Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24 October 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study conducted in acccordance with recognised guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Principles of method if other than guideline:
Screening for the eye irritancy potential of PF-00346643 using the Bovine Corneal Opacity and Permeability test (BCOP test). This report describes the ocular irritation properties of PF-00346643 on an isolated bovine cornea. The possible ocular irritancy of PF-00346643 was tested through topical application for 10 minutes.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): PF-00346643
- Substance type: pure substance
- Physical state: pale yellow oil
- Analytical purity: 88.9%
- Lot/batch No.: 115565-67-1
- Expiration date of the lot/batch: 31 May 2008
- Stability under test conditions: stable
- Storage condition of test material: in a refrigerator (2-8°C) in the dark

Test system

Vehicle:
unchanged (no vehicle)
Duration of treatment / exposure:
10 minutes
Observation period (in vivo):
Observation/measurements in the study were recorded electronically using Multiskan spectrum version 1.00 for optical density measurement.

Results and discussion

Any other information on results incl. tables

Table 1 Summary of opacity, permeability and in vitro scores

Treatment

Mean Opacity1

Mean Permeability1

Mean in vitro irritation Score 1,2

Negative control

0(0)

0.000 (0.004)

0.0 (0.1)

Positive control

87

4.400

153.3

PF-00346643

2

-0.001

2.0

 1

Negative control corrected values (between brackets uncorrected values) Calculated using the negative control mean opacity and mean permeability values.

2

The uncorrected individual in vitro irritancy scores for the negative controls ranged from 0.0 to 0.1. The individual positive control in vitro irritancy scores ranged from 136.1 to 172.4

The corneas treated with PF-00346643 showed an opacity value of 2 and a permeability value ranging from -0.002 to -0.001. Hence, the in vitro irritancy score of all corneas was 2.0 after 10 minutes of treatment with PF-00346643.

See background material section for detailed results tables.

Applicant's summary and conclusion

Conclusions:
The test is valid and PF-00346643 is non irritant in the Bovine corneal Opacity and Permeability test under the experimental conditions described.