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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: - | 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
Due to the lack of defined LC50 values for the majority of the constituents (LC50 higher than the tested doses), it is not possible to quantitatively derive the registered substance’s LC50; however, based on the available data on the constituents, acute hazard from the relevant constituents is not expected and as such the substance does not meet the criteria for the classification as per the CLP regulation.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- Oral study waived. Inhalation route appears to be more relevant.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- other: Assessment based on available information for constituents
- Adequacy of study:
- weight of evidence
- Study period:
- 2022
- Reliability:
- other: Assessment
- Rationale for reliability incl. deficiencies:
- other: Assessment based on the available information for the constituents.
- Principles of method if other than guideline:
- An assessment of acute inhalation endpoint of the registered substance was performed based on the information available on the constituents (see attachment for full details).
- Test type:
- other: Assessment based on the information available for the constituents.
- Key result
- Remarks on result:
- other: It is not possible to quantitatively derive the registered substance’s LC50. However, based on the available data on the constituents, acute hazard from the relevant constituents is not expected and the CLP classification criteria not met.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Due to the lack of defined LC50 values for the majority of the constituents (LC50 higher than the tested doses), it is not possible to quantitatively derive the registered substance’s LC50. However, based on the available data on the constituents, acute hazard from the relevant constituents is not expected and the registered substance does not meet the criteria for the classification as per the CLP regulation (See attachment for full assessment).
- Executive summary:
A constituent-based approach for the read across was applied for the substance.
Toxicity data available for the known constituents (except quartz) showed that these constituents did not cause lethality in test animals up to the highest inhalation concentrations tested; however, data on several main constituents come from studies where highest concentrations used were far below the limit concentrations typically suggested by regulatory guidelines; therefore, hazard at higher doses cannot be ruled out. Nonetheless, it is noteworthy that these major constituents in the test substance usually exist in in the powder forms and at the highest testing concentrations which are recommended by regulatory acute inhalation studies (up to 5 mg/L), dry powder aerosols of poorly soluble substances tend to form conglomerates causing physical obstruction of the animals’ airways and impaired respiration and suffocation. Death caused via this mode of action should not be misdiagnosed as toxic effect (see also OECD Guidance #39 on Inhalation Toxicity Studies 2018, section 69). This appears to be the reason why the data available in the literature for these constituents is usually at low concentrations.
For quartz, no acute inhalation toxicity data is available. Silicosis is one of the oldest known occupational diseases. It has only been observed following occupational exposure to respirable crystalline silica and not through exposure to crystalline silica in ambient air. Long term exposure to silica is more relevant because it is potentially carcinogenic and causes progressive, irreversible, fibrotic lung disease. Although acute hazard of quartz is not known, at low concentrations available in the registered substance (~1%), acute toxicity of quartz appears to be even less relevant. For example: low-level crystalline silica exposure on beaches and in ambient air in general, there is no evidence that such low-level exposure causes health effects.
Among the unknown constituents (~6%), no one component is present at >1% w/w; hence, they are not relevant for the acute toxicity hazard classification as per the CLP regulation.
In conclusion, due to the lack of defined LC50 values for the majority of the constituents (LC50 higher than the tested doses), it is not possible to quantitatively derive the registered substance’s LC50; however, based on the available data on the constituents, acute hazard from the relevant constituents is not expected and the registered substance does not meet the criteria for the classification as per the CLP regulation.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Physical form:
- inhalation: dust
- Quality of whole database:
- Available information on constituents allows to build a weight of evidence based assessment. See the attached assessment in the endpoint record.
Additional information
Justification for classification or non-classification
A constituent-based approach for the read across was applied for the substance.
Toxicity data available for the known constituents (except quartz) showed that these constituents did not cause lethality in test animals up to the highest inhalation concentrations tested; however, data on several main constituents come from studies where highest concentrations used were far below the limit concentrations typically suggested by regulatory guidelines; therefore, hazard at higher doses cannot be ruled out. Nonetheless, it is noteworthy that these major constituents in the test substance usually exist in in the powder forms and at the highest testing concentrations which are recommended by regulatory acute inhalation studies (up to 5 mg/L), dry powder aerosols of poorly soluble substances tend to form conglomerates causing physical obstruction of the animals’ airways and impaired respiration and suffocation. Death caused via this mode of action should not be misdiagnosed as toxic effect (see also OECD Guidance #39 on Inhalation Toxicity Studies 2018, section 69). This appears to be the reason why the data available in the literature for these constituents is usually at low concentrations.
For quartz, no acute inhalation toxicity data is available. Silicosis is one of the oldest known occupational diseases. It has only been observed following occupational exposure to respirable crystalline silica and not through exposure to crystalline silica in ambient air. Long term exposure to silica is more relevant because it is potentially carcinogenic and causes progressive, irreversible, fibrotic lung disease. Although acute hazard of quartz is not known, at low concentrations available in the registered substance (~1%), acute toxicity of quartz appears to be even less relevant. For example: low-level crystalline silica exposure on beaches and in ambient air in general, there is no evidence that such low-level exposure causes health effects.
Among the unknown constituents (~6%), no one component is present at >1% w/w; hence, they are not relevant for the acute toxicity hazard classification as per the CLP regulation.
In conclusion, due to the lack of defined LC50 values for the majority of the constituents (LC50 higher than the tested doses), it is not possible to quantitatively derive the registered substance’s LC50; however, based on the available data on the constituents, acute hazard from the relevant constituents is not expected and the registered substance does not meet the criteria for the classification as per the CLP regulation.
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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