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EC number: 262-553-6 | CAS number: 60996-20-5
- 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
Specific investigations: other studies
Administrative data
- Endpoint:
- specific investigations: other studies
- Remarks:
- Respiratory irritation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Protocol for the sensory irritation test in accordance with ASTM E981-84 and with respect to the housing etc. of the animals, according to the OECD Guideline for Testing of Chemicals no. 403, Acute inhalation toxicity, adopted 12 May 1981.
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- in vivo
- Endpoint addressed:
- respiratory irritation
Test material
- Test material form:
- solid: particulate/powder
- Details on test material:
- NOCOLOK 100 flux is a white crystalline powder and has the following characteristics:
Name of test material: NOCOLOK 100 flux
Batch number: 2701 (22 January 1998)
Contents:
K(28-31%)
Al (16-18%)
F (49-53%)
Ca (< 0.2%)
Fe (<0.03%)
Bulk density: 416 g/l
Melting point: 565°C
Storage conditions: room temperature
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- Swiss Webster
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- The animals were individually housed under conventional conditions in macrolon cages with sterilized sawdust bedding. The number of air changes was about 10 per hour. A 12-hour light and 12-hour dark cycle was maintained. The temperature was between 20.0 and 23.5°C, relative humidity was between 47 and 70%.
During exposure the animals had no access to feed or water and were housed individually in the restrainers. Immediately after exposure, the animals were returned to their living cages and were kept there until necropsy seven days after exposure.
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Vehicle:
- air
- Details on exposure:
- Animals were exposed to the test atmosphere in an experimental set-up. The animals were secured in modified plastic animal restrainers (Battelle) and placed individually in one of the four plethysmographs connected to a central exposure chamber. The animals were allowed to breath freely from a stream of fresh test atmosphere. Pressure transducers connected to the plethysmographs were sensing changes caused by in and expiration. A void filling was placed in each of the plethysmographs to reduce the chamber volume in order to increase signal strength. The electronically amplified signals were transmitted to a polygraph recorder for off-line manual calculations.
Sampling ports for the actual concentration, temperature and relative humidity measurements were located in the exhaust pipe, just above the central exposure chamber. The unit was illuminated externally by normal laboratory TL-lighting.
The inhalation equipment was designed to expose mice to a continuous supply of fresh test atmosphere. The test atmosphere was generated by delivering the test material using a dry material helix feeder to a jet mill (Institute's design), operated with dry pressurized air (less than 1% humidity). By means of an eductor, in fact used as a pump, a small fraction of the aerosol was withdrawn from the exhaust of the jet mill. Because the eductor withdrew the aerosol perpendicular to the main flow, the heavier particles could not make the turn and only smaller particles were selected for- the test atmosphere. The maximum attainable concentration was 600 mg/m3 with this setup.
The test atmosphere was passed to the inlet of the exposure unit. From there, the test atmosphere was directed towards the animal noses. At the outlet of the unit the test atmosphere was exhausted (see also Figure 1). The input pressures of the jet mill and the eductor were set at the desired levels (5.0, 2.0 and 2.0 bar for the mill, the jet and the eductor, respectively) at the beginning of the exposure period.
Particle size measurement: measurements were carried out using a 10-stage cascade impactor with a largest cut-off size of 32 pm. The Mass Median Aerodynamic Diameter (MMAD) and the mean geometric standard deviation (GSD) were calculated.
The mass median aerodynamic diameter of the particles was assessed twice, the results were 0.8 and 1.0 µm, respectively and the geometric standard deviations were 2.5 and 2.7, respectively. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The concentration of the test material in the test atmosphere was determined one or two times during each exposure by gravimetric analysis.
- Duration of treatment / exposure:
- single exposure
- Frequency of treatment:
- 20 or 30 minutes
Doses / concentrations
- Remarks:
- Doses / Concentrations:
283, 592 and 604 mg/m3
Basis:
analytical conc.
- No. of animals per sex per dose:
- 4 males
- Control animals:
- yes
- Details on study design:
- Sensory irritation
Sensory (respiratory) irritation is a reflex mechanism of the trigeminal nerve and results in a decreased breathing frequency which, if low enough, is characterized by a post-inspiratory apnoea.
The groups were exposed by inhalation for a single 30-min period (for exposures A and B a 20-min period was accidentally used), after an acclimatization period of 10 minutes. A recovery period of 20 minutes in the animal restrainers was allowed after exposure.
The control respiratory rate was measured during the acclimatization period as the average of six ~20-sec periods recorded at 1-min intervals immediately preceding the exposure period. During the exposure period, the respiratory rate was measured for ~20-sec periods at 1-min intervals during the first six minutes of exposure and at 2-min intervals for the remainder of the exposure period. After exposure, rates were measured 5 times for ~20 sec at 1-min intervals, followed by 3-min intervals (after exposures A and B rates were measured 6 times for ~20 sec at 1-min intervals, followed by 2-min intervals). At the same time, changes in tidal volume were monitored by measuring the amplitude of the breathing signal. The response R, measured as the relative decrease in breathing rate, was calculated as follows:
R (during exposure): 1 - (exposure value/mean pre-exposure value)
R (after exposure): 1 - (recovery value/mean pre-exposure value).
Examinations
- Examinations:
- Behaviour, clinical signs and mortality
The mice were visually inspected just before exposure, for reactions to treatment during the exposure, shortly after exposure, and at least once daily during the observation period.
Body weights
Body weights were recorded just prior to exposure (day 0) and on days 1 and 7.
Necropsy
At the end of the 7-day observation period, all mice were killed by exsanguination from the abdominal aorta under ether anaesthesia. All mice were subsequently necropsied and examined for gross pathological changes. In addition, absolute and relative lung weights were determined.
Results and discussion
- Details on results:
- A decrease in breathing rate or post-inspiratory apnoea were not seen in the breathing pattern.
During exposure, no changes in behaviour were seen. No abnormalities were seen in clinical signs during the 7-day observation period. None of the mice died. Dose (exposure*time) related weight decrease was not observed. Abnormalities at necropsy consisted primarily of discoloured areas on the lungs to a varying extent in the highest concentration group.
From the results of the present study in mice, it was concluded that a sensory irritation response of inhalable particles of aluminium potassium fluoride at the technically highest attainable concentration under the conditions of this study (604 mg/m3) was not found.
Applicant's summary and conclusion
- Conclusions:
- Multiconstituent aluminium potassium fluoride does not induce sensory irritation in the respiratory tract.
- Executive summary:
The airway irritating properties of multiconstituent aluminium potassium fluoride were studied in a GLP study by exposing three groups of four male mice to test atmospheres containing the substance at concentrations of 283, 592 and 604 mg/m3 for a single period of 20, 20 and 30 minutes, respectively (TNO, 1999).
A decrease in breathing rate or post-inspiratory apnoea were not seen in the breathing pattern. During exposure, no changes in behaviour were seen. No abnormalities or clinical signs were seen during
the 7-day observation period. None of the mice died. Dose (exposure*time) related weight decrease was not observed. Abnormalities at necropsy consisted primarily of discoloured areas on the lungs to a varying extent in the highest concentration group.
From the results of the present study in mice, it was concluded that a sensory irritation response of inhalable particles of multiconstituent aluminium potassium fluoride at the technically highest attainable concentration under the conditions of this study (604 mg/m3) was not found.
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