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Diss Factsheets
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EC number: 221-394-2 | CAS number: 3085-30-1
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
Materials and methods
- Objective of study:
- distribution
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Male Sprague-Dawley rats were treated daily by gastric intubation (6 days/wk) with 100 mg aluminium/kg body weight in the form of aluminium hydroxide (9 wk) or with tap-water (control, 9 wk). Young adult and aged Wistar rats were treated with 100 mg aluminium/kg body weight as aluminium hydroxide or with carboxymethylcellulose (vehicle controls). The cerebral cortex, hippocampus, cerebellum and samples of bone from each rat were analysed for aluminium, after digestion with nitric acid, using graphite furnace atomic absorption spectroscopy.
Test material
- Reference substance name:
- Aluminium hydroxide
- EC Number:
- 244-492-7
- EC Name:
- Aluminium hydroxide
- Cas Number:
- 21645-51-2
- Molecular formula:
- AlH3O3
- IUPAC Name:
- aluminum trihydroxide
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- rat
- Strain:
- other: Sprague-Dawley and Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: male Sprague Dawley from Anticimes Solantuna Sweden, male and female Wistar rats from Möllegaard Ejby Denmark
- Age at study initiation: young no data; aged 2 years
- Weight at study initiation: young males 140 g, females 300 g; aged no data
- Housing: no data
- Diet standard pellet diet (Astra Ewos, Södertälj Sweden) ad libitum
- Water: tap water ad libitum
ENVIRONMENTAL CONDITIONS: no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Duration and frequency of treatment / exposure:
- young rats: 9 weeks, daily, 6 days/week
aged rats: 4 weeks, daily, 6 days/week
Doses / concentrations
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Remarks:
- as Al
- No. of animals per sex per dose / concentration:
- 8 males Sprague Dawley for controls and 9 male Sprague Dawly at 100 mg/kg bw
No data on Wistar rats - Control animals:
- yes, concurrent vehicle
- Statistics:
- Kruskal-Wallis, Mann-Whitney U-test, student t-test
Results and discussion
Main ADME results
- Type:
- distribution
- Results:
- no increases of aluminium concentration compared to control was found in the brain or the bone. No difference was established between young and aged rats
Metabolite characterisation studies
- Metabolites identified:
- no
Any other information on results incl. tables
No accumulation of aluminium was seen.
Sprague Dawley |
Average concentration aluminium in µg/g wet weight |
|||
|
cortex |
hippocampus |
cerebellum |
bone |
controls |
0.0013 |
0.0014 |
0.0022 |
0.355 |
Al(OH)3 |
0.0013 |
0.0014 |
0.0011 |
0.410 |
Applicant's summary and conclusion
- Conclusions:
- No accumulation of aluminium in the brain or bones is seen in rats treated with Al(OH)3 for 9 weeks. No difference was observed between aged and young rats
- Executive summary:
Male Sprague-Dawley rats were treated daily by gastric intubation (6 days/wk) with 100 mg aluminium/kg body weight in the form of aluminium hydroxide (9 wk) or with tap-water (control, 9 wk). Young adult and aged Wistar rats were treated with 100 mg aluminium/kg body weight as aluminium hydroxide or with carboxymethylcellulose (vehicle controls). The cerebral cortex, hippocampus, cerebellum and samples of bone from each rat were analysed for aluminium, after digestion with nitric acid, using graphite furnace atomic absorption spectroscopy. The mean aluminium concentrations detected in the control Sprague-Dawley rats were 0.013-0.022 microgram/g wet weight in the various brain regions and 0.355 microgram/g in the bone. No significant increase in tissue aluminium concentrations was observed in Sprague-Dawley or Wistar rats after treatment with aluminium hydroxide.
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