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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
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- chronic toxicity: inhalation
- Remarks:
- other: See deficiencies
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June 1976 - Nov 1978
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study was completed before OECD guidlines were established, nevertheless it fulfills the essential requirements for determination of chronic toxicity by inhalation. Clinical chemistry and haematology were less vigorous, there was no urinanalysis or opthalmoscopy. Group sizes wre half those used in modern assays for carcinogenicity but sufficient for extended chronic toxicity but is only supplementary for carcinogenicity.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Study was carried out before guidelines were established, whole body inhalation study was used to examine chronic toxicity and detect carcinogenicity.
- GLP compliance:
- no
- Remarks:
- Study carried out before GLP established
- 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:
- Saffil alumina fibre, Median diameters circa 3 microns and length circa 50 microns. Material is indefinitely stable at room temperature.
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: Seven weeks old at delivery to lab
- Weight at study initiation: 143 g for Males +/- 20% , Females: 148 g +/- 20%
- Housing: 12 or 13 cages constructed in stainless steel mesh. in purpose built exposure chambers.
- Diet : Cubed powder 'O' ad libitum
- Water : Municipal supply ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): nominal 22 degrees C
- Humidity (%): neither controlled or recorded
- Air changes (per hr): During exposure minimum flow rate of 100 litres per minute was maintained
- Photoperiod (hrs dark / hrs light): 12 hours light/ dark cycle.
IN-LIFE DATES: From: June 1976 To: November 1978
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- whole body
- Vehicle:
- air
- Remarks on MMAD:
- MMAD / GSD: Not measured, respirable dust selected using a Mines Research respirable sampler (MRE600).
- Details on inhalation exposure:
- Exposure in whole body chambers to target concentration of 12mg / m3 of respirable dust as measured using MRE600 portable dust monitor placed on top of the cages. Dusts were generated using a Timbrell dust generator.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Dust measured using MRE600 portable dust monitor.
- Duration of treatment / exposure:
- Interim sacrifices after 14 and 27 weeks, one rat per sex per group after 56 weeks exposure. Surviving rats in Saffil groups exposed for 86 weeks, and in asbestos group for 77 weeks.
- Frequency of treatment:
- 7 hours per day, 5 days per week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
For both saffil groups overall cumulative dose of 7000 mg/m3 hours respirable dust was used.
Basis:
analytical conc.
- No. of animals per sex per dose:
- Groups of fifty rats, 25 of each sex were used for each dust and for air control.
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Study was designed to compare aluminosilicate fibre as manufactured with the same material after artificial aging to mimic after use fibres and with the known pathogenic chrysotile asbestos.
- Positive control:
- UICC Chrysotile A
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
Animals examined before and after each exposure period and at least once a day when not exposed
DETAILED CLINICAL OBSERVATIONS: Yes
Thorough clinical examination including palpation for tumours at least fortnightly.
BODY WEIGHT: Yes
At study start, at removeal from chamber and subsequently every 2 weeks until termination
HAEMATOLOGY / Blood chemistry
- Time schedule for collection of blood: heart blood at sacrifice. Blood was also taken from the tail vein of 8 male and 8 female rats per group before exposure and at 14 and 27 weeks. Where possible the same rats were sampled at each time point.
- Parameters checked : Glucose, urea and alanine and aspartate transaminases were measured in plasma. - Sacrifice and pathology:
GROSS PATHOLOGY: Yes
Full necropsy as soon as possible after death. Special attention to thoracic cavity and parietal pleura All macroscopic abnormalities and full tissue list sampled, Respiratory and digestive tracts, liver kidney, spleen adrenals heart, representative lymph nodes and gross abnormalities processed.
HISTOPATHOLOGY: Yes
Abnormalities were examined microscopically ( H and E with special stains at pathologist discretion) Other tissues were stored.
Samples of lung tissue from control rats and those inhaling chrysotile asbestos from both and 27 week sacrifice, were examined in the electron microscope for evidence of asbestos fibres in tissue.- Statistics:
- Bodyweights: Student’s t test
Tumour incidence: Fishers exact test
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- There were no biologically significant intergroup differences in mortality. Although control rats tended to die earlier.
- Mortality:
- no mortality observed
- Description (incidence):
- There were no biologically significant intergroup differences in mortality. Although control rats tended to die earlier.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Body weight - there were no statistically differences in males, though females that had inhaled heated saffil tended to lower body weight which reached statistical difference on some occasions. Pre exposure weights were lower for these rats so these minor
- 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:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- Urea, glucose, alanine and aspartate transaminase were measured in plasma
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Fibrosis in asbestos control, not in Saffil. Saffil fibres in lungs of exposed rats. 1 male sacrificed at 14 weeks had focal necrosis of olfactory epithelium with proliferation of Bowman's glands. Focal necrosis of olfactory epithelium was seen in all rat
- Histopathological findings: neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Excess tumors in asbestos control only generally seen late in the experiment. Tumors were of epithelial origin, adenomas and adinocarcinomas or squamous cell carcinomas. An adenoma of the nasal septum was seen in one male rat. One male rat in the asbestos
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- > 12 mg/m³ air
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
- 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
Mean body weights male rats(g) at selected intervals during the study
Weeks on test |
|
control |
Aged SAFFIL |
UICC chrysotile
|
SAFFIL |
0 |
Mean S D |
144.9 7.1 |
142.5 13.2 |
142.9 9.8 |
142.5 7.0 |
88 |
Mean S D |
571.2 40.0 |
575.6 51.8 |
568.7 36.8 |
575.1 44.8 |
100 |
Mean S D |
543.5 54.8 |
542.4 56.7 |
511.5 47.5 |
554.2 50.9 |
120 |
Mean S D |
448.2 47.0 |
455.2 43.7 |
461.0 42.6 |
462.7 31.6 |
128 term) |
Mean S D |
436.3 30.6 |
418.0 47.9 |
425.0 46.0 |
393.3 43.2 |
Mean body weights female rats(g) at selected intervals
Weeks on test |
|
control |
UICC chrysotile |
SAffil |
Aged SAFFIL |
0 |
Mean S D |
149.7 12.8 |
144.8 13.2 |
144.1 11.1 |
150.0 17.9 |
88 |
Mean S D |
380.9 58.3 |
328.6* 50.2 |
340.3* 40.4 |
374.1 64.6 |
100 |
Mean S D |
380.9 55.0 |
345.1 45.5 |
.335.2* 19.7 |
.369.8 .336.1 |
120 |
Mean S D |
354.6 77.7 |
350.0 55.2 |
311.3 22.3 |
351.6 39.4 |
128 (term)32 |
Mean S D |
318.0 45.3 |
388.0 |
281.8 11.1 |
338.8 43.2 |
Incidence of neoplastic findings and selected tumour types
|
Control |
Aged SAFFIL |
UICC Asbestos |
SAFFIL |
Males |
||||
Number Examined* |
19 |
19 |
19 |
13 |
Total number of neoplasms |
11 |
12 |
17 |
12 |
Rats with benign tumours |
6 |
7 |
6 |
4 |
Rats with malignant tumours |
2 |
3 |
5 |
4 |
Pulmonary tumours |
||||
Adenoma |
0 |
0 |
0 |
0 |
Adenocarcinoma |
0 |
0 |
0 |
0 |
Carcinoma |
0 |
0 |
1 |
0 |
Females |
||||
Number Examined* |
19 |
20 |
20 |
19 |
Total number of neoplasms |
29 |
31 |
36 |
28 |
Rats with benign tumours |
11 |
13 |
9 |
9 |
Rats with malignant tumours |
5 |
5 |
8 |
7 |
Pulmonary tumours |
||||
Adenoma |
0 |
0 |
4 |
0 |
Adenocarcinoma |
0 |
0 |
1 |
0 |
Carcinoma |
0 |
0 |
2 |
0 |
Nasal sinus adenoma |
0 |
0 |
1 |
0 |
Applicant's summary and conclusion
- Conclusions:
- Inhalation of polycrystalline fibres in either as manufactured or thermally aged forms at the maximally achievable aerosol concentrations did not result in fibrosis or other progressive lung disease in rats, no tumours of the respiratory tract or pleura were seen after Saffil inhalation. the positive control UICC chrysotile A asbestos produced the expected results.
- Executive summary:
This study raises no concerns over the inhalation of the test material. However testing is difficult with a material one of whose essential properties is large diameter fibres which preclude more aggressive testing.
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