REPORT 

Study Title: 

DETERMINATION OF THE FLASH POINT 

OF DEA/Acid anhydride reaction product 

Data Requirement I Test Guidelines: 

EEC Directive 92/69, A.9 

EN 22719 

Study Director: 

Mrs. Alessandra Tognucci 

Study Completion Date: 

September 19, 2003 

Test Facility: 

RCC Ltd 

Environmental Chemistry & Pharmanalytics 

CH-4452 ltingen/Switzerland 

Sponsor: 

Rockwoollnternational A/S 

Hovedgaden 584 

DK-2640 Hedehusene 

Denmark 

RCC Study Number: 

848619 

Page 1 of 11 
RCC Study Number 848619 

DENAcid anhydride reaction product 

GLP CERTIFICATE 

REPORT 

The Swiss GLP Monitoring Authorities 

Swiss Federal 

Offrce of 

Public Health 

Swiss Agency for the 

Environment, Forests 

and Landscape 

./ Swlssmedic 

r d" Swiss Agency for SWlssme lC TherapeuUcProducts 

Statement of GLP Compliance 

It is hereby confirmed that 

during the period of 

the following Test Facilities of 

November 18 - 22, 2002 

RCC Ltd 

4452 ltingen 

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 Landscape with respect to the compliance with the Swiss legislation on Good Laboratory Practice. 

Test Facilities 

·Toxicology 

• Environmental Chemistry and 

Pharmanalytics 

Areas of expertise • 

TOX, ACC, MUT, 

OTH (Safety Pharmacology) 

ACC, ECT, ENF, EMN, PCT, 

RE.S, 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. 

Bern, March 2003 

Federal Office of Public Health 

The Director 

Prof. Th. Zeltner 

• TOX =Toxicology: ACC =Analytical and Clinical Chemislry: ECT =Environmental toxlclty on aquatic and terrestrial organisms; ENF =Behaviour tn water, soli and air. Bioaecumulation ; EMN =Studies on effects on mesocosms and natural 

ecosystems: MUT .. Mutagenicity; PCT = Physical-chemical testing ; RES = Residue studies : OTH = Oth~r, to be specified. 

Page 2 
RCC Study Number 848619 

DENAcid anhydride reaction product 

GOOD LABORATORY PRACTICE 

REPORT 

STATEMENT OF COMPLIANCE 

RCC Study Number: 

Test Item: 

Study Director: 

Title: 

848619 

DEA/Acid anhydride reaction product 

Mrs. Alessandra Tognucci 

Determination of the Flash Point of DEAl Acid 

anhydride reaction product 

Page 3 

This study was conducted in compliance with the Swiss Ordinance relating to Good 

Laboratory Practice, adopted February 2"", 2000 [RS 813.016.5]. This Ordinance is based on 

the OECD Principles of Good Laboratory Practice, as revised in 1997 and adopted November 

261

h, 1997 by decision of the OECD Council [C(97)186/Final]. . 

Study Director: Mrs. Alessandra Tognucci 
RCC Study Number 848619 

DEA/Acid anhydride reaction product 

SIGNATURES 

Study Director: 

Management : 

REPORT Page4 

Dr. Jorn SchreitmOIIer 
RCC Study Number 848619 REPORT Page 5 

DEAl Acid anhydride reaction product 

QUALITY ASSURANCE UNIT 

RCC Ltd, Environmental Chemistry & Pharmanalytics, CH-4452 ltingen I Switzerland 

STATEMENT 

RCC Study Number: 848619 

Test Item: DEA!Acid anhydride reaction product 

Study Director: Mrs. Alessandra Tognucci 

Title: Determination of the Flash Point of DEAl Acid anhydride 

reaction product 

The general facilities 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: 

Dates and Types of QAU Inspections Dates of Reports to the Study 

Director and to the Management 

June 06, 2003 Study Plan June 06, 2003 

May 19, 2003 Process based (Pre-test) May 19, 2003 

August 28, 2003 Final report August28, 2003 

This statement also confirms that this final report reflects the raw data. 

Quality Assurance: Mrs. Diana Burgin 

~.:.~~·························· Date: b_ep~ A9' 2oo3 
RCC Study Number 848619 

DENAcid anhydride reaction product 

CONTENTS 

REPORT Page 6 

GLP CERTIFICATE ........................................................................................................ 2 

STATEMENT OF COMPLIANCE .................................................................................... 3 

SIGNATURES ................................................................................................................ 4 

' 

QUALITY ASSURANCE UNIT ........................................................................................ 5 

CONTENTS ...................................... : ............................................................................. 6 

PREFACE ....................................................................................................................... 7 

DATA REQUIREMENT I TEST GUIDELINES ................................................................ 8 

SUMMARY OF STUDY PLAN AMENDMENTS .............................................................. 8 

1 PURPOSE ............................................................................................................. 9 

2 MATERIAL AND METHODS .................................................................................. 9 

2.1 TEST ITEM ................................................................................................... 9 

2.2 TEST SYSTEM ............................................................................................. 9 

2.3 PERFORMANCE OF THE TEST ................................................................ 10 

2.3.1 Principle of the Test ...................................................................... 10 

2.3.2 Preliminary Test ............................................................................ 10 

2.3.3 Main Study .................................................................................... 10 

2.4 DATA HANDLING ...................................................................................... 10 

3 RESULTS ............................................................................................................ 11 
RCC Study Number 848619 

DEA!Acid anhydride reaction product 

PREFACE 

GENERAL 

Title: 

Sponsor: 

Study Monitor: 

Test Facility: 

RESPONSIBILITIES 

Study Director: 

Deputy Study Director: 

Technical Coordinator: 

Reporting: 

Head of RCC Quality Assurance: 

SCHEDULE 

Experimental starting date: 

Experimental completion date: 

Study completion date: 

ARCHIVING 

REPORT Page 7 

Determination of the Flash Point of DEA/Acid anhydride 

reaction product · 

Rockwoollnternational A/S 

Hovedgaden 584 

DK-2640 Hedehusene 

Denmark 

Mr. Flemming A. Simonsen 

Danish Toxicology Centre 

Kogle Aile 2 

Dk-2970 H0RSHOLM 

Denmark 

RCC Ltd 

Environmental Chemistry & Pharmanalytics 

Zelgliweg 1 

CH-4452 ltingen/Switzerland 

Mrs. Alessandra Tognucci 

Mr. Michael Lindemann 

Mrs. Barbara FIOkiger 

Mrs. Mirjam Weissenfeld 

Mrs. Iris Wuthrich 

July 22, 2003 

July 22, 2003 

September 19, 2003 

RCC Ltd, CH-4452 ltingen/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. 
RCC Study Number 848619 

DENAcid anhydride reaction product 

REPORT 

DATA REQUIREMENT I TEST GUIDELINES 

Page 8 

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.9 "Flash point", EEC Publication No. L383, December 1992. 

ASTM D 93-85, Standard Test Methods for Flash Point by Pensky-Martens Closed Tester, 

1990 Annual Book of ASTM Standards. 

EN 22719 Petroleum Products and Lubricants - Determination of flash point - PenskyMartens closed cup method (ISO 2719: 1988), October 1993. 

DIN 51755, PrOfung von Mineralolen und anderen brennbaren FIOssigkeiten, Bestimmung 

des Flammpunktes im geschlossenen Tiegel nach Abei-Pensky, September 1978. 

SUMMARY OF STUDY PLAN AMENDMENTS 

There were no amendments to the study plan. 

RCC Study Number 848619 

DEA!Acid anhydride reaction product 

REPORT 

2.3 PERFORMANCE OF THE TEST 

2.3.1 Principle of the Test 

Page 10 

The test item was placed in a test vessel which was progressively heated until the vapour 

reached a sufficiently high concentration in air to produce a flammable mixture which could 

be ignited. 

2.3.2 Preliminary Test 

A preliminary test was performed using the Pensky-Martens flash point tester. 

The cup of the flash point apparatus was filled with the test item to the level indicated by the 

filling mark. The lid was placed on the cup and the latter was placed in the oven, whereafter a 

thermometer was inserted. An attempt was made to ignite the vapour of the test item by 

means of a test flame, at each temperature that is a multiple of 10 K, starting at 

approximately 5'C or at 1 K above the melting point, if the melting point is found to be below 

200'C. 

2.3.3 Main Study 

No main test was performed due to the result found in the preliminary test. 

2.4 DATA HANDLING 

The flash point is the lowest temperature at 101.3 kPa, at which the test liquid in a closed test 

vessel evolves vapours, under the conditions defined in the test method, in such amount that 

a flammable vapour I air mixture was produced in the test vessel. 
RCC Study Number 848619 

DEA!Acid anhydride reaction product 

3 RESULTS 

REPORT Page 11 

The determination of the flash point 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. 9 "Flash point", EEC Publication No. L383, December 1992. 

To verify the use of the Pensky-Martens closed flash point tester, the flash point of paraxylene was tested. Therefore, para-xylene was heated from 15°C up to the flash point. A 

clear flash point was observed at a para-xylene temperature of 28°C at the actual 

atmospheric pressure of 97.8 kPa. After correction for the atmospheric pressure, the flash 

point of para-xylene was determined to be at 28.9°C. This result was in accordance with the 

criteria given in the guideline. 

In the preliminary test, the test item was heated from 18°C to 120°C. The test was stopped 

when the flame of the ignition source was blown out by contact with the test item vapour. This 

effect might be caused by evolving water vapour, since the test item contains between 5 and 

15% water. 

The atmospheric pressure on the day of the measurement was 97.8 kPa. 

No flash point was observed in this temperature range.