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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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed according to the OECD guideline No.429 (2010) and in compliance with the GLP.
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:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Principles of method if other than guideline:
- Only the highest test substance concentration was tested. This reduced Local Lymph Node Assay (LLNA) uses fewer animals than the full standard LLNA and is considered suitable for non-toxic substances with no alerting structure for sensitizing properties.
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
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
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source : Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: approx. 9 weeks old
- Weight at study initiation: 21 - 24 g
- Housing: group housed in Makrolon MII type cages.
- Diet (e.g. ad libitum): free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany)
- Water (e.g. ad libitum): free access to tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.3 - 22.1°C
- Humidity (%): 44-72%
- Air changes (per hr): approximately 15 air changes per hour.
- Photoperiod (hrs dark / hrs light): 12h/12h
Study design: in vivo (non-LLNA)
Induction
- Concentration / amount:
- Not applicable
Challenge
- Concentration / amount:
- Not applicable
- No. of animals per dose:
- Not applicable
- Details on study design:
- Not applicable
- Challenge controls:
- Not applicable
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Remarks:
- Merck, Darmstadt, Germany
- Concentration:
- For the preliminary test the concentrations were 25 and 50% of the test item.
For the main test the concentrations were 0 and 50% of the test item. - No. of animals per dose:
- For the preliminary test: 2 females/dose (no control) were treated.
For the main test: 5 females were treated for both the control and the 50% concentration (total of 10 animals). - Details on study design:
- RANGE FINDING TEST
- Compound solubility: The test item was soluble in dimethyl formamide. A solution was obtained at the maximum tested concentration of 50%.
- Irritation: Measurement of the ear thickness (using a digital thickness gauge) was performed prior to dosing on Days 1, 3 and 6. Very slight erythema was observed on the dorsal surface of the ears on Day 3 for both animals at a 50% test substance concentration. No signs of systemic toxicity were observed in any of the animals examined. Variations in ear thickness during the observation period were less than 25% from Day 1 pre-dose values. Based on these results, a 50% test substance concentration was selected for the main study.
- Lymph node proliferation response: no measurement
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Lymph node cell proliferative responses were measured.
- Criteria used to consider a positive response: The results were expressed as disintegration per minute (dpm) for each animal and for each dose group. Stimulation indices (SI) were calculated according to the following formula: SI = dpm of treated group / dpm of control group. The test item was considered as a skin sensitizer when the SI for a dose group is higher than or equal to 3.
TREATMENT PREPARATION AND ADMINISTRATION
The test item was prepared in the vehicle at the chosen concentrations. All dosage form preparations were prepared within 4 hours prior to each treatment. On days 1, 2 and 3, a dose-volume of 25 μL of the control or dosage form preparations was applied to the dorsal surface of both ears. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Not performed.
Results and discussion
- Positive control results:
- The most recent check with Alpha-hexylcinnamicaldehyde showed that the calculated EC3 value was found to be in the acceptable range of 4.8 and 19.5%.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: The SI value calculated for the 50% test substance concentration was 1.5.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: The mean DPM/animal value for the experimental group treated with a 50% test substance concentration was 319. The mean DPM/animal value for the vehicle control group was 219 DPM.
Any other information on results incl. tables
No irritation of the ears was observed in any of the animals examined. No mortality occurred and no clinical signs of systemic toxicity were observed in the animals of the main study. Body weights and body weight gain of experimental animals remained in the same range as controls over the study period. All auricular lymph nodes of the animals of the experimental and control groups were considered normal in size. No macroscopic abnormalities of the surrounding area were noted in any of the animals.
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.
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