[No public or meaningful name is available]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion

Remarks:

in vitro

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18 October to 19 October 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study in accordance with a recognised test method

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: OECD Guideline 431 (adopted 13 April 2004)

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 January 2008
- Stability under test conditions: stable
- Storage condition of test material: in refrigerator (2-8°C) in the dark

Test animals

Details on test animals or test system and environmental conditions:

Not applicable in vitro test conducted

Results and discussion

Any other information on results incl. tables

The mean absorption at 540 nm measured after treatment with PF-00346643 and controls are presented in Table 1 (see attached background information). The individual OD₅₄₀ measurements are presented in Appendix l (see attached background information).

Table 2 (see attached background information) shows the mean tissue viability obtained after 3 minutes and 1 hour treatment with PF-00346643 compared to the negative control tissues. Skin corrosion is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after 3 minutes and 1 hour treatment with PF-00346643 compared to the negative control tissues was 106% and 108% respectively. Since the mean relative tissue viability for PF-00346643 was not below 50% after 3 minutes treatment and not below 15% after 1 hour treatment PF-00346643 is considered to be not corrosive.

The absolute mean OD₅₄₀ (optical density at 540 nm) of the negative control tissues was within the laboratory historical control data range (See appendix ll in attached background information). The mean relative tissue viability of the 3 minutes exposure of the positive control was 7%. The maximum inter tissue variability in viability between two tissues treated identically was less than 10% and the maximum difference in percentage between the mean viability of two tissues and one of the two tissues was less than 5%. It was therefore concluded that the test system functioned properly.

Historical control data for in vitro skin corrosion studies is given in Appendix II (see attached background information)

Applicant's summary and conclusion

Conclusions:

It is concluded that this test is valid and that PF-00346643 is not corrosive in the in vitro skin corrosion test under the experimental conditions described in this report.