REPORT 

Study Title: 

DETERMINATION OF THE RELATIVE DENSITY 

OF DEAl Acid anhydride reaction product 

Data Requirement I Test Guidelines: 

OECD No. 109 

EEC Directive 92/69, A.3 

Study Director: 

Mrs. Alessandra Tognucci 

Study Completion Date: 

December 1 0, 2003 

Test Facility: 

RCC Ltd 

Environmental Chemistry & Pharmanalytics 

CH-4452 ltingen/Switzerland 

Sponsor: 

Rockwool International A/S 

Hovedgaden 584 

DK-2640 Hedehusene 

Denmark 

RCC Study Number: 

848617 

Page 1 of 13 
RCC Study Number 848617 REPORT 

DEAl Acid anhydride reaction product 

GLP CERTIFICATE 

The Swiss GLP Monitoring Authorities 

Swiss Federal 

Office of 

Publlc Health 

Swiss Agency for the 

Environment. Forests 

and Landscape 

Swissmedic 

/ • Swiss Agency for 

S Wl S Sm ed1 C Therapeutic Products 

Statement of GLP Compliance 

It is hereby confirmed that 

during the period of 

the following Test FaciiHies 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, 

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. 

Bern, March 2003 

Federal Office of Public Health 

The Director 

Prof. Th. Zeltner 

• TOX =Toxicology : ACC =Analytical and Clinical Chemistly : ECT = Environmental toxicity on aquatic and terrestrial 

organisms : ENF = Behaviour In water, soil and air. Bioaccumulation : EMN =Studies on effects on mesocosms and natural 

ecosystems: MUT • Mutagenicity; PCT • Physicak:hemlcal testing :RES = Residue stud)es ; OTH • ~· to be specified. 

Page 2 
RCC Study Number 848617 

DEA/Acid anhydride reaction product 

GOOD LABORATORY PRACTICE 

REPORT 

STATEMENT OF COMPLIANCE 

RCC Study Number: 848617 

Test Item: DEAl Acid anhydride reaction product 

Study Director: Mrs. Alessandra Tognucci 

Title: Determination of the Density 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 2nd, 2000 [RS 813.016.5]. 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]. , 

Study Director: 

lv Date:~ 
RCC Study Number 848617 REPORT Page4 

DEAl Acid anhydride reaction product 

SIGNATURES 

Study Director: Tognucci 

Management: Dr. Jorn SchreitmOIIer 

~-1~~~~~·····~··················· 
RCC Study Number 848617 

DEAl Acid anhydride reaction product 

REPORT Page 5 

QUALITY ASSURANCE UNIT 

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

STATEMENT 

RCC Study Number: 848617 

Test Item: DEAl Acid anhydride reaction product 

Study Director: Mrs. Alessandra Tognucci 

Title: Determination of the Density 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 

October 17, 2003 Measurements October 17, 2003 

December 02 I 03, 2003 Final report December 03,2003 

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

Quality Assurance: Margot Richter-Auer 

.. d.!: .. .r?.(0.~(~ ... ::.t/.!~~- ..... ············· 

Date: Z)c~ ~ /01 t>ZOO 3 
RCC Study Number 848617 REPORT Page 6 

DEAl Acid anhydride reaction product 

CONTENTS 

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

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

SIGNATURES .... ~ ............................................................................................................ 4 

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

CONTENTS .................................................................................................................... 6 

PREFACE ....................................................................................................................... ? 

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

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

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

2 MATERIALS AND METHODS ................................................................................ 9 

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

2.2 PRINCIPLE OF THE TEST ........................................................................... 9 

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

2.3.1 Apparatus ...................................................................................... 10 

2.3.2 Calibration of the Densitometer ..................................................... 1 0 

2.3.3 General Test Procedure ................................................................ 10 

2.3.4 Repeatability ................................................................................. 1 0 

2.4 DATA HANDLING ....................................................................................... 11 

2.4.1 Definitions ..................................................................................... 11 

2.4.2 Calculation .................................................................................... 11 

3 RESULTS ............................................................................................................ 12 

Table 1: Results of the Calibration Using Air and Water ........................................... 13 

Table 2: Determination of the Density of DEAl Acid anhydride reaction product ........ 13 
RCC Study Number 848617 

DEA/Acid anhydride reaction product 

PREFACE 

GENERAL 

Title: 

Sponsor: 

Monitoring Scientist: 

Test Facility: 

RESPONSIBILITIES 

Study Director: 

Deputy Study Director: 

. Technical Coordinator: 

Head of RCC Quality Assurance: 

SCHEDULE 

Experimental starting date: 

Experimental completion date: 

Study completion date: 

ARCHIVING 

REPORT 

Determination of the Density of 

DEAl Acid anhydride reaction product 

Rockwool International 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 

Dr. Ute Schmiedel 

Mrs. Katalin Kiss 

Mrs. Iris Wuthrich 

October 17, 2003 

October 31 , 2003 

December 10, 2003 I wih 

Page 7 

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 848617 REPORT Page 8 

DEAl Acid anhydride reaction product 

DATA REQUIREMENT f. TEST GUIDELINES 

This study followed the procedures indicated by the following internationally accepted 

guidelines and recommendations: 

EEC Directive 92/69, Methods for the determination of physico-chemical properties, A.3 

"Relative density'', EEC Publication No. L383, December 1992. 

OECD Guideline for Testing of Chemicals, No. 109, "Density of Liquids and Solids", adopted 

July 27, 1995. 

SUMMARY OF STUDY PLAN AMENDMENTS 

First Amendment to Study Plan: 

1) Concerning: Schedule 

Alteration: Anticipated experimental starting date 

Anticipated experimental completion date 

Anticipated date of draft report 

Reason for Alteration: Test item batch delivered later 

2) Concerning: Test Item 

Alteration: New batch used for study 

New expiration date 

Reason for Alteration: New batch to be used by request of sponsor 

RCC Study Number 848617 REPORT Page 10 

DEAl Acid anhydride reaction product 

2.3 PERFORMANCE OF THE TEST 

2.3.1 Apparatus 

Instrument: Oscillating densitometer, PAAR DMA-48. 

Conditions: The test was performed at 20°C ± 0.1 oc. 

2.3.2 Calibration of the Densitometer 

The apparatus must be calibrated before use in case the last calibration was performed more 

than one week ago. This is done by determination of the resonance frequency (period time) 

of the tube when filled with water and with air, respectively. The calibration will normally be 

performed at 20.0°C ± 0.1 oc. 

On the days of the present experiments, the calibration was checked by the measurement of 

air and water, resulting in the expected value for air of 0.001204 gtcm3 and for water of 

0.9982 g/cms at 20.0°C. The accepted range is 0.9982 ± 0.0003 g/cm . The print out is given 

in the raw data and details are later given in this report. 

2.3.3 General Test Procedure 

The test item was then injected into the U-tube by means of a disposable plastic syringe, 

avoiding air bubbles. The test item for the first test was filled in at 20°C. For better prevention 

of air bubble formation, the sample for the second test was filled in at about 30°C. The 

sample was then thermostated to 20.0°C in the apparatus. The density was read from the 

display after a constant oscillating frequency (constant period time) was reached. 

2.3.4 Repeatability 

Two tests with two measurements each were performed. The measurements did not vary by 

more than 0.0003 g/cm3 and were therefore accepted to be valid. 
RCC Study Number 848617 REPORT Page 11 

DEAl Acid anhydride reaction product 

2.4 DATA HANDLING 

2.4.1 Definitions 

The density (p) of a substance is the quotient of the mass (m) and the volume (V) of that 

substance at a specific temperature. 

m P=-

V 

Sl unit is in [kg/m3]. 1 g/cm3 corresponds with 1000 kg/m3 • 

(1) 

The relative density Di0 of solids or liquids is the ratio between the mass of a volume of 

substance to be examined, determined at 20°C, and the mass of the same volume of water, 

determined at 4°C. The relative density has no dimension. The mass of water, determined at 

4°C, is 0.99997 g/cm3 (as published by the Physikalisch-Technische Bundesanstalt in 

Braunschweig, Germany, PTB-Mitt. 81 (1971 ), p. 412-415) 

Di0 = pI 0.99997 (2) 

2.4.2 Calculation 

During this study the density (g/cm3

) was determined at 20.0°C. To calculate the relative 

density (no dimension), the factor 0.99997 of equation (2) was applied. As result, the relative 

densityDi0 is given. 
RCC Study Number 848617 

DEA/Acid anhydride reaction product 

3 RESULTS 

REPORT Page 12 

The determination of the density of the test item was performed in accordance with the EEC 

directive 92/69, Methods for the determination of physico-chemical properties, A.3 "Relative 

density'', EEC Publication No. L383, December 1992 and the OECD Guideline for Testing of 

Chemicals, No. 109, "Density of Liquids and Solids" using an oscillating densitometer. As the 

density of the test item was determined at 20.0°C, the relative density is stated. 

First, the apparatus was tested by determination of the density of air and water at 20.0°C. 

The results for water are given in Table 1. The measured values are in the accepted range of 

0.9982 ± 0.0003 g/cm3. 

Table 2 shows the individual measurements for the density of DEA/Acid anhydride reaction 

product. From these, the mean and the corrected values were calculated and given in the 

same table. The tabulated values represent rounded results obtained from calculation using 

the exact raw data. 

In conclusion, the relative density of the DEA/Acid anhydride reaction product was 

determined to be 

Di0 = 1.2907 
RCC Study Number 848617 REPORT Page 13 

DEAl Acid anhydride reaction product 

Table 1: Results of the Calibration Using Air and Water 

The density of air was measured to be 0.001204 g/cm3

• 

Test No. Temperature Density 

[oC) [g/cm3] 

measured mean value theoretical 

value 

1 20.0 0.9982 

2 20.0 0.9982 0.9982 0.9982 

Table 2: Determination of the Density of DEA/Acid anhydride reaction product 

Test No. Temperature Density 

[oC] [g/cm3] 

measured mean value corrected 

(standard for relative 

deviation) density 

1 20.0 1.2908 

1 20.0 1.2906 1.2907 

1.2907 

2 20.0 1.2905 (0.0001) 

2 20.0 1.2907 

Calculation of the relative density 

Di0 = 1.2907 I 0.99997 = 1.2907