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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
Immunotoxicity
Administrative data
Description of key information
Orale exposure:
After three months treatment with Al2(SO4)3 in a dose of 300 mg/kg bw., hemoglobin and hematocrit levels of Al and Al+Vit E groups were significantly decreased compared to the control. Reductions in serum haemoglobin (14%) and haematocrit (13%) were described. There was an increase in the levels of liver iron (59%) and ferritin with Al, but Vit E had no effect on the changes of all blood and liver parameters caused by Al. From the results presented in this report, a Lowest Observed Adverse Effect Level (LOAEL) for Aluminium sulfate of 300 mg/kg/day was established, based on significantly decreased hemoglobin and hematocrit levels of Al .
Inhalation exposure:
Several animal studies have found histological alterations in the lymphoreticular system, in particular granulomas in the hilar lymph nodes; these effects are secondary to the pulmonary effects (Steinhagen et al. 1978; Thomson et al. 1986) and resulted from the removal of aluminum from the lungs by alveolar macrophages.
Dermal exposure:
No studies were located regarding immunological/lymphoreticular effects in animals after dermal exposure to various forms of aluminum.
For dermal exposure we taken that:
-the average weight of mouse is 80g (60-100g),
-the dose is applied over an area which is approximately 10% of the total body surface=0.008kg
corrected dermal LOAEL= oral LOAEL
300 mg/kg bw/dw 0.008 kg =
LOAELmouse 2.4 mg/kg bw/day
Key value for chemical safety assessment
Effect on immunotoxicity: via oral route
Link to relevant study records
- Endpoint:
- immunotoxicity
- Remarks:
- chronic
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Reliable without restrictions. Well-presented study, with relevant measurement of chemical concentrations
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPP 85-7 (Immunotoxicity)
- Deviations:
- yes
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- mouse
- Strain:
- Balb/c
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- This study was performed on 21 adult female Balb-c mice that were aged 16 to 20 weeks. The animals were divided into three groups (n=7 each). All rats were fed ad libitum.
- Route of administration:
- other: Ad libitum
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- This study was performed on 21 adult female Balb-c mice that were aged 16 to 20 weeks. The animals were divided into three groups (n=7 each). All rats were fed ad libitum. In the first and second groups, 877/µmol Al2(SO4)3 (aluminum sulfate)/kg body weight were daily given in the drinking water for three months. Vitamin E (Vit E; a -tocopherol) was also administered once a week (20 mg/kg body weight) by subcutaneous injection in to the animals of the second group during the three months. The animals of the con¬trol group were given only drinking water during this period. At the end of the experimental period, all the animals were anaesthetized with ether vapor, and blood was removed by cardiac punc¬ture, after which the animals were killed by cervical dislocation.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- three months
- Frequency of treatment:
- daily
- Remarks:
- Doses / Concentrations:
877 μmol/kg b.w./day = 300 mg /kg b.w./day aluminium sulphate
Basis:
nominal in water - No. of animals per sex per dose:
- 21 adult female Balb-c mice
- Control animals:
- yes
- Details on study design:
- See attached material
- Observations and clinical examinations performed and frequency:
- This study was performed on 21 adult female Balb-c mice that were aged 16 to 20 weeks. The animals were divided into three groups (n=7 each). All rats were fed ad libitum. In the first and second groups, 877/µmol Al2(SO4)3 (aluminum sulfate)/kg body weight were daily given in the drinking water for three months. Vitamin E (Vit E; a -tocopherol) was also administered once a week (20 mg/kg body weight) by subcutaneous injection in to the animals of the second group during the three months.
The animals of the control group were given only drinking water during this period. At the end of the experimental period, all the animals were anaesthetized with ether vapor, and blood was removed by cardiac punc¬ture, after which the animals were killed by cervical dislocation. Whole blood samples and sera of the subjects were collected into tubes. Hemoglobin concentrations and hematocrit levels were determined in the whole blood, while the levels of ferritin, transferrin, iron, and total iron binding capacity (TIBC) were determined in the serum.
The liver tissue samples were taken immediately after the sacrifices, weighed, and diluted with distillate water in the ratio of 1:1. Then, the samples were homogenated. The homogenates were centrifuged at 2000 x g for 6 minutes, and supernatants were obtained. Iron levels of the supernatants and sera were analyzed with commercial kits (ILAB, Milano, Italy) by using an auto analyzer (ILAB 900, Milano, Italy). Ferritin levels of the supernatants and sera were determined by an immune-analyzer (Tosoh Corporation, Tokyo, Japan) with commercial kits (Eurogenetics, Tessenderlo, Belgium). Serum transferrin and TIBC levels were analyzed with commercial kits (ILAB, Milano, Italy) by using an auto analyzer (ILAB 900, Milano, Italy). The percentage of transferrin saturation of blood samples was calculated.
The results were evaluated with Mann Whitney U and Kruskal Wallis tests for the significance
between and among groups, respectively. Statisti¬cal analysis was made with SPSS 9.0 (Statistical Package for Social Sciences). The results are expressed as a mean ± standard deviation (S.D.). Animal care and all experimental procedures used were in accordance with those detailed in the Guide for Care and Use of Laboratory Ani¬mals, which was published by the U.S. Depart¬ment of Health and Human Services. - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Cell viabilities:
- See attached material
- Humoral immunity examinations:
- See attached material
- Specific cell-mediated immunity:
- See attached material
- Non-specific cell-mediated immunity:
- See attached material
- Other examinations:
- See attached material
- Statistics:
- See attached material
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- hemoglobin and hematocrit levels of Al and Al+Vit E groups were significantly decreased compared to the control. Reductions in serum haemoglobin (14%) and haematocrit (13%) were described. There was an increase in the levels of liver iron (59%) and ferri
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- hemoglobin and hematocrit levels of Al and Al+Vit E groups were significantly decreased compared to the control. Reductions in serum haemoglobin (14%) and haematocrit (13%) were described. There was an increase in the levels of liver iron (59%) and ferri
- Body weight and weight changes:
- not examined
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Ophthalmological findings:
- effects observed, treatment-related
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- hemoglobin and hematocrit levels of Al and Al+Vit E groups were significantly decreased compared to the control. Reductions in serum haemoglobin (14%) and haematocrit (13%) were described. There was an increase in the levels of liver iron (59%) and ferri
- Urinalysis findings:
- effects observed, treatment-related
- Gross pathological findings:
- no effects observed
- Details on results:
- The data and statistical comparisons of blood parameters for the group with chronically admin¬istered Al (Al group), the group with chronically administered Al plus Vit E (Al+Vit E group), and the control group are illustrated in Table 1. Hemoglobin and hematocrit levels of Al and Al+Vit E groups were significantly decreased compared to the control.
Table 2 shows the data and statistical compari¬sons of liver tissue parameters for the Al group, the Al+Vit E group, and the control group. Iron and ferritin levels of the two groups were significantly higher than those of the control.
When the Al group and the Al+Vit E group were compared, we found no significant differ¬ences in the levels of all blood and tissue parame¬ters (Table 1, Table 2). - Cell viabilities:
- effects observed, treatment-related
- Humoral immunity examinations:
- effects observed, treatment-related
- Specific cell-mediated immunity:
- effects observed, treatment-related
- Non-specific cell-mediated immunity:
- effects observed, treatment-related
- Other functional activity assays:
- effects observed, treatment-related
- Other findings:
- effects observed, treatment-related
- Dose descriptor:
- LOAEL
- Effect level:
- 300 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: see 'Remark'
- Conclusions:
- Turgut et al. (2004)exposed mice to aluminium for 3 months through drinking water containing aluminium sulphate. The estimated dose was 877 μmol/kg b.w./day = 300 mg of /kg b.w./day. Serum levels of aluminium were not reported. Reductions in serum haemoglobin (14%) and haematocrit (13%) were described. The levels of iron in serum were elevated by 59% with a small increase in the levels of Tf.
- Executive summary:
After three months treatment with Al2(SO4)3 in a dose of 300 mg/kg bw., hemoglobin and hematocrit levels of Al and Al+Vit E groups were significantly decreased compared to the control. Reductions in serum haemoglobin (14%) and haematocrit (13%) were described. There was an increase in the levels of liver iron (59%) and ferritin with Al, but Vit E had no effect on the changes of all blood and liver parameters caused by Al. From the results presented in this report, a Lowest Observed Adverse Effect Level (LOAEL) for Aluminium sulfate of 300 mg/kg/day was established, based on significantly decreased hemoglobin and hematocrit levels of Al .
Reference
Table 1.Blood Parameters of Aluminum, Aluminum+Vitamin E and Control Groups (Mean ± S.D.)
|
Control (n=7) |
Aluminum (n=7) |
Aluminum+Vitamin E (n=7) |
Hemoglobin (g/dl) |
15.32 ± 0.24a*,b*,c* |
13.18 ± 1.60a*,c* |
13.68± 1.16b*,c* |
Hematocrit (%) |
35.20 ± 1.74a*,b*,c* |
30.75 ± 2.68a*,c* |
31..34± 2.73b*,c* |
Transferrin (mg/dl) |
132.85 ± 4.59 |
143.14 ± 18.39 |
140..85± 26.92 |
Iron (mg/dl) |
42.00± 41.13 |
67.42± 56.68 |
96.85 ± 82.75 |
TIBC(µg/dl) |
601.00 ±26.94 |
620.71 ± 41.12 |
636.00 ± 65.17 |
Ferritin (ng/ml) |
0.08±0.02 |
0.06 ± 0.03 |
0.08± 0.06 |
Transferrin saturation (%) |
6.75±6.24 |
10.43 ± 8.00 |
14.31± 10.71 |
a and b: Shows significance between two groups.
c: Shows significance among three groups. TIBC: Total iron binding capacity.
*p<0.05.
Table 2.Liver Parameters of Aluminum, Aluminum+Vitamin E and Control Groups (Mean ± S.D.)
|
Control (n=7) |
Aluminum (n=7) |
Aluminum+Vitamin E (n=7) |
Iron (µg/dl) |
2.02 ± 0.33a*,b* |
2.64 ± 0.47a* |
2.59 ± 0.55b* |
Ferritin (ng/ml) |
2.16 ± 0.90a+,b+,c+
|
4.69 ± 1.69a+,c+
|
4.40 ± 1.1b+,c+
|
a and b: Shows significance between two groups. c: Shows significance among three groups.
TIBC: Total iron binding capacity.
*p<0.05,+p<0.01
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LOAEL
- 300 mg/kg bw/day
- Study duration:
- chronic
- Species:
- mouse
Effect on immunotoxicity: via inhalation route
Link to relevant study records
- Endpoint:
- immunotoxicity: chronic inhalation
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Reliable with restrictions.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPP 85-7 (Immunotoxicity)
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- adults Fischer 344 rats and Hartley guinea pigs
- Route of administration:
- inhalation: dust
- Vehicle:
- other: Wright dust feed mechanism.
- Details on exposure:
- Groups of rats and guinea pigs were exposed, by inhalation, to 0.25, 2.5, and 25 mg/m3 of aluminum chlorhydrate (ACH) for six months to study the effects of a common component of antiperspirants. Similar groups of animals of both species exposed to clean air served as controls. The ACH was generated as a particulate dust using a Wright dust feed mechanism. After six months of exposure, animals were sacrificed.
- Duration of treatment / exposure:
- 6 months
- Frequency of treatment:
- 5 day/ week, 6 hours/day
- Remarks:
- Doses / Concentrations:
0.25, 2.5, and 25 mg/m3 of aluminum chlorhydrate (ACH) for six months
Basis:
actual ingested - Control animals:
- yes
- Observations and clinical examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule:daily
BODY WEIGHT: Yes
- Time schedule for examinations:daily
OPHTHALMOSCOPIC EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Decreases in body weight were seen in rats exposed to 25 mgAl/m3 of ACH.
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- not examined
- Gross pathological findings:
- no effects observed
- Details on results:
- NOAEL -3.8 mg/m³ air was estabished. Histological alterations in the lymphoreticular system, in particular granulomas in the hilar lymph nodes; these effects are secondary to the pulmonary effects and resulted from the removal of aluminum from the lungs by alveolar macrophages.
- Cell viabilities:
- no effects observed
- Humoral immunity examinations:
- no effects observed
- Specific cell-mediated immunity:
- no effects observed
- Non-specific cell-mediated immunity:
- no effects observed
- Other functional activity assays:
- not examined
- Other findings:
- not examined
- Dose descriptor:
- NOAEL
- Effect level:
- 3.8 mg/m³ air
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Histological alterations in the lymphoreticular system, in particular granulomas in the hilar lymph nodes; these effects are secondary to the pulmonary effects and resulted from the removal of aluminum from the lungs by alveolar macrophages.
- Conclusions:
- NOAEL -3.8 mg/m³ air was estabished. Histological alterations in the lymphoreticular system, in particular granulomas in the hilar lymph nodes; these effects are secondary to the pulmonary effects and resulted from the removal of aluminum from the lungs by alveolar macrophages.
- Executive summary:
Groups of rats and guinea pigs were exposed, by inhalation, to 0.25, 2.5, and 25 mgAl/m3 of aluminum chlorhydrate (ACH) for six months to study the effects of a common component of antiperspirants. Similar groups of animals of both species exposed to clean air served as controls. The ACH was generated as a particulate dust using a Wright dust feed mechanism. After six months of exposure, animals were sacrificed. Decreases in body weight were seen in rats exposed to 25 mg/m3 of ACH. Marked increases in lung weights and significant increases in lung to body weight ratios were seen in rats and guinea pigs exposed to 25 mg/m3 of ACH. The lungs of all rats and guinea pigs showed significant dose-related increases in aluminum accumulation when exposed to either 0.25, 2.5, or 25 mg/m3 of ACH. The lungs of all rats and guinea pigs exposed to either 2.5 or 25 mg/m3 of ACH contained exposure-related granulomatous reactions characterized by giant vacuoled macrophages containing basophilic material in association with eosinophilic cellular debris.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEC
- 3.8 mg/m³
- Study duration:
- chronic
- Species:
- rat
Effect on immunotoxicity: via dermal route
Link to relevant study records
- Endpoint:
- immunotoxicity
- Remarks:
- chronic
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Reliable without restrictions. Well-presented study, with relevant measurement of chemical concentrations
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPP 85-7 (Immunotoxicity)
- Deviations:
- yes
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- mouse
- Strain:
- Balb/c
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- This study was performed on 21 adult female Balb-c mice that were aged 16 to 20 weeks. The animals were divided into three groups (n=7 each). All rats were fed ad libitum.
- Route of administration:
- other: Ad libitum
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- This study was performed on 21 adult female Balb-c mice that were aged 16 to 20 weeks. The animals were divided into three groups (n=7 each). All rats were fed ad libitum. In the first and second groups, 877/µmol Al2(SO4)3 (aluminum sulfate)/kg body weight were daily given in the drinking water for three months. Vitamin E (Vit E; a -tocopherol) was also administered once a week (20 mg/kg body weight) by subcutaneous injection in to the animals of the second group during the three months. The animals of the con¬trol group were given only drinking water during this period. At the end of the experimental period, all the animals were anaesthetized with ether vapor, and blood was removed by cardiac punc¬ture, after which the animals were killed by cervical dislocation.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- three months
- Frequency of treatment:
- daily
- Remarks:
- Doses / Concentrations:
877 μmol/kg b.w./day = 300 mg /kg b.w./day aluminium sulphate
Basis:
nominal in water - No. of animals per sex per dose:
- 21 adult female Balb-c mice
- Control animals:
- yes
- Details on study design:
- See attached material
- Observations and clinical examinations performed and frequency:
- This study was performed on 21 adult female Balb-c mice that were aged 16 to 20 weeks. The animals were divided into three groups (n=7 each). All rats were fed ad libitum. In the first and second groups, 877/µmol Al2(SO4)3 (aluminum sulfate)/kg body weight were daily given in the drinking water for three months. Vitamin E (Vit E; a -tocopherol) was also administered once a week (20 mg/kg body weight) by subcutaneous injection in to the animals of the second group during the three months.
The animals of the control group were given only drinking water during this period. At the end of the experimental period, all the animals were anaesthetized with ether vapor, and blood was removed by cardiac punc¬ture, after which the animals were killed by cervical dislocation. Whole blood samples and sera of the subjects were collected into tubes. Hemoglobin concentrations and hematocrit levels were determined in the whole blood, while the levels of ferritin, transferrin, iron, and total iron binding capacity (TIBC) were determined in the serum.
The liver tissue samples were taken immediately after the sacrifices, weighed, and diluted with distillate water in the ratio of 1:1. Then, the samples were homogenated. The homogenates were centrifuged at 2000 x g for 6 minutes, and supernatants were obtained. Iron levels of the supernatants and sera were analyzed with commercial kits (ILAB, Milano, Italy) by using an auto analyzer (ILAB 900, Milano, Italy). Ferritin levels of the supernatants and sera were determined by an immune-analyzer (Tosoh Corporation, Tokyo, Japan) with commercial kits (Eurogenetics, Tessenderlo, Belgium). Serum transferrin and TIBC levels were analyzed with commercial kits (ILAB, Milano, Italy) by using an auto analyzer (ILAB 900, Milano, Italy). The percentage of transferrin saturation of blood samples was calculated.
The results were evaluated with Mann Whitney U and Kruskal Wallis tests for the significance
between and among groups, respectively. Statisti¬cal analysis was made with SPSS 9.0 (Statistical Package for Social Sciences). The results are expressed as a mean ± standard deviation (S.D.). Animal care and all experimental procedures used were in accordance with those detailed in the Guide for Care and Use of Laboratory Ani¬mals, which was published by the U.S. Depart¬ment of Health and Human Services. - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Cell viabilities:
- See attached material
- Humoral immunity examinations:
- See attached material
- Specific cell-mediated immunity:
- See attached material
- Non-specific cell-mediated immunity:
- See attached material
- Other examinations:
- See attached material
- Statistics:
- See attached material
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- hemoglobin and hematocrit levels of Al and Al+Vit E groups were significantly decreased compared to the control. Reductions in serum haemoglobin (14%) and haematocrit (13%) were described. There was an increase in the levels of liver iron (59%) and ferri
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- hemoglobin and hematocrit levels of Al and Al+Vit E groups were significantly decreased compared to the control. Reductions in serum haemoglobin (14%) and haematocrit (13%) were described. There was an increase in the levels of liver iron (59%) and ferri
- Body weight and weight changes:
- not examined
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Ophthalmological findings:
- effects observed, treatment-related
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- hemoglobin and hematocrit levels of Al and Al+Vit E groups were significantly decreased compared to the control. Reductions in serum haemoglobin (14%) and haematocrit (13%) were described. There was an increase in the levels of liver iron (59%) and ferri
- Urinalysis findings:
- effects observed, treatment-related
- Gross pathological findings:
- no effects observed
- Details on results:
- The data and statistical comparisons of blood parameters for the group with chronically admin¬istered Al (Al group), the group with chronically administered Al plus Vit E (Al+Vit E group), and the control group are illustrated in Table 1. Hemoglobin and hematocrit levels of Al and Al+Vit E groups were significantly decreased compared to the control.
Table 2 shows the data and statistical compari¬sons of liver tissue parameters for the Al group, the Al+Vit E group, and the control group. Iron and ferritin levels of the two groups were significantly higher than those of the control.
When the Al group and the Al+Vit E group were compared, we found no significant differ¬ences in the levels of all blood and tissue parame¬ters (Table 1, Table 2). - Cell viabilities:
- effects observed, treatment-related
- Humoral immunity examinations:
- effects observed, treatment-related
- Specific cell-mediated immunity:
- effects observed, treatment-related
- Non-specific cell-mediated immunity:
- effects observed, treatment-related
- Other functional activity assays:
- effects observed, treatment-related
- Other findings:
- effects observed, treatment-related
- Dose descriptor:
- LOAEL
- Effect level:
- 300 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: see 'Remark'
- Conclusions:
- Turgut et al. (2004)exposed mice to aluminium for 3 months through drinking water containing aluminium sulphate. The estimated dose was 877 μmol/kg b.w./day = 300 mg of /kg b.w./day. Serum levels of aluminium were not reported. Reductions in serum haemoglobin (14%) and haematocrit (13%) were described. The levels of iron in serum were elevated by 59% with a small increase in the levels of Tf.
- Executive summary:
After three months treatment with Al2(SO4)3 in a dose of 300 mg/kg bw., hemoglobin and hematocrit levels of Al and Al+Vit E groups were significantly decreased compared to the control. Reductions in serum haemoglobin (14%) and haematocrit (13%) were described. There was an increase in the levels of liver iron (59%) and ferritin with Al, but Vit E had no effect on the changes of all blood and liver parameters caused by Al. From the results presented in this report, a Lowest Observed Adverse Effect Level (LOAEL) for Aluminium sulfate of 300 mg/kg/day was established, based on significantly decreased hemoglobin and hematocrit levels of Al .
Reference
Table 1.Blood Parameters of Aluminum, Aluminum+Vitamin E and Control Groups (Mean ± S.D.)
|
Control (n=7) |
Aluminum (n=7) |
Aluminum+Vitamin E (n=7) |
Hemoglobin (g/dl) |
15.32 ± 0.24a*,b*,c* |
13.18 ± 1.60a*,c* |
13.68± 1.16b*,c* |
Hematocrit (%) |
35.20 ± 1.74a*,b*,c* |
30.75 ± 2.68a*,c* |
31..34± 2.73b*,c* |
Transferrin (mg/dl) |
132.85 ± 4.59 |
143.14 ± 18.39 |
140..85± 26.92 |
Iron (mg/dl) |
42.00± 41.13 |
67.42± 56.68 |
96.85 ± 82.75 |
TIBC(µg/dl) |
601.00 ±26.94 |
620.71 ± 41.12 |
636.00 ± 65.17 |
Ferritin (ng/ml) |
0.08±0.02 |
0.06 ± 0.03 |
0.08± 0.06 |
Transferrin saturation (%) |
6.75±6.24 |
10.43 ± 8.00 |
14.31± 10.71 |
a and b: Shows significance between two groups.
c: Shows significance among three groups. TIBC: Total iron binding capacity.
*p<0.05.
Table 2.Liver Parameters of Aluminum, Aluminum+Vitamin E and Control Groups (Mean ± S.D.)
|
Control (n=7) |
Aluminum (n=7) |
Aluminum+Vitamin E (n=7) |
Iron (µg/dl) |
2.02 ± 0.33a*,b* |
2.64 ± 0.47a* |
2.59 ± 0.55b* |
Ferritin (ng/ml) |
2.16 ± 0.90a+,b+,c+
|
4.69 ± 1.69a+,c+
|
4.40 ± 1.1b+,c+
|
a and b: Shows significance between two groups. c: Shows significance among three groups.
TIBC: Total iron binding capacity.
*p<0.05,+p<0.01
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LOAEL
- 2.4 mg/kg bw/day
- Study duration:
- chronic
- Species:
- mouse
Additional information
Orale exposure:
After three months treatment with Al2(SO4)3 in a dose of 300 mg/kg bw., hemoglobin and hematocrit levels of Al and Al+Vit E groups were significantly decreased compared to the control. Reductions in serum haemoglobin (14%) and haematocrit (13%) were described. There was an increase in the levels of liver iron (59%) and ferritin with Al, but Vit E had no effect on the changes of all blood and liver parameters caused by Al. From the results presented in this report, a Lowest Observed Adverse Effect Level (LOAEL) for Aluminium sulfate of 300 mg/kg/day was established, based on significantly decreased hemoglobin and hematocrit levels of Al .
Inhalation exposure:
Several animal studies have found histological alterations in the lymphoreticular system, in particular granulomas in the hilar lymph nodes; these effects are secondary to the pulmonary effects (Steinhagen etal. 1978; Thomson et al. 1986) and resulted from the removal of aluminum from the lungs by alveolar macrophages.
Dermal exposure:
No studies were located regarding immunological/lymphoreticular effects in animals after dermal exposure to various forms of aluminium.
For dermal exposure we taken that:
-the average weight ofmouseis80g (60-100g),
-the dose is applied over an area which is approximately 10% of the total bodysurface=0.008kg
corrected dermal LOAEL= oral LOAEL
300 mg/kg bw/dw 0.008kg =
LOAELmouse2.4mg/kg bw/day
Justification for selection of effect on immunotoxicity via dermal route endpoint:
Dermal exposure:
No studies were located regarding immunological/lymphoreticular effects in animals after dermal exposure to various forms of aluminium.
For dermal exposure we taken that:
-the average weight of mouse is 80g (60-100g),
-the dose is applied over an area which is approximately 10% of the total body surface=0.008kg
corrected dermal LOAEL= oral LOAEL
300 mg/kg bw/dw 0.008 kg =
LOAELmouse 2.4 mg/kg bw/day
Justification for classification or non-classification
There are conclusive but not suffcient data for the classification of substance Aluminium sulphate with regard to immunotoxicity.
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