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EC number: 246-140-8 | CAS number: 24304-00-5
- 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: oral
Administrative data
- Endpoint:
- chronic toxicity: oral
- Remarks:
- combined repeated dose and carcinogenicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Chronic toxicity and tumorigenicty study of aluminium potassium sulfate in B6C3F1 mice
- Author:
- Oneda, S.
- Year:
- 1 994
- Bibliographic source:
- In Vivo 8(3): 271-278
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.33 (Combined Chronic Toxicity / Carcinogenicity Test)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 7784-24-9
- Cas Number:
- 7784-24-9
- IUPAC Name:
- 7784-24-9
- Reference substance name:
- aluminium potassium sulfate dodecahydrate
- IUPAC Name:
- aluminium potassium sulfate dodecahydrate
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): Aluminium potassium sulfate
- Molecular formula (if other than submission substance): AlK (SO4)2 x 12H2O, APS
- Lot/batch No.: M5P2968
- Other: test chemical received from Nacalai Tesque Co., LtD., Kyoto, Japan)
Constituent 1
Constituent 2
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Co. Japan Inc., Atsugi, Japan)
- Age at study initiation: 6 weeks
- Housing: 5 per plastic cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +/- 2°C
- Humidity (%): 55 +/- 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- DIET PREPARATION
the test chemical was mixed with the basal diet (CE-2, Nippon CLEA Co. Ltd, Tokyo, Japan) at the various concentrations mentioned below. The diets containing the test item were prepared every 2 or 3 months and kept in light-shielded boxes at room temperature. Since the test item is rather stable compound, the stability of the compound in the diet was not monitored after preparation. - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- N.A.
- Duration of treatment / exposure:
- 20 months
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 1.0, 2.5, 5.0 and 10.0 (w/w)
Basis:
nominal in diet
- No. of animals per sex per dose:
- 5 groups of 60 animals of each sex and concentration
- Control animals:
- yes, plain diet
- Details on study design:
- - Dose selection rationale:
Preliminary study: 5 weeks, daily diet
Concentration: 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
Based on the results 10.0% (w/w) was chose for the high dose level and 5.0, 2.5 and 1.0% were selected as the middle to low dose levels - Positive control:
- N.A.
Examinations
- Observations and examinations performed and frequency:
- The animals were observed weekly for clinical signs of illness or death, food consumption and body weights
- Sacrifice and pathology:
- Spontaneously died animals were necropsied
After 20 months:
All surving animals were killed by exanguination under ether anesthesia without prior fasting. Gross findings were observed and the following organs of all mice were weighed: brain, pituitary, heart, lungs, liver, spleen, kidneys, adrenals and testes. These organs and the eye balls, harderian gland, submandibular gland, thyroid, thymus, trachea, bronchis, pancreas, stomach, small and large intestines, epididymis, prostate, ovaries, uterus, vagina, mammary glands, mesenteric lymph nodes, femoral bone marrow and skin were fixed in 10% neutraliszed formalin, embedded in paraffin, sectioned and stained with hematoxylin and eosin (HE). - Other examinations:
- N.A.
- Statistics:
- Data were analysed statistically by the students-t test for body weight and organ weights (absolute and relative weight) and X² test for histopathological examinations
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- MORTALITY
The survival rates at the end of the dosing period were 73.3% (male) and 78.3% (female) in the control group, and 86.7%-95.0% (male) and 86.7-91.7% (female) in the treatment group.
BODY WEIGHT AND WEIGHT GAIN
Both the male and the female mice in the high dose level exhibited slight growth retardation compared with the control group after 1 month, and those in the 1.0 and 2.5 % dose groups exhibited a slight increase in body weight after 3 months. Both male and female mice receiving 5.0% test item showed growth similar to that in the control group
FOOD CONSUMPTION
Food consumption did not show any variation among the groups throughout the experimental period for either males or females
ORGAN WEIGHTS
A significant increase in the absolute organ weight was observed in the kidneys and heart in both sexes in the 1.0, 2.5 and 5.0% dose groups, in the pituitary in the males in the 2.5% dose group and the brain in the females in the 1.0% group compared with those in the control group. Additionally, there were significant decreases in the absolute organ weight of the liver in both sexes in the 5.0 and 10.0% dose groups, the heart and brain in both sexes in the high dose group and lungs in the males and spleen in the females in the 10% high dose group compared with those in the control group. There was a significant increase in the relative organ weight of the kidneys in the males in the 5.0% dose group and a significant decrease in the relative organ weight of the liver in both sexes in 5.0 and 10% groups and spleen in the females in the high dose group.
HISTOPATHOLOGY: NON-NEOPLASTIC
The incidence of myocardial eosinophilic cytoplasm showed a significant dose-dependent decrease in the male mice in the treatment groups. A comparison between the sexes revealed a significant decrease in the incidence of hepatocytic anisonucleosis, myocardial eosinophilic cytoplasm and acinar cell vacuolation of sumandibular gland in females; and lymphocyte infiltration in the renal cortex and pelvis, and vacuolation of cerebrellar white matter in the males
HISTOPATHOLOGY: NEOPLASTIC (if applicable)
The incidence of the male tumour bearing mice was 40.9%, and 54.5, 36.5, 42.9 and 17.5% in the control group and 1.0, 2.5, 5.0 and 10.0% dose groups, respectively, while that of female tumour.bearing mice was 29.8, 23.6, 17.3, 11.5 and 13.5% respectively.
HISTORICAL DATA
The incidence of all tumours and non-tumorous changes was withinh the normal range reported for spontaneous changes in B6C3F1 mice.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 100 000 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects notified
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- In conclusion, the results of the present study indicate that long-term administration of a diet containing 10% (w/w) aluminium potassium sulfate does not exert tumorgenicity or any other toxic actions in male and female B6C3F1 mice. Thus, the NOAEL can be considered to be 100000 ppm (10 % w/w).
- Executive summary:
In a chronic (20 months) combined repeated oral dose toxicity and carcinogenicity study (similar to EU method B.33) aluminium potassium sulfate dodecahydrate was administered orally via the diet to 60 male and female B6C3F1 mice at concentrations of 0, 10000, 25000, 50000 and 100000 ppm. The animals were treated with the test item 7 days per week for a period of 20 months. The treatment does not exert tumourgenicity or any other toxic action (mortality, food consumption, body weights, organ weights and histopathology) in any dose group investigated. Based on the results the chronic NOAEL for both sexes can be considered to be 100000 ppm which equals 15000 mg/kg bw/day.
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