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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)
Endpoint summary
Administrative data
Description of key information
It is concluded that the substance Aluminium sulphate does not meet the criteria to be classified for human health hazards for Repeated toxicity
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: oral
- 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:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 120-130 g
- Housing: Communally
- Diet (e.g. ad libitum): Ad libitum, standard rat chow
- Water (e.g. ad libitum): Ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25 degrees Celsius, controlled
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: drinking water
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Male Sprague Dawleyrats were given 0.3% aluminum sulfate (as 3.7% aluminum sulfate octadecahydrate solution) in drinking water for thirty days. During the last three weeks of aluminum sulfate administration, treated animals consumed 18 + or - 0.8 mL of aluminum sulfate solution/day/rat (2.0 mmoles of aluminum/day/rat) and controls consumed /about/ 28 mL of water/day/rat. Using a Lafayette passive avoidance device, an impairment of both consolidation and extinction of a passive avoidance task was seen in rats (n=4 to 10).
General motor activity was measured in an open field apparatus and a Lafayette step-up avoidance device was used for active avoidance tasks. To assess working memory in an appetitive task paradigm, a standard, wooden open eight-arm maze was used. - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 30 days
- Frequency of treatment:
- Ad libitum
- Remarks:
- Doses / Concentrations:
0.3% aluminum sulfate (as 3.7% aluminum sulfate octadecahydrate solution) in drinking water
Basis:
nominal in water - No. of animals per sex per dose:
- 10
- Control animals:
- yes
- Details on study design:
- Male Sprague Dawleyrats were given 0.3% aluminum sulfate (as 3.7% aluminum sulfate octadecahydrate solution) in drinking water for thirty days. During the last three weeks of aluminum sulfate administration, treated animals consumed 18 + or - 0.8 mL of aluminum sulfate solution/day/rat (2.0 mmoles of aluminum/day/rat) and controls consumed /about/ 28 mL of water/day/rat. Using a Lafayette passive avoidance device, an impairment of both consolidation and extinction of a passive avoidance task was seen in rats (n=4 to 10).
General motor activity was measured in an open field apparatus and a Lafayette step-up avoidance device was used for active avoidance tasks. To assess working memory in an appetitive task paradigm, a standard, wooden open eight-arm maze was used. No impairment of performance was observed on an active avoidance task (n=6, controls=4), radial arm maze (n=10, controls=4) or open field activity measure. - Positive control:
- Not relevant
- Observations and examinations performed and frequency:
- Administration of aluminum sulfate in the drinking water of male Srpague-Dawley rats for 30 days resulted in a reduction in the number of days to reach extinction criterion on a passive avoidance task (38% control level). The behaviroal deficit was not due to nonspecific effects caused by lower fluid consumption. Partial reversal of the deficit was prduced by discontinuing aluminum treatment 2 weeks prior to testing (p<0.05). Injection of the aluminum chelator deferoxamine returned the performance of the aluminum treated animals to control levels in a dose dependent manner but had no effect on control animals.
- Sacrifice and pathology:
- BIOCHEMISTRY
- Choline acetyltransferase: measured using the method of Fonnum. Determination of ChAT activity in brain homogenates by scintillation counting of 14-C acetylchonline
- Muscarinic receptors: receptor binding in brain region homogenates measured using the method of Vickroy et al.
- Inositol phospholipid hydrolysis: phosphoinositide metabolism was determined by measurement of [3-H]myo-inositol-1-phosphate (M1P) accumulation using a modification of the method of Berridge et al. Metabolism was determined in both the lipid and aqueous phase of cortices/hippocampi (scintillation counting)
- Protein determination: Protein concentration was determined by the method of Lowry et al. - Statistics:
- BEHAVIOUR:
- Activity: Student's t-test
- Passive avoidance: Fisher's exact test + ANOVA
- Active avoidance: ANOVA + Student's t-test
- Radial Arm Maze: Student's t-test + ANOVA - Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- 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
- Urinalysis findings:
- effects observed, treatment-related
- Behaviour (functional findings):
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- effects observed, treatment-related
- Details on results:
- Administration of aluminum sulfate in the drinking water of male Srpague-Dawley rats for 30 days resulted in a reduction in the number of days to reach extinction criterion on a passive avoidance task (38% control level). The behaviroal deficit was not due to nonspecific effects caused by lower fluid consumption. Partial reversal of the deficit was prduced by discontinuing aluminum treatment 2 weeks prior to testing (p<0.05). Injection of the aluminum chelator deferoxamine returned the performance of the aluminum treated animals to control levels in a dose dependent manner but had no effect on control animals.
No differenced in open field activity were evident across groups. These results indicate that the behavioral impairment is a specific, reversible, toxic effect of the aluminum administration. - Dose descriptor:
- NOAEL
- Effect level:
- 342 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: see 'Remark'
- Critical effects observed:
- not specified
- Conclusions:
- No differenced in open field activity were evident across groups. These results indicate that the behavioral impairment is a specific, reversible, toxic effect of the aluminum administration.
- Executive summary:
Administration of aluminum sulfate in the drinking water of male Sprague-Dawley rats for thirty days resulted in an impairment of both consolidation and extinction of a passive avoidance task. No impairment of performance was observed on an active avoidance task, radial arm maze or open field activity measure. Biochemical analysis indicated a slight (less than 10%) but significant increase in hippocampal muscarinic receptor number after aluminum treatment as determined by tritiated quinuclidinyl benzilate (3H-QNB) binding. No changes were found in choline acetyltransferase (ChAT) activity, phosphoinositide hydrolysis, 3H-QNB binding in the cortex or tritiated pirenzepine (3H-PZ) binding in the hippocampus or cortex. These results indicate that cholinergic degeneration was not the cause of the observed cognitive impairments.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 342 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Link to relevant study records
- Endpoint:
- chronic toxicity: inhalation
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- 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:
- according to guideline
- Guideline:
- OECD Guideline 452 (Chronic Toxicity Studies)
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- other: rats, hamsters, guinea pigs
- Strain:
- not specified
- Sex:
- male/female
- Route of administration:
- inhalation
- Type of inhalation exposure:
- whole body
- Vehicle:
- air
- Details on inhalation exposure:
- Aluminium oxide dust was used as a negative control. Two chambers, containing 30 rats and 30 hamsters each, were held at dust concentrations of 100 mg/m3of the pyro powder and the atomized metal powder respectively, two additional chambers were held 50 mg/m3of the respective powders. Six chambers, each containing 30 rats and 15 guinea pigs, were maintained at dust concentrations of 15 and 30 mg/m3respectively, for each of the three types of metallic aluminium powders. The animals were exposed for 6 hr daily, 5 days each week, for 6 months for the 50 and 100 mg/m3groups, and for 12 months for all other animals. An additional group of 30 rats and 30 hamsters was exposed to aluminium oxide dust at an average concentration of 75 mg/m3 for 6 months, and 30 rats and 12 guinea pigs were exposed to aluminium oxide at a concentration of 30 mg/m3 for one year.
Intratracheal injection of the aluminium powders at different dose levels was also conducted. - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 6 months; some animals were exposed for 1 year.
- Frequency of treatment:
- Animals were exposed for 6 hr/day, 5 days/week, for 6
months; some animals were exposed for 1 year. - Remarks:
- Doses / Concentrations:
15, 30, 50 , 75 , 100 mg/m3,
Basis:
nominal conc. - No. of animals per sex per dose:
- Two chambers, containing 30 rats and 30 hamsters each, Six chambers, each containing 30 rats and 15 guinea pigs, group of 30 rats and 30 hamsters , and group of 30 rats and 12 guinea pigs .
- Control animals:
- yes
- Details on study design:
- Rats, guinea pigs, and hamsters were exposed to 3 different types of aluminium powder (British pyro powderflake like particles, American powder with flake like particles, and powder comprised of atomized spherical particles) in inhalation chambers at varying concentrations.
Animals were exposed for 6 hr/day, 5 days/week, for 6 months; some animals were exposed for 1 year - Observations and examinations performed and frequency:
- Histological examination of the lungs
All three species of animals developed alveolar proteinosis, the severity and extent of which were not consistently or clearly related either to the type of aluminium powder or to the severity of the dust exposure. The alveolar proteinosis resolved spontaneously and the accumulated dust deposits cleared rapidly from the lungs after cessation of exposure. Intratracheal injection of large doses of aluminium powders into rats produced focal pulmonary fibrosis; no fibrosis occurred in the lungs of hamsters following intratracheal injection. - Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- 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):
- not examined
- Ophthalmological findings:
- effects observed, treatment-related
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- effects observed, treatment-related
- Behaviour (functional findings):
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- effects observed, treatment-related
- Details on results:
- Pulmonary fibrosis was not apparent following inhalation of the aluminium powders in hamsters and guinea pigs; however scattered small scars resulted from foci of lipid pneumonitis in rats.
All three species of animals developed alveolar proteinosis, the severity and extent of which were not consistently or clearly related either to the type of aluminium powder or to the severity of the dust exposure. The alveolar proteinosis resolved spontaneously and the accumulated dust deposits cleared rapidly from the lungs after cessation of exposure. Intratracheal injection of large doses of aluminium powders into rats produced focal pulmonary fibrosis; no fibrosis occurred in the lungs of hamsters following intratracheal injection. - Dose descriptor:
- NOAEC
- Effect level:
- 15 mg/m³ air
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
- Dose descriptor:
- NOAEC
- Effect level:
- 30 mg/m³ air
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
- Dose descriptor:
- NOAEC
- Effect level:
- 50 mg/m³ air
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
- Dose descriptor:
- NOAEC
- Effect level:
- 75 mg/m³ air
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: overall effects Pulmonary fibrosis was not apparent following inhalation of the aluminium powders in hamsters and guinea pigs; however scattered small scars resulted from foci of lipid pneumonitis in rats.
- Dose descriptor:
- NOAEC
- Effect level:
- 100 mg/m³ air
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: overall effects Pulmonary fibrosis was not apparent following inhalation of the aluminium powders in hamsters and guinea pigs; however scattered small scars resulted from foci of lipid pneumonitis in rats.
- Critical effects observed:
- not specified
- Conclusions:
- The results of this experiment indicate that inhalation of fine metallic aluminium powders does not produce fibrogenic effects, and that intratracheal injection of these powders is likely an artefact of the injection itself.
- Executive summary:
The fibrogenic potential of very fine metallic aluminium powder was investigated byGross et al. (1973). Three different types of aluminium powder were tested. Pyro powder and flaked powder were composed of flake-like particles, and the atomized powder consisted of atomized spherical particles.
Aluminium oxide dust was used as a negative control. Two chambers, containing 30 rats and 30 hamsters each, were held at dust concentrations of 100 mg/m3of the pyro powder and the atomized metal powder respectively, two additional chambers were held 50 mg/m3of the respective powders. Six chambers, each containing 30 rats and 15 guinea pigs, were maintained at dust concentrations of 15 and 30 mg/m3respectively, for each of the three types of metallic aluminium powders. The animals were exposed for 6 hr daily, 5 days each week, for 6 months for the 50 and 100 mg/m3groups, and for 12 months for all other animals. An additional group of 30 rats and 30 hamsters was exposed to aluminium oxide dust at an average concentration of 75 mg/m3for 6 months, and 30 rats and 12 guinea pigs were exposed to aluminium oxide at a concentration of 30 mg/m3for one year.
Intratracheal injection of the aluminium powders at different dose levels was also conducted.
Pulmonary fibrosis was not apparent following inhalation of the aluminium powders in hamsters and guinea pigs; however scattered small scars resulted from foci of lipid pneumonitis in rats.
All three species of animals developed alveolar proteinosis, the severity and extent of which were not consistently or clearly related either to the type of aluminium powder or to the severity of the dust exposure. The alveolar proteinosis resolved spontaneously and the accumulated dust deposits cleared rapidly from the lungs after cessation of exposure. Intratracheal injection of large doses of aluminium powders into rats produced focal pulmonary fibrosis; no fibrosis occurred in the lungs of hamsters following intratracheal injection.
The results of this experiment indicate that inhalation of fine metallic aluminium powders does not produce fibrogenic effects, and that intratracheal injection of these powders is likely an artefact of the injection itself.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEC
- 15 mg/m³
- Study duration:
- chronic
- Species:
- rat
Repeated dose toxicity: inhalation - local effects
Link to relevant study records
- Endpoint:
- chronic toxicity: inhalation
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- 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:
- according to guideline
- Guideline:
- OECD Guideline 452 (Chronic Toxicity Studies)
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- other: rats, hamsters, guinea pigs
- Strain:
- not specified
- Sex:
- male/female
- Route of administration:
- inhalation
- Type of inhalation exposure:
- whole body
- Vehicle:
- air
- Details on inhalation exposure:
- Aluminium oxide dust was used as a negative control. Two chambers, containing 30 rats and 30 hamsters each, were held at dust concentrations of 100 mg/m3of the pyro powder and the atomized metal powder respectively, two additional chambers were held 50 mg/m3of the respective powders. Six chambers, each containing 30 rats and 15 guinea pigs, were maintained at dust concentrations of 15 and 30 mg/m3respectively, for each of the three types of metallic aluminium powders. The animals were exposed for 6 hr daily, 5 days each week, for 6 months for the 50 and 100 mg/m3groups, and for 12 months for all other animals. An additional group of 30 rats and 30 hamsters was exposed to aluminium oxide dust at an average concentration of 75 mg/m3 for 6 months, and 30 rats and 12 guinea pigs were exposed to aluminium oxide at a concentration of 30 mg/m3 for one year.
Intratracheal injection of the aluminium powders at different dose levels was also conducted. - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 6 months; some animals were exposed for 1 year.
- Frequency of treatment:
- Animals were exposed for 6 hr/day, 5 days/week, for 6
months; some animals were exposed for 1 year. - Remarks:
- Doses / Concentrations:
15, 30, 50 , 75 , 100 mg/m3,
Basis:
nominal conc. - No. of animals per sex per dose:
- Two chambers, containing 30 rats and 30 hamsters each, Six chambers, each containing 30 rats and 15 guinea pigs, group of 30 rats and 30 hamsters , and group of 30 rats and 12 guinea pigs .
- Control animals:
- yes
- Details on study design:
- Rats, guinea pigs, and hamsters were exposed to 3 different types of aluminium powder (British pyro powderflake like particles, American powder with flake like particles, and powder comprised of atomized spherical particles) in inhalation chambers at varying concentrations.
Animals were exposed for 6 hr/day, 5 days/week, for 6 months; some animals were exposed for 1 year - Observations and examinations performed and frequency:
- Histological examination of the lungs
All three species of animals developed alveolar proteinosis, the severity and extent of which were not consistently or clearly related either to the type of aluminium powder or to the severity of the dust exposure. The alveolar proteinosis resolved spontaneously and the accumulated dust deposits cleared rapidly from the lungs after cessation of exposure. Intratracheal injection of large doses of aluminium powders into rats produced focal pulmonary fibrosis; no fibrosis occurred in the lungs of hamsters following intratracheal injection. - Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- 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):
- not examined
- Ophthalmological findings:
- effects observed, treatment-related
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- effects observed, treatment-related
- Behaviour (functional findings):
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- effects observed, treatment-related
- Details on results:
- Pulmonary fibrosis was not apparent following inhalation of the aluminium powders in hamsters and guinea pigs; however scattered small scars resulted from foci of lipid pneumonitis in rats.
All three species of animals developed alveolar proteinosis, the severity and extent of which were not consistently or clearly related either to the type of aluminium powder or to the severity of the dust exposure. The alveolar proteinosis resolved spontaneously and the accumulated dust deposits cleared rapidly from the lungs after cessation of exposure. Intratracheal injection of large doses of aluminium powders into rats produced focal pulmonary fibrosis; no fibrosis occurred in the lungs of hamsters following intratracheal injection. - Dose descriptor:
- NOAEC
- Effect level:
- 15 mg/m³ air
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
- Dose descriptor:
- NOAEC
- Effect level:
- 30 mg/m³ air
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
- Dose descriptor:
- NOAEC
- Effect level:
- 50 mg/m³ air
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
- Dose descriptor:
- NOAEC
- Effect level:
- 75 mg/m³ air
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: overall effects Pulmonary fibrosis was not apparent following inhalation of the aluminium powders in hamsters and guinea pigs; however scattered small scars resulted from foci of lipid pneumonitis in rats.
- Dose descriptor:
- NOAEC
- Effect level:
- 100 mg/m³ air
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: overall effects Pulmonary fibrosis was not apparent following inhalation of the aluminium powders in hamsters and guinea pigs; however scattered small scars resulted from foci of lipid pneumonitis in rats.
- Critical effects observed:
- not specified
- Conclusions:
- The results of this experiment indicate that inhalation of fine metallic aluminium powders does not produce fibrogenic effects, and that intratracheal injection of these powders is likely an artefact of the injection itself.
- Executive summary:
The fibrogenic potential of very fine metallic aluminium powder was investigated byGross et al. (1973). Three different types of aluminium powder were tested. Pyro powder and flaked powder were composed of flake-like particles, and the atomized powder consisted of atomized spherical particles.
Aluminium oxide dust was used as a negative control. Two chambers, containing 30 rats and 30 hamsters each, were held at dust concentrations of 100 mg/m3of the pyro powder and the atomized metal powder respectively, two additional chambers were held 50 mg/m3of the respective powders. Six chambers, each containing 30 rats and 15 guinea pigs, were maintained at dust concentrations of 15 and 30 mg/m3respectively, for each of the three types of metallic aluminium powders. The animals were exposed for 6 hr daily, 5 days each week, for 6 months for the 50 and 100 mg/m3groups, and for 12 months for all other animals. An additional group of 30 rats and 30 hamsters was exposed to aluminium oxide dust at an average concentration of 75 mg/m3for 6 months, and 30 rats and 12 guinea pigs were exposed to aluminium oxide at a concentration of 30 mg/m3for one year.
Intratracheal injection of the aluminium powders at different dose levels was also conducted.
Pulmonary fibrosis was not apparent following inhalation of the aluminium powders in hamsters and guinea pigs; however scattered small scars resulted from foci of lipid pneumonitis in rats.
All three species of animals developed alveolar proteinosis, the severity and extent of which were not consistently or clearly related either to the type of aluminium powder or to the severity of the dust exposure. The alveolar proteinosis resolved spontaneously and the accumulated dust deposits cleared rapidly from the lungs after cessation of exposure. Intratracheal injection of large doses of aluminium powders into rats produced focal pulmonary fibrosis; no fibrosis occurred in the lungs of hamsters following intratracheal injection.
The results of this experiment indicate that inhalation of fine metallic aluminium powders does not produce fibrogenic effects, and that intratracheal injection of these powders is likely an artefact of the injection itself.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEC
- 15 mg/m³
- Study duration:
- chronic
- Species:
- rat
Repeated dose toxicity: dermal - systemic effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: dermal
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Critical effects observed:
- not specified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 8.55 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Repeated dose toxicity: dermal - local effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: dermal
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Critical effects observed:
- not specified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 4.41 mg/cm²
- Study duration:
- subacute
- Species:
- rabbit
Additional information
Dermal exposure:
No studies were located regarding long term exposure local effects in animals after dermal exposure to various forms of Aluminium.
For dermal exposure we taken that:
-the average weight of rats is 250g (200-300g),
-the dose is applied over an area which is approximately 10% of the total body surface=0.025 kg
corrected dermal NOAEL= oral NOAEL
342 mg/kg bw/day 0.025 kg =
NOAELrat 8.55 mg/kg bw/day
No studies were located regarding long term exposure systemic effects in animals after dermal exposure to various forms of Aluminium.
For dermal exposure we taken that:
-the average weight of rats is 250g (200-300g),
-the dose is applied over an area which is approximately 10% of the total body surface=0.025 kg
corrected dermal NOAEL= oral NOAEL
342 mg/kg bw/day 0.025 kg =
NOAELrat 8.55 mg/kg bw/day
The dose descriptor for dermal irritation/corrosion come from dermal acute study and dermal Repeated toxicity study. In these studies, the dose is reported in the unit mg/kg of body weight/day. This needs to be modified to enable comparison with the human exposure, generally expressed in mg/cm2/day.
We have taken that:
• the average weight of rabbits is 2.4 kg , used by LANSDOWN A.B.G..,1973
• the dose is applied over an area which is approximately 10% of the total body surface, and
• the total body surface of rabbits is on the average 1270 cm2 used by LANSDOWN A.B.G.,1973
The generic modification from the NOAELtest (in mg/kg of body weight) to NOAELmodified (in mg/cm2/day) will be
NOAELin mg/cm2 = ((dose in mg/kg bw)x (average animal weight in kg)) / Treated surface in cm2)
NOAELtest* 2.4/127= NOAELmodified
The highest dose not causing irritation/corrosion was 233.5 mg/kg bw in 5day dermal toxicity study in rabbits of LANSDOWN A.B.G..,1973,
the modified dose descriptor would be
NOAELmodified =233.5 mg/kg*2.4 kg/127cm2=4.41 mg/cm2
Justification for selection of repeated dose toxicity dermal - systemic effects endpoint:
No studies were located regarding long term exposure local effects in animals after dermal exposure to various forms of Aluminium.
For dermal exposure we taken that:
-the average weight of rats is 250g (200-300g),
-the dose is applied over an area which is approximately 10% of the total body surface=0.025 kg
corrected dermal NOAEL= oral NOAEL
342 mg/kg bw/day 0.025 kg =
NOAELrat 8.55 mg/kg bw/day
No studies were located regarding long term exposure systemic effects in animals after dermal exposure to various forms of Aluminium.
For dermal exposure we taken that:
-the average weight of rats is 250g (200-300g),
-the dose is applied over an area which is approximately 10% of the total body surface=0.025 kg
corrected dermal NOAEL= oral NOAEL
342 mg/kg bw/day 0.025 kg =
NOAELrat 8.55 mg/kg bw/day
Justification for selection of repeated dose toxicity dermal - local effects endpoint:
The dose descriptor for dermal local effects come from dermal acute study and dermal Repeated toxicity study. In these studies, the dose is reported in the unit mg/kg of body weight/day. This needs to be modified to enable comparison with the human exposure, generally expressed in mg/cm2/day.
We have taken that:
• the average weight of rabbits is 2.4 kg , used by LANSDOWN A.B.G..,1973
• the dose is applied over an area which is approximately 10% of the total body surface, and
• the total body surface of rabbits is on the average 1270 cm2 used by LANSDOWN A.B.G.,1973
The generic modification from the NOAELtest (in mg/kg of body weight) to NOAELmodified (in mg/cm2/day) will be
NOAELin mg/cm2 = ((dose in mg/kg bw)x (average animal weight in kg)) / Treated surface in cm2)
NOAELtest* 2.4/127= NOAELmodified
The highest dose not causing irritation/corrosion was 233.5 mg/kg bw in 5day dermal toxicity study in rabbits of LANSDOWN A.B.G..,1973,
the modified dose descriptor would be
NOAELmodified =233.5 mg/kg*2.4 kg/127cm2=4.41 mg/cm2
Repeated dose toxicity: via oral route - systemic effects (target organ) neurologic: behaviour; neurologic: brain (multiple sections); other: all gross lesions and masses
Repeated dose toxicity: inhalation - systemic effects (target organ) cardiovascular / hematological: lymph nodes; respiratory: lung
Repeated dose toxicity: dermal - systemic effects (target organ) digestive: liver; digestive: stomach; neurologic: behaviour; neurologic: brain (multiple sections); urogenital: kidneys
Justification for classification or non-classification
Based on the hazard assessment of aluminium sulphate in section 2.1 and 2.2.in IUCLID 5.4., available data for the substance and following the “Guidance on Information Requirement and Chemical Safety Assessment R.8. Characterisation of dose [concentration]- response for human health” andaccording to the criteria described in Directive 67/548 and in the CLP Regulation:
Directive 67/548 |
Repeated dose toxicity R33 Danger of cumulative effects. T; R48/23 Toxic; Toxic: danger of serious damage to health by prolonged exposure through inhalation. T; R48/23/24 Toxic; Toxic: danger of serious damage to health by prolonged exposure through inhalation and in contact with skin. T; R48/23/24/25 Toxic; Toxic: danger of serious damage to health by prolonged exposure through inhalation, in contact with skin and if swallowed. T; R48/23/25 Toxic; Toxic: danger of serious damage to health by prolonged exposure through inhalation, in contact with skin and if swallowed. T; R48/24 Toxic; Toxic: danger of serious damage to health by prolonged exposure in contact with skin. T; R48/24/25 Toxic; Toxic: danger of serious damage to health by prolonged exposure in contact with skin and if swallowed. T; R48/25 Toxic; Toxic: danger of serious damage to health by prolonged exposure if swallowed. Xn; R48/20 Harmful; Harmful: danger of serious damage to health by prolonged exposure through inhalation. Xn; R48/20/21 Harmful; Harmful: danger of serious damage to health by prolonged exposure through inhalation and in contact with skin. Xn; R48/20/21/22 Harmful; Harmful: danger of serious damage to health by prolonged exposure through inhalation, in contact with skin and if swallowed. Xn; R48/20/22 Harmful; Harmful: danger of serious damage to health by prolonged exposure through inhalation and if swallowed. Xn; R48/21 Harmful; Harmful: danger of serious damage to health by prolonged exposure in contact with skin. Xn; R48/21/22 Harmful; Harmful: danger of serious damage to health by prolonged exposure in contact with skin and if swallowed. Xn; R48/22 Harmful; Harmful: danger of serious damage to health by prolonged exposure if swallowed.
|
CLP |
Repeated dose toxicity STOT Rep. Exp. 1 STOT Rep. Exp. 2 H372: Causes damage to organs <or state all organs affected, if known> through prolonged or repeated exposure <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>. H373: May cause damage to organs <or state all organs affected, if known> through prolonged or repeated exposure <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>. |
It is concluded that the substance aluminium sulphate does not meet the criteria to be classified for human health hazards for Repeated dose toxicity
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