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EC number: 700-403-8 | CAS number: -
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 436 (Acute Inhalation Toxicity: Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Details on test material:
- - Purity: 25.1% solids in water
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: RccHan®:WIST
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 9 to 12 weeks old
- Weight at study initiation: 369 g and 210 g for males and females of group 1; 302 g and 209 g for males and females of group 2
- Fasting period before study: no
- Housing: animals were housed in groups of three, separated by sex, in macrolon cages (type 4S) with a bedding of wood shavings and a wooden block and strips of paper as environmental enrichment.
- Diet: rodent diet (Rat & Mouse No. 3 Breeding Diet, RM3) from a commercial supplier (SDS Special Diets Services, Whitham, England) ad libitum
- Water: domestic mains tap-water ad libitum
- Acclimation period: 28 days group 1; 8 days group 2
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 45-65%
- Air changes (per hr): about 10 per hour
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark.
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- other: humidified air during exposure of the first group or with a stream of compressed dry air for the second group
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: cylindrical stainless steel column, surrounded by a transparent cylinder
- Exposure chamber volume: about 50 litres
- Method of holding animals in test chamber: secured in plastic animal holders
- Source and rate of air: at least 1 litre/min for each rat
- Method of conditioning air: The air entering the unit was controlled at 22 ± 3˚C. The target range for the relative humidity was 30% - 70%.
- System of generating particulates/aerosols: The test material was diluted in demineralized water (10% w/w) and continuously stirred by a magnetic stirrer. An amount of test material, controlled by a peristaltic pump (Peristaltic pump Minipulse, Gilson, Villiers le Bel, France), was nebulized using an air-driven atomizer (Schlick type 970/S, Coburg, Germany). The atomizer was supplied with a stream of humidified air during exposure of the first group or with a stream of compressed dry air for the second group. The air pressure on the atomizer was regulated by a reducing valve and the airflow was measured with a mass view meter (MASSVIEW, Bronkhorst Hi Tec, Ruurlo, The Netherlands). The test atmosphere was introduced at the top of the exposure chamber, directed downward and led to the noses of the animals. At the bottom of the unit the test atmosphere was exhausted.
- Method of particle size determination: Particle size distribution measurements were carried out by means of a 10-stage cascade impactor (2110k cascade impactor, Sierra instruments, Carmel Valley, California, USA).
- Treatment of exhaust air: no data
TEST ATMOSPHERE
- Brief description of analytical method used: The actual concentration of the test material in the test atmosphere was measured by gravimetric analysis. Representative test atmosphere samples were obtained from the animals’ breathing zone by passing approximately 50 L (group 1) or 25 L (group 2) test atmosphere at 5 L/min through fibre glass filters (Sartorius, 13400- 47). Filters, contained in a drying cup, were weighed before sampling, loaded with a sample of test atmosphere, weighed, dried for at least 15 minutes but not longer than about half an hour (which was sufficient to obtain a stable filter weight) and weighed again. The loaded filters were dried by means of a stream of compressed dry air controlled by a mass flow controller (0.125 normal litre/min/filter). A total number of 8 samples were taken during exposure of each group of animals. The actual concentration was calculated by dividing the amount of test material present on the filter after drying by the volume of the sample taken (the dry mass was converted to ‘test material’ as such using a solids content of 25.1%). The atmospheric concentration of total solids was also calculated by dividing the dried mass on the filter by the volume of the sample taken.
- Samples taken from breathing zone: yes
TEST ATMOSPHERE
MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.):
- Group 1:
- preliminary test atmosphere generation: MMAD 2.23 μm, GSD 1.94
- during exposure, 1st measurement: MMAD 2.19 μm, GSD 2.01
- during exposure, 2nd measurement: MMAD 2.18 μm, GSD 1.99
Group 2:
- preliminary test atmosphere generation: MMAD 2.33 μm, GSD 2.13
- during exposure, 1st measurement: MMAD 2.42 μm, GSD 1.91
- during exposure, 2nd measurement: MMAD 2.26 μm, GSD 2.12
- Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- Group 1 = 126 (± 9) mg total solids/m3 (504 mg test material/m3, corrected for solids)
Group 2 = ± 19 mg total solids/m3 (1046 mg test material/m3, corrected for solids) - No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: On the exposure day, the animals were observed for clinical signs just before exposure, four times during exposure (about once per hour), and twice after exposure. During the observation period, each animal was observed daily in the morning hours by cage-side observations and, if necessary, handled to detect signs of toxicity. On working days, all cages were checked again in the afternoon. In
weekends only one check per day was carried out. During exposure, when observation was hindered by the restraining tubes, attention was
directed to breathing abnormalities and restlessness. All abnormalities, signs of ill health, and reactions to treatment and mortality were recorded.
- Frequency of weighing: The body weight of each (surviving) animal was recorded on days -1, 0 (just before exposure), 1, 3, 7 and 14 (prior to necropsy).
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- >= 126 - <= 263 other: mg total solids/m3
- Exp. duration:
- 4 h
- Remarks on result:
- other: gravimetric measurement
- Mortality:
- Group 1, 126 mg total solids/m3: 0 males died and 1 of 3 females died
Group 2, 263 mg total solids/m3: 2 of 3 males and 2 of 3 females died - Clinical signs:
- other: 126 mg total solids/m3: During exposure, treatment-related clinical signs were seen in all animals (restless and altered breathing frequency). After exposure, treatment-related clinical signs were seen in two female animals (hunched posture, blepharospas
- Body weight:
- 126 mg total solids/m3: All male and one female animal had lost weight the day after exposure and gained weight thereafter. One female animal had gained a little weight on the day after exposure, lost weight in the period day 1-3 and gained weight thereafter.
263 mg total solids/m3: The surviving male and female animal had lost weight the day of exposure and showed catch up growth thereafter. - Gross pathology:
- 126 mg total solids/m3: The female that was found dead on the day after exposure had blood at the nose and dark red and poorly collapsed lungs.
One surviving female showed a swollen uterus at scheduled necropsy. The latter finding was not ascribed to treatment because it is a common background finding in female rats. Necropsy of the other survivors showed no abnormalities.
263 mg total solids/m3: The two male and two female animals that were found dead on the day after exposure had blood around their noses and dark red lungs. The surviving male and female animal had grey discoloured lungs.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 based on GHS criteria
- Conclusions:
- LC50 is between 126 mg total solids/m3 and 263 mg total solids/m3.
- Executive summary:
The aim of the study was to determine the acute inhalation toxicity of the test substance in rats.
A group of three males and three females was exposed to 126 mg total solids/m3 for four hours. Mass median aerodynamic diameter was 2.19 – 2.18 µm and geometric standard deviation was 2.01 – 1.99. During exposure, treatment-related clinical signs were seen in all animals (restless and altered breathing frequency). After exposure, treatment-related clinical signs were seen in two female animals (hunched posture, blepharospasm, dyspnea) and in one male animal (blepharospasm). One female was found dead on the day after exposure. Following some initial weight loss, body weight development was considered to be in the normal range for rats of this strain and age. At necropsy of survivors, no treatment related abnormalities were seen.
A second group of three males and three females was exposed to 263 mg total solids/m3 for four hours. Mass median aerodynamic diameter was 2.42 – 2.26 µm and geometric standard deviation was 1.91 -2.12. During exposure, treatment-related clinical signs were seen in all animals (altered breathing rate, mostly increased, and shallow breathing). After exposure, all animals showed irregular breathing, piloerection, blepharospasm and lethargy. On the day after exposure, two male animals and two female animals were found dead. The surviving animals showed no abnormalities from the day after exposure until scheduled sacrifice. These animals had lost weight on the day of exposure and grew normally thereafter. At necropsy, the surviving animals had grey discoloured lungs. This finding was considered to be related to treatment.
As one animal died following exposure to 126 mg total solids/m3 and two male and two female animals died at 263 mg total solids/m3, it was concluded that the 4-hour LC50 of the test substance in rats was between 126 and 263 mg total solids/m3.
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