• 

• 

• 

• 

• 

• 

• 

• 

• 

REPORT 

SANITIZED 

DETERMINATION OF THE FREEZING TEMPERATURE OF 

1,1,3,3-TETRAMETHYLBUTYL PEROXYPIVALATE 

( ,---...._. NOTOX Project \ NOTOX Substance 

'----./ 

- Page 1 of 9 · 
 

• 

• 

• 

• 

• 

• • 

• 

• 

Page 2 -
 

• 

• 

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

The DECO Principles of Good Laboratory Practice 

which are essentially in conformity with: 

The United States Food and Drug Administration. Title 21 Code of Federal Regulations Part 58. 

The United States Environmental Protection Agency (riFRA}. Title 40 Code of Federal Regulations Part 160. 

The United States Environmental Protection Agency (TSCA}. Title 40 Code of Federal Regulations Part 792 . 

Study Director Management 

• c-'"'' "2';Kc"~" J.A.M.W. van Helvoirt .. -~d-o.f~istry ( ~-~~ 

" 

"'\ ) ' oat~ Date: 

• 

- Page 3 -
 

• 

• 

• 

• 

• 

• 

• 

• 

• 

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

were inspected . 

DATES OF QAU INSPECTIONS/AUDITS 

on-site inspection (s) 

22 July 1997 

protocol inspection (s) 

29 May 1997 

report audit (s) 

31 July 1997 

Head of Quality Assurance C.J. MitGhell B.Sc . 

'-

Date: 

------------

) 

· Page 4 · 

REPORTING DATES 

22 July 1997 

29 May 1997 

31 July 1997 
• 

In a preliminary test it was found that 1,1,3,3-TETRAMETHYLBUTYL PEROXYPIVALATE does not solidify at a temperature of ·82'C (191 K). 

From this it was concluded that the freezing temperature of 1,1,3,3- TETRAMETHYLBUTYL PEROXYPIVALATE is< -82'C (< 191 K) . 

- Page 5 -
 

• 

• 

• 

• 

• 

Study Monitor 

Testing Facility 

Study-Director 

Study Plan 

TEST SUBSTANCE 

Identification 

Chemical name 

CAS No. 

Descrirtion 

Batch 

Purity Test substance storage 

Stability under storage conditions 

Expiry date 

; 

r 

' 

Hambakenwetering 3 5231 DD 's-Hertogenbosch 

The Netherlands 

--"""-· --") '-. 

Start : 14 July 1997 

Completed : 14 July 1997 

1,1,3,3-tetramethylbutyl peroxypivalate Propaneperoxic acid, 2,2-dimethyl-,1,1,3,3- tetramethylbutyl ester {9CI) 

22288-41-4 

c1ourless .l_~uid 

o~errTTl<:ate of Analysis 

In freezer in the dark 

Stable 

Not indicated 

The sponsor is responsible for the completeness and GLP Compliance of all 

test substance data. 

PURPOSE 

• The purpose of the study was to eva1uate the freezing temperature of the test substance . 

• 

• Page 6 

• 
• 

g 

g 

ge

, May 12, 1981. 

European Economic Community (EEC), EEC-Directive 92169 EEC, Part A, Methods for the determination of physico-chemical properties, A.l "Melting/Freezing temperature", EEC Publication No. L383, December 1992. 

ARCHIVING 

NOTOX B.V. will archive the following data for at least 10 years: protocol, report, test substance reference sample and raw data. 

TEST SYSTEM AND RATIONALE 

Test system 

Rationale 

The test was performed using a jacketed sample tube with stopper to support a calibrated thermometer and a brass stirrer, placed in a vacuum flask. 

Recognized by the international guidelines as recommended test system (EEC, OECD) . 

VALIDATION Of THE TEST PROCEDURE 

The test procedure as outlined in this report is validated periodically, using n·octane and water. The results are in accordance with the NOTOX criteria for validation. 

PERFORMANCE OF THE TEST 

Preliminary test: 

An initial trial determination was performed to make an estimation of the freezing point/freezing range of 1,1,3,3-TETRAMETHYLBUTYL PEROXYPIVALATE. In this test, approximately 5 ml test substance was stored for 1 hour at a 

temperature of 5'C (:278 K), -29'C (244 K) and ·82'C (191 K). After this period, the test substance was visually checked. 

. Page 7 
 

• 

• 

• 

• 

The difference between the temperature at the beginning and at the final stage 

of freezing is within 1 K, therefore, the temperature at the final stage of 

freezing is taken as the freezing point. 

Results are given in degrees centigrade ('C) and in Kelvin (K) • 

RESULTS 

Preliminary test: 

Results are shown in table 1. 

Table 1. Observations during preliminary test . 

Temperature Observations 

·c (K) after 1 hour 

5 (278) liquid 

-29 (244) 1 i quid 

-82 (191) liquid 

• Main study: 

• 

• 

• 

• 

The main study was not performed. 

During the preliminary test, it was found that 1,1,3,3-TETRAMETHYLBUTYL PEROXYPIVALATE remained a liquid without showing any indication of a freezing 

process. 

In conclusion, the freezing point of 1,1,3,3-TETRAMETHYLBUTYL PEROXYPIVALATE 

is< -a2•c (< 191 K) . 

- Page 8 -
Certificate of/Analysis 

:· . •'·' 

Pro'cli.iet niima ·rr~d&'ruime satchnumbar 

:_ ..... 

: 1,1,3.3 .- telramethylbutyl peroxy pivalate 

cl'rigonax 425 

. ':'"'--.:= - """-·--~ -~--. A?_a;y~~~ ~~cunlan~tJ.of_y---- -) 

. . . I ~II~~?a~ \ . 

. ·.· .. 

:~~- Atithoi-l~~d hv-···-.--· -. : ______ _ 

Nariie:' .· -

rU:r1cuOn 

Data- · Slg.n~ttira ( 

Page 9 

Centra/Research 

)