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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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06 January 2010 to 20 January 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 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- 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: <30°C
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CRL:(WI)BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Young adult
- Weight at study initiation: 200-299 g
- Fasting period before study: Not applicable
- 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: 21 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: 20 January 2010
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Shaved back
- % coverage: 10%
- Type of wrap if used: terile gauze pad, kept in contact with skin with a patch of adhesive hypoallergeic plaster and entire trunk wrapped with semi occlusive plastic wrap
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes with body temperature water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- For solids, paste formed: No - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- 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: Clinical observations made 1 and 5 6 hours after application and once each day for 14 days thereafter. Body weights recorded on days 0 (beginning of the experiment), 7 and 14
- Necropsy of survivors performed: Yes - Statistics:
- Not applicable (limit test, no mortalities)
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality
- Clinical signs:
- other: No adverse clinical or dermal signs
- Gross pathology:
- No macroscopic findings
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information no mortalities at limit dose of 2000 mg/kg bw Criteria used for interpretation of results: EU
- Conclusions:
- The acute dermal LD50 of SYN545192 was greater than 2000 mg/kg bw in male and female CRL:(WI) BR rats.
- Executive summary:
The acute dermal toxicity of SYN545192 was assessed in male and female CRL:(WI) BR rats. A single 24 hour dermal application was administered followed by a 14 day observation period. Animals were observed individually after dosing at 1 and 5 hours post treatment and once each day for 14 days thereafter. Body weight was measured on days 0, 7 and 14. All animals were examined macroscopically at the end of the study.
No mortality occurred. No adverse clinical or dermal signs were observed in any of the animals. There were no effects on bodyweight and no macroscopic findings at necropsy.
The acute dermal LD50 of SYN545192 was greater than 2000 mg/kg bw in male and female CRL:(WI) BR rats.
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