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[7 TX 425-C75 

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~ SAtVtT'iZED 

REPORT 

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~ DEVELOPMENT AND VALIDATION OF AN ANALYT7CAL METHOD FOR 

1,1,3,3-TETRAMHTHYLSUTYL PEROXYPIVAI.ATE 

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~ NOTOX Projea\i 

NOTOX Substanct 

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1, ~.,3,3 - TETRAMETHYLBUTYL PEf20XYP IVALATE N4TOX Projea:~ 

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CONFIdENTXALTTY STATEMENT 

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~ This report contains the unpublished results T 'of research sponsored by AKZO 

Nobel Chemicals $.V., Repraductzorr, issue or disc1osure to third partTes 

in any form is not permit;ted without prior wr7tten authorization frnm the 

sponsor. 

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1,1,3,3-TETRAMETHYLBUTYL PEROXYPIVALATE NOTOX Proj, ( ~ 

~ STATEMENT OF GLP COMPLIANCE 

NOTOX B.V., 's-Hertogenbosch, The Netherlands 

fA 

The study described in this report has been correctly reported and was 

conducted in compliance with the most recent edition of: 

i~ The OECD Principles of Good Laboratory Practice 

which are essentially in conformity with: 

The United States Food and Drug Administration. Titie 21 Code of Federal 

~ Regulations Part 58. 

The United States Environmental Protection Agency (FIFRA). Title 40 Code 

of Federal Regulations Part 160. 

The United States Environmental Protection Agency (TSCA). Title 40 Code of 

r Federal Regulations Part 792. 

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+ Study Director Management 

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1,1,3,3-TETRAMETHYLBUTYL PEROXYPIVALATE NOTOX Projea 

A QUALITY ASSURANCE STATEMENT 

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~ NOTOX B.V., 's-Hertogenbosch, The Netherlands 

This report was audited by the NOTOX Quality Assurance Unit to ensure that 

p the methods and results accurately reflect the raw data. 

The dates of Quality Assurance inspections and audits are given below. 

During the on-site inspections procedures applicable to this type of study 

were inspected. 

~ DATES OF QAU INSPECTIONSlAUDITS REPORTING DATES 

on-site inspection (s) 

« 24 - Juiy - 1997 24 - Ju1y - 1997 

protocol inspection (s) 

22 - May - 1997 22 - May 1997 

S report audit (s) 

04 - August - 1997 04 - August - 1997 

C] 

Head of Quality Assurance 

C.J. Mitchell B.Sc. 

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1,1,3,3-TETRAMETHYLBUTYL PEROXYPIVALATE NOTOX ProjeFt 

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SUMMARY 

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1,1,3,3-TETRAMETHYLBUTYL PEROXYPIVALATE NOTOX Projer 

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PREFACE 

Sponsor AKZO Nobe1 Chemicals B.V. 

P.O. Box 247 

® 3800 AE AMERSFOORT 

The Netherlands 

----~ 

Study Monitor ( 1 

Testing Facility NOTO-X-6-v . / 

~p Hambakenwetering 3 

5231 DD 's-Hertogenbosch 

TheNeClier lands``\ 

Study Director 

~ Study plan Ol—Jti-lY 1-99%~ 

Completed: 15 July 1997 

TEST SUBSTANCE 

~ Identification 1,1,3,3-TETRAMETHYLBUTYL PEROXYPIUALATE 

Chemical name Propaneperoxic acid, 2,2-dimethyl-,1,1,3,3- 

tetramethyibutyi ester (9CI) 

e CAS No. 22288-41-4 

Description Colnurless 1iauid 

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Batch d-L „~ 

r Purity ~See CertiTicate of Analysis 

Test substance storage In freezer in the dark 

Stability.under storage 

conditions Stable 

~ Expiry date Not indicated 

The sponsor is responsible for the completeness and 6LP Compliance of all 

test substance data. 

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1,1,3,3-TETRAMETHYLBUTYL PEROXYPIVALATE NOTOX Projeot,- ' 

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PURPOSE AND PRINCIPLE 

The purpose of the study was to develop and to validate a method for the 

puantJ.tata-ve-anal-ysrs- -ef--~1;3 3--TE~RAMETH _~BUTYL PEROXYPIVALATE. 

♦ `'--_ 

ARCHIVIN6 

4 NOTOX B.V. wi11 archive the foilowing data for at least 10 years: 

protocol, report, test substance reference sample and raw data. 

ANALYTICAL METHOD 

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STANDARD SOLUTIONS 

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OF THE ANALYTICAL METHOD 

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NOTOX Project 

Certificate of Anafysis 

Central Research 

product name :1,1,3,3 - tetramethylbutyf peroxy pivalate 

'Trade,name r--TLgonax 426 

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