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EC number: 232-051-1 | CAS number: 7784-18-1
- 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
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented, according to accepted guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Version / remarks:
- - reliability scoring based on 1981 guideline
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1300 (Acute inhalation toxicity)
- Version / remarks:
- - 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EEC (Annex II, point 5.2.3)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: J-MAFF test guidelines for acute inhalation studies
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Aluminium fluoride
- EC Number:
- 232-051-1
- EC Name:
- Aluminium fluoride
- Cas Number:
- 7784-18-1
- Molecular formula:
- AlF3
- IUPAC Name:
- aluminum trifluoride
- Details on test material:
- - Name of test material (as cited in study report): ALF3, Aluminium fluoride
- Physical state: dry solid, white powder
- Analytical purity: not reported
- Lot/batch No.: XP01_00008_01
- Expiration date of the lot/batch: not reported; however, the authors assumed stable for the duration of the study
- Storage condition of test material: in the dark at room temperature, 20°C, and in the original container
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Sprague-Dawley Crl: CD® (SD) IGS BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Limited, Manston Road, Margate, Kent, England
- Age at study initiation: approximately 9-10 weeks
- Weight at study initiation: mean body weights of 284-293 g for males and 220-236 g for females
- Fasting period before study: not reported
- Housing: by sex, in groups of 5 per cage (stainless steel and wire mesh) suspended on a movable rack
- Diet (e.g. ad libitum): SDS rat and mouse diet (RM1 (E) SQC expanded pellet), ad libitum
- Water (e.g. ad libitum): tap water supplied by Anglian Water, ad libitum
- Acclimation period: 12 days, except 3 days for 2 replacement animals
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.5-21.0°C
- Humidity (%): 30-62%
- Air changes (per hr): 15 per hr
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose only
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- EXPOSURE SYSTEM
Dust generator: A turntable dust generator was used to produce the test atmospheres containing the dust of AlF3. The test substance flowed from the hopper, assisted by agitation, into a concentric groove milled into the turntable. As the turntable rotated, the dust passed under the air ejector and was aspirated into the chamber air supply.
Exposure chambers: The snout-only exposure chambers used for the exposures were of cylindrical form (30 cm internal diameter, 45 cm height) and made of aluminium alloy. The internal surfaces of the chamber have a conformal chemically resistant coating. The chambers have an enclosed volume of approximately 30 litres. The rats were held for exposure in moulded polycarbonate restraining tubes which were attached at evenly spaced ports in the cylindrical section of the chamber, and were designed to allow only the snout to project into the chamber. Each rat was restrained in a forward position by an adjustable foamed plastic stopper which also provided a seal for the tube.
The test atmosphere entered through a port at the top centre of the chamber and passed out through a port at the base section below the level of the rats.
The exposure system was positioned inside a large cabinet equipped with an extract fan exhausting to atmosphere through an absolute filter.
Airflow balance: A soft rubber bag was incorporated downstream of the exposure chamber and, once partially inflated, served as a sensitive visual indicator of the balance between the passive test substance/air supply and exhaust airflows within the exposure system.
PROCEDURE
The test substance was used as supplied.
A supply of clean, dry air was connected to the generator and the supply pressure was adjusted to give a flow rate of 40 litres/minute, measured at the generator outlet. The passive test substance pick-up air flow was 12 litres/minute. An in-line flow meter was used to monitor the generator air supply throughout the exposure. The exhaust air flow was calibrated and adjusted to balance the chamber air supply.
The powder hopper was filled with AlF3 and attached to the generator. The turntable speed controller was set for an initial speed of 1.1 revolutions per minute (rpm) and was expected to generate a particulate aerosol at the maximum practicable concentration. The performance of the turntable generator with the test substance was assessed during preliminary generation trials. The rats to be exposed were placed into separate restraining tubes and the tubes were then attached to ports in the exposure chamber.
The turntable motor was switched on and the exposure was timed for 4 hours following a 2-minute equilibration period. The rotational speed of the turntable was adjusted on one occasion in order to increase the level of the maximun practicable concentration but was limited by the amount of test substance available.
Following the exposure period, the turntable was stopped and the exposure chamber was allowed to clear before the animals were removed for examination.
The rats were returned to the holding cages and food and water supplies were restored. The test rats were kept in a ventilated cabinet overnight and then returned to the holding room for the remainder of the observation period.
The control group was treated similarly but received clean air only for 4 hours. The control animals were returned to the holding room at the end of the exposure period. - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- The time-weighted average chamber concentration was 0.530 mg/L and was considered to be the maximum practicable. The nominal concentration was 232.0 mg/L
- No. of animals per sex per dose:
- 5 animals/sex in each the control and test group
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed intermittently for signs of reaction to the test substance during exposure and at least twice daily throughout the observation period; animals were weighed at least twice during the week prior to exposure, prior to exposure (Day 0) and weekly during the observation period, including the day of death.
- Necropsy of survivors performed: yes
- Other examinations performed: Clinical signs were recorded at the end of the chamber equilibration period, at 0.25, 0.5, and 1.0 hours, then at hourly intervals during the exposure. Clinical signs were recorded immediately following exposure and then at 1.0 and 2.0 hours post-exposure. During the observation period, clinical signs were recorded once in the morning and then as necessary following a later check for survival. A visual inspection of water bottles was conducted daily. The lungs (including the larynx and trachea) were removed, dissected clear of surrounding tissue, weighed, and the weights were recorded.
Results and discussion
- Preliminary study:
- Preliminary experimental work: The test substance, AlF3, was supplied as a dry solid, white powder. Attempts were made to pack a sample of the test substance into a Wright Dust Feed mechanism (WDF) canister, using a hydraulic bench press to assist packing, at a variety of pressures ranging from 0.1 to 3.0 tons. It was not possible to pack the test substance sufficiently to allow generation using a WDF. The test substance was then processed in order to produce a powder suitable for generating with a WDF. The processed test substance was still unsuitable for packing and in addition, one of the processing methods altered the colour of the test substance. It was considered that the test substance was not suitable for generation of a test aerosol using a WDF and the associated processing methods. A summary of test material preparation methods is presented in Table A (see attached file).
A turntable dust generator was used to produce the test atmosphere containing a particulate aerosol generated from the test substance, as supplied. The conditions used during Preliminary Generation Trial 2, summarized in Table B (see attached file) were selected, with the exception of the passive pick-up (12 litres/minute), for exposure of test rats to a particulate aerosol generated at the maximum practicable concentration.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 0.53 mg/L air
- Exp. duration:
- 4 h
- Remarks on result:
- other: 0.530 mg/L was considered the maximum practicable concentration
- Mortality:
- There were no unscheduled deaths.
- Clinical signs:
- other: Tables 1 and 3 (see attached files) summarize clinical signs observed during the exposure and observation period, respectively. During exposure: exaggerated breathing was evident in all test rats from 4 hours into exposure; soiling of the fur with excreta
- Body weight:
- There were no treatment-related effects on body weights.
- Gross pathology:
- There were no treatment-related findings at necropsy. Small dark foci were noted on the lungs of 2 males in the test group, 1 male in the control group, and 1 female in the test group.
- Other findings:
- A visual appraisal of the water bottles indicated that the amount of water consumed by test animals was similar to that of the control animals. There were no treatment-related effects on lung weights.
Any other information on results incl. tables
As Table 3 illustrates (see attached file), the mass median aerodynamic diameter (MMAD) of the test aerosol was 8.5 µm and approximately 42% of the particulates were considered of a respirable size (< 7 µm in aerodynamic diameter).
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP (EC 1272/2008)
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