# REPORT
StudyTitle: 

### DETERMINATION OF THE FLASH POINT OF DEA/Acid anhydride reaction product
Data RequirementITest 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: RockwoollnternationalA/S Hovedgaden 584 DK-2640 Hedehusene Denmark RCC Study Number: 848619 Page 1of 11RCC Study Number 848619 DENAcid anhydride reaction product 

# GLP CERTIFICATE REPORT

The Swiss GLP Monitoring Authorities Swiss Federal Offrceof Public Health Swiss Agencyforthe Environment, Forests and Landscape ./ Swlssmedic 

## r 

## d" SwissAgencyfor SWlssme lC TherapeuUcProducts 

# Statement of GLP Compliance

It is herebyconfirmed that duringthe 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 forthe Environment, Forests and Landscape with respect to the compliance with the Swiss legislation on Good Laboratory Practice. Test Facilities ·Toxicology

• Environmental Chemistryand

Pharmanalytics Areas ofexpertise• 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. Itwas found that the aforementioned testfacilities 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 ofPublicHealth The Director

Prof. Th. Zeltner

• TOX=Toxicology: ACC =Analyticaland Clinical Chemislry: ECT=Environmental toxlcltyon aquaticand terrestrial organisms; ENF =Behaviourtn water, soli and air. Bioaecumulation ;EMN =Studieson effects on mesocosmsand natural ecosystems: MUT
.. Mutagenicity; PCT=Physical-chemical testing ; RES=Residue studies :OTH=

**Oth~r,**tobespecified. Page 2RCC Study Number848619 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 ofthe 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 ofGood Laboratory Practice, as revised in 1997 and adopted November 261 h, 

### 1997 by decision ofthe OECD Council [C(97)186/Final].

.

Study Director: Mrs. Alessandra TognucciRCC Study Number 848619 DEA/Acid anhydride reaction product 

# SIGNATURES

Study Director:

Management : REPORT Page4

Dr. Jorn SchreitmOIIerRCC Study Number 848619 REPORT Page 5 DEAl Acid anhydride reaction product 

# QUALITYASSURANCE 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 ofthe 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 reportwere audited by the QualityAssurance Unit. The dates are given below: Dates and Types ofQAU Inspections Dates of Reports to the Study Directorand 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 thatthis final report reflects the raw data. QualityAssurance: Mrs. Diana Burgin



# ~.:.~~··························

Date:



# b_ep~

# A9'

# 2oo3RCC Study Number848619 DENAcid anhydride reaction product 

# CONTENTS REPORT Page 6

GLP CERTIFICATE........................................................................................................2 STATEMENT OF COMPLIANCE....................................................................................3 SIGNATURES ................................................................................................................4 

### ' QUALITYASSURANCE UNIT........................................................................................5 CONTENTS......................................:.............................................................................6 PREFACE.......................................................................................................................7 DATA REQUIREMENT 

### ITEST GUIDELINES ................................................................ 8 SUMMARY OF STUDY PLAN AMENDMENTS ..............................................................8 1 PURPOSE.............................................................................................................9 2 MATERIALAND METHODS.................................................................................. 9 2.1 TEST ITEM...................................................................................................9 2.2 TEST SYSTEM............................................................................................. 9 2.3 PERFORMANCE OFTHE TEST................................................................ 10 2.3.1 Principle ofthe Test ...................................................................... 10 2.3.2 PreliminaryTest............................................................................ 10 2.3.3 Main Study.................................................................................... 10 2.4 DATA HANDLING ...................................................................................... 10 3 RESULTS............................................................................................................ 11RCC 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 QualityAssurance:
SCHEDULE Experimental starting date: Experimental completion date: Study completion date:
ARCHIVING REPORT Page 7

Determination ofthe 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 oftest item and the final report ofthe present study for at leastten years. No data will be discarded withoutthe sponsor's consent.RCC Study Number 848619 DENAcid anhydride reaction product REPORT 

# DATA REQUIREMENT 

# ITEST 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, 1990Annual Book ofASTM 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

Therewere 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 ofthe 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 testwas performed using the Pensky-Martens flash pointtester. The cup ofthe 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 latterwas 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, ifthe 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 lowesttemperature at 101.3 kPa, at which the test liquid in aclosed test vessel evolves vapours, underthe conditions defined in the test method, in such amount that aflammable vapour 

### I air mixturewas produced in the testvessel.RCC Study Number848619 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 ofthe 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 ofthe measurementwas 97.8 kPa. No flash pointwas observed in this temperature range.