540-17). 

This study was designed to be compatible with the procedures indicated by the following 

internationally accepted guidelines and recommendations: 

• OECD Guidelines for the Testing of Chemicals No. 404 "Acute Dermal 

Irritation/Corrosion" (adopted 24 April2002) 

• Method B4 Acute Toxicity (Skin Irritation) of Commission Regulation (EC) No. 

440/2008 

Initial considerations 

In the absence of data suggesting that the test item was unlikely to produce severe 

irritation/corrosion, an ex vivo pre-screen test, the Transcutaneous Electrical Resistance Assay, 

was performed. The results of the pre-screen test indicated that the test item was considered not 

to be corrosive to the skin and the in vivo test was performed. The results of the Transcutaneous 

Electrical Resistance Assay are given in the Appendix. 

Experimental Starting Date: 

Experimental Completion Date: 

04 June 2014 

11 July 2014 

Test item characterization data are the responsibility of the Sponsor. 

All raw data will be retained inL..Ic_8_1 _______________ __. 
RESULTS 

Individual skin reactions following the 3-Minute and 1-Hour exposure periods are given in 

Table 1 and individual skin reactions following a 4-Hour exposure period are given in Table 2. 

3-Minute and 1-Hour semi-occluded applications of the test item to the intact skin of one rabbit 

produced no evidence of skin irritation. 

A single 4-Hour, semi occluded application of the test item to the intact skin of two rabbits 

produced no evidence of skin irritation. 

CONCLUSION 

The test item produced a primary irritation index of 0.0 and was classified as non-irritant to 

rabbit skin according to the Draize classification scheme. No corrosive effects were noted. 

1 Hour 0 0 

Erythema/Eschar 24 Hours 0 0 Formation 

48 Hours 0 0 

72 Hours 0 0 

Immediately 0 0 

1 Hour 0 0 

Edema Formation 24 Hours 0 0 

48 Hours 0 0 

72 Hours 0 0 
(

) 

Erythema/Eschar 24 Hours 0 0 0 Fonnation 

48 Hours 0 0 (O) 

72 Hours 0 0 0 

Immediately 0 0 (0) 

1 Hour 0 0 (0) 

Edema Fonnation 24 Hours 0 0 0 

48 Hours 0 0 (O) 

72 Hours 0 0 0 

Sum of24 and 72-Hour Readings (S) : 0 

Primary Irritation Index (S/4) 0/6 = 0.0 

Classification NON-IRRITANT 

Primary Irritation Classification Index 

0 Non-irritant 

>0-2 Mild initant 

>2-5 Moderate irritant 

>5-8 Severe irritant 

( ) = Total values not used for calculation of primary irritation index 
Methods 

The prepared pelt from the rat was used for skin disc preparation. The integrity of the pelt was 

confirmed using a Quality Control test. Only acceptable pelts were used to supply skin discs for 

use in the assay. 

The test item was applied to the epidermal surface of three skin discs for a contact period of 

24 hours. At the end of the contact period the test item was removed using a jet of warm tap 

water. Corrosive substances produce an irreversible loss of normal stratum corneum integrity 

and function, this is measured as a reduction in the inherent transcutaneous electrical resistance. 

Test items that give a mean electrical resistance of 5 kn or less are considered likely to be 

corrosive in vivo. The transcutaneous electrical resistance was measured using a low voltage 

alternating current electronic databridge. 

Results 

The results are summarized as follows: 

Test Item Contact Period Mean Electrical Resistance (Standard Deviation) 

24 Hours 14.2 kn (± 1.3) 

Conclusion 

Following assessment of the data the test item was considered unlikely to have the potential to 

cause corrosion in vivo.