Study Director: 

Test Facility: [ ] 

Sponsor: [ ] 

1 Study Number: 41301965 

Study Completion Date: 23 July 2013 

Page 1 of 11 
1.1 Guidelines I Regulations .......................................................................................... 7 

2 TEST ITEM ........................................................................................................................... 8 

3 TEST ...................................................................................................................................... 9 

3.1 Auto-Ignition Temperature (Liquids and Gases and Low Melting Point 

Solids) ...................................................................................................................... 9 

3.1.1 Test System ............................................................................................... 9 

3.1.2 Principle ofthe Test ................................................................................... 9 

3 .1.3 Perfonnance of the Test. ............................................................................ 9 

3.1.4 Data Handling ............................................................................................ 9 

3.1.5 Results ..................................................................................................... 10 

3.1.6 Conclusion ............................................................................................... 10 

APPENDIX ................................................................................................................................... 11 

Appendix 1 Monitoring Authority Statement of GLP Compliance .......................................... 11 
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(

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Practice Regulations 1999 (SI 1999/3106 as amended by SI 2004/0994)). These Regulations are 

in accordance with GLP standards published as OECD Principles on Good Laboratory Practice 

(revised 1997, ENV/MC/CHEM(98)17); and are in accordance with, and implement, the 

requirements ofDirectives 2004/9/EC and 2004/10/EC. 

These principles are compatible with Good Laboratory Practice regulations specified by 

regulatory authorities throughout the European Community, the United States (EPA and FDA), 

and Japan (MHLW, MAFF and METI). 

This report fully and accurately reflects the procedures used and data generated. There were no 

circumstances considered to have affected the integrity ofthe study or the validity of the data. 

Study Director: 

[ ] 

Date: 2 3 JUL Z013 
these audits and inspections are given below. 

Reported to the relevant 

Dates and Types ofQA Inspections Study Director and Test 

Facility Management 

Date of Inspection Type of Inspection Phase Inspected Report Date 

31 May 2013 Study Plan Verification N/A 31 May2013 

02 April20 13 Process - based Auto-Ignition Temperature 02 April 20 13 

(Liquids and Gases) 

10 July 2013 Report Audit N/A 10 July2013 

This statement confirms that this final report reflects the raw data and the procedures followed. 

Quality Assurance: [ ] 

[ 

·········" ] 

Date: i 4 JUL 2013 

There were no dev

(

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Archiving 

Unless instructed otherwise by the Sponsor, the Study Plan, all raw data (paper and electronic) 

and the final report will be retained in the [ ] archives for 

fifteen years after which instructions will be sought as to further retention or disposal. Further 

retention or return of the data will be chargeable to the Sponsor. 

No data will be discarded without contacting the Sponsor to obtain their written consent. 
g

Methods for the determination of physico-chemical properties. 
• Sample was melted with pennission of the sponsor on 08/05113, 

post melting the sample was an amber liquid. 

Sponsor confirmed sample was okay for testing post melt. 
Instrument: Carbo lite flask heater 

3.1.2 Principle of the Test 

The auto-ignition temperature is the lowest temperature at which the test item will ignite when 

mixed with air under the conditions defined in the test method. 

3.1.3 Performance of the Test 

The test flask was heated in a flask heater. Aliquots of test item (tested as received) were 

injected into the flask using a syringe and the flask observed for signs of ignition over a 300 

second period. This procedure was repeated, varying the sample size, as necessary, until the 

lowest temperature at which ignition, if any, occurred within 300 seconds of insertion, was 

determined. 

3.1.4 Data Handling 

The auto-ignition temperature is the lowest temperature that will result in the ignition of the test 

item injected into the test flask. 

The room temperature and atmospheric pressure is recorded for each day of the test. 

1 Based on, Anon (1987), Electrical Apparatus for Explosive Gas Atmospheres. Part 4: Method of Test for Ignition 

Temperature. JEC Publications 79-4, Pl-19. 
(

) 

350 70 >300 

400 70 >300 

450 (clean flask) 70 >300 

500 (clean flask) 70 3 

490 70 4 

480 70 6 

470 (clean flask) 70 >300 

476 70 11 

472 70 >300 

474 (clean flask) 70 >300 

474 (clean flask) 200 6 

470 200 >300 

472 (clean flask) 200 >300 

472 (clean flask) 400 >300 

472 (clean flask) 600 >300 

472 (clean flask) 800 >300 

472 (clean flask) 1000 >300 

Room temperature: 19 °C to 20 °C 

Atmospheric pressure: 101.1 kPa to 103.0 kPa 

3.1.6 Conclusion 

g

, g

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No ignition, grey fumes emitted. 

No ignition, grey fumes emitted. 

No ignition, grey fumes emitted. 

Orange flame, grey fumes emitted. 

Orange flame, grey fumes emitted. 

Orange flame, grey fumes emitted. 

No ignition, grey fumes emitted. 

Orange flame, grey fumes emitted. 

No ignition, grey fumes emitted. 

No ignition, grey fumes emitted. 

Orange flame, grey fumes emitted. 

No ignition, grey fumes emitted. 

No ignition, grey fumes emitted. 

No ignition, grey fumes emitted. 

No ignition, grey fumes emitted. 

No ignition, grey fumes emitted. 

No ignition, grey fumes emitted. 

The test item has been determined to have an auto-ignition temperature of 474 ± 5 °C. 
THE DEPARTMENT OF HEALTH OF THE GOVERNMENT 

OF THE UNITED KINGDOM 

GOOD LABORATORY PRACTICE 

STATEMENT OF COMPLIANCE 

IN ACCORDANCE WITH DIRECTIVE 2004/9/EC 

TEST FACIUTY TEST TYPE(S) 

[ ] 

DATE OF INSPECTION 

10 July 2012 

Anal~lcaVCIInlcal 

Chemistry 

Environmental Toxicity 

Environmental Fate 

Mutagenicity 

Phys/Chem. Tests 

Toxicology 

An inspection for compliance with the Principles of Good Laboratory Practice was 

carried out at the above test facility as part of the UK Good Laboratory Practice 

Compliance Monitoring Programme. 

This statement confirms that, on the date of issue, the UK Good Laboratory 

Practice Monitoring Authority were satisfied that the above test facility was 

operating in compliance with the OECD Principles of Good Laboratory Practice. 

This statement constitutes a Good Laboratory Practice Instrument (as defined In the 

UK Good Laboratory Practice Regulations 1999). 

p::?~~ 

'30 f, f,z... 

Dr. AndrewJ. Grey • 

Head, UK GLP Monitoring Authority • •