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EC number: 810-161-6 | CAS number: 1229654-66-3
- 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:
- 22 May - 18 Jun 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Version / remarks:
- adopted in 2009
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1300 (Acute inhalation toxicity)
- Version / remarks:
- adopted in 1998
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.2 (Acute Toxicity (Inhalation))
- Version / remarks:
- adopted in 2008
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- GYEMSZI National Institute for Quality- and Organizational Development in Healthcare and Medicines, Budapest, Hungary
- Test type:
- traditional method
- Limit test:
- yes
Test material
- Reference substance name:
- 1-(3-chloropyridin-2-yl)-N-[4-cyano-2-methyl-6-(methylcarbamoyl)phenyl]-3-{[5-(trifluoromethyl)-2H-1,2,3,4-tetrazol-2-yl]methyl}-1H-pyrazole-5-carboxamide
- EC Number:
- 810-161-6
- Cas Number:
- 1229654-66-3
- Molecular formula:
- C22 H16 Cl F3 N10 O2
- IUPAC Name:
- 1-(3-chloropyridin-2-yl)-N-[4-cyano-2-methyl-6-(methylcarbamoyl)phenyl]-3-{[5-(trifluoromethyl)-2H-1,2,3,4-tetrazol-2-yl]methyl}-1H-pyrazole-5-carboxamide
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CRL:(WI) rats
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 9 - 11 weeks
- Weight at study initiation: 324 - 435 g (males), 213 - 234 g (females)
- Housing: 5 animals of the same sex per cage (individual in case of sighting group) in type III solid floor cages with stainless stell mesh lids, deep wood sawdust bedding (Lignocel® Hygienic Animal Bedding, J. Rettenmaier & Söhne GmbH+Co. KG, Rosenberg, Germany)
- Diet: ssniff SM R/M-Z+H (ssniff Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Mass median aerodynamic diameter (MMAD):
- 3.64 µm
- Geometric standard deviation (GSD):
- 2.4
- Remark on MMAD/GSD:
- The mean mass median aerodynamic diameter was 3.72 µm in the sighting group and 3.64 µm in the main study. The geometric standard deviation was 2.47 in the sighting group and 2.40 in the main study.
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: concentric anodised aluminium chambers with a computer control system incorporating pressure detectors and mass flow controllers (TSE Rodent Exposure System; TSE Systems GmbH, Bad Homburg, Germany)
- Exposure chamber volume: 3.85 L (Theoretical Volume)
- Method of holding animals in test chamber: Each rat was individually held in a tapered, polycarbonate restraining tube fitted onto a single tier of the chamber.
- Source and rate of air: filtered air at 0.7 L/min
- System of generating particulates/aerosols: generation of an aerosol using a Dust Generator Budiman (TSE Systems GmbH, Bad Homburg, Germany) at the top of the chamber under dynamic conditions
- Method of particle size determination: The particle size of the test atmosphere was determined three times during the exposure period using a 7-stage impactor of Mercer style (TSE Systems GmbH, Bad Homburg, Germany) isolating particles in the discrete aerodynamic size ranges. Samples were taken from an unoccupied exposure port and the weight of the test item was determined gravimetrically.
- Treatment of exhaust air: Used aerosol entered the outer cylinder from where it was exhausted through a suitable filter system.
- Temperature, humidity in air chamber: 25.0 - 27.1°C, 25.0 - 50.0%,
TEST ATMOSPHERE
- Brief description of analytical method used: The test substance concentration was determined by gravimetric analysis (glass-fibre filter, Whatman GmbH, Dassel, Germany)
- Samples taken from breathing zone: yes
TEST ATMOSPHERE
- Particle size distribution: During the study the test atmosphere was respirable to the animals. see table 1
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): see table 1 - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- gravimetric
- Duration of exposure:
- 4 h
- Concentrations:
- 4.83 mg/L (sighting group, analytical)
5.01 mg/L (main study, analytical, maximum attainable concentration) - No. of animals per sex per dose:
- 1 (sighting group)
5 (main study) - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed hourly during exposure, 1 h after exposure and twice daily thereafter for mortality/ moribundity; hourly during exposure, twice on the day of exposure and once daily thereafter for clinical signs. Bodyweights were determined prior to treatment and on Days 1, 3, 7 and 14.
- Necropsy of survivors performed: yes
Results and discussion
- Preliminary study:
- In the preliminary sighting study 1 male and 1 female were exposed to test substance target concentration of 5.0 mg/L. No mortality occured during the study.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.01 other: mg/L air (gravimetrical)
- Based on:
- test mat.
- Remarks:
- maximum attainable concentration
- Exp. duration:
- 4 h
- Mortality:
- 1/5 male died shortly after the exposure
- Clinical signs:
- other: Wet fur and fur staining were observed in most animals on the day of exposure and one day after exposure. These observations were considered to be related to the restraint and exposure procedures and therefore, not considered to be treatment-related. Slig
- Body weight:
- Bodyweight loss was observed in the majority of animals, which is due to the restrained procedure during the exposure. However, the mean bodyweight and bodyweight gain of the animals at termination of the study was in the normal range, compared to untreated animals of the same age and strain.
- Gross pathology:
- No macroscopic changes were noted. However, dark/red discoloration of the non-collapsed lungs was macroscopically found in the dead animal.
Any other information on results incl. tables
Table 2 Mortality and clinical signs
Group |
Mortality |
Clinical Signs |
Males |
||
Sighting group (4.83 mg/L) |
0/1 |
1/1 |
Main study group (5.01 mg/L) |
1/5 |
5/5 |
Females |
||
Sighting group (4.83 mg/L) |
0/1 |
1/1 |
Main study group (5.01 mg/L) |
0/5 |
5/5 |
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/GHS criteria not met; no classification required according to Regulation (EC) No. 1272/2008
- Conclusions:
- CLP: not classified
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