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EC number: 617-365-2 | CAS number: 82597-69-1
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Experimental start date: 16 November 2017; Experimental termination date: 17 November 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- 2016
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Potassium (1R,3R)-3-[(1Z)-2-chloro-3,3,3-trifluoroprop-1-en-1-yl]-2,2-dimethylcyclopropanecarboxylate and Potassium (1S,3S)-3-[(1Z)-2-chloro-3,3,3-trifluoroprop-1-en-1-yl]-2,2-dimethylcyclopropanecarboxylate
- Cas Number:
- 82597-69-1
- Molecular formula:
- C9 H10 Cl F3 O2 . K
- IUPAC Name:
- Potassium (1R,3R)-3-[(1Z)-2-chloro-3,3,3-trifluoroprop-1-en-1-yl]-2,2-dimethylcyclopropanecarboxylate and Potassium (1S,3S)-3-[(1Z)-2-chloro-3,3,3-trifluoroprop-1-en-1-yl]-2,2-dimethylcyclopropanecarboxylate
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature in the dark
In vitro test system
- Test system:
- human skin model
- Remarks:
- https://www.mattek.com/products/epiderm/
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: epithelial, derived from human skin
- Source strain:
- not specified
- Justification for test system used:
- This model incorporates several features, which make it advantageous in the study of potential dermal corrosivity
- Details on test system:
- Duplicate tissues were treated with the test item for exposure periods of 3 and 60 minutes. Negative and positive control groups were treated for each exposure period. At the end of the exposure period the test item was rinsed from each tissue before each tissue was taken for MTT loading. After MTT loading each tissue was placed in 2 mL isopropanol for MTT extraction.
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 25 mg of the test item
- Duration of treatment / exposure:
- 3 and 60 minutes.
- Number of replicates:
- Duplicate tissues
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 3 Minute exposure
- Run / experiment:
- Quantitative MTT assessment
- Value:
- 49.6
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Remarks:
- See Table 1
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 60 Minute exposure
- Run / experiment:
- Quantitative MTT assessment
- Value:
- 6.4
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Remarks:
- See Table 1
Any other information on results incl. tables
- Potential direct reduction of MTT by the test item was controlled. Experiment showed that MTT is not directly reduced by the test substance.
- The test item was colourless in solution in water. Therefore, it was considered that the test item does not cause colour interference in the test.
TABLE 1 Mean OD570Values and Viabilities for the Negative Control Item, Positive Control Item and Test Item
Tissue |
Exposure Period (minute) |
Mean OD570of individual tissues |
Mean OD570of duplicate tissues |
Standard Deviation |
Coefficient of Variation |
Relative Mean Viability (%) |
Negative Control |
3 |
1.683 |
1.805 |
0.173 |
9.6 |
100* |
1.927 |
||||||
60 |
1.860 |
1.715 |
0.205 |
12.0 |
||
1.570 |
||||||
Positive Control |
3 |
0.087 |
0.076 |
0.016 |
na |
4.2 |
0.065 |
||||||
60 |
0.056 |
0.056 |
0.000 |
na |
3.3 |
|
0.056 |
||||||
Test Item |
3 |
0.936 |
0.896 |
0.057 |
6.3 |
49.6 |
0.856 |
||||||
60 |
0.107 |
0.110 |
0.004 |
na |
6.4 |
|
0.113 |
* The mean % viability of the negative control tissue is set at 100%
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Remarks:
- This meets the criteria for classification as UN GHS H314 Combination of sub categories 1B and 1C.
- Conclusions:
- The mean percent cell viability for the Test Item at 3 and 60 minutes was 49.6% and 6.4%, respectively, therefore under the conditions of this assay the test item was considered to be corrosive to the skin. This meets the criteria for classification as UN GHS H314 Combination of sub categories 1B and 1C.
- Executive summary:
The purpose of this test is to evaluate the skin corrosivity potential of the test item using the EpiDerm™ Human Skin Model after treatment periods of 3 and 60 minutes.
Corrosion is directly related to cytotoxicity in the EpiDerm™ tissue. Cytotoxicity is determined by the reduction of MTT (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide) to formazan by viable cells in the test item treated tissues relative to the corresponding negative control. The results are used to make a prediction of the corrosivity potential of the test item.
Duplicate tissues were treated with the test item for exposure periods of 3 and 60 minutes. Negative and positive control groups were treated for each exposure period. At the end of the exposure period the test item was rinsed from each tissue before each tissue was taken for MTT‑loading. After MTT loading each tissue was placed in 2 mL isopropanol for MTT extraction.
At the end of the formazan extraction period each well was mixed thoroughly and three aliquots of 200 mL were transferred to the appropriate wells of a pre-labelled 96‑well plate. The optical density (OD) was measured at 570 nm (OD570).
Data are presented in the form of percentage cell viability (MTT reduction in the test item treated tissues relative to negative control tissues).
The quality criteria required for acceptance of results in the test were satisfied.
The mean percent cell viability for the Test Item at 3 and 60 minutes was 49.6% and 6.4%, respectively, therefore under the conditions of this assay the test item was considered to be corrosive to the skin. This meets the criteria for classification as UN GHS H314 Combination of sub categories 1B and 1C.
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