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EC number: 233-135-0 | CAS number: 10043-01-3
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Density
- Particle size distribution (Granulometry)
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- Endpoint summary
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- 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
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- Endocrine disrupter testing in aquatic vertebrates – in vivo
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- Toxicological Summary
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- Additional toxicological data

Carcinogenicity
Administrative data
Description of key information
- Weight of evidence studies: A lifetime study in rats and mice exposed via the drinking water to 5 ppm aluminium potassium sulphate and a 20-month feeding study in mice on aluminium potassium sulphate administered via the diet at 1, 2.5, 5 and 10%.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Read-across substance; details of test item, environmental conditions not reported; only one dose tested; food and water consumption, hematology not reported
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Aluminum (as the Aluminum potassium sulfate) was administered to groups of Swiss mice of the Charles River CD strain, (54/sex/dose) at the concentrations of 5 ppm in drinking water for life-term.
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Species:
- mouse
- Strain:
- Swiss
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Random-bred white Swiss mice of the Charles River CD strain were born in testing laboratory from purchased pregnant females from Charles River Mouse Farms, Inc., N. Wilmington, United States.
- Housing: Animals were housed 6/sex/cage
- Diet: The diet was composed of whole untreated Balborye flour (60 %), powdered skim milk (30 %), corn oil (9 %), and iodized sodium chloride (1 %), with added vitamins and iron; ad libitum
- Water: Basal drinking water, doubly deionized and with no detectable cations, contained soluble salts as simple complexes (in ppm): zinc, 50; manganese, 10; copper, 5; chromium, 5; cobalt, 1; and molybdenum, 1., ad libitum - Route of administration:
- oral: drinking water
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- No data
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- Life-term
- Frequency of treatment:
- Daily
- Post exposure period:
- None
- Dose / conc.:
- 5 ppm (nominal)
- Remarks:
- 5 ppm aluminum (as the potassium sulfate);
nominal in water - No. of animals per sex per dose:
- 54
- Control animals:
- other: basal water without any of the abnormal metals
- Details on study design:
- No data
- Positive control:
- None
- Observations and examinations performed and frequency:
- CLINICAL OBSERVATIONS: Yes
BODY WEIGHT: Yes
- Time schedule for examinations: Rats were weighed at days 30, 60, 90, 120, 150, 180, 360 and 540.
FOOD CONSUMPTION: No data
WATER CONSUMPTION: No data
OPHTHALMOSCOPIC EXAMINATION: No data
HAEMATOLOGY AND CLINICAL CHEMISTRY: No data
URINALYSIS: No data - Sacrifice and pathology:
- Animals dying a natural death were weighed and dissected, gross tumors were detected, and some sections were made of heart, lung, liver, kidney, and spleen for microscopic examination.
- Other examinations:
- None
- Statistics:
- - Student's t test was used to test the difference between control and treatment groups for mortality and body weight.
- Chi-square analysis was used to test the difference between control and treatment groups for incidence of tumors. - 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):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- 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:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- effects observed, treatment-related
- Details on results:
- MORTALITY:
No marked effects in longevity of the mice were observed.
BODY WEIGHT AND WEIGHT GAIN:
Aluminum did not affect growth and body weights when compared with the controls.
HISTOPATHOLOGY: NEOPLASTIC
- Leukemia lymphoma was found most frequently in the female mice treated with aluminum, however no significant difference was observed in males when compared with control group. - Dose descriptor:
- NOAEL
- Effect level:
- 5 ppm (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Aluminum had slight effects (p<0.05) in females
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified. Effect type:carcinogenicity (migrated information)
- Conclusions:
- Under the test conditions, aluminum induced the gross tumors in females.
- Executive summary:
In a carcinogenicity study, Aluminum (as the potassium sulphate) was administered to groups of Swiss mice of the Charles River CD strain (54/sex/dose) at the concentrations of 5 ppm in drinking water for life-term. Control animals were treated with basal water. Rats were weighed at days 30, 60, 90, 120, 150, 180, 360 and 540. Animals dying a natural death were weighed and dissected, gross tumors were detected, and some sections were made of heart, lung, liver, kidney, and spleen for microscopic examination.
No marked effects in longevity of the mice were observed. Aluminum did not affect growth and body weights when compared with the controls. Leukemia lymphoma was found most frequently in the female mice treated with aluminum, however no significant difference was observed in males when compared with control group.
Under the test conditions, aluminum induced the gross tumors in females.
Reference
Table 7.7/1: Body weight - results
Age (days) |
Control |
Aluminum 5 ppm |
Males |
Body weight (g) |
|
30 |
21.7 ± 0.33 |
21.4 ± 1.44 |
60 |
33.0 ± 0.33 |
32.2 ± 1.82 |
90 |
37.7 ± 0.53 |
36.7 ± 1.06 |
120 |
41.5 ± 0.53 |
40.2 ± 1.35 |
150 |
43.0 ± 0.64 |
42.1 ± 1.64 |
180 |
43.5 ± 0.95 |
43.4 ± 1.18 |
360 |
45.2 ± 1.59 |
47.5 ± 1.68 |
540 |
37.7 ± 2.12 |
41.0 ± 2.80 |
Females |
Body weight (g) |
|
30 |
20.5 ± 0.49 |
18.8 ± 0.81 |
60 |
26.5 ± 0.36 |
25.5 ± 0.81 |
90 |
31.1 ± 0.83 |
30.5 ± 0.81 |
120 |
34.5 ± 0.83 |
34.1 ± 1.33 |
150 |
35.7 ± 1.13 |
36.4 ± 1.64 |
180 |
37.6 ± 1.23 |
38.3 ± 1.64 |
360 |
43.0 ± 3.00 |
44.4 ± 3.05 |
540 |
34.5 ± 2.32 |
35.7 ± 2.78 |
Table 7.7/2: Effects of trace metals on tumors, edema, and blanching of the incisor teeth of mice fed for life
Group |
No. autopsied |
Mean weight at death |
No. with white teeth |
Edema |
Tumors |
||||
No. |
Multiple |
LL |
Lung |
% of mice with tumors |
|||||
Males |
|||||||||
Control |
38 |
28 |
3 |
0 |
11 |
2 |
3 |
5 |
28.9 |
Aluminum 5 ppm |
41 |
28 |
11 |
10 |
15 |
9 |
9 |
9 |
36.6 |
Females |
|||||||||
Control |
47 |
26 |
19 |
3 |
14 |
4 |
3 |
9 |
29.8 |
Aluminum 5 ppm |
41 |
33 |
5 |
4 |
19 |
12* |
10** |
11 |
46.3 |
*P<0.025; **significance of difference between means by chi-square p<0.05
Table 7.7/3: Life-spans and longevities of mice fed on aluminum
Group |
No. mice |
Mean |
50 % dead |
75 % dead |
90 % dead |
Last |
Longevity |
Males |
days |
||||||
Control |
54 |
540 |
602 |
648 |
789 |
1010 |
920 ± 28.2 |
Aluminum 5 ppm |
54 |
568 |
568 |
668 |
819 |
1086 |
936 ± 48.9 |
Females |
days |
||||||
Control |
54 |
533 |
539 |
622 |
691 |
1001 |
823 ± 60.3 |
Aluminum 5 ppm |
54 |
533 |
524 |
611 |
702 |
958 |
846 ± 44.0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 850 mg/kg bw/day
- Study duration:
- chronic
- Species:
- mouse
- Quality of whole database:
- Non-GLP, possibly non-OECD study but sufficient to determine an adequate conclusion.
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Harmonized classification:
The substance has no harmonized classification for carcinogenicity according to the Regulation (EC) No. 1272/2008 (CLP).
Self classification:
Based on the available data, the substance is not classified for carcinogenicity according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
Additional information
The available existing carcinogenicity studies are of low quality and are not adequate to conclude definitively on the potential carcinogenicity of aluminium sulphate. However, the available data do not indicate any concern with regard to potential carcinogenic activity in either rats or mice.
The available epidemiological studies provide limited evidence that certain exposures in the aluminium production industry are carcinogenic to humans, giving rise to cancer of the lung and bladder. However, the aluminium exposure was confounded by exposure to other agents including polycyclic aromatic hydrocarbons, aromatic amines, nitro compounds and asbestos, most of which are known carcinogens. Thus it was concluded that there is no evidence of increased cancer risk in non-occupationally exposed persons and indicates that aluminium itself is not a human carcinogen (IARC, Monograph 100F, 2012).
This view is also shared by the SCCS (2014) that stated that the available information does not support any concern regarding the potential carcinogenicity of aluminium compounds.
Both ATSDR and the WHO conclude that there are no indications for the carcinogenic potential of aluminium. From ATSDR 2008 (reported in the pesticide dossier by EFSA in 2009): The available data do not indicate that aluminium is a potential carcinogen. It has not been shown to be carcinogenic in epidemiological studies in humans, nor in animal studies using inhalation, oral and other exposure routes (Oneda et al. 1994, Schroeder & Mitchener, 1975). Although these studies have limitations ranging from use of only one species to a single dose level and limited histological examinations, the evidence strongly suggests that aluminium is not carcinogenic, indicating the additional carcinogenicity testing is not warranted.
There are some publications in the literature that suggest a weak association between the cosmetic use of aluminium and breast cancer but definitive evidence is lacking. Also, the WHO and SCCS in 2014 have reviewed these data and conclude that the reported association is spurious and of no concern, consequently these documents have not been included as either short summaries or as robust summaries in this dossier.
In terms of genotoxicity potential a GLP, Klimisch Grade 1 in vivo micronucleus study on aluminium hydroxide has been used as a read-across study in support of three key in vitro studies. The RA in vivo study provided a negative conclusion for in vivo genotoxicity, which is in agreement with the Key in vitro study results. A total of six in vitro studies and 1 in vivo study have been included as weight of evdence or disregarded studies. Some of these studies provided negative results that were in agreement with the conclusions of the Key and RA studies. However, some of the studies also provided contrary positive conclusions. But none of the studies reported as positive were GLP and were classified as Klimisch grade 3 or 4. An expert review revealed that none of these studies was considered to be sufficiently reliable to add any significant weight against the strength of the Key and RA studies.
In agreement with the general scientific concensus, the available data on carcinogenicity provides sufficient evidence that aluminium sulphate is not carcinogenic to animals or to humans.
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.
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