Registration Dossier

Administrative data

skin irritation / corrosion
in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18 October to 19 October 2007
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study in accordance with a recognised test method

Data source

Reference Type:
study report
Report Date:

Materials and methods

Test guidelineopen allclose all
according to
EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
according to
other: OECD Guideline 431 (adopted 13 April 2004)
GLP compliance:

Test material

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 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

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.