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EC number: 234-391-6 | CAS number: 11138-49-1
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented publication which meets basic scientific principles
Data source
Reference
- Reference Type:
- publication
- Title:
- Investigation of the aluminium biokinetics in humans: a 26Al tracer study.
- Author:
- Steinhausen, C. et al.
- Year:
- 2 004
- Bibliographic source:
- Food and Chemical Toxicology 42: 363-371
Materials and methods
- Objective of study:
- toxicokinetics
- Principles of method if other than guideline:
- Aluminium absorption, distribution, speciation and excretion in six healthy volunteers and in two patients with chronic renal failure were investigated following administration of a single oral or i.v. dose of 26Al.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Aluminium chloride
- EC Number:
- 231-208-1
- EC Name:
- Aluminium chloride
- Cas Number:
- 7446-70-0
- Molecular formula:
- AlCl3
- IUPAC Name:
- aluminum trichloride
- Details on test material:
- - Name of test material (as cited in study report): AlCl3
- Analytical purity: no data
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- 26Al
Test animals
- Species:
- human
- Strain:
- not specified
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Eight male human individuals were investigated in the present study, six healthy volunteers and two patients with chronic renal failure (chronic glomerulonephritis in both cases).
Administration / exposure
- Route of administration:
- other: single oral dose and i.v. dose
- Vehicle:
- not specified
- Details on exposure:
- A single oral dose of 26Al was administered to three volunteers and to two patients, an i.v. dose was administered to three volunteers.
- Duration and frequency of treatment / exposure:
- single treatment
Doses / concentrations
- Remarks:
- Doses / Concentrations:
The oral dose consisted of 100 ng 26Al together with 100 μg 27Al given as the chemical compound AlCl3.
The i.v. dose was 1 ng 26Al together with 20 μg 27Al given also as AlCl3.
- No. of animals per sex per dose / concentration:
- not applicable
- Control animals:
- no
- Details on dosing and sampling:
- PHARMACOKINETIC STUDY (Absorption, distribution, speciation, excretion)
- Tissues and body fluids sampled: urine, blood
- Time and frequency of sampling: Blood samples were taken in intervals between 5 minutes and 512 days after administration. Daily urine samples were collected for 24 hours and pooled, over time periods of up to 9 days.
- Other: For the speciation measurements, blood samples were taken after 5 min., 20 min., 1 h, 4 h and 24 h after i.v. administration.
Results and discussion
- Preliminary studies:
- no data
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Oral administration to healthy volunteers:
The numbers of 26Al atoms in serum reach their maximum values between 1.5 and 6 h after administration with about 2.5 x 10-4, 1.3 x 10-4, 4 x 10-4 relative to the administered dose for the volunteers.
Oral administration to patients with chronic renal failure:
The numbers of 26Al atoms in the blood plasma reach their maximum values with about 1.4 x 10-4 relative to the administered dose 4 h after administration.
Intravenous administration to healthy volunteers:
Fifteen minutes after administration the amount of 26Al atoms has decreased to about 40% of the administered dose for both volunteers. - Details on distribution in tissues:
- no data
- Details on excretion:
- Oral administration to healthy volunteers:
In the urine collected, about 7 x 10-4 and 1.4 x 10-3 26Al atoms relative to the administered dose are measured after 4 and 9 days. The experimentalaluminium clearances were obtained to be in the range from 2.2 to 17 mL/min for the healthy volunteers compared to creatinine clearances in the range between 120 and 150 mL/min. The number of 26Al atoms in the accumulated urine of the first 4 days is obtained to be about 1.4 x 10-4 relative tothe administered dose.
Oral administration to patients with chronic renal failure:
In the accumulated urine, about 5 x 10-4 and 3 x 10-4 26Al atoms relative to the administered dose are measured after 5 and 7 days. The experimental aluminium clearances were obtained to be 4.0 and 3.5 mL/min compared with the creatinine clearances of 38 and 32 mL/min, respectively.
Intravenous administration to healthy volunteers:
In the accumulated urine, about 28 and 25% of the i.v. administered 26Al atoms were measured after 5 days. Analysing the urine data, it is evident thatafter 5 days the majority of 26Al atoms is still stored in the body. The experimental aluminium clearances were obtained to be 3.1 and 2.2 mL/min compared to the creatinine clearances of 143 and 122 mL/min, respectively.
Metabolite characterisation studies
- Metabolites identified:
- not measured
Any other information on results incl. tables
The simulations show that the p.o. dose of 26Al stored in the bones is about 3% of that one of the i.v. dose. The i.v. blood plasma concentration of 26Al is found to be one million times larger than the p.o. concentration immediately after i.v. administration, and 30 times larger after years after i.v. administration.
The fast decrease in the plasma concentration after minutes for i.v. administration is due to the distribution to the interstitial fluid with a short time constant. The 26Al plasma concentration after years is caused by the reverse transport from the bones into the plasma. The transport to and from the peripheral compartments (liver and spleen, muscles, bones) and excretion determine the time dependence over the whole investigated time period.
The largest long-term deposition of aluminium occurs in the bones.
After years, all 26Al taken up is excreted via the urine. As seen from the long-term measurements of 26Al in the accumulated urine and as obtained from the simulations, the uptake factor of 26Al after oral application, about 99.9% of 26Al are excreted by the intestinal tract as faeces.
26Al in the accumulated urine is lower for patients with chronic renal failure due to the reduced function of the kidneys compared with healthy volunteers. This means that more 26Al is stored in the body of patients with chronic renal failure than in healthy volunteers.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): bioaccumulation potential cannot be judged based on study results
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