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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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EC number: 603-073-2 | CAS number: 12549-23-4
- 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:
- short-term repeated dose toxicity: inhalation
- Data waiving:
- exposure considerations
- Justification for data waiving:
- other:
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
In accordance with column 2 of REACH Annex VIII, the most appropriate route of administration, having regard to the likely route of human exposure, should be selected for the short-term repeated dose toxicity study (required in section 8.6.1). Testing by inhalation route was not deemed appropriate, as the calculated vapour pressure of the substance is very low (less than 1.2 x 10^-9 Pa), and the particle size of the substance is so large that it excludes any likely exposure through inhalation. This route of exposure is therefore not relevant for the substance. Instead, the study is performed for the oral route and documented in the IUCLID endpoint 7.5.1.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- vapour pressure
- Type of information:
- calculation (if not (Q)SAR)
- Remarks:
- Migrated phrase: estimated by calculation
- Adequacy of study:
- key study
- Study period:
- 14.05.2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The calculation method is detailed in the following guidelines: - Method A.4 of Commission Regulation (EC) No 440/2008 of 30 May 2008, Part A Methods for the determination of physico-chemical properties - Method 104 of the OECD Guidelines for Testing of Chemicals, 23 March 2006
- Reason / purpose for cross-reference:
- reference to other study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.4 (Vapour Pressure)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 104 (Vapour Pressure Curve)
- Deviations:
- no
- GLP compliance:
- not specified
- Type of method:
- other: Calculation
- Key result
- Temp.:
- 25 °C
- Vapour pressure:
- < 0 Pa
- Remarks on result:
- other: Estimation (calculation)
- Transition / decomposition:
- yes
- Remarks:
- decomposition
- Transition temp.:
- > 230 - ca. 300 °C
- Conclusions:
- In accordance with column 2 of REACH Annex VII, the vapour pressure study (required in section 7.5) does not need to be conducted if the melting point is above 300 °C. The substance's melting point is > 450 °C as determined in the Melting/Freezing Temperature test performed according to test guidelines. The substance has also been found to decompose at 230-300 °C and therefore it was not deemed necessary to perform the actual study. An estimation was, however, thought to be informative for the consideration of human exposure through air. Through calculation the vapour pressure of the substance has been estimated to be less than 1.2 x 10^-9 Pa at 25 °C.
- Executive summary:
The vapour pressure of the substance has been calculated to be less than 1.2 x 10^-9 Pa at 25 °C using a procedure detailed in Method A.4 of Commission Regulation (EC) No 440/2008 of 30 May 2008, Part A: Methods for the determination of physico-chemical properties and Method 104 of the OECD Guidelines for Testing of Chemicals, 23 March 2006. The actual study does not need to be conducted.
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24.5.-11.9.2014
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The determination was carried out using a procedure designed to be compatible with that given in European Commission Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances’, 2002 and the results can therefore be thought of as reliable with restrictions. A known amount of test item was sieved with a mesh of 100 μm and the percentage of test item to pass through the sieve was calculated. According to the Integrated testing strategy for granulometry (Guidance on Information Requirements and Chemical Safety Assessment Chapter R.7a: Endpoint specific guidance Version 3.0, August 2014) no further testing is necessary if there are virtually no particles with diameters below 100 μm. The study is GLP compliant.
- Qualifier:
- according to guideline
- Guideline:
- other: European Commission Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances’, 2002.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Certificate included in the study report.
- Type of method:
- sieving
- Type of distribution:
- mass based distribution
- Key result
- Remarks on result:
- other: The percentage of test item having an inhalable particle size of less than 100 μm was determined to be 1.05%. The test item has been considered to be essentially non-inhalable.
- No.:
- #1
- Size:
- ca. 100 µm
- Distribution:
- ca. 1.05 %
- Remarks on result:
- other: The percentage of test item having an inhalable particle size of less than 100 μm was determined to be 1.05%. The test item has been considered to be essentially non-inhalable.
- Conclusions:
- A screening test consisting of sieving a known amount of test item with a 100 μm mesh concluded that only 1.05 % of the test item passed through the sieve and is inhalable. According to the Integrated testing strategy for granulometry (Guidance on Information Requirements and Chemical Safety Assessment Chapter R.7a: Endpoint specific guidance Version 3.0, August 2014) no further testing is necessary. The test item is considered to be essentially non-inhalable.
- Executive summary:
The proportion of test item having an inhalable particle size of less than 100 μm was determined by a sieve method to be 1.05%. Particle size data was acquired using a procedure designed to be compatible with that given in European Commission Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances’, 2002. The test item is considered to be essentially non-inhalable.
Data source
Materials and methods
Results and discussion
Target system / organ toxicity
- Critical effects observed:
- not specified
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.