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EC number: 604-314-4 | CAS number: 142844-00-6
- 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:
- combined repeated dose and carcinogenicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From: 24th May 1988 To: 14th November 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- There was little attempt to justify the use of the doses particularly the MTD. The gravimetric estimate of 30 mg/m3 was used for all types of fibre in two species with no further range finding efforts. Otherwise the study was a very high quality but the test substance used was heavily contaminated by non fibrous particulate not produced during the normal handling and use of this product. These particles were not completely enumerated during the study and their significance not realised.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
- Reference Type:
- publication
- Title:
- The Importance of fibre biopersistence and lung Dose in Determining the chronic Inhalation -Effects of X607,RCF1 and Chryotile Asbestos in rats
- Author:
- Hesterberg TW et al.
- Year:
- 1 998
- Bibliographic source:
- Toxicology and Applied Phamacology 153, 68-82
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies)
- Deviations:
- yes
- Remarks:
- to make it suitable for use with fibres
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- oxo[(oxoalumanyl)oxy]alumane; silanedione
- EC Number:
- 604-314-4
- Cas Number:
- 142844-00-6
- Molecular formula:
- amorphous glass Si(n)O(3n+1) polymeric anions bonded to Zr and Al(3+)
- IUPAC Name:
- oxo[(oxoalumanyl)oxy]alumane; silanedione
- Details on test material:
- - Name of test material (as cited in study report): RCF 1
- Substance type: mineral fibre
- Physical state: solid
- Analytical purity: assumed>99%
- Stability under test conditions:indefinite
- Batch number : 7309
- Storage condition of test material:room temperature , protected from the light
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Kingston, Stone Ridge, N.Y., USA
- Age at study initiation: 8 weeks
- Weight at study initiation: 130-150g
- Housing: during exposure and beginning of recovered, stainless steel wire cages, during major part of recovery period Macrolon Cages Type IV with standard softwood bedding
- Diet (e.g. ad libitum): pelleted standard Kliba 343, rat/mouse maintenance diet
- Water: ad libitum
- Acclimation period: 18 days from day of delivery
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Humidity (%): 30 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12hrs
IN-LIFE DATES: From: 24th May 1988 To: 14th November 1990
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Remarks on MMAD:
- MMAD / GSD: Fibre sizes are not reported as MMAD. Fibre respirability is determined by fibre diameters with mass playing a secondary role. The aerosol:WHO fibres had a mean length of 16+- 3 and a diameter of 0.8+- 0.2.
- Details on inhalation exposure:
- Exposure was for 104 weeks. The aerosol was generated by a brush disperser, fed with test material. Static was neutralised using a 63 nickel radiation source. The airflow to each animal was 1 litre/min calculated to be laminar. The animals were restrained in Battelle tubes.
-GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: flow -past nose-only design
- Method of holding animals in test chamber: makrolon tubes, batelle?
- System of generating particulates/aerosols: fibres were aerosolised using a stepping motor and stainless steel brush to bring them into the tangential air stream, following aerosolisation the fibres passed through a Nickel63 charge neutraliser to reduce electrostatic charge
- Temperature, humidity, pressure in air chamber: 22degC, 30-70%
- Air flow rate: 0.9 litre/ airport/min?
- Method of particle size determination: fibre size measurements carried out by SEM
TEST ATMOSPHERE
- Brief description of analytical method used: mass concentration (gravimetric), fibre number concentration, fibre size measurements and impactor sampling.
- Samples taken from breathing zone: yes - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Fibres were collected on membrane filters and quanitified by weighing and microscopy. Fibre lengths were measured using light microscopy and diameters using SEM.
- Duration of treatment / exposure:
- 104 weeks followed by 23 weeks recovery (until survival less than 20%)
- Frequency of treatment:
- 6 hours/day/5days/week
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
RCF1 - 162 WHO f/ml +/- 37
Basis:
analytical conc.
- Remarks:
- Doses / Concentrations:
RCF1 - 91 WHO f/ml +/- 34
Basis:
analytical conc.
- Remarks:
- Doses / Concentrations:
RCF1 - 36 WHO f/ml +/-17
Basis:
analytical conc.
- No. of animals per sex per dose:
- 140 males
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale:as fractions of the dose used in the study report number 092507 (30mg) section 7.7.2
- Rationale for animal assignment (if not random):random
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily prior and following exposure and once daily on non- exposure days
BODY WEIGHT: Yes
- Time schedule for examinations:each during acclimation period , weekly dueing the first 13 weeks and at least monthly thereafter
- Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Other examinations:
- Samples of neoplastic tissue were taken and sent frozen in liquid nitrogen to CIIT North Carolina. Lungs were examined under a dissection microscope for detection and identification of small macroscopic lesions. Lungs were inflated with formaldehyde photographed and sections taken for histopathology after sacrifices at 13, 26, 39 and 52 weeks lungs were instilled with Karnowski's fixative and sampled as detailed in full study report.
- Statistics:
- Body weight and organ weight were analysed using Dunnetts' test ,age specific survival rates were calculated . Statistical evaluations for the neoplastic lesions was performed according to Peto et al 1980.
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):
- not examined
- 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:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- effects observed, treatment-related
- Other effects:
- not specified
- Details on results:
- The exposures and tumour and fibrosis data are shown in table 1
Effect levels
- Key result
- Dose descriptor:
- LOAEC
- Remarks:
- Fibrosis
- Effect level:
- ca. 9 - < 16 mg/m³ air
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- histopathology: non-neoplastic
- Remarks on result:
- other:
- Remarks:
- Fibrosis at 16 and 9 mg/m3 just reached significant levels but not at the 3 mg/m3. None of the tumour incidences were higher than the the historical control values for this strain of animals
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Table 1 Exposure conditions and results for the 3 exposure levels of RCF and control (air).
Number of animals at risk |
Aerosol conc. f/ml (SD) Mg/m3 (SD) |
Concentration of Non-fibrous particles <3µm diameter (mean no. of particles/ml)
|
Aerosol fibre dimensions
Geometric mean (GSD |
Fibrosis
(Wagner Grade) |
Tumour Incidence %
|
||
diameter |
length |
Lung |
Mesothelial |
||||
132 |
na |
na |
na |
na |
1 |
0.8 |
0
|
126 |
162 (37) 16.5 (1.1) |
156 |
0.82 (1.99) |
13.8 (2.4) |
4.2 |
1.6 |
0 |
128 |
91 (34) 8.8 (0.7) |
141 |
0.80 (2.03) |
13.9 (2.5) |
4.0 |
3.9 |
0.8 |
125 |
36 (17) 3.0 (0.4) |
51 |
0.80 (2.06) |
13.5(2.6) |
3.2 |
1.6 |
0 |
Applicant's summary and conclusion
- Conclusions:
- The particle contaminated RCF1 was still capable of causing overload at these low concentrations used but not until late in life consequently there was not a significant increase in tumour burden.
- Executive summary:
The deficencies in the 30mg/m3 study (section 7.5.3.5) were repeated in this lower dose study. Only one of the four samples of RCF was tested at these concentrations
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