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Diss Factsheets
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EC number: 213-485-0 | CAS number: 957-68-6
- 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
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- sub-chronic toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- According to column 2 of Annex IX "Testing by the inhalation route is appropriate if: — exposure of humans via inhalation is likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size."
Toxic effects in humans by inhalation of the substance are unlikely, not only by the intended uses, but also because the substance has a very low vapour pressure. The substance is used as an intermediate in a closed process in industrial sites, with no likelihood of exposure. No professional or consumer exposure is intended.
An acute inhalation toxicity study in rats did not show systemic toxic effects at the highest limit concentration of 5 mg/L, therefore not indicating systemic effects after inhalation exposure.
Also local effects of mucous membranes are not likely. An indication was obtained from the in vivo eye irritation studies showing no irritation of the mucuous membrane. In the acute inhalation toxicity test, only dyspnoe during and shortly after the exposure period (which is likely a sign of discomfort of the rats being restricted in the inhalation tubes, because the same signs were reported in the last 8 reports of this specific test facility applying quite different substances), and no macroscopic lesions were observed with aerosols of the test item. Therefore no relevant indications were obtained that the test item might cause local lesions to the mucosa of the respiratory tract.
The NOEC for the inhalation route can be derived from the NOELoral, taking into account a higher (2-fold) absorption at inhalation compared to oral, as is described in the Guidance Document on Information Requirements Chapter R.8.4.2. It is considered that this approach is sufficient for a risk assessment.
The oral toxicity studies are performed more routinely than the inhalation experiments, and they cause less complications and more reliable results. In the ECHA Guidance on Info Requirements Part 7.a of August 2014, p. 294 it is stated "Concerning repeated dose toxicity testing the oral route is the preferred one. However, ...".
The revised guideline of July 2017 states: "Concerning repeated dose toxicity testing, the oral route is the default one because it is assumed to maximise systemic availability (internal dose) of most substances."And also: "Testing by the inhalation route is the default route for gases and the preferred route for liquids of high to very high vapour pressure at ambient temperature (>25 kPa or boiling point below 50 °C) for which inhalation is usually the predominant route of human exposure." And: "... for dusts (including nanomaterials), testing by the inhalation route is appropriate if human inhalation exposure is likely ...". The test substance is not a liquid, it has a low vapour pressure and the exposure of humans is unlikely.
The NOEC for the inhalation route can be derived from the NOELoral, taking into account a higher (2-fold) absorption at inhalation compared to oral, as is described in the Guidance Document on Information Requirements Chapter R.8.4.2. It is considered that this approach is sufficient for a risk assessment.
An inhalation animal experiment is therefore considered not to be justified.
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
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.