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EC number: 613-982-6 | CAS number: 66742-57-2
- 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:
- 02 OCT 2014 - 29 JAN 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 26 July 2013
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hess. Ministerium für Unwelt, Energie, Landwirtschaft und Verbraucherschutz, Mainzer Straße 80, D-65189 Wiesbaden (18 November 2014)
Test material
- Reference substance name:
- 4-[(3-fluorophenyl)methoxy]benzaldehyde
- EC Number:
- 613-982-6
- Cas Number:
- 66742-57-2
- Molecular formula:
- C14H11FO2
- IUPAC Name:
- 4-[(3-fluorophenyl)methoxy]benzaldehyde
- Test material form:
- solid: crystalline
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: The RHE™-model was obtained by culturing adult human keratinocytes on a polycarbonate filter under conditions which permit their terminal differentiation and the reconstruction of an epidermis with a functional horny layer.
- Justification for test system used:
- To reduce animal testing, this alternative in vitro method was used. The human skin RHE™-model closely mimics the biochemical and physiological properties of the upper parts of the human skin, i.e the epidermis.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: RHE™-model (SkinEthic Laboratories, Lyon, France)
- Tissue batch number(s): 14-RHE-024
- Expiration date: October 27, 2014
- Date of initiation of testing: October 22, 2014
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature
- Temperature of post-treatment incubation (if applicable): 37°C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume and number of washing steps: Using a multi pipette the tissues were gently rinsed with a minimum volume of 25 mL DPBS to remove any residual test item. Excess DPBS was removed by gently shaking the inserts and blotting the bottom with blotting paper.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 h
- Spectrophotometer: microplate reader (ELx800, BioTek Instruments GmbH, Bad Friedrichshall, Germany)
- Wavelength: 570 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: OD=1.286 (±0.076) (Acceptance criterion: OD > 0.7)
- Barrier function: 5.7 h (Acceptance criterion: 4.0 h <= ET50 <= 10.0 h)
- Morphology: Well differentiated epidermis consisting of basal, spinous, granular layers and a stratum corneum. 6 viable cell layers present. Absence of significant histological abnormalities.
NUMBER OF REPLICATE TISSUES: 3
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 viability after 42 minutes exposure is less than or equal to 50%.
- The test substance is considered to be non-irritant to skin if the viability after 42 minutes exposure is greater than 50%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 16 mg
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 16 µL
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 16 µL
- Concentration (if solution): 5 % - Duration of treatment / exposure:
- 42 min
- Duration of post-treatment incubation (if applicable):
- 42 h
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean relative viability
- Value:
- 78.43
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- ACCEPTANCE OF RESULTS:
The negative control OD values were 2.445, 2.588 and 2.510 and, thus, in the range of >= 0.8 and <= 3.0.
- Acceptance criteria met for negative control: After treatment with the negative control (DPBS-buffer) the mean OD was 2.515 (standard deviation: 2.85%) and, thus, higher than the historically established boundary of 1.383.
- Acceptance criteria met for positive control: After treatment with the positive control (5% aqueous solution of sodium dodecyl sulfate) the mean viability value was 0.83% (standard deviation: 2.77%) and, thus, lower than the historically established boundary of 3.60%.
- Acceptance criteria met for variability between replicate measurements: The standard deviation of the negative control and the positive control was <=18%, respectively. The standard deviation of the three tissues treated with the test item was 7.97% and, thus, <= 18%.
Any other information on results incl. tables
A table of the results is attached under 'Attached background material'.
Applicant's summary and conclusion
- Interpretation of results:
- other: EU GHS criteria not met
- Conclusions:
- The tissue viability after treatment with the test item was higher than 50% (mean viability: 78.43%). Therefore, the test item is not considered to possess an irritant potential to skin.
- Executive summary:
This in vitro study was performed according to OECD Guideline 439 (Reconstructed Human Epidermis Test) following GLP. The test 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 item, the negative or the positive control for 42 minutes (± 1 minute). 16 µL of either the negative control (DPBS-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 (DPBS-buffer) the mean OD was 2.515. Treatment with the positive control (5% aqueous solution of sodium dodecyl sulfate) revealed a mean viability value of 0.83%. Therefore, the study fulfilled the validity criteria. The tissue viability after treatment with the test item was 78.43% and, thus, higher than 50%, i.e. according to UN GHS classification the test item is considered as non-irritant to skin.
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