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EC number: 614-074-2 | CAS number: 675106-31-7
- 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:
- key study
- Study period:
- 12/1974 - 10/1977
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study preceded guidelines and GLP but was audited at ICI to standards equivalent to GLP. Compared to OECD 453 this study lacked clinical pathology in the context of information available from other studies any deficiencies do not materially limit the utility of this study.
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
- Objective of study:
- distribution
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD 453
- Deviations:
- not applicable
- Principles of method if other than guideline:
- Feeding study not primarily for toxicokinetic purposes but distribution of fibres was extensively studied.
- GLP compliance:
- no
- Remarks:
- study preceded introduction of GLP
Test material
- Reference substance name:
- oxo[(oxoalumanyl)oxy]alumane
- EC Number:
- 614-074-2
- Cas Number:
- 675106-31-7
- Molecular formula:
- UVCB
- IUPAC Name:
- oxo[(oxoalumanyl)oxy]alumane
- Details on test material:
- 2 batches ASK619-625 , ASK627-632 milled, median diameter by TEM was 2.05 microns and length 18 microns, purity assumed to be 100%
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- rat
- Strain:
- other: Alpk/AP Wistar derived
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Source: Bred at ICI CTL
- Age at study initiation: 8 weeks at delivery
- Weight at study initiation: Males: 200g +/- 20% , female: 185g +/-20%
- Housing: per cage in suspended wire cages
- Individual metabolism cages: no
- Diet cubed powder 'O' incorporated into 2.5% w/v aqueous agar, ad libitum
- Water : municipal drinking water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 oC +/- 2 oC
- Humidity (%): not controlled
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hours light , 12 hours dark.
IN-LIFE DATES: From: December 1974 To: October 1977
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: agar gel
- Details on exposure:
- Groups of 64 rats per sex given diet as follows:
Group 1 control agar diet
Group 4 experimental fibre at 0.025 % in diet w/w
Group 5 experimental fibre at 0.25 % in diet w/w
Group 6 experimental fibre at 2.5 % in diet w/w - Duration and frequency of treatment / exposure:
- All rats exposed for 2 years or after 70% overall mortality
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Group 1 control agar diet
Group 4 experimental fibre at 0.025 % in diet w/w
Group 5 experimental fibre at 0.25 % in diet w/w
Group 6 experimental fibre at 2.5 % in diet w/w
- No. of animals per sex per dose / concentration:
- 64
- Control animals:
- yes, concurrent vehicle
- Positive control reference chemical:
- UICC chrysotile asbestos at 0.025 and 1.25 %
- Details on study design:
- - Dose selection rationale:
Following a short preliminary study the highest concentration of alumina fibre was selected so that the received dose was more than 1g/kg
This dose did not meet the normal criteria for maximum tolerated dose in that there were only minor effects on body weight - Details on dosing and sampling:
- Lungs, livers, alimentary canal and remaining carcass were examined for fibre and aluminium contents.
- Statistics:
- Data from males and females were analysed separately. For body weights, food consumption, tissue analysis and alumina fibre in ashed residues were compared to the control values using Student's t test (2 sided). Organ weights were examined by analysis of variance and covariance of body weight. Tumour incidence : Fisher's exact test. Mortality was analysed using the NCI programme were appropriate a test for trend was included.
Results and discussion
Main ADME results
- Type:
- other: absorption and distribution cannot be distinguished.
- Results:
- absorption and distribution cannot be distinguished.: Fibres measured as fibres or as aluminium, largely remained in the alimentary canal. This is complicated by the difficulty of measuring aluminium in biological material.
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Not quantified
- Details on distribution in tissues:
- See table below
Transfer into organs
- Test no.:
- #1
- Transfer type:
- other: Unknown
- Observation:
- other: elemental and fibre analysis
- Details on excretion:
- Not measured
Metabolite characterisation studies
- Metabolites identified:
- no
- Details on metabolites:
- This material is not metabolised, aluminium found outside the gut is of an unknown speciation.
Any other information on results incl. tables
Distribution of Aluminium in some organs after feeding on alumina fibres
|
|
control |
0.025% alumina fibre |
0.25% alumina fibre |
2.5% alumina fibre |
Lungs (mg Al/organ) |
Mean S D |
2.97 3.73 |
3.94 1.77 |
3.08* 1.22 |
3.70* 1.91 |
Lungs (mg Al/organ (excluding 2 outliers) |
Mean S D |
1.69 1.04 |
3.36** 0.69 |
|
|
LiversµgAl /organ Males (excluding outliers) |
Mean S D |
38.9 34.2 |
36.8 29.9 |
22.2 7.3 |
15.3 9.0 |
LiversµgAl /organ Females (excluding outlier) |
Mean S D |
12.7 4.2 |
67.5 56.2 |
62.2 33.4 |
53.3 61.7 |
Aluminium in carcass (µgAl/g wet weight), sexes combined |
Mean S D |
13.5 23.5 |
9.2 11.5 |
9.7 12.9 |
9.6 14.8 |
Fibres in Alimentary tract (total) Males |
Mean S D |
119 109 |
167 71 |
97 33 |
237 73 |
Fibres in Alimentary tract (total) Females |
Mean S D |
292 337 |
393 353 |
432 168 |
132 126 |
* Significantly different at 5% level
**Significantly different at 1% level
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): low bioaccumulation potential based on study results
Ther was no evidence of systemic toxicity resulting from administration of the fibre and no evidence that the material penetrated the gastrointestinal tract in fibrous form. Aluminium could be absorbed in small quantities but did not accumulate in the organs or carcass on prolonged administration. - Executive summary:
There was a very small accumulation of aluminium of dubious statistical significance in the lungs of animals fed alumina fibre.
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