose reproductive screening study showed limited evidence of absorption and did not show evidence of metabolism or excretion.
The test item was found to be mutagenic in bacteria in one study in either the absence or presence of metabolic activation and weakly clastogenic in mammalian cells in vitro in the absence of metabolic activation. The test item was however found to be non-mutagenic in mammalian (CHO) cells.
Absorption
Although the test item is lipophobic in nature the high water solubility (234 g/l at 20.0°C) and small molecular size of the substance should allow absorption through the gastro-intestinal tract via passive diffusion. This would suggest that the gastrointestinal tract provides a route of absorption, following oral administration, and thereby facilitating systemic distribution via the circulatory system.
Limited dermal absorption may occur via the skin due to small molecular size (less than 100 g/mol) and water solubility. There is evidence of mild dermal irritation and the test item is also considered to be a moderate skin sensitizer. Therefore damage to the skin surface may allow for increased penetration of the substance through the skin.
The proporation of the test item having an inhalable particle size of less than 100 μm was determined to be 2% and therefore the test item is considered to be essentially non-inhalable. The low vapour pressure value (7.2 x 10-5 Pa at 25ºC) shows that the substance is not available as a vapour therefore inhalation is not a significant route of exposure.
Distribution
Once absorbed, the test item may be distributed in serum due to the water solubility and may therefore be distributed systemically. The positive response in a skin sensitisation study suggests that the test item may bind to carrier proteins in the circulatory systems
, thereby facilitating systemic distribution. The low log octanol/water partition coefficient (log10Pow-2.94) and high water solubility would also suggest that the test item is not lipophilic and would not accumulate in body fat.
Metabolism
The results of the repeated dose reproductive/developmental screening study did not show evidence to indicate the substance influenced hepatic metabolism.
The positive result in a reverse mutation assay and the negative result in a mutagenicity study using mammalian (CHO) cells in vitro showed no evidence that genotoxicity is either enhanced or diminished in the presence of a metabolising system. However, a chromosome aberration study did show the substance to be weakly clastogenic in the absence of the metabolising system. This effect however may be due to a cytotoxic mode of action of the test item rather than a true genotoxic mechanism.
Excretion
There is no evidence to indicate the route of excretion but highly water-soluble products are not favourable for biliary excretion and therefore urinary excretion may well be a significant route for this material. In addition to the high water solubility, a molecular weight of below 300 g/mol in the rat is also a characteristic favourable for urinary excretion. Any test item that is not absorbed will be excreted in the faeces.
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.
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