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# REPtJRT 

# SAtViTrzEo STATBfUlENT UN THE PYRQPHORiC PRAPBR1°IB S Of: 1,1,3,3-TBI'RAiViBTHYLBUTYLPBROXY F'iVALA7"B



## ~ _...;., NOTOX project , NOTOX Substanc 

## ~ - Fage 1 of 8 -`,. 1,1,3,3-TETRAMETHYLSUTYLREROXY PIVALATE NOTOX Projec ` y, : CONF3QENTIALITY STATEMENT This report contains fhe unpublished results of research sponsored by Akzo Nobel Chem' icafs 

### B.V.. Fteproduction, issue or disctosure to third Qarties in any form is not permitted without prior written authorfzation from the sponsor.

~ r.J. ~ ~~~[ •~ ~~~~~~ i

.2rStudy Director



### Date 

# ~ . 1,1,3,3-TETRAMETHYLBUTYLPEROXY PIVALATE NOTOX Proje 

# ~ ~ STATEMENT OF GLP COMPLIANCE NOTOX B.V.,'s-Hertogenbosch, The Netherlands 

### The study described in this report has been correotly reported and was conducted in compliance with the most recent edition of: 

### The OECD Principles of Good Laboratory Practice which are essentialiy tn conformity with: The United States Food and Drug Administration. Title 21 Code of Federal Regulations Part 58. The United States EnvPronmental Protection Agency (FfFRA). Title 40 Code of Federal Regulations Part 160. The United States Environmental Protection Agency ('i'SCA). Titie 40 Code of Federal Regulations Part 792. .



### Management Dr. Ir. H. Wiliems

~ l Head-of_Chemistry



### Dafe:

-3-1,1,3,3-TETRAMETHYLBUTYLPEROXY PIVALATE NOTOX Projec i \ 

### ~ QUALITY ASSURANCE STATEMENT NOTOX B.V.,'s-Hertogenbosch, The Netherlands This report was audited by the NOTOX Quality Assurance Unit to ensure that the methods and results accurately reflect the raw data. The dates of Quality Assurance inspections and audits are given below. DATES OF QAU INSPECTIONS/AUDITS protocol inspection (s) 11 February 1999 report audit (s) 16 August 1999
Head of Quality Assurance C.J. Mitchell B.Sc.

Date: 

# ~ REPORTING DATES 11 February 1999 16 August 1999

4-1,1,3,3-TETRAMETHYLBUTYLPEROXY PIVALATE NOTOX Pro'ect

.. ~ _.._. ~ ~ Sponsor AKZO Nobel Chemicals B.V. P.O. Box 247 3800 AE Amersfoort 

### Iholetherla. d

~ f Study Monitor Testing Facility ----- ---- ✓ NOTOX B.V.' Hambakenwetering 3 5231 DD's-Hertogenbosch 

### Th etherlands 

### Study Director Study Plan Start : 13 August 1999 Completed : 13 August 1999 

### TESTSUBSTANCE Identification 1,1,3,3-TETRAMETHYLBUTYLPEROXY PIVALATE AKZO Nobel trade name Trigonox 425 

### Chemical name 1,1,3,3-Tetramethylbutylperoxy pivalate CAS no. 22288-41-1 

### Description ---Colourtess-liqu'Ld Batch Number

~ '" ~ - -See - Certificate Purity of-Ana(ysis 

### Test substance storage In freezer in the dark Stability under storage conditions Stable Expiry date 01 January 2000 The sponsor is responsible for the completeness and GLP Compiiance of all 

### testsubstance data. The purpose of the study was to evaluate the pyrophoric properties of the test substance. GUIDELINES 

### The procedures for the determination of the pyrophoric properties are described tn the following guidefine: 

### European Economic Community (EEC), EEC directive 92/69 EEC, Part A, Methods for the determination of physioo-chemical properties, A-13: "Pyrophoric properties of solids and liquids", EEC Publicatfon No. L383, December 1992.



### -5-1,1,3,3-TETRAMETHYLBUTYLPEROXY PIVALATE NOTOX Proj ct ARCH IVING NOTOX B.V. wilf archive the following data for at least 10 years: protocol, report, test substance reference sample and raw data. Thereafter, no data will be withdrawn wifhout the sponsor's written consent. From the composition and the structuraf formula of 1,1,3,3-TETRAMETHYLBUTYLPEROXY PIVALATE (see Appendix and Figure 1, respectively), it can be concluded that 1,1,3,3- TETRAMETHYLBUTYLPEROXY PIVALATE is not pyrophoric. The test substance does not contain any chemical group that might lead to spontaneous ignition a short time after coming into contact with air at room temperature (circa 20 0 C). Furthermore, experience in handling shows that the test substance does not ignite coming in contact with air. O


# ~ O/O Figure 1. Structural formula of 1,1,3,3-TETRAMETHYLBUTYLPEROXY PIVALATE.

MNOTOXProjectl ~ 

# ~~ 1,1,3,3-TETRAMETNYLBUTYLPEROXY PIVALATE APPENDIX: CERTIFICATE OFANALYSIS 

## AKZO iV±DBEL ®

Product name : 1,1,3,3-tetramethylbutyl Tradename : Trigonox425 

### Batch num be 

### r t Centra! Research page 1 of 2

File code Analytical documentation 

# ~ Authodzed by'' — ° '-, -- -- Name Function Date Signature 

# ~

-7-~ ---, 1,1,3,3-TETRAMETHYLBUTYLPEROXY PIVALATE NOTOX Projeot t/ 

## 14KZ0 NOBEL o• i ~ o Centrcrl Research page 2 or2

M .