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

553
RCC 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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RCC Study Number 845425 REPORT Page 3

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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RCC Study Number 845425 REPORT Page 4

TKA 40278 (CG1827)

SIGNATURES

Study Director: nucci

Date:

Management: Dr. J6rn SchreitmQller

Date:

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RCO 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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RCC Study Number 845425 REPORT Page 6

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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RCC Study Number 845425 REPORT Page 7

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

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RCC 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.

560
RCC 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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RCC Study Number 845425 REPORT Page 10

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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RCC Study Number 845425 REPORT Page 11

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 was performed.

In conclusion, TKA 40278 (CGI 827) is not "highly flammable" according to the criteria of the

guideline.

563