Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- chronic toxicity: oral
- Remarks:
- combined repeated dose and carcinogenicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well documented study according to EU Method B.33 (Combined Chronic Toxicity / Carcinogenicity Test)
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:
- EU Method B.33 (Combined Chronic Toxicity / Carcinogenicity Test)
- Deviations:
- not specified
- GLP compliance:
- not specified
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*12 H2O (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:
- other: basal diet
- Analytical verification of doses or concentrations:
- yes
- 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: Concentration: 2, 1, 0.2 and 0% (w/w) Main study: Concentrations: 10, 5, 2.5. 1.0, 0 %Basis:nominal in diet
- No. of animals per sex per dose:
- 5 groups of 60 animals of each sex and concentration
- Details on study design:
- Temperature: 23 +/- 2 °CRelative Humidity: 55 +/- 10 %12hr-light/12hr-dark cycle
Examinations
- Observations and examinations performed and frequency:
- Weekly control for clinical signs of illness or death, food consumption and body weight
- Sacrifice and pathology:
- Spontaneously died animals were necropsied.After 20 month: All surviving animals were killed by exsanguination 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, bronchi, 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
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:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- 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
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 10 other: %
- Based on:
- test mat.
- Remarks:
- in diet
- Sex:
- male/female
- Basis for effect level:
- gross pathology
- Dose descriptor:
- NOAEL
- Effect level:
- 15 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Remarks:
- as AlK(SO4)2*12H2O
- Sex:
- male/female
- Basis for effect level:
- other: calculated from daily basal diet of 3.5 g/d per mouse and start weight for male mouse of 22 g and 18 g for female mouse according to study
- Dose descriptor:
- NOAEL
- Effect level:
- 8 160 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Remarks:
- AlK(SO4)2
- Sex:
- male/female
- Basis for effect level:
- other: calculated from AlK(SO4)2*12 H2O
- Dose descriptor:
- NOAEL
- Effect level:
- 853 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Remarks:
- as Al from AlK(SO4)2
- Sex:
- male/female
- Basis for effect level:
- other: calculated from AlK(SO4)2
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The results of the present study indicate that long-term administration of a diet containing 10.0 % aluminium potassium bis sulphate (AlK(SO4)2*12H2O) does not exert tumorgenicity or any other toxic actions in B3C6F1 mice.Slight growth retardation compared with controls at 10% groups after 1 month.Slight increase of body weight at 1 and 2.5% groups after 3 month.Similar growth at 5% groups compared with controls.NOAEL-20 month B3C6F1 male/female mice oral: 10 % aluminium potassium bis sulphate *12H2O (w/w).NOAEL: 853 mg Al/kg bw/d = 8160 mg aluminium potassium bis sulphate/kg bw/d.
- Executive summary:
The results of the present study indicate that long-term administration of a diet containing
10.0 % aluminium potassium bis sulphate (AlK(SO4)2*12H2O) does not exert tumorgenicity or
any other toxic actions in B3C6F1 mice.
Slight growth retardation compared with controls at 10% groups after 1 month.
Slight increase of body weight at 1 and 2.5% groups after 3 month.
Similar growth at 5% groups compared with controls.
NOAEL-20 month B3C6F1 male/female mice oral: 10 % aluminium potassium bis sulphate *12H2O (w/w).
NOAEL: 853 mg Al/kg bw/d = 8160 mg aluminium potassium bis sulphate/kg bw/d.
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.
