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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

Genetic toxicity: in vivo
Administrative data
- Endpoint:
- genetic toxicity in vivo
- Remarks:
- Type of genotoxicity: other: tumorgenicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well documented study equivalent or similar EU method B 33
Data source
Reference
- Reference Type:
- publication
- Title:
- Chronic toxicity and tumorigenicity study of aluminum potassium sulfate in B6C3F1 mice
- Author:
- Oneda S, Takasaki T, Kurowaki K, et al.
- Year:
- 1 994
- Bibliographic source:
- In Vivo 8(3):271-278
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: EU Method B.33 (Combined Chronic Toxicity / Carcinogenicity Test)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Type of assay:
- other: combined repeated dose and carcinogenicity
Test material
- Reference substance name:
- Aluminium potassium sulfate
- IUPAC Name:
- Aluminium potassium sulfate
- Details on test material:
- Aluminium potassium sulfate as dodecahydrate: AlK(SO4)2*12H2O (APS)Lot.No. M5P2968 from Nacalai Tesque Co., Ltd., Kyoto, Japan
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- basal diet
- Duration of treatment / exposure:
- 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)
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:Preliminary study: 5 weeks, daily diet Concentration: 2, 1, 0.2 and 0% (w/w) Main study: 20 months, daily diet Concentrations: 10, 5, 2.5, 1 and 0 % (w/w)Basis:nominal in water
- No. of animals per sex per dose:
- 5 groups of 60 animals of each sex and concentration
- Control animals:
- yes
Examinations
- Details of tissue and slide preparation:
- Weekly control for clinical signs of illness or death, food consumption and body weight.Spontaneously died animals were necropsied.After 20 month: All surviving 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, kidney 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% neutralized formalin, embedded in paraffin, sectioned and stained with hematoxylin and cosin (HE).
- Statistics:
- Data were analyzed statistically by the students t-test for body weight and organ weights (absolute and relative weight), and X² testfor histopathological examinations.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negativeThe results of the present study indicate that long-term administration of a diet containing 10.0 % aluminium potassium sulfate (AlK(SO4)2*12H2O) does not exert tumorgenicity or any other toxic actions in B3C6F1 mice.NOEC-20 month B3C6F1 male/female mice oral: 10 % aluminium potassium bis(sulphate)*12H2O (w/w).
- Executive summary:
The results of the present study indicate that long-term administration of a diet containing 10.0 % aluminium potassium sulfate (AlK(SO4)2*12H2O) does not exert tumorgenicity or any other toxic actions in B3C6F1 mice. NOEC-20 month B3C6F1 male/female mice oral: 10 % aluminium potassium bis(sulphate)*12H2O (w/w).
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