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Diss Factsheets
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EC number: - | 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
Description of key information
Skin irritation (OECDTG439): not irritant
Skin corrosion (OECDTG431: not corrosive
Eye irritation (OECDTG437): not irritant
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation:
The substance was tested in triplicate in an in vitro skin irritation test according to OECD TG 439 test guideline and GLP principles. Tissues were exposed to the substance, a negative control (PBS) and a positive control (5% SDS) for 15 minutes. The substance was tested for direct MTT reduction and colour interference.
The solutions did not turn blue / purple, nor a blue / purple precipitate was observed. The OD for the test item solution was >0.08, it was concluded that the test item did interfere with the MTT endpoint. In addition to the normal procedure, three tissues were treated with test item. Instead of MTT solution these tissues were incubated with assay medium. The non-specific color by the test item was 4.66% of the negative control tissues. The OD of the tissues incubated with assay medium was subtracted from the ODs of the test item treated tissues incubated with MTT medium.
Acceptability criteria for the negative control, positive control and variability between measurements were met.
The cell viability of the tissues exposed to the substance was 96% for 15 minutes exposure. Since the mean relative tissue viability for the substance was above 50%, the substance is considered to be not irritant.
Skin corrosion:
The substance was tested in duplicate in an in vitro skin corrosion test according to OECD TG 431 test guideline and GLP principles. Tissues were exposed to the substance, a negative control (Milli-Q water) and a positive control (8.0 N KOH) for 3 minutes and 60 minutes. The substance was tested for direct MTT reduction and colour interference, the test item induced colour interference. Acceptability criteria for the negative control, positive control and variability between measurements were met.
The cell viability of the tissues exposed to the substance were 99% and 85% for 3 minutes and 60 minutes exposure, respectively. Both values did not exceed thereshold for corrosivity (50% after 3 minutes exposure and 15% after 60 minutes exposure), therefore the substance is considered not to be corrosive.
Eye irritation:
A Bovine Corneal Opacity and Permeability test (BCOP) was performed with the substance according to OECD guideline 437 and GLP principles. The substance was tested as it is. The mean in vitro irritancy
score of the positive control ( 20% (w/v) Imidazole) was 115, and the mean in vitro irritancy score of the negative control (physiological saline) was 0.8. It was therefore concluded that the test conditions were adequate and that the test system functioned properly. The substance did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 0.9 after 240 minutes of treatment.
Since the substance induced an IVIS ≤ 3, no classification is required for eye irritation or serious eye damage.
Justification for classification or non-classification
Based on the available study results, the substance does not have to be classified and has no obligatory labelling requirement for skin and eye irritation according to Regulation (EC) No 1272/2008 and its amendments.
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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