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Diss Factsheets
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EC number: 953-182-7 | 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 June 2020 to 3 August 2020
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-[(4-{5-AMINO-4-CYANO-1-[(2S)-1,1,1-TRIFLUOROPROPAN-2-YL]-1H-PYRAZOL-3-YL}PHENYL)METHYL]-5-FLUORO-2-METHOXYBENZAMIDE
- EC Number:
- 953-182-7
- Cas Number:
- 2101703-40-4
- Molecular formula:
- C22H19F4N5O2
- IUPAC Name:
- N-[(4-{5-AMINO-4-CYANO-1-[(2S)-1,1,1-TRIFLUOROPROPAN-2-YL]-1H-PYRAZOL-3-YL}PHENYL)METHYL]-5-FLUORO-2-METHOXYBENZAMIDE
Constituent 1
- Specific details on test material used for the study:
- Lot Number: 60394-18-001
Physical Description: Light Brown powder
Receipt date: 8 June 2020
Storage: Room temperature
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
Test system
- Vehicle:
- other: Deionised water
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- 20% (w/v) dilution in sterile, deionized water
- Duration of treatment / exposure:
- Three corneas were incubated in the presence of the test article at 32 ± 1 °C for 4 hours. Three corneas were incubated in the presence of each control at 32 ± 1 °C for 4 hours. After removal of the test or control article from the corneas, a final opacity was determined.
- Observation period (in vivo):
- The corneas did not receive a postexposure incubation
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Three corneas were incubated in the presence of the test article at 32 ± 1 °C for 4 hours. Three corneas were incubated in the presence of each control at 32 ± 1 °C for 4 hours.
The test article was dosed and rinsed from the corneas using the open chamber method. In the open chamber method, the anterior chamber windows were removed and the test article was applied directly onto the exposed epithelium of the corneas. After exposure, the test article was directly rinsed from the exposed corneas.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- ca. 1.4
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the in vitro score of 1.4, and the prediction model found in OECD test guideline 437, the test article is predicted to not require classification or labelling for ocular irritation (GHS No Category) and the test article is predicted to be a non-irritant.
- Executive summary:
The Bovine Corneal Opacity and Permeability Assay (BCOP) was used to assess the potential ocular irritancy of the test article to isolated bovine corneas. The methods and procedures used in this assay were consistent with OECD Test Guideline 437: Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage (2017).
The test article was administered to the test system as a 20% (w/v) dilutionin sterile, deionized water. The positive control (20% (w/v) dilution of imidazole prepared in Complete Minimal Essential Medium (without phenol red)) and the negative control (sterile, deionized water) were tested concurrently. After vortexing, the test article dilution was not fully soluble, and formed a cloudy light brown non-viscous suspension with brown particles.
Three corneas were incubated in the presence of the test article at 32 ± 1 °C for 4 hours. Three corneas were incubated in the presence of each control at 32 ± 1 °C for 4 hours. After removal of the control articles from the corneas, a final opacity was determined (i.e., the corneas did not receive a postexposure incubation). Following the rinsing process, but prior to reading the opacity values for the
corneas treated with the test article, a bulb burnt out in the opacitometer. The corneas treated with test article were placed back into the incubator (for approximately 30 minutes) until another opacitometer was calibrated which was then used to measure the final opacity readings. The test article was dosed and rinsed from the corneas using the open chamber method. In the open
chamber method, the anterior chamber windows were removed and the test article was applied directly onto the exposed epithelium of the corneas. After exposure, the test article was directly rinsed from the exposed corneas.
For regulatory purposes, the In Vitro Score (IVIS) cut-off values for identifying test chemicals as inducing serious eye damage (UN GHS Category 1) and test chemicals not requiring classification for eye irritation or serious eye damage (UN GHS No Category) are found in the table below (OECD 437, adopted 9 October 2017). This guidance on categorization applies only to a test article evaluated using the appropriate standard protocols as described in OECD 437.IVIS UN GHS </=3 No Category >3;</=55 No prediction can be made >55 Category 1 The following classification system was used:-
In Vitro Score
Up to 4=Non-irritant
>4-12 = Slight irritant
>12.1 to 25 =Mild irritant
25.1 to 55 = moderate irritant
55.1 and above = Severe irritant
Based on the in vitro score of 1.4, and the prediction model found in OECD test guideline 437, the test article is predicted to not require classification or labelling for ocular irritation (GHS No Category) and is predicted to be a non-irritant.
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