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EC number: - | 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:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
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
Test material
- Reference substance name:
- (2S)-1,1-bis(4-fluorophenyl)propan-2-yl L-alaninate hydrochloride
- Cas Number:
- 2171323-89-8
- Molecular formula:
- C18H20CIF2NO2
- IUPAC Name:
- (2S)-1,1-bis(4-fluorophenyl)propan-2-yl L-alaninate hydrochloride
Constituent 1
- Specific details on test material used for the study:
- Substance name: X12485647
Lot #: SS17000602-2 (TSN402954)
Purity: 98%
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Mass median aerodynamic diameter (MMAD):
- 2.74 µm
- Geometric standard deviation (GSD):
- 1.78
- Analytical verification of test atmosphere concentrations:
- no
- Duration of exposure:
- 4 h
- Concentrations:
- 0.52 and 0.051 mg/L
- No. of animals per sex per dose:
- 3
- Control animals:
- no
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50 cut-off
- Effect level:
- 0.125 mg/L air
- Based on:
- other: TWA
- Exp. duration:
- 4 h
- Mortality:
- Group I: All rats exposed to 0.52 mg/L air (TWA) found dead.
Group II: No mortality was observed in male or female rats exposed for 4 hours to an aerosol concentration of 0.051 mg/L air (TWA). - Clinical signs:
- other: abdominal breathing were observed in all animals during exposure and lethargy was observed in rats which survived post 4-hour exposure period, exposed to a dust aerosol concentration of 0.52 mg/L air (TWA).
- Body weight:
- Group II: A decrease in the body weight was observed on day 1, which recovered by day 3. Body weight then continued to increase until the end of the observation period, when compared with day 0 body weight in male rat. A decrease in the body weight was observed on day 1 and 3, which recovered by day 7. Body weight then continued to increase until the end of the observation period, when compared with day 0 body weight in all female rats.
- Gross pathology:
- An external examination of rats, which were found dead or terminally sacrificed did not reveal any abnormality.
The visceral examination of the rats, which were found dead, revealed reddish discolouration in the lungs (rat N˚ 3, 4 and 6) whereas the other rats which were found dead or terminally sacrificed, did not reveal any abnormality.
The lesions observed in rats which had died were considered to be related to the treatment with the test item.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 based on GHS criteria
- Conclusions:
- Inhalation LC50 cut off (Rat): 0.125 mg/L
- Executive summary:
The acute inhalation toxicity of the test substance was investigated in the Wistar rats (RccHan:WIST) using the acute toxic class method. Two sets of 3 male and 3 female rats each, approximately 9-10 weeks old and weighing 183.3-245.8 g on the day of exposure, were exposed to dust aerosol of the test substance using a nose-only inhalation exposure system. Rats were exposed for 4 hours, followed by a 14-day post-exposure observation period, during which body weight and clinical observations were recorded. Survivors were sacrificed and a necropsy was performed in all rats.
Initially, one group (group I) was exposed with a time-weighted average concentration of 0.52 mg/L air. The mass median aerodynamic diameter (MMAD) of the test substance aerosol was determined to be 2.74 µm with a geometric standard deviation (GSD) of 1.78. All rats were found dead by day 1 post exposure. Clinical signs of abdominal breathing were observed in all animals during exposure and lethargy was also observed in rats which survived post end of the 4 hour exposure period. Macroscopic examination of rats which died revealed reddish discolouration of the lungs in 3/6 rats while other found dead rats did not reveal any abnormality.
As more than 2 mortalities were observed, a second group of rats (group II) was exposed to a time-weighted average concentration of 0.051 mg/L air. The mass median aerodynamic diameter (MMAD) of the test substance aerosol was determined to be 2.95 µm with a geometric standard deviation (GSD) of 1.68. No mortality or clinical signs were observed in any (male or female) rats, exposed to a dust aerosol concentration of 0.051 mg/L air. A decrease in the body weight was observed on day 1, which recovered by day 3. Body weight then continued to increase until the end of the observation period, when compared with day 0 body weight in male rats. A decrease in the body weight was observed on day 1 and 3, which recovered by day 7. Body weight then continued to increase until the end of the observation period, when compared with day 0 body weight in female rats. No internal or external gross abnormality was recorded at the post-mortem examination.
In conclusion, based on these results generated under the experimental conditions of this study, the 4-hour acute inhalation median lethal concentration of the test substance, in Wistar rats (male and female combined), was greater than 0.05 to 0.5 mg/L air and the LC50 cut-off value was 0.125 mg/L air.
Based on results of this study, the GHS classification of the test substance for acute inhalation toxicity is as mentioned below: Globally Harmonized System of Classification and Labelling of Chemicals (GHS 2019): Category 2
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