Registration Dossier
Registration Dossier
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EC number: 951-622-2 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12th Nov 2018 - 13th Nov 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- 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
Test animals / tissue source
- Species:
- cattle
Test system
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- ince no workable suspension of PF-07085579 in physiological saline could be obtained, the test item was used as delivered by the sponsor and added pure on top of the corneas
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Duration of treatment / exposure:
- 240 ± 10 minutes
at 32 ± 1°C.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- Mean Opacity
- Value:
- ca. -2.1
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- other: Mean Permeability
- Run / experiment:
- Mean Permeability
- Value:
- ca. 0.069
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Mean in vitro irritation score
- Value:
- ca. -1.1
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The negative control responses for opacity and permeability were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on
the corneas. The mean in vitro irritancy score of the positive control (20% (w/v) Imidazole) was 140 and within two standard deviations of the current historical positive control mean. It was therefore concluded that the test conditions were adequate and
that the test system functioned properly. PF-07085579 did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of -1.1 after 240 minutes of treatment.
In conclusion, since PF-07085579 induced an IVIS ≤ 3, no classification is required for eye irritation or serious eye damage. - Executive summary:
The objective of this study was to evaluate the eye hazard potential of PF-07085579 as measured by its ability to induce opacity and increase permeability in an isolated bovine
cornea using the Bovine Corneal Opacity and Permeability test (BCOP test). This report describes the potency of chemicals to induce serious eye damage using isolated
bovine corneas. The eye damage of PF-07085579 was tested through topical application for approximately 240 minutes.
The study procedures described in this report were based on the most recent OECD guideline. Batch GR13449 of PF-07085579 was a white solid with a purity of 100%. Since no workable
suspension in physiological saline could be obtained, the test item was used as delivered and added pure on top of the corneas.
The negative control responses for opacity and permeability were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on
the corneas. The mean in vitro irritancy score of the positive control (20% (w/v) Imidazole) was 140 and within two standard deviations of the current historical positive control mean. It
was therefore concluded that the test conditions were adequate and that the test system functioned properly.
PF-07085579 did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of -1.1 after 4 hours of treatment.
In conclusion, since PF-07085579 induced an IVIS ≤ 3, no classification is required for eye irritation or serious eye damage.
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