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Diss Factsheets
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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
- 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: other routes
Administrative data
- Endpoint:
- sub-chronic toxicity: other route
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- No data
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Study was not conducted according to a guideline or under GLP conditions. Alternative route of exposure was used (IP). Methods and results are reported concise, but clear.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- publication
- Title:
- Effects of aluminum sulfate on erythropoiesis in rats.
- Author:
- Farina M, Lara FS, Brandão R, Jacques R and Rocha JBT.
- Year:
- 2 002
- Bibliographic source:
- Toxicol Lett. 132(2):131-139.
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Rats were administered aluminum sulphate by intraperitoneal injection for 3 months. At the end of the experimental period, enzyme assay, hematological parameters, TBARS reaction, aluminum analysis and protein quantification were studied.
- GLP compliance:
- no
- Limit test:
- yes
Test material
- Reference substance name:
- Automatically generated during migration to IUCLID 6, no data available
- IUPAC Name:
- Automatically generated during migration to IUCLID 6, no data available
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): Aluminum sulfate
- Source: Merck, Darmstadt, Germany.
- Analytical purity: 99.5 %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 12 weeks
- Weight at study initiation: 350 g
- Diet: Food, ad libitum
- Water: Deionized water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 22–25 °C
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- physiological saline
- Details on exposure:
- Aluminum sulfate was dissolved in physiological saline solution to permit single administrations of volume doses of 1 mL/kg bw.
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 3 months
- Frequency of treatment:
- Five times a week for 3 months
Doses / concentrations
- Remarks:
- Doses / Concentrations:
50 µmol/kg bw/day (Aluminum)
- No. of animals per sex per dose:
- 12 males/dose
- Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- No data
- Sacrifice and pathology:
- No data
- Other examinations:
- At the end of the experimental period (24 h after the last administration) the rats were anesthetized with ether vapor and bled by puncture of the vena cava. Whole blood was collected into tubes containing heparin for hemoglobin and hematocrit determinations. Iron content and TIBC were determined in serum. Aluminum concentrations were analysed in tissues (liver, kidney and brain); δ- ALA-D activity was assayed according to the method of Sassa (1982).
- Determination of hematological parameters: Blood hemoglobin was determined by the cyanmethemoglobin method (Ventura et al., 1967) and hematocrit was determined according to the method (Strumia et al.,1954).
- Thiobarbituric acid reactie substances (TBARS) reaction: Lipid peroxidation products were evaluated as TBARS measured at 532 nm and expressed as malondialdehyde equivalents.
- Aluminum analysis: Al was analyzed by electrothermal atomic absorption spectroscopy (Allen and Yokel, 1992).
- Iron status: Analysis of iron content (serum) was conducted by flame atomic absorption spectroscopy (Arroyo and Diaz-Rubio, 1972). The amount of Fe3+ needed to fully saturate plasma transferrin was determined (Labtest Lab, Brazil).
- Protein quantification: Protein was measured by the method of Bradford (1976) using bovine serum albumin (BSA) as standard. - Statistics:
- The results are expressed as mean ± standard deviation. Comparison between groups was carried out by the Student test, with the level of significance set at P≤0.05.
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- 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 specified
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- - Hematological parameters: After treatment (3 months) with i.p. injections of aluminum sulfate, the hemoglobin content of the Al group decreased significantly (32 %, P<0.01) compared with control. In addition, hematocrit was also significantly decreased (24 %, P<0.01) in the Al group.
- δ- ALA-D activity: Al treatment did not change δ- ALA-D activity in liver, kidney or brain of the Al group compared with control.
- Aluminum distribution: Al group showed a significant increase in aluminum concentration in the liver when compared with control. In contrast to the liver, renal and cerebral concentrations of aluminum did not differ between groups.
- Iron status: Serum iron concentration was significantly lower in aluminum-treated rats. However, aluminum treatment did not change TIBC.
- TBARS reaction: The serum TBARS did not vary after the experimental treatment. Furthermore, aluminum exposure did not change TBARS levels in liver, kidney or brain.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Table 7.5.4/1: Results
Concentrations |
Hb (g/L) |
Hct% |
δ-ALA-D (nmol porphobilinogen/mg protein per h) |
Fe (serum) |
TIBC |
Al concentration (µg/g wet weight) |
TBARS levels (MDA equivalents) |
|||||||
Liver |
Kidney |
Brain |
Liver |
Kidney |
Brain |
Plasma |
Liver |
Kidney |
Brain |
|||||
Control |
14.0 ± 2.0 |
46.7 ± 3.4 |
6.4 ± 0.6 |
4.1 ± 0.4 |
1.7 ± 0.5 |
276 ± 43 |
582 ± 57 |
0.182 ± 0.013 |
0.230 ± 0.032 |
0.335 ± 0.020 |
2.1 ± 1.2 |
0.81 ± 0.07 |
0.74 ± 0.06 |
0.44 ± 0.07 |
Aluminum sulfate - 50 µmol/kg bw/day (Aluminum) |
9.4 ± 2.4* |
35.5 ± 7.8* |
5.6 ± 0.3 |
3.9 ± 0.7 |
1.6 ± 0.3 |
189 ± 75** |
528 ± 33 |
0.920 ± 0.042* |
0.247 ± 0.020 |
0.365 ± 0.041 |
1.9 ± 0.6 |
0.82 ± 0.11 |
0.69 ± 0.12 |
0.44 ± 0.08 |
MDA equivalents: µmol MDA/mg protein for hepatic, renal and cerebral homogenates and µmol MDA/l for serum. Fe concentration and TIBC are expressed as µg/dl.
Results are reported as mean ± S.D.
*P<0.01 significant compared with control; **P<0.05 significant compared with control.
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions, exposure to aluminum sulfate promotes signs of anemia in rats as a consequence of alterations in iron status.
- Executive summary:
In a repeated dose study, groups of Wistar rats (12 males/dose) administered with Aluminum sulfate at the dose of 50 µmol/kg bw/day (Aluminum) in physiological saline by intraperitoneal injection for 3 months. Control group received physiological saline solution (1 mL/kg bw/day). At the end of the experimental period, enzyme assay, hematological parameters, TBARS reaction, aluminum analysis and protein quantification were performed.
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