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Diss Factsheets
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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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This is not a guideline study so there is no standard against which it can be directly assessed. When compared to OECD 407 the investigation lacked clinicla pathology, behaviour and eye examination and had a very restricted tissue list.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- not specified
- GLP compliance:
- no
- Remarks:
- Study preceded introduction of GLP
- Limit test:
- no
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:
- Name of test material: Saffil alumina fibre
- Substance type: White milled fibre
- Physical state: solid
- Analytical purity: assumed to be 100%
- Lot/batch No.: Bag 3
- Expiration date of the lot/batch: indefinitely stable
- Stability under test conditions: indefinitely stable
- Storage condition of test material: ambient
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Alpk/ AP (Wistar derived)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: bred at ICI CTL
- Age at study initiation: not specified
- Weight at study initiation: males 165- 174 g females 161- 164 g (inferred from data)
- Housing: Controls and tests Sub groups A suspended wire cages Sub groups B individual metabolism cages
- Diet: cubed powder 'O' incorporated into 2.5% w/v aqueous agar ad libitum
- Water : municipal drinking water ad libitum
ENVIRONMENTAL CONDITIONS :
not specified
IN-LIFE DATES:
not stated
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: 2.5% agar mixture with diet
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
DIET PREPARATION
- Rate of preparation of diet : not stated
- Mixing appropriate amounts with: cubed powder 'O' and 2.5 % agar
- Storage temperature of food: not stated
VEHICLE
- Justification for use and choice of vehicle : palatability study
- Concentration in vehicle: 2.5% and 10% - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 6 weeks
- Frequency of treatment:
- continuous
Doses / concentrations
- Remarks:
- Doses / Concentrations:
2.5 % and 10%
Basis:
nominal in diet
- No. of animals per sex per dose:
- 2 per sex in control group, 3 per sex in test groups
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Palatability
- Rationale for animal assignment (if not random): Not stated - Positive control:
- None
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS:
- Time schedule: Daily
BODY WEIGHT: Measured weekly
FOOD CONSUMPTION AND COMPOUND INTAKE
- Food consumption for each animal in a metabolism cage was measured daily together with urine and faecal output
URINALYSIS: Aluminium content only
- Metabolism cages used for collection of urine: Yes
- Animals fasted: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Not studied
HISTOPATHOLOGY: Not studied - Statistics:
- Analysis of variance
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- 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:
- not examined
- Urinalysis findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Aluminium in urine rose in proportion to dose ingested
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY: None
BODY WEIGHT AND WEIGHT GAIN: See table
FOOD CONSUMPTION: See table
Aluminium balance: see table
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- > 4 000 mg/kg bw (total dose)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: overall effects mortality; body weight; food consumption
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Table 1 Body weight, Food intake and excretion
|
Males |
Females |
||||
Control |
2,5% SAFFIL |
10% SAFFIL |
Control |
2,5% SAFFIL |
10% SAFFIL |
|
Dry matter intake (g/wk) |
153.2 |
157.0 |
180.5 |
140.4 |
159.9 |
161.6 |
Dry matter intake of Oakes diet (g/wk) |
145.7 |
144.9 |
154.7. |
133.0 |
143.0 |
138.5 |
SAFFIL intake (g/wk) |
0 |
4.0 |
17.2 |
0 |
4.0 |
15.4 |
Faeces weight (g/wk) |
4205 |
49.0* |
62.1** |
36.1 |
42.4** |
54.2** |
Urine volume (ml/wk) |
144.9 |
94.9* |
126.1 |
128.6 |
134.4 |
168.7 |
Bodyweight at week 6 (g) |
393 |
364 |
371 |
263 |
275 |
279 |
Wk 6 bodywt (% initial wt) |
226. |
220 |
222 |
163 |
168 |
171 |
*Significantly different from control at the 5% level
**Significantly different from control at the 1% level
Chemical analysis
The aluminium balance is shown in Table 2. There was a small increase in urinary aluminium excretion but essentially all of the ingested aluminium is recovered in the faeces
The ingested aluminium was shown to be excreted rapidly when the subgroups ’b’ were fed control diet during week 7 when >90% of excess aluminium was recovered in the faeces within 24 hours
Aluminium content of tissues was not significantly increased, except for the residual carcasses, where there was a significant increase at week 6 in rats fed 10% SAFFIL in the diet. The difference was no longer significant at week 7 after 1 week on control agar diet.
Table 2 Aluminium balance (mg Al /week )
|
Control |
2.5% SAFFIL |
!0% SAFFIL |
Males |
|||
Mean intake |
25 +/-5 |
1935 +/-112 |
8079+/-313 |
Mean in faeces |
38+/-3 |
2135 +/-80 |
8039 +/-409 |
Mean in Urine |
0.052 +/-0.01 |
0.16 +/-0.047 |
0.245 +/-0.025 |
Mean balance |
150% |
110% |
101% |
Females |
|||
Mean intake |
23 +/-5 |
1912+/-31 |
7231 +/-188 |
Mean in faeces |
28 +/-13 |
1915 +/-47 |
6980 +/-193 |
Mean in Urine |
0.098+/-0.039 |
0.249 +/-0.041 |
0.496 +/-0.077 |
Mean balance |
122% |
100% |
97% |
Applicant's summary and conclusion
- Conclusions:
- Administration of the test substance in diet at the highest level that could be incorporated corresponded to a daily intake in excess of 6 g/ kg / day. The lower dose was considered to be the maximum that could be used for long term studies. The aluminium retention by the rats was minimal, urinary excretion of aluminium corresponded to about 50% of that which can be extracted in 5 % acetic acid.
It was concluded that the LD50 for Saffil fibres was not less than that for calcined alumina and in excess of 4g/kg. - Executive summary:
This study did not raise any concerns on the oral toxicity of the test article. The lack of absorption indicates that no further activity is to be expected.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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