Aluminium potassium bis(sulphate)

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:

1994

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

Test material information

Constituent 1

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

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).