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EC number: 691-719-4 | CAS number: 1072957-71-1
- 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:
- sighting exposures 08 February 2010 to 17 March 2010, main exposures 12 March 2010 to 26 March 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1300 (Acute inhalation toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.2 (Acute Toxicity (Inhalation))
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- N-[11-(dichloromethylidene)tricyclo[6.2.1.0²,⁷]undeca-2,4,6-trien-3-yl]-3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxamide
- EC Number:
- 691-719-4
- Cas Number:
- 1072957-71-1
- Molecular formula:
- C18H15Cl2F2N3O
- IUPAC Name:
- N-[11-(dichloromethylidene)tricyclo[6.2.1.0²,⁷]undeca-2,4,6-trien-3-yl]-3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxamide
- Details on test material:
- - Name of test material (as cited in study report): SYN545192 tech.
- Physical state: Beige powder
- Analytical purity: 97.0% (by HPLC)
- Purity test date: 25 February 2009
- Expiration date of the lot/batch: End February 2013
- Storage condition of test material: Room temperature (15-25°C)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Wistar CRL:(WI)BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8-10 weeks
- Weight at study initiation: 233-349 g
- Fasting period before study: None
- Housing: 5/sex/cage in solid-floor Type III cages with stainless steel mesh lids
- Diet: ssniff® SM R/M-Z+H "Autoclavable complete feed for rats and mice – breeding and maintenance" ad libitum
- Water: Tap water ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22±3°C
- Humidity: 30-70% (during animal exposure humidity was 5-14%)
- Air changes: At least 15 per hr
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES (main exposure): From: 12 March 2010 To: 26 March 2010
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: TSE Rodent Exposure System (TSE Systems GmbH, Bad Homburg, Germany)
- Exposure chamber volume: 3.85 L
- Method of holding animals in test chamber: Individually held in a tapered, polycarbonate restraining tube fitted onto a single tier of the exposure chamber.
- Dynamic atmosphere generation: The test item was aerosolised using a rotating brush powder disperser (Palas GmbH, Karlsruhe, Germany) located at the top of the exposure chamber. Compressed air was supplied by means of an oil-free compressor and passed through a suitable filter system prior to introduction to the dust generator. Airflows and relative pressures within the system were constantly monitored and controlled ensuring a uniform distribution and constant flow of fresh aerosol to each exposure port. The flow of air through each port was at least 0.7 L/min.
TEST ATMOSPHERE
- Brief description of analytical method used: A known volume of test atmosphere passed through weighed GF10 glass fibre filters. The difference in the pre and post sampling weights, divided by the volume of atmosphere sampled, was equal to the actual achieved test atmosphere concentration. The nominal concentration was calculated by dividing the mass of test material disseminated into the chamber by the total volume of air that through the chamber during the same period.
- Samples taken from breathing zone: Yes
MMAD / GSD (Mass median aerodynamic diameter / Geometric st. dev.)
- Particle size distribution: The particle size of the test atmosphere was determined three times during the exposure period using a 7-stage impactor of Mercer style. The total amount collected for each stage was used to determine the cumulative amount below each cut-off point size. In this way, the proportion (%) of aerosol less than 0.56, 0.92, 1.51, 2.50, 4.11, 6.78 and 11.17 μm was calculated. From these data the MMAD and GSD were determined.
- Samples taken from breathing zone: Yes
MMAD was 3.21 µm, GSD was 2.40 - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- mean achieved atmosphere concentration was 0.56 mg/L
- Duration of exposure:
- 4 h
- Concentrations:
- 0.5 mg/L
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Morbidity/mortality - hourly during exposure, 1 hour after exposure and twice daily thereafter for 14 days. Clinical signs - hourly during exposure, immediately after exposure, 1 hour after exposure and once daily thereafter for 14 days. Body weights - Prior to treatment (day 0), days 1, 3, 7 and 14
- Necropsy of survivors performed: Yes - Statistics:
- Not applicable
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 0.56 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: nose only
- Mortality:
- 1/5 females found dead on day 1
- Clinical signs:
- other: Wet fur and fur staining on the day of exposure and on several days after exposure were observed. These observations were considered to be related to the restraint and exposure procedures and, in isolation, were considered not to be biologically significa
- Body weight:
- No treatment-related effects
- Gross pathology:
- Dark/red diffuse discolouration of the collapsed or non-collapsed lungs was observed in the animal found dead. A specific cause of death was not identified. In rats receiving 0.56 mg/L of SYN545192 and surviving to termination on Day 14, no macroscopic changes were recorded.
Any other information on results incl. tables
Sighting exposures:
First Sighting Exposure: Mean achieved atmosphere concentration 2.48 mg/L. MMAD was 2.65 μm±3.03 (GSD). Both females died on day 1.
Second Sighting Exposure: Mean achieved atmosphere concentration 1.03 mg/L. MMAD was 2.92 μm±2.53 (GSD). Both females died on day 1 or on day 5.
Clinical observations and gross pathology are as described in main exposure group.
Table 1: Summary of acute study test atmosphere characteristics of SYN545192
Test atmosphere characteristics |
|||
Parameter |
Sighting exposures |
Main exposure |
|
|
1st |
2nd |
|
Target concentration |
n/a |
n/a |
0.50 mg/L |
Analytical concentration |
2.48±0.31 mg/L (n=18) |
1.03±0.09 mg/L (n=18) |
0.56±0.06 mg/L (n=18) |
Nominal concentration |
8.14 mg/L |
3.76 mg/L |
3.77 mg/L |
Particle size MMAD; GSD |
2.65 µm;3.03 (n=3) |
2.92 µm;2.53 (n=3) |
3.21 µm;2.40 (n=3) |
|
Cumulative mass |
||
Particles<0.56µm (%) |
10.80 |
5.15 |
3.70 |
Particles0.56-0.92µm (%) |
17.25 |
10.91 |
8.49 |
Particles 0.92-1.51 µm (%) |
27.35 |
21.32 |
14.35 |
Particles 1.51-2.50 µm (%) |
38.01 |
35.42 |
30.71 |
Particles 2.50-4.11 µm (%) |
64.24 |
60.54 |
58.80 |
Particles 4.11-6.78 µm (%) |
84.15 |
85.91 |
81.64 |
Particles 6.78-11.17 µm (%) |
91.02 |
93.38 |
94.44 |
Particles >11.17 µm (%) |
100.00 |
100.00 |
100.00 |
Flow rate (individual tube) |
0.7 L/min |
0.7 L/min |
0.7 L/min |
|
|
|
|
Air flow in (mean) |
20.0 L/mi |
30.4 L/min |
30.4 L/min |
Air flow out (mean) |
24.8 L/min |
34.0 L/min |
45.4 L/min |
Temperature (mean) |
20.6°C |
24.0°C |
23.4°C |
Relative humidity (mean) |
7.6% |
8.0% |
6.0% |
Oxygen concentration |
20.0% |
20.0% |
20.0% |
Actual equilibration time allowed |
24 mins |
41 min |
66 min |
Applicant's summary and conclusion
- Interpretation of results:
- toxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the experimental conditions of this study, one death occurred in a group of 10 rats exposed to a mean achieved atmosphere of 0.56 mg/L for 4 hours. The acute inhalation LC50 of SYN545192 formulation, in Wistar Crl:(WI) BR strain rats is, therefore, greater than 0.56 mg/L.
- Executive summary:
A group of Wistar Crl:(WI) BR strain rats (5 males and 5 females) was exposed to a target aerosol concentration of 0.5 mg/L SYN545192. The animals were exposed for 4 hours using a nose-only exposure system, followed by a 14 day observation period. Aerosol concentrations were measured gravimetrically. The particle size distribution of the test aerosol was determined regularly during the exposure period. Clinical observations and body weights were recorded throughout the study and at the end of the scheduled period the animals were killed and subjected to a gross examination post mortem.
The mean achieved atmosphere concentration was 0.56 mg/L. The MMAD was 3.21 μm±2.40 (GSD).
One death occurred in a group of 10 rats exposed to a mean achieved atmosphere of 0.56 mg/L for 4 hours. The acute inhalation LC50 of SYN545192 formulation, in Wistar Crl:(WI) BR strain rats is, therefore, greater than 0.56 mg/L.
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