# REPORT
Study Title: DETERMINATION OF THE FLAMMABILITY OF TKA 40278 (CGI 827) Data Requirement / Test Guidelines: EEC Directive 92/69, A.10 Study Director: Mrs. Alessandra Tognucci Study Completion Date: April 16, 2003 Test Facility: RCC Ltd Environmental Chemistry & Pharmanalytics CH-4452 Itingen/Sv~tzerland S_p_onsor: CIBA SPECIALTY CHEMICALS INC. CH - 4002 Basel/Switzerland RCC Study Number: 845425 Page I of 11



### 553RCC Study Number 845425 REPORT Page 2

TKA 40278 (CGI 827) 

# GLP CERTIFICATE

The Swiss GLP Monitoring Authorities


# Statement of GLP Compliance
It is hereby confirmed that dudng the pedod of the following Test Facilities of 

### November 18- 22,

### 2002 RCC Ltd 4452 Itingen Switzerland
were Inspected, by the Federal Office of Public Health, the Swiss Agency for Therapeutic Products and the Swiss Agency for the Environment, Forests and Landscapa with respect to the compliance with the Swiss legislation on Good Laboratory Practice. Test Facilities Areas of expertise * - Toxicology

- Environmental Chemistry and Pharmanalytics TOX, ACC, MUT, OTH (Safety Pharmacology) ACC, ECT, ENF, EMN, PCT, RES, OTH (Animal metabolism) The inspections were performed in agreement with the OECD Guidelines for National GLP Inspections and Audits. It was found that the aforementioned test facilities were operating in compliance with the Swiss Ordinance relating to Good Laboratory Practice [RS 813.016.5] at the time they were inspected. Federal Office of Public Health The Director
Bern, March 2003 Prof. Th. Zeltner



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TKA 40278 (CGI 827) 

### GOOD LABORATORY PRACTICE 

# STATEMENT OF COMPLIANCE RCC S~udy Number: Test Item: 

### 845425 TKA 40~78 (CGI 827) Study Director: Mrs. Alessandra Tognucci Title: 

### Determination of the Flammability of TKA 40278 (CGI 827) This study was conducted in compliance with the Swiss Ordinance relating to Good Labo~atory Practice, adopted February 2n~, 2000 [RS 813.016.5], This Ordinance is based on the OECD Principles of Good Laboratory Practice, as revised in 1997 and adopted November 26~, 1997 by decision of the OECD Council [C(97)186/Final]. 

### The purity of the test item s excluded from the statement of compliance (purity available in Analytical Certificate No. 14026512-1; Ciba Specialty Chemicals Inc.).

Study Di~’ector: Inucci



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TKA 40278 (CG1827) 

# SIGNATURES

Study Director: 

### nucci

Date:

Management: 

### Dr. J6rn SchreitmQller

Date:



### 556RCO Study Number 845425 REPORT Page 5

TKA 40278 (CGI 827) 

# QUALITY ASSURANCE UNIT RC(~ ILi£1, Environmental Chemistry & Pharmanalytics, CH-4452 Itingen / Switzerland ST/~TEMENT RCC S’tudy Number: 845425 Test Item: TKA40278(CGI827) 

### Study Director: Title: Mrs. Alessandra Tegnucci Determination of the Flammability of TKA 40278 (CGI 827) The general faciliti~s and activities are inspected periodically and the results are reported to the responsible person and the management. 

### Study procedures were periodically inspected. The study plan and this report were audited by the Quality Assurance Unit. The dates are given below: Date~n~i~l’y~es of~QAU Inspections ~ " Dates of Reports to the Study Director and to the Management September 16, 2002 Study Plan September 16, 2002 November 21, 2002 Process based (Pre-test) November 22, 2002 April 07, + 09, 2003 Final report April 09; 2003 

### This statement also confirms that this final report reflects the raw data. Quality Assurance: ~ Mrs. M. Richter-Auer

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TKA 40278 (CG1827) 

# CERTIFICATION OF GLP AND VERIFICATION OF THE REPORT

The statement of Co~npliance with Good Laboratory Practice found in this report, and signed by the Study Director is truthful and accurate, and this report as provided by the testing facility is complete and unaltered.

Signature of the Sponsor:

Date:



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TKA 40278 (CGI 827) 

# CONTENTS
GLP CERTIFICATE ........................................................................................................ 2 STATEMENT OF COMPLIANCE ....... i
............................................................................ 3 SIGNATURES

................................................................................................................ 4 QUALITY ASSURANCE UNIT ........................................................................................ 5 CERTIFICATION OF GLP AND VERIFICATION OF THE REPORT .............................. 6 CONTENTS .................................................................................................................... 7 PREFACE

....................................................................................................................... 8 DATA REQUIREMENT / TEST GUIDELINES ................................................................ 9 SUMMARY OF STUDY PLAN AMENDMENTS ........................ ~ .....................................

9 1 PURPOSE ........................................................................................................... 10 ~--MATERIAL AND METHODS ................................................................................ 10 2.1 TEST ITEM

................................................................................................. 10 2.2 STUDY DESIGN .................................................................... i ....................

10 2,2.1 Method .......................................................................................... 10 2.2.2 Preparations before the Test ........................................................ 11 2.2.3 Preliminary Test ............................................................................ 11 2.2.4 Main Study .................................................................................... 11 3 RESULTS ............................................................................................................ 11



### 559RCC Study Number 845425 REPORT Page 8

TKA 40278 (CGI 827) 

# PREFACE
GENERAL Title! Sponsor: Monitoring Scientist: Test Facility:

RESPONSIBILITIES 

### Study Director: Deputy Study Director: Technical Coordinator: Head of RCC Quality Assurance: Determination of the Flammability of TKA (CGI 827) CIBA SPECIALTY CHEMICALS INC. CH-4002 Basel/Switzerland Dr. Moung Sook Lee RCC Ltd Environmental Chemistry & Pharmanalytics Zelgliweg 1 CH-4452 Itingen/Switzerland

Mrs. Alessandra Tognucci Dr. Ute Schmiedel Mrs. Barbara FI0kiger Mrs. Iris W0thrich 40278

SCHEDULE 

### Experimental starting date: Experimental completion date: Study completion date: December 19, 2002 December 19, 2002 April 16, 2003/waj


### ARCHIVING RCC Ltd, CH-4452 Itingen/Switzerland will retain the study plan, raw data, a sample of test item and the final report of the present study for at least ten years. No data will be discarded without the sponsor’s consent.

560RCC Study Number 845425 REPORT Page 9

TKA 40278 (CGI 827) 

# DATA REQUIREMENT / TEST GUIDELINES
This study followed the procedures indicated by the following internationally accepted guidelines and recommendations: EEC Directive 92/69, Part A, Methods for the determination of physico-chemical properties, A.10 "Flammability (solids)", EEC Publication No. L383, December 1992.


# SUMMARY OF STUDY PLAN AMENDMENTS
There were no amendments to the study plan.



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TKA 40278 (CG1827) 

# 1 PURPOSE The ~l~urpose of the study was to evaluate the flammability of TKA 40278 (CGI 827).


# 2 MATERIAL AND. METHODS 2.1 TEST ITEM Data as provided by the sponsor. Identity: Product Name: Batch: 

### Purity: Appearance: Expiration date: Storage: TKA 40278 CGI 827 KL 01/02 ’See Analytical Certificate, Study No. 14026512-1 Ciba Specialty Chemicals Inc. Solid, slightly yellow August 30, 2004 At room temperature at about 20 °C. The test item is light sensitive.



### 2.2 STUDY DESIGN 2.2.1 Method The study was performed as described in the guideline and in accordance with the RCC Ltd Standard Operating Procedures. The test item in its commercial form was made into a pile of 250 mm length. An attempt was then made to ignite the sample with the aim to measure the burning time, if applicable.

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TKA 40278 (CGI 827) 

### 2:2.2 Preparations before theTest---- The test item was loosely filled into a mould. The mould is made of aluminum, has a length of 250 mm and a triangular cross section with an inner height of 10 mm and an inner width of 20 mm. On both sides of the mould in a longitudinal direction two metal sheets are mounted as lateral limitations which project 2 mm beyond the upper edge of the triangular cross section. Then the mould was dropped three times from a height of 2 cm onto a solid surface. The lateral limitations were remo~/ed and the excess substance scraped off. An aluminum plate was placed on top of the mould, the apparatus was inverted and the mould removed. The te~t was conducted in a fume cupboard with constant air speed. Additionally, a draught screen was erected around the apparatus. The flame of a gas burner was used as ignition source. 

### 2.2.3 Preliminary Test The test item in its commercial form was made into a pile of 250 mm length. An attempt was then made to ignite the sample with the aim to determine the burning time over a distance of 200 mm. 2.2.4 Main Study No further tests were performed according to the results obtained in the preliminary test. 

# 3 RESULTS The determination of the flammability of the test item was performed in accordance with the EEC Directive 92/69, Part A, Methods for the determination of physico-chemical properties, A. 10 "Flammability (solids)", EEC Publication No. L383, December 1992. 

### TKA 40278 (CGI 827) could not be ignited with a flame during the preliminary test (contact time of about 2 minutes). In contact with the ignition source, TKA 40278 (CGI-827) melted, evolving sparks. A yellow melt remained. Therefore, no main test wasperformed. In conclusion, TKA 40278 (CGI 827) is not "highly flammable" according to the criteria of the guideline.

563