Registration Dossier
Registration Dossier
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EC number: 951-622-2 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 3rd Dec 2018 - 7th Dec 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Qualifier:
- according to guideline
- Guideline:
- other: EC Guideline 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. L142, 31 May 2008.
- GLP compliance:
- yes
Test material
- Reference substance name:
- cis-N-hydroxy-3-[methyl(1H-pyrrolo[2,3-d]pyrimidin- 4-yl)amino]cyclobutanecarboxamide
- EC Number:
- 951-622-2
- Molecular formula:
- C12H15N5O2
- IUPAC Name:
- cis-N-hydroxy-3-[methyl(1H-pyrrolo[2,3-d]pyrimidin- 4-yl)amino]cyclobutanecarboxamide
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Duration of treatment / exposure:
- 3 minutes - 1 hour
- Number of replicates:
- The test was performed on a total of 4 tissues per test item together with a negative control and positive
control. Two tissues were used for a 3-minute exposure to PF-07085579 and two for a 1-hour
exposure.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3-minute application viability (percentage of control)
- Value:
- ca. 102
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1-hour application viability (percentage of control)
- Value:
- ca. 87
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The relative mean tissue viability
obtained after the 3-minute and 1-hour treatments with PF-07085579 compared to the
negative control tissues was 102% and 87% respectively. Because the mean relative tissue
viability for PF-07085579 was not below 50% after 3 minutes treatment and not below 15%
after 1 hour treatment PF-07085579 is considered to be not corrosive.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- In conclusion, PF-07085579 is not corrosive in the in vitro skin corrosion test under the experimental conditions described in this report.
- Executive summary:
Corrosion on a human three dimensional epidermal model (EpiDerm (EPI-200)). The
possible corrosive potential of PF-07085579 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.
Skin tissue was moistened with 25 µL of Milli-Q water and at least 25 mg of PF-07085579 was applied directly on top of the skin
tissue. The positive control had a mean relative tissue viability of 4.1% after the 1-hour exposure.
The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was
within the acceptance limits of OECD 431 (lower acceptance limit ≥0.8 and upper acceptance
limit <_ 2.8) and the laboratory historical control data range. In the range of 20 - 100%
viability the Coefficient of Variation between tissue replicates was <_ 15%, 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-07085579 compared to the negative control tissues was 102% and 87%, respectively.
Because the mean relative tissue viability for PF-07085579 was not below 50% after the
3-minute treatment and not below 15% after the 1-hour treatment PF-07085579 is considered
to be not corrosive.
In conclusion, PF-07085579 is not corrosive in the in vitro skin corrosion test under the
experimental conditions described in this report.
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