Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06 January 2010 to 02 February 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 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- up-and-down procedure
- Limit test:
- no
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: <30°C
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CRL:(WI)BR
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 220-234 g
- Fasting period before study: Overnight
- Housing: Individually in Type II polypropylene cages
- Diet: ssniff® SM R/M-Z+H "Autoclavable complete feed for rats and mice – breeding and maintenance" ad libitum
- Water: Municipal tap water ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3°C
- Humidity: 30-70%
- Air changes: 15-20 per hr
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: 06 January 2010 To: 02 February 2010
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 1%
- Details on oral exposure:
- VEHICLE: 1% Carboxymethylcellulose (high viscosity)
- Dose volume: 10 mL
- Rationale for the selection of the starting dose: Limit test was not performed as SYN545192 was likely to cause mortality at a dose level of 2000 mg/kg bw. The starting dose in the main study was 175 mg/kg bw. Oral administration is considered to be an appropriate dose route as it is a possible route of human exposure. - Doses:
- 17.5, 55, 175 mg/kg body weight
- No. of animals per sex per dose:
- 1, 4, 3 at 17.5, 55, 175 mg/kg body weight respectively
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations made 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and once each day for 14 days thereafter. Body weights recorded on day -1 and days 0 (beginning of the experiment) 7 and 14 (surviving animals).
- Necropsy of survivors performed: Yes - Statistics:
- Not applicable
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 55 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 0/1 at 17.5, 1/4 at 55 and 3/3 at 175 mg/kg bw
- Clinical signs:
- other: None at 17.5 mg/kg. Decreased activity (4/4), dyspnoea (4/4), incoordination (4/4), hunched back (1/4) at 55 mg/kg. Decreased activity (3/3), prone position (3/3), incoordination (3/3), piloerection (3/3), dyspnoea (3/3), decreased respiratory rate (1/3),
- Gross pathology:
- Intercurrent deaths: Non-collapsing or dark/red discolouration of the lungs and/or thymus, frothy material in the trachea or enlarged atria in the heart (considered to be due to agonal or post mortem changes).
Terminal necropsy, 1 animal dosed at 55 mg/kg showed dark/red discolouration of the lungs. No macroscopic findings were observed in the other surviving animals at dose levels of 55 mg/kg and 17.5 mg/kg.
Any other information on results incl. tables
Table 1: Acute oral toxicity of SYN545192 in the rat, application scheme and mortality data
Animal number |
Dose (mg/kg bodyweight) |
Survival |
7004 |
175 |
Died 6 hours after dosing |
7002 |
55 |
Survived |
7003 |
175 |
Died on day 1 |
7006 |
55 |
Survived |
7008 |
175 |
Died on day 1 |
7010 |
55 |
Died 2 hours after dosing |
7009 |
17.5 |
Survived |
7011 |
55 |
Survived |
Applicant's summary and conclusion
- Interpretation of results:
- toxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral LD50 of SYN545192 was calculated to be 55 mg/kg bodyweight in female CRL:(WI) BR rats.
- Executive summary:
The acute oral toxicity of SYN545192 was assessed in female CRL:(WI) BR rats. A single oral (gavage) dose was administered followed by a 14 day observation period. The animals were fasted overnight prior to treatment. Surviving animals were observed individually after dosing at 30 minutes, 1, 2, 3, 4 and 6 hours post treatment and once each day for 14 days thereafter. Body weight was measured on Day -1 and just before treatment and weekly after. All surviving animals were examined macroscopically at the end of the study.
SYN545192 caused mortalities at 175 mg/kg bw (3/3) and at 55 mg/kg bw (1/4).
The acute oral LD50 was calculated to be 55 mg/kg body weight in female CRL:(WI) BR rats.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.