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-5 

## -

REPORT APPROVAL

STUDY DIlGCTOR:

Chemist

MANAGEMENT: /0-$- 3J

DATE

Willard B. Nixon, 4h.~.

Director of Chemistry DATE- 6 -

TABLE OF CONTENTS

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

Statement of No Data Co nfidentiality Claims..................................................................................2

Good Laboratory Practice Co mpliance Stat ement ...........................................................................3

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

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

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

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

Introduc tion ................................................................................................................... ...................8

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

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

Materials an d 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 In volved in the Study................................................................................22SUMMARYINTRODUCTION

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- 9 -

the label as Tall Oil Fatty Ac id; 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 receive d from Sigma Chemical Company on June 10,

1998 and was assigned . identification numbe r 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 assi gned expiration date of August 21, 2006 was

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

The benzophenone reference standard was r eceived 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 r eceived 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 expi ration date of August 21, 2006 was given. The

purity reported was 99.9%. The reference sta ndard 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 caffe ine 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 refe rence standards were selected to demonstrate

the accuracy of the instrument across a range of temperatures.A subsample of the test substance was transfe rred 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 tr ansferred 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 temp erature at which a stead y stream of bubbles was

observed emerging from the open end of a capillary s ubmerged 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 th e 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 determin ations for presented in Table 1.

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

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

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

between the first emergence and a rapid, conti nuous 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 Coop eration and Development. 103. Guideline for Testing of

Chemicals. Boiling Point

.- 17 -- 18 -- 19 -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