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EC number: 938-723-7 | CAS number: 1688656-88-3
- 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 corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 November 2015 to 20 November 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-amino-1-methyl-3-propyl-1H-pyrazole-5-carboxamide hydrochloride
- EC Number:
- 938-723-7
- Cas Number:
- 1688656-88-3
- Molecular formula:
- C8H14N4O.HCL
- IUPAC Name:
- 4-amino-1-methyl-3-propyl-1H-pyrazole-5-carboxamide hydrochloride
- Test material form:
- solid: particulate/powder
- Details on test material:
- Batch 2000533289
Purity/Composition 100.2%
Constituent 1
- Specific details on test material used for the study:
- Batch 2000533289 (taken from label) Purity/Composition 100.2% Test item storage At room temperature Stable under storage conditions until 03 November 2019 (expiry date) (taken from label)
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: MatTek Corporation, Ashland MA, U.S.A.
- Justification for test system used:
- Recommended test system in international guidelines (OECD and EC).
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- Tissues On the day of receipt the tissues were kept on agarose and stored in the refrigerator. On the next day, at least one hour before starting the assay the tissues were transferred to 6-well plates with 0.9 ml DMEM medium.
DMEM (Dulbecco’s Modified Eagle’s Medium) Supplemented DMEM medium, serum-free supplied by MatTek Corporation and Life Technologies.
MTT medium MTT concentrate (5 mg/ml) diluted (1:5) with MTT diluent (supplemented DMEM). Both supplied by MatTek Corporation.
Environmental conditions All incubations, with the exception of the test item incubation of 3 minutes at room temperature, were carried out in a controlled environment, in which optimal conditions were a humid atmosphere of 80 - 100% (actual range 62 - 83%), containing 5.0 ± 0.5% CO2 in air in the dark at 37.0 ± 1.0°C (actual range 36.1 - 37.3°C). Temperature and humidity were continuously monitored throughout the experiment. The CO2 percentage was monitored once on each working day. Temporary deviations from the temperature, humidity and CO2 percentage may occur due to opening and closing of the incubator door. Based on laboratory historical data these deviations are considered not to affect the study integrity. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- Approximately 25 mg of PF-01049573-01; UK-084443-01 was applied directly on top of the skin tissue.
- Duration of treatment / exposure:
- 3-minute and 1-hour treatments
- Number of replicates:
- 3
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 MINUTE EXPOSURE
- Value:
- ca. 82
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 HOUR EXPOSURE
- Value:
- ca. 88
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- PF-01049573-01; UK-084443-01 was checked for colour interference in aqueous conditions and possible direct MTT reduction by adding the test item to MTT medium. Because the solutions did not turn blue / purple nor a blue / purple precipitate was observed it was concluded that PF-01049573-01; UK-084443-01 did not interfere with the MTT endpoint.
The relative mean tissue viability obtained after the 3-minute and 1-hour treatments with PF-01049573-01; UK-084443-01 compared to the negative control tissues was 82% and 88% respectively. Because the mean relative tissue viability for PF-01049573-01; UK-084443-01 was not below 50% after 3 minutes treatment and not below 15% after 1 hour treatment PF-01049573-01; UK-084443-01 is considered to be not corrosive.
The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the laboratory historical control data range. The mean relative tissue viability following 3-minute exposure to the positive control was 6%. The maximum inter-tissue variability in viability between two tissues treated identically was less than 15% and the maximum difference in percentage between the mean viability of two tissues and one of the two tissues was less than 8%. It was therefore concluded that the test system functioned properly.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Finally, it is concluded that this test is valid and that PF-01049573-01; UK-084443-01 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-01049573 -01; UK-084443-01 using a human skin model.
This report describes the ability of PF-01049573-01; UK-084443-01 to induce skin corrosion on a human three dimensional epidermal model (EpiDerm (EPI-200)). The possible corrosive potential of PF-01049573-01; UK-084443-01 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 2000533289 of PF-01049573-01; UK-084443-01 was a white powder with a purity of 100.2%. Skin tissue was moistened with 25 Nl of Milli-Q water and approximately 25 mg of PF-01049573 -01; UK-084443-01 was applied directly on top of the skin tissue.
The positive control had a mean relative tissue viability of 6% after 3 minutes exposure. The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the laboratory historical control data range. The acceptability criteria for the maximum inter-tissue variability in viability between two tissues treated identically and the maximum difference in percentage between the mean viability of two tissues and one of the two tissues were met, indicating that the test system functioned properly.
Skin corrosion is expressed as the remaining cell viability after exposure to the test item. The relative mean tissue viability obtained after 3-minute and 1-hour treatments with PF-01049573-01; UK-084443-01 compared to the negative control tissues was 82% and 88%, respectively. Because the mean relative tissue viability for PF-01049573-01; UK-084443-01 was not below 50% after the 3-minute treatment and not below 15% after the 1-hour treatment PF-01049573-01; UK-084443-01 is considered to be not corrosive.
Finally, it is concluded that this test is valid and that PF-01049573-01; UK-084443-01 is not corrosive in the in vitro skin corrosion test under the experimental conditions described in this report.
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