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EC number: 619-510-5 | CAS number: 141573-95-7
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guideline study, no restrictions, fully adequate for assessment.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline no. 439: In vitro skin irritation: Reconstructed Human Epidermidis Test Method (adopted 22 July 2010)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- ethyl 3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxylate
- EC Number:
- 619-510-5
- Cas Number:
- 141573-95-7
- Molecular formula:
- C8H10F2N2O2
- IUPAC Name:
- ethyl 3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxylate
- Details on test material:
- - Name of test material (as cited in study report): DFMMP
- Lot/batch No.: Batch No. MKA13111
- Substance type: mono-constituent substance
- Physical state: powder
- Analytical purity: 99.0% (GC)
Constituent 1
Test animals
- Species:
- other: In vitro human skin model
- Strain:
- other: EPISKIN Standard model
- Details on test animals or test system and environmental conditions:
- TEST MATERIAL
- Source: SkinEthic Laboratories, Lyon, France
- Acclimation period: On the day of receipt the tissues were transferred to 12-well plates and preincubated with prewarmed Maintenance Medium for 24 hours at 37°C.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 37.1 – 37.4°C
- Humidity (%): 88 – 89% containing 5 +/- 0.5% CO2 in air
- Photoperiod (hrs dark / hrs light): dark
Test system
- Type of coverage:
- other: In vitro human skin model
- Preparation of test site:
- other: In vitro human skin model
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Negative control: Phosphate buffered saline; positive control: 5% Sodium dodecyl sulphate in PBS.
- Amount / concentration applied:
- An amount of 11.6 to 14.9 mg of DFMMP was applied directly on top of the skin tissue
- Duration of treatment / exposure:
- The skin tissues were exposed to DFMMP for 15 minutes at room temperature.
- Observation period:
- After the exposure period of 15 minutes, the tissues were washed to remove residual test substance, dried and moved to a new well with fresh medium. Subsequently the skin tissues were incubated for 42 hours at 37°C and hereafter determination of the cytotoxic (irritancy) effect was performed.
- Number of animals:
- Not applicable (in vitro study)
- Details on study design:
- The objective of this study was to evaluate DFMMP for its ability to induce skin irritation. For this purpose DFMMP was topically applied on a human three dimensional epidermal model and hereafter the cytotoxic (irritancy) effect was determined. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment.
PROTOCOL
- DFMMP was checked for possible direct MTT reduction before the study was started.
- The test was performed on a total of 3 tissues per treatment (DFMMP, negative and positive control). The tissues were exposed for 15 minutes.
- After a 42 hour post-incubation period, an extraction of formazan was performed and the amount of extracted formazan was determined spectrophotometrically at 570 nm
- Cell viability was calculated for each tissue as a percentage of the mean of the negative control tissues.
INTERPRETATION OF RESULTS
The in vitro skin irritation test is considered acceptable if it meets the following criteria:
a) The absolute mean OD570 (optical density at 570 nm) of the three tissues of the negative control should be within the laboratory historical control data range (SD % viability should be 18).
b) The mean relative tissue viability of the positive control should be 40% relative to the negative control (SD % viability should be 18).
c) The SD calculated from individual % tissue viabilities of the three identically treated replicates should be 18.
A test substance is considered irritant in the skin irritation test if the relative mean tissue viability of three individual tissues after 15 minutes of exposure to the test is ≤ 50% of the mean viability of the negative controls. A test substance is considered non-irritant in the in vitro skin irritation test if the relative mean tissue viability of three individual tissues after 15 minutes of exposure to the test substance is > 50% of the mean viability of the negative controls.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: Relative mean tissue viability compared to the negative control
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Remarks: The relative mean tissue viability after 15 minutes treatment with DFMMP compared to the negative control tissues was 101%.. (migrated information)
In vivo
- Irritant / corrosive response data:
- The relative mean tissue viability obtained after 15 minutes treatment with DFMMP compared to the negative control tissues was 101%. Since the mean relative tissue viability for DFMMP was above 50% after 15 minutes treatment DFMMP is considered to be non-irritant.
Applicant's summary and conclusion
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.