Study Title 

Study Director 

Test Facility 

Sponsor 

Internal distribution 

Study No. 

FINAL REPORT 

Flammability of 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) 

Statement of GLP compliance (Study Director) and signatures 

Quality Assurance 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 

10 
Study No. - Final report Page 3/10 

The Swiss GLP Monitoring Authorities 

Swiss Federal 

Office of 

Public Health 

Statement 

It is hereby confirmed that 

during the period of 

the following Test Facility of 

Swiss Agency for the 

Environment. Forests 

and Landscape 

March 31 - April 1 , 2005 

li 

lntercantonal Office 

for the 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 of expertise 

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 Agency for the Environment, 

Forests and Landscape 
Study No. - Final report Page 4/10 

STATEMENT OF 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 of the OECD Council [C(97)186/Final]. 

The undersigned declare that this study was carried out according to the procedures 

herein described and this report represents a true and accurate record of the results 

obtained. 

Study director 

Date: I 

Test Facility Management: 

Date: 
Study No. - Final report Page 5/10 

QUALITY ASSURANCE UNIT 

STATEMENT 

Study No. 

Test substance 

Study title Flammability of according to 92/69/CEE. 

Test facilities are periodically inspected and the results are reported to the responsible 

persons and the management. 

Experimental procedures were periodically inspected. The study plan and this final 

report were audited by the Quality Assurance Unit. The dates are given below: 

Dates and Types of QAU inspections 

March 16, 2007 Study plan 

March 28, 2007 Process (preliminary test) 

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 document and reported results reflect accurately the raw data of the study. 

Manager, Quality Assurance Unit 

Date 
Study No. - Final report Page 6/10 

SUMMARY 

The flammability of was has been determined according to the 92/69/CEE 

A. 1 0 test method 

should be considered as not highly flammable 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.1 0. 

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 

least ten years after issue of the 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 

Molecular Weight 

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. GENERAL TEST 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 a triangular cross-section of inner height 10 mm 

and width 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 over the next 1 00 

mm is measured. 

The test is performed six times, using a clean cool plate each time, unless a positive 

result is observed earlier (burning rate lower than 45 seconds). 

4. RESULTS 

The preliminary screening test was 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 

nor smouldering is observed. 

According to the test method, no further testing was carried out. 

5. CONCLUSION 

should be considered as not highly flammable according to this test.