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EC number: 606-647-0 | CAS number: 208338-50-5
- 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
- Study period:
- September 29, 2017 - December 12, 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- Commission Regulation (EU) No. 640/2012 amending, for the purpose of its adaption to technical progress, Regulations (EC) No. 440/2008 laying down test methods pursuant to Regulation (EC) No. 1907/2006 of the European Parliament and the council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- July 28, 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Skinethic skin irritation test -42bis Standard operating procedure (SOP) 2009
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (trans,trans)-5-{(4-Propyl[1,1-bicyclohexyl]-4-yl)-difluormethoxy}-1,2,3-trifluorbenzene
- EC Number:
- 606-647-0
- Cas Number:
- 208338-50-5
- Molecular formula:
- C₂₂H₂₉F₅O
- IUPAC Name:
- (trans,trans)-5-{(4-Propyl[1,1-bicyclohexyl]-4-yl)-difluormethoxy}-1,2,3-trifluorbenzene
Constituent 1
- Specific details on test material used for the study:
- Designation: Art. 274554 (CCQU-3-F)
Substance: CCQU-3-F (IS-8330) Licristal
Batch No.: D017086154
Article No.: 274554
CAS-No.: 208338-50-5
Appearance: White, solid
Purity (GC): 99.97%
Date of release:August 21, 2017
Expiry Date: August 31, 2019
Storage Conditions: +5°C to +30°C
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
No pre-treatment; the test item was applied undiluted.
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from a single donor
- Justification for test system used:
- standard model
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- No vehicle used in this study; The test item was applied neat to the tissues.
- Details on test system:
- CELL CULTURE
- Supplier: EpiSkin/SkinEthic Laboratories, Lyon, France)
- Source: human keratinocytes cultured on a polycarbonate filter in conditions which permit their terminal differentiation
- Format: 24 well plate
- Batch: 17-RHE-116
- Expires: November 20, 2017
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment: room temperature
- Temperature of post-treatment incubation: 37°C
REMOVAL OF THE TEST MATERIAL AND CONTROL
After the end of the treatment interval, the residual test item was removed immediately by gently rinsing with a minimum volume of 25 mL DPBS using a pipette. Excess DPBS was removed by gently shaking the inserts and blotting the bottom with blotting paper.
DYE BINDING METHOD
- Dye used in the dye-binding assay: MTT
- Spectrophotometer:ELx800, BioTek Instruments GmbH, Bad Friedrichshall, Germany at 570 nm - Control samples:
- yes, concurrent negative control
- Amount/concentration applied:
- TEST MATERIAL: 16 mg of solid test material
NEGATIVE CONTROL: 16 µL (Dulbecco`s Phosphate-Buffered Saline)
POSITIVE CONTROL: 16 µL (5% aqueous solution of sodium dodecyl sulfate in deionised water) - Duration of treatment / exposure:
- 42 min (± 1 minute)
- Duration of post-treatment incubation (if applicable):
- 42 hours (± 1 hour)
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Experiment 1 / Run 1
- Value:
- 91.7
- Vehicle controls validity:
- not applicable
- Remarks:
- The test item was applied neat to the tissues
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: none
- Direct-MTT reduction: none
- Colour interference with MTT: none
ACCEPTANCE OF RESULTS:
Acceptability of the Quality Control Data of the Skin Model with Reference to Historical Batch Data:
Acceptance Criterion Result
Negative control OD ≥ 0.8 and ≤ 3.0 1.729 to 1.961
Acceptability of the Positive and Negative Control stated by Episkin/SkinEthic Laboratories:
Acceptance Criterion Result
Mean OD negative control ≥ 1.2 1.829
Mean viability positive control < 40% 0.9%
SD of group-mean value ≤ 18% 0.0% (positive control)
6.5% (negative control)
Acceptability of the Positive and Negative Control based on Historical Data of the Testing Laboratory:
Acceptance Criterion Result
Mean OD negative control ≥ 1.455 1.829
Mean viability positive control ≤ 2.97% 0.9%
Test Item Data Acceptance Criteria:
Acceptance Criterion Result
SD of group-mean value ≤ 18% 6.4%
The study met all acceptance criteria.
Any other information on results incl. tables
Group | Time / [min] | Mean OD | Mean Relative viability / [%] |
Negative Control | 42 | 1.829 | 100 |
Positive Control | 42 | 0.017 |
0.9 |
Test Material |
42 |
1.777 |
97.1 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- UN GHS: No Caterory (according to OECD TG 439)
- Conclusions:
- This study was performed according to GLP and the methods applied are fully compliant with OECD TG 439. Under the conditions of the present study, the test item Art. 274554 (CCQU-3-F) is not considered to possess an irritant potential to skin (UN GHS: No Category).
- Executive summary:
This study was performed according to GLP and the methods applied are fully compliant with OECD TG 439. Under the conditions of the present study, the test item Art. 274554 (CCQU-3-F) is not considered to possess an irritant potential to skin (UN GHS: No Category).
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