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EC number: 638-734-4 | CAS number: 157248-24-3
- 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:
- weight of evidence
- Study period:
- 2011-01-11 to 2011-03-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
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:
- 2009
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 2010
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-ethoxy-2,3-difluoro-4'-propyl-1,1'-biphenyl
- EC Number:
- 638-734-4
- Cas Number:
- 157248-24-3
- Molecular formula:
- C₁₇H₁₈F₂O
- IUPAC Name:
- 4-ethoxy-2,3-difluoro-4'-propyl-1,1'-biphenyl
- Test material form:
- solid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: not specified
- Justification for test system used:
- The test system used is a established standard model for in vitro skin irritation testing.
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- The test item was not dissolved in a vehicle. However, the tissue surface was wetted with 10 µL deionised water before application.
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: The applied human in vitro skin model RHE was produced by SkinEthic Laboratories (Lyon, France).
- Tissue batch number: 11022A0209
No further details were specified.
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature
- Temperature of post-treatment incubation: 37 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: 1, using at least 25 mL PBS
- Observable damage in the tissue due to washing: not specified
- Modifications to validated SOP: no
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1.0 mg/L
- Incubation time: 3 h +/- 5 min
- Spectrophotometer: plate spectrophotometer, not further specified
- Wavelength: 570 nm
No further details were specified.
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
No details were specified.
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
The pretest for MTT-reducing capacity of the test item showed that the test item did not reduce MTT. Therefore, no controls were used.
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be irritant to skin if the mean tissue viability is equal or less than 50 %.
- The test substance is considered to be non-irritant to skin if the mean tissue viability is more than 50 %. - Control samples:
- yes, concurrent negative control
- yes, concurrent vehicle
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied: 16 mg
NEGATIVE CONTROL
- Amount applied: 16 µL
POSITIVE CONTROL
- Amount applied: 16 µL
- Concentration: 5 % in deionised water - Duration of treatment / exposure:
- 42 +/- 1 min
- Duration of post-treatment incubation (if applicable):
- 42 +/- 1 h
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean value
- Value:
- 126.44
- Vehicle controls validity:
- not examined
- 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: Not specified
- Direct-MTT reduction: MTT was not reduced by the test item.
- Colour interference with MTT: No change in color observed.
DEMONSTRATION OF TECHNICAL PROFICIENCY: Not specified
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes. The optical density of negative control (mean value: 1.822 +/- 0.06 %) was >= 1.2 and standard deviation was <= 18 %.
- Acceptance criteria met for positive control: Yes. The relative cell viability of the positive control (mean value: 1.51, standard deviation 0.21 %) was < 40 % and standard deviation was <= 18 %.
- Acceptance criteria met for variability between replicate measurements: Yes. The standard deviation of 6.88 was <= 18 %.
Any other information on results incl. tables
Group | Time / [min] | Mean OD | Mean Relative viability / [%] |
Negative Control | 42 | 1.822 | 100 |
Positive Control | 42 | 0.028 |
1.51 |
Test Material |
42 |
2.303 |
126.44 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item showed no skin irritation potential.
- Executive summary:
The objective of the present study was to investigate potential of the test material to induce skin irritation in an in vitro human skin model. The test conducted according to OECD 439 consisted of a topical exposure of the test item to a human reconstructed skin model followed by a cell viability test. Cell viability was quantitatively measured by dehydrogenase conversion of MTT into a blue formazan salt after extraction from tissues. The percent reduction of cell viability in comparison to untreated negative controls was used to predict the skin irritation potential. Triplicates of the human skin RHE-model were treated with the test material, the negative or the positive control for 42 minutes (± 1 minute). 16 µL of either the negative control (PBS-buffer) or the positive control (5 % aqueous solution of sodium dodecyl sulfate) were applied to the tissues. Before adding the solid test item, 10 µL of deionised water was spread to the epidermis surface to improve the contact between the test item and the epidermis. Afterwards, 16 mg of the test item were applied to the tissues. After treatment with the negative control the mean OD was 1.822 and thus >1.2. Treatment with the positive control revealed a mean viability value of 1.51 % (study acceptance criteria: < 40 %). Therefore, the study fulfilled the validity criteria. The mean tissue viability after treatment with the test material was 126.44 %, clearly exceeding 50 %. Therefore, the test material is considered as non-irritant to the skin in this in vitro assay.
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