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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 233-135-0 | CAS number: 10043-01-3
- 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- 13.4 mg/m³
- Most sensitive endpoint:
- neurotoxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 12.5
- Dose descriptor starting point:
- NOAEL
- Value:
- 190 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 168 mg/m³
- Explanation for the modification of the dose descriptor starting point:
For potential inhalation exposure, route-to-route extrapolation from the oral NOAEL value (30 mg/kg bw/d) of aluminium and therefore Aluminium sulphate (via aluminium citrate in a read-across approach) was performed. As specific data for the starting route (oral) is determined (see Toxicokinetics section) and extrapolated data is assumed for the end route (inhalation), assumptions have been made. Hence, it was determined that a limited absorption of 1% occurs by the oral route, leading to a conservative internal NOAEL based on the conservative absorption rate (<<1% for aluminium citrate and aluminium sulphate in Priest's study). By comparison, a similar conservative rate of absorption is assumed for the inhalation route (i.e. 1%) leading to a maximal external NOAEL. Moreover, in the case of oral-to-inhalation extrapolation, it is proposed to include an additional default factor of 2, i.e. the absorption percentage by oral route is half that of the inhalation absorption as suggested on page 19 of Guidance Document, Chapter R.8. Finally, to convert the oral NOAEL into inhalatory NOAEC, a rat default respiratory volume was used corresponding to the daily duration of human exposure (sRVrat: 0.38 m3/kg bw/8 h). For workers a correction was added for the difference between respiratory rates under standard conditions (sRVhuman: 6.7 m3 for an 8-h exposure period) and under conditions of light activity (wRV: 10 m3 for an 8-h exposure period). Thus, for aluminium sulphate, the corrected dose descriptor for inhalation is 168 mg/m3 for workers considering a molecular mass of 342.1 g/Mol.
- AF for dose response relationship:
- 1
- Justification:
- Based on NOAEL [ECHA default, Chapter R8 guidance].
- AF for differences in duration of exposure:
- 1
- Justification:
- The study exposed the animals until they were 1 year of age.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not applicable for oral to inhalation extrapolation [ECHA default, Chapter R8 guidance].
- AF for other interspecies differences:
- 2.5
- Justification:
- 2.5 for remaining differences (rats to humans) [ECHA default, Chapter R8 guidance].
- AF for intraspecies differences:
- 5
- Justification:
- ECHA default, Chapter R8 guidance for the worker
- AF for the quality of the whole database:
- 1
- Justification:
- The available information as a whole meets the tonnage driven data requirement of REACH. Moreover, reliability and consistency are observed across the different studies.
- AF for remaining uncertainties:
- 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:
- 3.8 mg/kg bw/day
- Most sensitive endpoint:
- neurotoxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 190 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 190 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
For potential dermal exposure, route-to-route extrapolation from the oral NOAEL value (30 mg Aluminium /kg bw/d) was performed. The oral absorption rate is below 1% (see Toxicokinetics section). Moreover, in the absence of specific data about dermal absorption and on the assumption that, in general, dermal absorption will not be higher than oral absorption, no default factor should be introduced when performing oral to dermal extrapolation (see Guidance Document, Chapter R.8, pp 19). Thus, it is assumed that dermal absorption is not higher to 1% for Aluminium sulphate. Then, applying a correction factor based on the ratio between the molecular mass of Aluminium ion (26,98 g/mL) including two moles of Aluminium and Aluminium sulphate (342,1 g/mol), the corrected starting descriptor for Aluminium sulphate is 190 mg/kg bw/day for workers exposed by dermal route.
- AF for dose response relationship:
- 1
- Justification:
- Based on NOAEL [ECHA default, Chapter R8 guidance].
- AF for differences in duration of exposure:
- 1
- Justification:
- The study exposed the animals until they were 1 year of age.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- 4 for allometric scaling (rats to humans) [ECHA default, Chapter R8 guidance].
- AF for other interspecies differences:
- 2.5
- Justification:
- Remaining differences between rat and human
- AF for intraspecies differences:
- 5
- Justification:
- ECHA default, Chapter R8 guidance.
- AF for the quality of the whole database:
- 1
- Justification:
- The available information as a whole meets the tonnage driven data requirement of REACH. Moreover, reliability and consistency are observed across the different studies.
- AF for remaining uncertainties:
- 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:
- medium hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.3 mg/m³
- Most sensitive endpoint:
- neurotoxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 190 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 83 mg/m³
- Explanation for the modification of the dose descriptor starting point:
For potential inhalation exposure, route-to-route extrapolation from the oral NOAEL value (30 mg/kg bw/d) of Aluminium ion and therefore Aluminium sulphate (via aluminium citrate in a read-across approach) was performed. As specific data for the starting route (oral) is determined (see Toxicokinetics section) and extrapolated data is assumed for the end route (inhalation), assumptions have been made. Hence, it was determined that a limited absorption of 1% occurs by the oral route, leading to a conservative internal NOAEL based on the conservative absorption rate (<<1% for aluminium citrate and aluminium sulphate in Priest's study). By comparison, a similar conservative rate of absorption is assumed for the inhalation route (i.e. 1%) leading to a maximal external NOAEL. Moreover, in the case of oral-to-inhalation extrapolation, it is proposed to include an additional default factor of 2, i.e. the absorption percentage by oral route is half that of the inhalation absorption as suggested on page 19 of Guidance Document, Chapter R.8. Finally, to convert the oral NOAEL into inhalatory NOAEC, a rat default respiratory volume was used corresponding to the daily duration of human exposure (sRVrat: 1.15 m3/kg bw/24 h). Thus, for aluminium sulphate, the corrected dose descriptor is 168 mg/m3 for general population exposed by considering a molecular mass of 342.1 g/Mol.
- AF for dose response relationship:
- 1
- Justification:
- Based on NOAEL [ECHA default, Chapter R8 guidance].
- AF for differences in duration of exposure:
- 1
- Justification:
- The study exposed the animals until they were 1 year of age.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not applicable for oral to inhalation extrapolation [ECHA default, Chapter R8 guidance].
- AF for other interspecies differences:
- 2.5
- Justification:
- Remaining differences between rat and human.
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default, Chapter R8 guidance.
- AF for the quality of the whole database:
- 1
- Justification:
- The available information as a whole meets the tonnage driven data requirement of REACH. Moreover, reliability and consistency are observed across the different studies.
- AF for remaining uncertainties:
- 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:
- 1.9 mg/kg bw/day
- Most sensitive endpoint:
- neurotoxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 190 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 190 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
For potential dermal exposure, route-to-route extrapolation from the oral NOAEL value (30 mg Aluminium /kg bw/d) was performed. The oral absorption rate is below 1% for Aluminium sulphate (see Toxicokinetics section). Moreover, in the absence of specific data about dermal absorption and on the assumption that, in general, dermal absorption will not be higher than oral absorption, no default factor should be introduced when performing oral to dermal extrapolation (see Guidance Document, Chapter R.8, pp 19). Thus, it is assumed that dermal absorption is not higher to 1% for Aluminium sulphate. Then, applying a correction factor based on the ratio between the molecular mass of Aluminium ion (26,98 g/mL) including two moles of Aluminium and Aluminium sulphate (342,1 g/Mol), the corrected starting descriptor for Aluminium sulphate is 190 mg/kg bw/day for the general population exposed by dermal route.
- AF for dose response relationship:
- 1
- Justification:
- Based on NOAEL [ECHA default, Chapter R8 guidance].
- AF for differences in duration of exposure:
- 1
- Justification:
- The study exposed the animals until they were 1 year of age.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- 4 for allometric scaling (rats to humans) [ECHA default, Chapter R8 guidance].
- AF for other interspecies differences:
- 2.5
- Justification:
- Remaining differences between rat and human.
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default, Chapter R8 guidance.
- AF for the quality of the whole database:
- 1
- Justification:
- The available information as a whole meets the tonnage driven data requirement of REACH. Moreover, reliability and consistency are observed across the different studies.
- AF for remaining uncertainties:
- 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:
- 1.9 mg/kg bw/day
- Most sensitive endpoint:
- neurotoxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 190 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 190 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
For potential oral exposure, extrapolation from the oral NOAEL value from Aluminium ion (30 mg/kg bw/d) was performed. The Aluminium sulphate oral absorption rate is below 1% in animals (see Toxicokinetics section). Similar rate of absorption was observed in human. Therefore, the oral absorption is considered at a maximum rate of 1% for Aluminium sulphate in human. Then, a correction factor based on the ratio between the molecular mass of Aluminium ion (26,98 g/mL) including two moles of Aluminium and Aluminium sulphate (342,1 g/mol) was applied to extrapolate the corrected starting point for Aluminium sulphate to Aluminium ion. Finally, the corrected dose descriptor for oral route is 190 mg/kg bw/day for the general population.
- AF for dose response relationship:
- 1
- Justification:
- Based on NOAEL [ECHA default, Chapter R8 guidance].
- AF for differences in duration of exposure:
- 1
- Justification:
- The study exposed the animals until they were 1 year of age.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- 4 for allometric scaling (rats to humans) [ECHA default, Chapter R8 guidance].
- AF for other interspecies differences:
- 2.5
- Justification:
- Remaining differences between rat and human.
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default, Chapter R8 guidance.
- AF for the quality of the whole database:
- 1
- Justification:
- The available information as a whole meets the tonnage driven data requirement of REACH. Moreover, reliability and consistency are observed across the different studies.
- AF for remaining uncertainties:
- 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:
- medium hazard (no threshold derived)
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.
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