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### [7 TX 425-C75

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~ 

# SAtVtT'iZED REPORT s

~ 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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~ Page I of 16 - 

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1, ~ 

### .,3,3 - 

### T E 

### TRAM E 

### THYLBUTYL PEf20XYP I 

### VALAT E 

### N4TOX Projea: ~ M CONFIdENTXALTTY STATEMENT

~ ~ This report contains the unpublished results T 'of research sponsored by AKZO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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### _ page 2 _ ®0 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. 

### w
+ Study Director Management
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### Page 3 - V❑ 1,1,3,3-TETRAMETHYLBUTYL PEROXYPIVALATE NOTOX Projea 

### A QUALITY ASSURANCE STATEMENT k
~ 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. e ❑ [7 Page 4 - 

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### NOTOX ProjeFt 0 

### SUMMARY

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

### 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 1-99% ~ ~ Study plan Ol—Jti-lY 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 ./~ 

### 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, - '

! 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 

### i
[: STANDARD SOLUTIONS 

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### 0 0 ❑ OF THE ANALYTICAL METHOD

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~ DATA HANDkI-NG" – --" ® ❑

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## RESUL n 

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## n WN OTOX Project 

# Certificate of Anafysis Centr al Resea rch 

### product name :1,1,3,3 - tetramethylbutyf peroxy pivalate 'Trade,name r- -TLgonax 426 

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