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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 260-599-1 | CAS number: 57158-29-9
- 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
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 22.7 mg/m³
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 18
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 409 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- The route to route extapolation was conducted in accordance with ECHA Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of dose [concentration]-response for human health, Version: 2.1, November 2012.
- AF for dose response relationship:
- 1
- Justification:
- Default when starting point is a NOAEL.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default for sub-acute to chronic.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Inter-species variability with respect to toxicokinetics following oral or dermal administration of inorganic aluminium or zirconium substances is not to be expected: absorption of both metals from the gastrointestinal tract has been shown to be low to negligible, thus indicating poor systemic availability. Moreover, any metabolism of Al or Zr as inorganic ions can be excluded. There are no reasons to assume that this behaviour which is based on the physico-chemical properties of the substance will be different between experimental animals and humans. Therefore, it is considered to be justified to apply substance-specific assessment factors accounting for a correction for differences in metabolic rate of 1 and for remaining differences of 1 instead of using the respective default factors of 4 and 2.5, respectively.
- AF for other interspecies differences:
- 1
- Justification:
- Inter-species variability with respect to toxicokinetics following oral or dermal administration of inorganic aluminium or zirconium substances is not to be expected: absorption of both metals from the gastrointestinal tract has been shown to be low to negligible, thus indicating poor systemic availability. Moreover, any metabolism of Al or Zr as inorganic ions can be excluded. There are no reasons to assume that this behaviour which is based on the physico-chemical properties of the substance will be different between experimental animals and humans. Therefore, it is considered to be justified to apply substance-specific assessment factors accounting for a correction for differences in metabolic rate of 1 and for remaining differences of 1 instead of using the respective default factors of 4 and 2.5, respectively.
- AF for intraspecies differences:
- 3
- Justification:
- This assessment factor is introduced since it is expected that a greater variability in response from the most to least sensitive human would be seen, relative to an experimental animal population. ECETOC (2003) has reviewed scientific literature on the distribution of human data for various toxicokinetic and toxicodynamic parameters to assess intraspecies variability within the human population, specifically by Renwick and Lazarus (1998) and Hattis et al. (1999). Considering that the data analysed by these authors includes both sexes, a variety of disease states and ages, the use of the 95th percentile of the distribution of the variability for these datasets is considered sufficiently conservative to account for intraspecies variability for the general population. Based on this, a default assessment factor of 5 is recommended by ECETOC (2003). A lower factor of 3 (i.e. closer to the 90th percentile of the distribution of the variability for these datasets) is proposed for the more homogeneous worker population. In the worker population, the more susceptible groups are typically excluded and/or may be protected from specific exposures. Thus, and in consideration of normal hygiene practices at the workplace, a lower value for the assessment factor is considered appropriate for workers.
- AF for the quality of the whole database:
- 1
- Justification:
- A reliable, guideline conform study conducted under GLP principles is the basis. Thus, AF=1.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties know, thus AF=1.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 108 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 6
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 650 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default when starting point is a NOAEL.
- AF for differences in duration of exposure:
- 1
- Justification:
- Exposure during organogenesis, thus AF=1.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Inter-species variability with respect to toxicokinetics following oral or dermal administration of inorganic aluminium or zirconium substances is not to be expected: absorption of both metals from the gastrointestinal tract has been shown to be low to negligible, thus indicating poor systemic availability. Moreover, any metabolism of Al or Zr as inorganic ions can be excluded. There are no reasons to assume that this behaviour which is based on the physico-chemical properties of the substance will be different between experimental animals and humans. Therefore, it is considered to be justified to apply substance-specific assessment factors accounting for a correction for differences in metabolic rate of 1 and for remaining differences of 1 instead of using the respective default factors of 4 and 2.5, respectively.
- AF for other interspecies differences:
- 1
- Justification:
- Inter-species variability with respect to toxicokinetics following oral or dermal administration of inorganic aluminium or zirconium substances is not to be expected: absorption of both metals from the gastrointestinal tract has been shown to be low to negligible, thus indicating poor systemic availability. Moreover, any metabolism of Al or Zr as inorganic ions can be excluded. There are no reasons to assume that this behaviour which is based on the physico-chemical properties of the substance will be different between experimental animals and humans. Therefore, it is considered to be justified to apply substance-specific assessment factors accounting for a correction for differences in metabolic rate of 1 and for remaining differences of 1 instead of using the respective default factors of 4 and 2.5, respectively.
- AF for intraspecies differences:
- 3
- Justification:
- This assessment factor is introduced since it is expected that a greater variability in response from the most to least sensitive human would be seen, relative to an experimental animal population. ECETOC (2003) has reviewed scientific literature on the distribution of human data for various toxicokinetic and toxicodynamic parameters to assess intraspecies variability within the human population, specifically by Renwick and Lazarus (1998) and Hattis et al. (1999). Considering that the data analysed by these authors includes both sexes, a variety of disease states and ages, the use of the 95th percentile of the distribution of the variability for these datasets is considered sufficiently conservative to account for intraspecies variability for the general population. Based on this, a default assessment factor of 5 is recommended by ECETOC (2003). A lower factor of 3 (i.e. closer to the 90th percentile of the distribution of the variability for these datasets) is proposed for the more homogeneous worker population. In the worker population, the more susceptible groups are typically excluded and/or may be protected from specific exposures. Thus, and in consideration of normal hygiene practices at the workplace, a lower value for the assessment factor is considered appropriate for workers.
- AF for the quality of the whole database:
- 2
- Justification:
- Applied as an additional safety factor, since the underlying study was conducted before internationally agree guidelines were available, and not conducted/reported under GLP principles.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties identified, thus AF=1.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 6.7 mg/m³
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 30
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 202 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- The route to route extapolation was conducted in accordance with ECHA Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of dose [concentration]-response for human health, Version: 2.1, November 2012.
- AF for dose response relationship:
- 1
- Justification:
- Default when starting point is a NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- Default for sub-acute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Inter-species variability with respect to toxicokinetics following oral or dermal administration of inorganic aluminium or zirconium substances is not to be expected: absorption of both metals from the gastrointestinal tract has been shown to be low to negligible, thus indicating poor systemic availability. Moreover, any metabolism of Al or Zr as inorganic ions can be excluded. There are no reasons to assume that this behaviour which is based on the physico-chemical properties of the substance will be different between experimental animals and humans. Therefore, it is considered to be justified to apply substance-specific assessment factors accounting for a correction for differences in metabolic rate of 1 and for remaining differences of 1 instead of using the respective default factors of 4 and 2.5, respectively.
- AF for other interspecies differences:
- 1
- Justification:
- Inter-species variability with respect to toxicokinetics following oral or dermal administration of inorganic aluminium or zirconium substances is not to be expected: absorption of both metals from the gastrointestinal tract has been shown to be low to negligible, thus indicating poor systemic availability. Moreover, any metabolism of Al or Zr as inorganic ions can be excluded. There are no reasons to assume that this behaviour which is based on the physico-chemical properties of the substance will be different between experimental animals and humans. Therefore, it is considered to be justified to apply substance-specific assessment factors accounting for a correction for differences in metabolic rate of 1 and for remaining differences of 1 instead of using the respective default factors of 4 and 2.5, respectively.
- AF for intraspecies differences:
- 5
- Justification:
- This assessment factor is introduced since it is expected that a greater variability in response from the most to least sensitive human would be seen, relative to an experimental animal population. ECETOC (2003) has reviewed scientific literature on the distribution of human data for various toxicokinetic and toxicodynamic parameters to assess intraspecies variability within the human population, specifically by Renwick and Lazarus (1998) and Hattis et al. (1999). Considering that the data analysed by these authors includes both sexes, a variety of disease states and ages, the use of the 95th percentile of the distribution of the variability for these datasets is considered sufficiently conservative to account for intraspecies variability for the general population. Based on this, a default assessment factor of 5 is recommended by ECETOC (2003).
- AF for the quality of the whole database:
- 1
- Justification:
- A reliable, guideline conform study conducted under GLP principles is the basis. Thus, AF=1.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties identified, thus AF=1.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 65 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 650 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default when starting point is a NOAEL
- AF for differences in duration of exposure:
- 1
- Justification:
- Exposure during organogenesis, thus AF=1.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Inter-species variability with respect to toxicokinetics following oral or dermal administration of inorganic aluminium or zirconium substances is not to be expected: absorption of both metals from the gastrointestinal tract has been shown to be low to negligible, thus indicating poor systemic availability. Moreover, any metabolism of Al or Zr as inorganic ions can be excluded. There are no reasons to assume that this behaviour which is based on the physico-chemical properties of the substance will be different between experimental animals and humans. Therefore, it is considered to be justified to apply substance-specific assessment factors accounting for a correction for differences in metabolic rate of 1 and for remaining differences of 1 instead of using the respective default factors of 4 and 2.5, respectively.
- AF for other interspecies differences:
- 1
- Justification:
- Inter-species variability with respect to toxicokinetics following oral or dermal administration of inorganic aluminium or zirconium substances is not to be expected: absorption of both metals from the gastrointestinal tract has been shown to be low to negligible, thus indicating poor systemic availability. Moreover, any metabolism of Al or Zr as inorganic ions can be excluded. There are no reasons to assume that this behaviour which is based on the physico-chemical properties of the substance will be different between experimental animals and humans. Therefore, it is considered to be justified to apply substance-specific assessment factors accounting for a correction for differences in metabolic rate of 1 and for remaining differences of 1 instead of using the respective default factors of 4 and 2.5, respectively.
- AF for intraspecies differences:
- 5
- Justification:
- This assessment factor is introduced since it is expected that a greater variability in response from the most to least sensitive human would be seen, relative to an experimental animal population. ECETOC (2003) has reviewed scientific literature on the distribution of human data for various toxicokinetic and toxicodynamic parameters to assess intraspecies variability within the human population, specifically by Renwick and Lazarus (1998) and Hattis et al. (1999). Considering that the data analysed by these authors includes both sexes, a variety of disease states and ages, the use of the 95th percentile of the distribution of the variability for these datasets is considered sufficiently conservative to account for intraspecies variability for the general population. Based on this, a default assessment factor of 5 is recommended by ECETOC (2003).
- AF for the quality of the whole database:
- 2
- Justification:
- Applied as an additional safety factor, since the underlying study was conducted before internationally agree guidelines were available, and not conducted/reported under GLP principles.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties identified, thus AF=1.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 15.5 mg/kg bw/day
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 30
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 464 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default when starting point is a NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- Default for sub-acute to chronic.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Inter-species variability with respect to toxicokinetics following oral or dermal administration of inorganic aluminium or zirconium substances is not to be expected: absorption of both metals from the gastrointestinal tract has been shown to be low to negligible, thus indicating poor systemic availability. Moreover, any metabolism of Al or Zr as inorganic ions can be excluded. There are no reasons to assume that this behaviour which is based on the physico-chemical properties of the substance will be different between experimental animals and humans. Therefore, it is considered to be justified to apply substance-specific assessment factors accounting for a correction for differences in metabolic rate of 1 and for remaining differences of 1 instead of using the respective default factors of 4 and 2.5, respectively.
- AF for other interspecies differences:
- 1
- Justification:
- Inter-species variability with respect to toxicokinetics following oral or dermal administration of inorganic aluminium or zirconium substances is not to be expected: absorption of both metals from the gastrointestinal tract has been shown to be low to negligible, thus indicating poor systemic availability. Moreover, any metabolism of Al or Zr as inorganic ions can be excluded. There are no reasons to assume that this behaviour which is based on the physico-chemical properties of the substance will be different between experimental animals and humans. Therefore, it is considered to be justified to apply substance-specific assessment factors accounting for a correction for differences in metabolic rate of 1 and for remaining differences of 1 instead of using the respective default factors of 4 and 2.5, respectively.
- AF for intraspecies differences:
- 5
- Justification:
- This assessment factor is introduced since it is expected that a greater variability in response from the most to least sensitive human would be seen, relative to an experimental animal population. ECETOC (2003) has reviewed scientific literature on the distribution of human data for various toxicokinetic and toxicodynamic parameters to assess intraspecies variability within the human population, specifically by Renwick and Lazarus (1998) and Hattis et al. (1999). Considering that the data analysed by these authors includes both sexes, a variety of disease states and ages, the use of the 95th percentile of the distribution of the variability for these datasets is considered sufficiently conservative to account for intraspecies variability for the general population. Based on this, a default assessment factor of 5 is recommended by ECETOC (2003).
- AF for the quality of the whole database:
- 1
- Justification:
- A reliable, guideline conform study conducted under GLP principles is the basis. Thus, AF=1.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties identified, thus AF=1.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
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.