GOOD LABORATORY PRACTICE COMPLIANCE STATEMENT 

SPONSOR: 
QUALITY ASSURANCE STATEMENT 

This study was examined for compliance with Good Laboratory Practice Standards as 

published by the U.S. Environmental Protection Agency in 40 CFR Part 160, 17 August 1989 and 

OECD Principles of Good Laboratory Practice, (ENVIMCICHEM (98) 17). The dates of all 

inspections and audits and the dates that any findings were reported to the Study Director and 

Laboratory Management were as follows: 

ACTIVITY: 

DATE REPORTED TO: 

DATE CONDUCTED: STUDY DIRECTOR: MANAGEMENT: 

Protocol June 14,2005 June 14,2005 June 22,2005 

Data and Draft Report September 27,2005 September 27,2005 October 5,2005 

Final Report October 5,2005 October 5,2005 October 5,2005 

All inspections were study-based unless otherwise noted. 

Linda R. Mitchell 

Manager of Regulatory and Ecotox Operations 

DATE 
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REPORT APPROVAL 

STUDY DIlGCTOR: 

Chemist 

MANAGEMENT: 

/0-$- 3J 

DATE 

Willard B. Nixon, 4h.~. 

Director of Chemistry 

DATE 
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TABLE OF CONTENTS 

Title Page..........................................................................................................................................1 

Statement of No Data Confidentiality Claims..................................................................................2 

Good Laboratory Practice Compliance Statement ...........................................................................3 

Quality Assurance Statement ...........................................................................................................4 

Report Approval ..............................................................................................................................5 

Table of Contents .............................................................................................................................6 

Summary ..........................................................................................................................................7 

Introduction ......................................................................................................................................8 

Objective ..........................................................................................................................................8 

Experimental Design ........................................................................................................................8 

Materials and Methods .....................................................................................................................8 

Test Substance.....................................................................................................................8 

Reference Standards............................................................................................................9 

Test Procedure.....................................................................................................................9 

Results ............................................................................................................................................10 

References ......................................................................................................................................11

TABLE 

Table 1. Determination of Boiling Point/Boiling Range for ..................................12 

APPENDIX 

Appendix 1. Protocol and Protocol Amendment ...........................................................................13 

Appendix 2. Personnel Involved in the Study................................................................................22 
 

SUMMARY 

 
 

INTRODUCTION 

Tests were conducted to determine the boiling point/boiling range of 

 This study was conducted by . for 

 analytical chemistry facility in Easton, Maryland. These tests 

were performed following procedures in the U.S. EPA Product Properties Test Guidelines, OPPTS 

830.7220, Boiling Point/Boiling Range (1) and OECD Guideline for the Testing of Chemicals, 103, 

Boiling Point (2). The experimental portion of this study was conducted on May 25, 2005. Raw data 

generated by nd a copy of the final report are filed under Project Number 

523C-108 in archives located on the 

 
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the label as Tall Oil Fatty Acid; lot/batch number 8488/035. No expiration date or purity was 

provided. The test substance was stored under ambient conditions. 

Reference Standards 

The caffeine reference standard was received from Sigma Chemical Company on June 10, 

1998 and was assigned . identification number 4504 upon receipt. The 

reference standard was described as a white powder and identified as: Caffeine; C-0750; Lot 

Number: 77H0122; CAS Number: 58-08-2. An assigned expiration date of August 21, 2006 was 

given. The purity reported was 99.7%. The reference standard was stored under ambient conditions. 

The benzophenone reference standard was received from Aldrich Chemicals Company on 

August 13, 2001 and was assigned Ltd. identification number 5716 upon 

receipt. The test substance was described as white crystalline chips and identified as: Benzophenone; 

(23,985-2); Lot Number: 04115TI; CAS Number: 119-61-9. An assigned expiration date of August 

21, 2006 was given. The purity reported was 99.9%. The reference standard was stored under 

ambient conditions. 

The anthraquinone reference standard was received from Aldrich Chemicals Company on 

August 13, 2001 and was assigned identification number 5714 upon 

receipt. The test substance, a tan powder, was identified as: Anthraquinone (A9,000-4); Lot Number: 

12416DX; CAS Number: 84-65-1. An assigned expiration date of August 21, 2006 was given. The 

purity reported was 99.9%. The reference standard was stored under ambient conditions. 

Test Procedure 

The boiling point/range was measured using a Büchi Melting Point B-540 instrument with 

boiling point tubes and boiling point capillaries, also supplied by Büchi. The calibration of the 

melting point instrument was confirmed using caffeine as a reference standard. In addition, the 

operation of the melting point instrument was tested each day, prior to use, with two reference 

standards; benzophenone and anthraquinone. The reference standards were selected to demonstrate 

the accuracy of the instrument across a range of temperatures. 
 

A subsample of the test substance was transferred to a boiling point tube, and a preliminary 

boiling point/range approximation was run from 30 to 400 oC at a rate of 10 oC per minute. 

Three subsamples of the test substance were transferred to boiling point tubes for the definitive 

test and boiling point capillaries were inserted. The boiling point determination was run from 30 to 

275 oC at a rate of 1.0 oC per minute. The temperature at which a steady stream of bubbles was 

observed emerging from the open end of a capillary submerged in the test substance was recorded and 

accepted as the boiling point. The boiling range was defined as the region between the first 

emergence of bubbles from the capillary tube and the emergence of a steady stream of bubbles. The 

barometric pressure was recorded at the time measurements were made. 

RESULTS 

The boiling point approximation test resulted in a measured boiling point of 251.3 oC. These 

results were used to determine the range of temperatures used in the definitive test. 

Results of the boiling point/boiling range determinations for presented in Table 1. 

The first emergence of bubbles from the boiling point capillaries was observed at 40.9, 40.7 and 

40.7°C for each of the three subsamples. A steady stream of bubbles was observed at 248.9, 248.3 

and 248.7°C for each of the three subsamples of the test substance. Since the range of temperatures 

between the first emergence and a rapid, continuous stream of bubbles exceeded 2°C, the mean 

boiling range was identified as 40.8 to 249°C (314 to 522 K). The mean boiling point of was 

249°C (522 K). 
 

REFERENCES 

 1. U.S. Environmental Protection Agency. 1996. Boiling Point/Boiling Range. Product 

Properties Test Guidelines. OPPTS 830.7220. 

2. Organisation for Economic Cooperation and Development. 103. Guideline for Testing of 

Chemicals. Boiling Point. 
 

 

 

 
 
 
 
 
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Appendix 2 

Personnel Involved in the Study 

The following key personnel were involved in the conduct or 

management of this study: 

1. Willard B. Nixon, Ph.D., Director of Chemistry 

2. Frank J. Lezotte, B.S., Chemist