StudyTitle Study Director
Test Facility

Sponsor

Internal distribution Study No. FINAL REPORT Flammabilityof according to 92/69/CEE, A.10.

Archives Author.Study No. - Final report


### CONTENTS:

Title page Contents Statement of GLP compliance (Swiss GLP monitoring authorities) Statementof GLP compliance (Study Director) and signatures QualityAssurance Unit Summary 1 . General information 2. Information on the test substance 2.1 . Identity 

### 3. 4. 5. 2.2. Physical-chemical and analytical data General test method Results Conclusion Total number of pages: 10 Page 2/10 Page

1 2 

### 3 4 

### 5 6 7 

### 8 8 8 9-10 10 10Study 

### No. - 

### Final report Page 3/10

The Swiss GLP Monitoring Authorities Swiss Federal Officeof Public Health 

# Statement
It is hereby confirmed that during the period of the following Test Facility of SwissAgencyforthe Environment. Forests and Landscape

March 31 - April 1 , 2005 

# lilntercantonal Office forthe Control of Medicines

was inspected by the Swiss Agency for the Environment, Forests and Landscape with respect to the compliance with the Swiss legislation on Good Laboratory Practice. Test Facility Areas ofexpertise

The inspection was performed in agreement with the OECD Guidelines for National GLP Inspections and Audits. It was found that the aforementioned test facility was operating in compliance with the Swiss Ordinance on Good Laboratory Practice [SR 813.016.51 at the time it was inspected.

Bern, June 2005 Swiss Agencyforthe Environment, Forests and LandscapeStudy No. - Final report Page 4/10
STATEMENTOF COMPLIANCE WITH GOOD LABORATORY PRACTICE: Study No. Test substance Title Flammability of according to 92/69/CEE, A.1 0. This study has been performed in compliance with the Swiss Ordinance relating to Good Laboratory Practice, adopted May 18th, 2005 [RS 813.112.1]. This ordinance is based on the OECD Principles of Good Laboratory Practice, as revised in 1997 and adopted November 26th, 1997 by decision ofthe OECD Council [C(97)186/Final]. The undersigned declare thatthis studywas carried out according to the procedures herein described and this report represents a true and accurate record ofthe results obtained. Study director

Date: I

Test Facility Management:

Date:Study No. - Final report Page 5/10
QUALITY ASSURANCE UNIT STATEMENT Study No. Testsubstance Studytitle Flammability of according to 92/69/CEE. Testfacilities are periodically inspected and the results are reported to the responsible persons and the management. Experimental procedureswere periodically inspected. The study plan and this final report were audited bythe Quality Assurance Unit. The dates are given below:
Dates and Types of QAU inspections March 16, 2007 Study plan March 28, 2007 Process (preliminarytest) Final report Dates of Reports to the Study Director and

to the Management March 16, 2007 March 28, 2007

The methods and procedures as used in the reference study are accurately described in this documentand reported results reflect accuratelythe raw data of the study. Manager, Quality Assurance Unit

DateStudy No. - Final report Page 6/10
SUMMARY

The flammability of was has been determined according to the 92/69/CEE A. 10test method
should be considered as not highlyflammable according to this test.Study No. - Final report Page 7/10
1. GENERAL INFORMATION Study No. Purpose Guidelines Study Director Laboratory Technicians Schedule: Study initiation date Start of experiments : End of experiments : Study completion date: Archives Determination of the Flammability of according to 92/69/CEE, A.10. 92/69/EEC, methods A.1 0.

March 13, 2007 March 28, 2007 March 28, 2007

The study plan, all data generated and recorded during the study and the final report will be stored in the Archives of the for at leastten years after issue ofthe final report.Study No. Final report Page 8/10


### 2. INFORMATION ON THE TEST SUBSTANCE 2.1 . Identity Commercial name Givaudan Code No. Chemical nature Empirical formula MolecularWeight CAS No. N/A



### 2.2. Physical-chemical and analytical data -General Aspect

- Sample tested Lot No. Purity Expiration date May 14, 2007.

### Study No. - Final report Page 9/10


### 3. GENERALTEST METHOD 3.1. Principle The substance is formed into an unbroken strip or powder train about 250 mm long and a preliminary screening test performed to determine if, on ignition by a gas flame, propagation by burning with flame or smouldering occurs. If propagation over 200 mm of the train occurs within a specified time then a full test programme to determine the burning rate is carried out. 

### 3.2 Definition and units Burning time expressed in seconds 

### 3.3. Reference substances None used 

### 3.4 Equipment

- a V-shaped mould 250 mm long with atriangular cross-section of inner height 10 mm andwidth 20 mm -a non-combustible, non-porous and low heat-conducting base plate (ceramic tile) -a gas burner

- a stop-watch 

### 3.5 Preliminary screening test The powdery substance is filled into the mould which is dropped three times onto a solid surface. The mould is filled up again if necessary and the excess substance is scarped off. The base plate is placed on the top of the mould, the apparatus is inverted and the mould removed. The pile is arranged across the draught in a fume cupboard. A hot flame from a gas burner is applied to one end of the pile until the powder ignites or for a maximum of 2 minutes. If the substance does not ignite and propagate combustion either by burning with flame or smouldering along 200 mm length within the 4 minutes test period, then the substance should not be considered as highly flammable and no further testing is required. If the substance propagates burning of a 200 mm length of the powder train in less than 4 minutes, the burning time is recorded and a burning rate test as described below (3.6) should be carried out.Study No. - Final report Page 10/10

3.6 Burning rate test A pile of substance is set up and ignited as described in the preliminary screening test above. When the pile has burned a distance of 80 mm, the rate of burning overthe next 100 mm is measured. Thetest is performed six times, using a clean cool plate each time, unless a positive result is observed earlier (burning rate lowerthan 45 seconds). 

### 4. RESULTS The preliminary screening testwas performed with The substance melts at the point where the flame is applied but no burning nor smouldering is observed when the gas flame is removed. Obviously, no propagation occurs. A Platinum wire electrically heated up to 1

# ooooc was also applied; no burning norsmouldering is observed. According to the test method, no further testing was carried out. 

### 5. CONCLUSION should be considered as not highlyflammable according to this test.