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EC number: 813-618-8 | CAS number: 1269400-04-5
- 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 corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25th August 2011 to 2nd November 2011
- 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
- Guideline:
- other: European Community (EC). Commission regulation (EC) No. 440/2008, Part B: Methods for the Determination of Toxicity and other health effects, Guideline B.40 BIS: "In Vitro Skin Corrosion: Human Skin Model Test". Official Journal of the European Union No.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- GLP compliance:
- yes
Test material
- Reference substance name:
- N'-(2-Cyano-5-methoxy-4-nitrophenyl)-N,N-dimethylimidoformamide
- EC Number:
- 813-618-8
- Cas Number:
- 1269400-04-5
- Molecular formula:
- C11H12N4O3
- IUPAC Name:
- N'-(2-Cyano-5-methoxy-4-nitrophenyl)-N,N-dimethylimidoformamide
- Test material form:
- solid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- Recommended test system in international guidelines (OECD and EC).
- Vehicle:
- water
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm Skin Model (EPI-200)
- Tissue batch number: Lot no.:15619 kit N
-- Date of initiation of testing: 12 September 2011
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37.0 - 37.4°C
REMOVAL OF TEST MATERIAL AND CONTROLS
-the tissues were washed with phosphate buffered saline (Invitrogen Corporation, Breda, The Netherlands) to remove residual test substance
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 ml MTT solution (1 mg/ml in PBS).
- Incubation time: approximately 1 hour
- Spectrophotometer: TECAN Infinite® M200 Pro Plate Reader
- Wavelength: 540 nm
NUMBER OF REPLICATE TISSUES: 4
PREDICTION MODEL / DECISION CRITERIA:
A test substance is considered corrosive in the skin corrosion test if:
a) The relative mean tissue viability obtained after 3-minute treatment compared to the negative control tissues is decreased below 50%.
b) In addition, a test substance considered non-corrosive (viability 50%) after the 3-minute treatment is considered corrosive if the relative tissue viability after 1-hour treatment with the test substance is decreased below 15%.
A test substance is considered non corrosive in the in vitro skin corrosion test if:
a) The relative mean tissue viability obtained after the 3-minute treatment compared to the negative control tissues is not decreased below 50%.
b) In addition, the relative tissue viability after the 1-hour treatment is not decreased below 15%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- Twenty-five mg of PF-05188294 was applied directly on top of the skin tissue. PF-05188294 was spread to match the size of the tissue.
- Duration of treatment / exposure:
- 3 minutes and 1 hour
- Number of replicates:
- Four
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 hour, mean
- Value:
- 96
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 minute, mean
- Value:
- 94
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- PF-05188294 is not corrosive in the in vitro skin corrosion test under the experimental conditions described in this report.
- Executive summary:
In vitro skin corrosion test with PF-05188294 using a human skin model.
This report describes the ability of PF-05188294 to induce skin corrosion on a human three dimensional epidermal model (EpiDerm (EPI-200)). The possible corrosive potential of PF-05188294 was tested through topical application for 3 minutes and 1 hour.
The study procedures described in this report were based on the most recent OECD and EC guidelines.
Batch E010011212 of PF-05188294 was an orange powder with a purity of 99.7%. Skin tissue was moistened with 25 μl of Milli-Q water and 25 mg of PF-05188294 was applied directly on top of the skin tissue.
The positive control had a mean relative tissue viability of 18% after 3 minutes exposure. The absolute mean OD540 (optical density at 540 nm) of the negative control tissues after 3 minutes exposure was within the laboratory historical control data range. The maximum inter-tissue variability in viability between two tissues treated identically was less than 24% and the maximum difference in percentage between the mean viability of two tissues and one of the two tissues was less than 14%, indicating that the test system functioned properly.
Skin corrosion is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after 3-minute and 1-hour treatments with PF-05188294 compared to the negative control tissues was 94% and 96%, respectively. Because the mean relative tissue viability for PF-05188294 was not below 50% after the 3-minute treatment and not below 15% after the 1-hour treatment PF-05188294 is considered to be not corrosive.
Finally, it is concluded that this test is valid and that PF-05188294 is not corrosive in the in vitro skin corrosion test under the experimental conditions described in this report.
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