Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 233-141-3 | CAS number: 10043-67-1
- 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
Based on the long-term key study from Oneda et al. the calculated LD50-mouse oral should be > 2000 mg/kg bw.
This result was used for classification of the substance.
Based on the oral NOAEL value of the key study the inhalative NOAEL of the substance was calculated.
NOAEL inhalative calculated from NOAEL oral:
NOAEL inhalative = 13.05 mg/m³.
The calculated LC50-inhalative should be > 5 mg/L (Limit CLP).
Based on the key study ( ATSDR report and publication of Lansdown) the calculated LD50-dermal
of aluminium potassium bis sulphate from read across substance aluminium sulfate resulted in a
calculated LD50-dermal of 100000 mg/kg bw aluminium potassium bis sulphate.
Based on all acute toxicity results aluminium potassium bis sulphate is not classified as acute toxic oral, inhalative and dermal according
EU regulation 1272/2008 and EU regulation 286/2011 (2. ATP).
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well documented study from Oneda et al according to EU Method B.33 (Combined Chronic Toxicity / Carcinogenicity Test),peer-reviewed report from ATSDR (2008)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: EU Method B.33 (Combined Chronic Toxicity / Carcinogenicity Test)
- Deviations:
- not specified
- Principles of method if other than guideline:
- In a preliminary study with male and female mice B6C3F1 5 week-diet was given in concentration of 2, 1, 0.2 and 0% Aluminium potassium bis(sulphate) for testing maximal dose of the substance.
- GLP compliance:
- not specified
- Test type:
- other: combined repeated dose and carcinogenicity
- Limit test:
- no
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
- Route of administration:
- oral: feed
- Vehicle:
- other: basal diet
- Doses:
- Preliminary study: 5 weeks, daily dietConcentration: 2, 1, 0.2 and 0% (w/w)No deaths, no abnormalities in clinical signs, food consumption, body weight or pathological evaluations at any dose.Main study: 20 months, daily dietConcentrations: 10, 5, 2.5, 1 and 0 % (w/w)
- No. of animals per sex per dose:
- 300 male, 300 female
- Control animals:
- yes
- Preliminary study:
- 2, 1, 0.2 and 0% (w/w) AlK(SO4)2*12H2O = 3000, 1500, 300 and 0 mg aluminium potassium bis(sulphate) or 170, 85, 17 and 0 mg Al/kg bw
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- 2 other: %
- Based on:
- test mat.
- Remarks:
- Aluminium potassium bis(sulphate)*12H2O
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- 3 000 mg/kg bw
- Based on:
- test mat.
- Remarks:
- AlK(SO4)2*12H2O
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- 170 mg/kg bw
- Based on:
- dissolved
- Remarks:
- Aluminium from AlK(SO4)2*12H2O
- Sex:
- male/female
- Dose descriptor:
- other: NOAEL
- Effect level:
- 8 160 other: mg/kg bw/day
- Based on:
- other: calculated from 10 % Aluminium potassium bis sulphate in diet
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- other: calculated from oral NOAEL: based on relation LD50/NOAEL ca. 2.3
- Remarks on result:
- other: Calculation LD50 from oral NOAEL= 8160 mg/kg bw/day: according to ATSDR 2008 p. 51-61 relation LD50 oral/NOAEL oral ca. 2.26. Therefore based on NOAEL oral from study of Oneda et al. the calculated LD50 oral is LD50 = 8160x2.26 = 18442 mg/kg bw
- Mortality:
- No death
- Clinical signs:
- other: No abnormalities in clinical signs, food consumption, body weight or pathological evaluations.
- Interpretation of results:
- not classified
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- LD0-5 weeks male/female Mice B6C3F1 = 2 % (w/w) as Aluminium potassium bis sulphate dodecahydrate in diet.LD0-5 weeks male/female mouse B6C3F1 = 3000 mg/kg bw Aluminium potassium bis sulphate dodecahydrate = LD0-5 weeks male/female mouse B6C3F1 = 1634 mg/kg bw Aluminium potassium bis sulphateCalculation of LD50 from NOAEL oral :Relation LD50 oral/NOAEL oral according to ATSDR 2008 ca. 2.26NOAEL oral - 20 months mouse B6C3F1 = 8160 mg/kg bw/day (see Key study Repeated dose toxicity oral)Calculated LD50 oral from NOAEL oral = 8160 x 2.26 = 18144 mg/kg bw Aluminium potassium bis sulphate.The calculated LD50 value should be LD50 > 2000 mg/kg bw (Limit acute oral toxicity GHS).Therefore the substance Aluminium potassium bis sulphate is not classified as acute oral toxic according to EU regulation 1272/2008 and EU regulation 286/2011 (2. ATP) under the test conditions.
- Executive summary:
LD0-5 weeks male/female Mice B6C3F1 = 2 % (w/w) as Aluminium potassium bis sulphate dodecahydrate.
LD0-5 weeks male/female mouse B6C3F1 = 3000 mg/kg bw Aluminium potassium bis sulphate dodecahydrate =
LD0-5 weeks male/female mouse B6C3F1 = 1634 mg/kg bw Aluminium potassium bis sulphate.
Calculation of LD50 from NOAEL oral :
Relation LD50 oral/NOAEL oral according to ATSDR 2008 ca. 2.26
NOAEL oral - 20 months mouse B6C3F1 = 8160 mg/kg bw/day (see Key study Repeated dose toxicity oral).
Calculated LD50 oral from NOAEL oral = 8160 x 2.26 = 18144 mg/kg bw Aluminium potassium bis sulphate.
The calculated LD50 value should be LD50 > 2000 mg/kg bw (Limit acute oral toxicity GHS).
Therefore the substance Aluminium potassium bis sulphate is not classified as acute oral toxic according to EU regulation 1272/2008 and EU regulation 286/2011 (2. ATP) under the test conditions.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 8 160 mg/kg bw
- Quality of whole database:
- Based on the long-term key study from Oneda et al. the calculated LD50 oral from NOAEL oral= 8160 mg/kg bw/day should be > 2000 mg/kg bw Aluminium potassium bis sulphate.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- calculation (if not (Q)SAR)
- Remarks:
- Migrated phrase: estimated by calculation
- Adequacy of study:
- key study
- Study period:
- 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Calculated from long-term oral key study from Oneda et al.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other:
- Deviations:
- not specified
- Principles of method if other than guideline:
- In the main study with male and female mice B6C3F1 5 week-diet was given in concentration of 10, 5, 2.5, 1 and 0 % (w/w) in diet.Exposure duration: 20 months, daily diet.Effects: No deaths, no abnormalities in clinical signs, food consumption, body weight or pathological evaluations at any dose.Calculation from repeated dose oral NOAEL-20 months for mouse = 8160 mg Aluminium potassium bis sulphate/kg bw*d.Oral absorption rate: 1%Inter-species factor: 1/7x2.5Intra-species factor: 1/5 for workersInhalative absorption rate: 50%Worker body weight: 70 kgInhalation volumen/8h: 10 m³ airCalculation NOAEL-inhalative mouse: 8160/100/7x2.5/5x2x70/10 = 13.05 mg Aluminium potassium bis sulphate/m³ air.
- GLP compliance:
- not specified
- Test type:
- fixed concentration procedure
- Limit test:
- yes
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
- Route of administration:
- other: calculation from oral NOAEL
- Type of inhalation exposure:
- other: calculation from oral NOAEL
- Vehicle:
- other: calculation from oral NOAEL
- Details on inhalation exposure:
- Calculation from oral NOAEL
- Analytical verification of test atmosphere concentrations:
- no
- Remarks:
- calculation from oral NOAEL
- Duration of exposure:
- 600 d
- Concentrations:
- Administration of aluminium potassium sulphate (APS) to B6C3F1 mice (60 males and 60 females per group) at levels of 0, 1,2.5, 5 or 10% in the diet for 20 months (equivalent to 1500, 3750, 7500 or 15000 mg/kgbw/day of aluminium potassium sulphate and 85, 213, 427 or 853 mg Al/kg bw/day).
- No. of animals per sex per dose:
- 300 male, 300 female
- Control animals:
- yes
- Sex:
- male/female
- Dose descriptor:
- other: NOAEL
- Effect level:
- 13.05 mg/m³ air
- Based on:
- other: test material: Calculation from oral NOAEL-mouse
- Exp. duration:
- 600 d
- Remarks on result:
- other: calculation from oral NOAEL-600d mouse
- Mortality:
- No death
- Clinical signs:
- other: No abnormalities in clinical signs, food consumption, body weight or pathological evaluations
- Body weight:
- no effects
- Gross pathology:
- no effects
- Interpretation of results:
- not classified
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- Calculation based on long-term oral key study of aluminium potassium bis sulphate from Oneda et al. resulted in an NOAEL inhalative -20 month mouse of NOAEL inhalative= 13.05 mg Aluminium potassium bis sulphate/m³ air.The resulting LC50 inhalative should be > 5 mg/L air (Limit GHS).Therefore the substance is not classified according to EU regulation 1272/2008 and EU regulation286/2011 (2. ATP).
- Executive summary:
Calculation based on long-term oral key study of aluminium potassium bis sulphate from Oneda et al.
resulted in an NOAEL inhalative -20 month mouse of NOAEL inhalative = 13.05 mg Aluminium potassium bis sulphate/m³ air.
The resulting LC50 inhalative should be > 5 mg/L air (Limit GHS).
Therefore the substance is not classified according to EU regulation 1272/2008 and EU regulation
286/2011 (2. ATP).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 13.05 mg/m³ air
- Quality of whole database:
- Calculated from oral NOAEL-20 month mouse = 8160 mg/kg bw*d the LC50 inhalative should be > 5 mg/m³ Aluminium potassium bis sulphate.
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: peer-reviewed report
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPP 81-2 (Acute Dermal Toxicity)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Species:
- mouse
- Strain:
- other: Carworth TF1
- Sex:
- female
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Duration of exposure:
- 5d/ 1x/d
- Control animals:
- not specified
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- 10 other: % (w/v)
- Based on:
- dissolved
- Remarks:
- Aluminium as Aluminium sulfate
- Remarks on result:
- other: LD0 = 10% (w/v) Aluminium as Aluminium sulfate
- Mortality:
- no mortality
- Clinical signs:
- other: no skin damage
- Interpretation of results:
- not classified
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- NOAEL-5d/1x/d mouse TFI: 10% (w/v) = 100 g/L as Aluminium sulfateCalculated for KAl(SO4)2: NOAEL: 13.25 % (w/v) = 132.5 g/L as KAl(SO4)2.The estimated LD50 should be > 2000 mg/kg bw for Aluminium potassium bis sulphate.Therefore aluminium potassium bis sulphate is not classified according to EU Regulation 1272/2008and 286/2011 (2. ATP).
- Executive summary:
NOAEL-5d/1x/d mouse TFI: 10% (w/v) = 100 g/L as Aluminium sulfate
Calculated for KAl(SO4)2:
NOAEL: 13.25 % (w/v) = 132.5 g/L as KAl(SO4)2.
The estimated LD50 should be > 2000 mg/kg bw for Aluminium potassium bis sulphate.
Therefore aluminium potassium bis sulphate is not classified according to EU Regulation 1272/2008
and 286/2011 (2. ATP).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 100 000 mg/kg bw
- Quality of whole database:
- Based on the key study the LD50 dermal is > 2000 mg/kg bw (Limit value GHS).
Additional information
Based on the long-term key study from Oneda et al. the calculated LD50-mouse oral should be > 2000 mg/kg bw.
This result was used for classification of the substance.
Based on the oral NOAEL of the key study the inhalative NOAEL of the substance was calculated.
Calculated NOAEL-inhalative: 13.05 mg/m³.
The corresponding LC50 -inhalative should be LC50 inhalative > 5 mg/L air (Limit CLP).
Based on the key study ( ATSDR report and publication of Lansdown) the calculated LD50-dermal
of aluminium potassium bis sulphate from read across substance aluminium sulfate resulted in an
calculated LD50-dermal of 100000 mg/kg bw aluminium potassium bis sulphate.
Based on all acute toxicity results aluminium potassium bis sulphate is not classified as acute oral, inhalative and dermal toxic
according EU regulation 1272/2008 and EU regulation 286/2011 (2. ATP).
Justification for selection of acute toxicity – oral endpoint
Well documented repeated dose study of aluminium potassium bis sulphate and peer-reviewed ATSDR
report. Calculation of LD50 oral from NOAEL oral.
Justification for selection of acute toxicity – inhalation endpoint
In the main study with male and female mice B6C3F1 5 week-diet was given in concentrations of 10, 5, 2.5, 1 and 0 % (w/w) in diet.
Exposure duration: 20 months, daily.
Effects: No deaths, no abnormalities in clinical signs, food consumption, body weight or pathological evaluations at any dose.
Calculation from repeated dose oral NOAEL-20 months for mouse = 8160 mg Aluminium potassium bis sulphate/kg bw/d.
Oral absorption rate: 1%
Inter-species factor: 1/7x2.5
Intra-species factor: 1/5 for workers
Inhalative absorption rate: 50%
Worker body weight: 70 kg
Inhalation volumen/8h: 10 m³ air
Calculation NOAEL-inhalative mouse: 8160/100/7x2.5/5x2x70/10 = 13.05 mg Aluminium potassium bis sulphate/m³ air.
Justification for selection of acute toxicity – dermal endpoint
Based on Key study the LD50 dermal is > 13.25% (m/v).
Calculated LD50: 100000 mg/kg bw
Justification for classification or non-classification
Based on the results of acute oral values and calculated long-term inhalative and acute dermal values
the substance aluminium potassium bis(sulphate) is not classified as acute oral, inhalative and dermal toxic
according CLP regulation EU 1272/2008 and EU regulation 286/2011 (2. ATP).
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.
