REPORT

J , 

## . .

[ Determination

of Hazardous Physico-Chemical Properties Study Director:

[

] Test Facility: 

# [ ] Sponsor:



# [



# ] 1 Study Number: 41301944 Study Completion Date:

03 September

20
1 3 Page

1 of 18



### ]I Study Number: 41301944

Report

Page2 

## CONTENTS CONTENTS ............................................................
................ ......................................

......... .........

2 STUDY DIRECTOR STATEMENT

OF GLP COMPLIANCE ....................................................



### 3 QUALITY ASSURANCE STATEMENT ......................................................................................



### 4 SUMM.ARY ....................................................................................................................................

5 

### GENERAL INFORMATION .......................................................

.......... ........................................

6 

### Schedule ............... ...............

.. .............................................................................................

.... 6 Deviations from Study Plan ............

... ....................................................................................

6 

### Archiving ............................................................................................................

. ..

. . . ..... .......

. 6 1 INTRODUCTION
AND PURPOSE ..................................................................

...... .............

7 1.1 Guidelines

I 

### Regulations

... .......................................................................................

7 2 TEST ITEM ...........................................................................................................................

8 3 TESTS ...............................................................................................................

. ............. .....
.. 9 3.1 Flash Point ...............................................................................................................

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

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

. ...........................................

9 3

. 1 .3 Performance

of the Test .............................................................................

9 3 .1.4 Data Handling ............................................................................................

9 3.1.5 Results .....................................................................................................

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

11 3.2 Explosive Properties ..............................................................................................

12 3.2.1 Test System .............................................................................................

12 3.2.2 Performance ofthe Prediction .............................................

. ........
... .......

. 12 3.2.3 Data Handling ................

.. .... ... .................................... .............................

12 3.2.4 Results .........

.. .................................................

........ .................................

12 3.2.5 Conclusion ...............................................................................................

12 3.3 Auto-Ignition temperature (Liquids and Gases) ....................................................

13 3.3.1 Test System ..................................................................................

..........

. 13 3.3.2 Principle
of the Test ......................................................................

...........
13 3.3.3 Performance ofthe Test ...........................................................................

13 3.3.4 Data Handling ..........................................................................................

13 3.3.5 Results

...

. ...........

. ................................

.. ...................................................

14 3.3.6 Conc lusion ...............................................................................................

15 3.4 Oxidizing Properties (Liquids) ..............................................................................

16 3.4.1 Test System ..........................................................................

.' ..................

16 3.4.2 Performance ofthe Prediction .................................................................

16 3

. 4.3 Data Handling .......................................................................................

... 16 3

. 4.4 Results ........................................

........ .....................................................

16 3.4.5 Conclusion .................................

. . . ...........................................................

16 APPENDICES ......................................................

. .........................................

.......

. ....... ................

17 Appendix

1 Compositional Information ..................................................

... ...............................

17 Appendix

2 Monitoring Authority Statement

of GLP Compliance
......

.. ............ ..................

.... 181StudyNwnber:41301944ReportSTUDYDIRECTORSTATEMENTOFGLPCOMPLIANCE1StudyNumber:StudyTitle:[]41301944[];:DeterminationofHazardousPhysico-ChemicalPropertiesPage3WiththeexceptionoftheexplosiveandoxidizingpropertiespredictionsthisstudywasperfonnedincompliancewithUKGLPstandards(ScheduleI,GoodLaboratoryPracticeRegulations1999(SI1999/3106asamendedbySI2004/0994)).TheseRegulationsareinaccordancewithGLPstandardspublishedasOECDPrinciplesonGoodLaboratoryPractice(revised1997,ENV/MC/CHEM(98)17);andareinaccordancewith,andimplement,therequirementsofDirectives2004/9/ECand2004/10/EC.TheseprinciplesarecompatiblewithGoodLaboratoryPracticeregulationsspecifiedbyregulatoryauthoritiesthroughouttheEuropeanCommunity,theUnitedStates(EPAandFDA),andJapan(MHLW,MAFFandMET!).Thisreportfullyandaccuratelyreflectstheproceduresusedanddatagenerated.Therewerenocircumstancesconsideredtohaveaffectedtheintegrityofthestudyorthevalidityofthedata.StudyDirector:[ ][]Date:-3SEP2013lstudy Number: 41301944

Report

Page4 

# QUALITY ASSURANCE STATEMENT 1 Study Number: 41301944 Study Title:

[



### ) ;: 

### Determination

of Hazardous Physico -Che mical Properties The general facilities and activities are inspected

at least once

a 

### year and the results are reported to the relevant responsible

pe rson and management. Study-related procedures conducted

at the test facility were audited and inspected. The details of these audits and inspection

s are given below.

Reported

to the relevant Dates and Types ofQA Inspections

Study Director and Test Facility Management Date of Inspection
Type of Inspection

Ph ase Inspected

Report Date 24 May 2013 Study Plan Verification

N / A

24 May2013 29 July 2013 Process

- based Flash Point

29 July 2013 02, 15 July 2013 Process

- based Auto-Ignition Temperature

02, 15 July 2013 (Liquids and Gases) 2 1 August 2013 Report Audit

N / A

21 August2013 

### This statement confirms that this final report reflects the raw data and the procedures followed. Quality Assurance: 

# [



# ] Date:
**~** 

## 0 4 SEP 2013IStudyNumber:41301944ReportSUMMARYThehazardousphysico-chemicalpropertiesof[summarizedbelow:PageS1havebeendetennined.TheresultsareFlashPoint.159±2°C,usingaclosedcupequilibriwnmethoddesignedtobecompatiblewithMethodA9FlashPointofCommissionRegulation(EC)No440/2008of30May2008.ExplosiveProperties.Predictednegativebasedonthechemicalstructureofthetestitem,usingaproceduredesignedtobecompatiblewithMethodA14ExplosivePropertiesofCommissionRegulation(EC)No440/2008of30May2008.Auto-IgnitionTemperature(LiquidsandGases).358±5°C,usingaproceduredesignedtobecompatiblewithMethodA15Auto-IgnitionTemperature(LiquidsandGases)ofCommissionRegulation(EC)No440/2008of30May2008.OxidizingProperties(Liquids).Predictednegativebasedonthechemicalstructureofthetestitem,usingaproceduredesignedtobecompatiblewithMethodA21OxidisingProperties(Liquids)ofCommissionRegulation(EC)No440/2008of30May2008.lStudyNumber

: 4 1 301944

Report GENERAL INFORMATION Schedule Experimental Starting Date: Experimental Completion Date: Deviations from Study Plan

06 June 2013 13 August 2013 There were no deviations (unplanned changes) from the study plan. Archiving

Page

6 Unless instructed otherwise

by the Sponsor, the study plan (General Study Plan and Study Specific Supplement),

all raw data (paper and electronic) and the final report will be retained

in the [ ] archives for five years after which instructions will be sought

as to turther retention

or di sposal. 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.I Study Number: 41301944

Report

Page

7 1 INTRODUCTION
AND PURPOSE The purpose
of this study
is to evaluate the hazardous physico-chemical properties

of the test item. 1.1 Guidelines

I Regulations The test methods described
are designed

to be compatible with the procedures indicated
by the following internationally accepted guidelines and recommendations: • Commission Regulation (EC) No 440/2008
(as amended)

of 30 May 2008, Part A: Methods
for the determination

of physico-chemical properties

.IStudyNumber:41301944ReportPage82TESTITEMInformationasprovidedbytheSponsor.Identification:Description:Batch:Purity:Structure:ExpiryDate:StorageConditions:AmbercoloredliquidNotsuppliedNotsuppliedInformationonthedetailedcompositionisprovidedinappendix1.30January2015Roomtemperature,undernitrogeninthedarkI Study Number: 41301944

Report

Page

9 3 TESTS 3.1 Flash Point 3.1.1 Test System The determination
was carried out using

a closed cup flash point tester

1 , using

a procedure designed

to be compatible with Method A9 Flash Point of Commission Regulation (EC) No 440/2008
of 30 May 2008. Instrument:

Setaflash flash point tester 30000-0. 3.1.2 Principle

of the Test The test item
is placed into the apparatus and progressively heated until the vapor reaches

a sufficiently high concentration

in air to produce

a flammable mixture which can be ignited. 3.1.3 Performance

of the Test An aliquot (approximately

2 g for temperatures

up to 100 °C and approximately

4 g for temperatures above 100 °C) of the test item was transferred

to the sample cup of the Setaflash 30000-0 tester. The sample was heated and allowed

to equilibrate

at the set temperature.
The test flame was introduced into the sample cup for approximately

2Yz seconds by sliding the cup shutter open. Observations were made for ignition
of the vapor.

If no ignition occurred, the temperature
was increased and the test flame re-introduced.
This was repeated until the lowest reproducible temperature

at which

a flash occurred

, using

a fresh sample, was determined. 3.1.4 Data Handling The flash point
is the lowest temperature

at 1 01.3 kPa, at which the test liquid
in a closed test vessel evolves vapors, under the conditions defmed
in the test method,

in such an amount that

a flammable vapor

I air mixture was produced

in the test vessel. 1 Based on, Anon (1983) Paints, Varnishes, Petroleum and Related Products- Determination ofFlash Point· Rapid Equilibrium Method

, lnternadonal Standard ISO 3679-2004
(E), Second Edition- 2004

- 04-01

, Pl-18 and Anon (1989) Flash Point of Liquids by Setaflash Closed·CupApparatus,ASTM D-3278-89, Pl-7

.IStudyNumber

: 41301944

Report The flash point was corrected
for the atmospheric pressure using Equation

3 .l where: c p

= Corrected flash point observed flash point

[ 0 C] ambient atmo

s pheric pre ss ure [kP a] 3.1.5 Results

c + 0.23
(1 01.325-

p) Results
of the flash point determination

are

s h o wn in the following table. Table 3.1 Temperature

( 0 C)

Ob

s ervation

s 25.0

No flash

. 30.0

No flash. 35.0

No flash. 40.0

No flash. 45.0

No flash. 50.0

No flash

. 55.0

No flas h . 60.0

No flash

. 65 .0

No flash

. 70 .0

No flash

. 75.0

No flash. 75.0 (fresh sam ple

) No flash

. 80 .0

No flash

. 85 .0

No fla
s h
. 90.0

No flash

. 95 .0

No flash

. 100.0

No flash

. 105.0 (fresh sample)
No fla sh.

Page 10 Equation
3.1IStudyNumber:41301944ReportTable3.1(continued)Temperature(OC)Observations110.0Noflash.115.0Noflash.120.0Noflash.125.0Noflash.130.0Noflash.135.0Noflash.140.0Noflash.145.0Noflash.150.0Noflash.155.0Noflash.155.0(freshsample)Noflash.160.0Ablueflashspreadacrossthesamplecup.155.0(freshsample)Noflash.156.0Noflash.157.0Noflash.158.0Noflash.159.0Ablueflashspreadacrossthesamplecup.159.0(freshsample)Ablueflashspreadacrossthesamplecup.159.0(freshsample)Ablueflashspreadacrossthesamplecup.157.0(freshsample)Noflash.157.0(freshsample)Noflash.Atmosphericpressure=Correctedflashpoint=101.4kPa158.983oc3.1.6ConclusionTheflashpointofthetestitemhasbeendeterminedtobe159±2°C.Page11IStudyNumber:41301944ReportPage123.2ExplosiveProperties3.2.1TestSystemThepredictionwasundertakenusingaproceduredesignedtobecompatiblewithMethodAl4ExplosivePropertiesofCommissionRegulation(EC)No440/2008of30May2008.3.2.2PerformanceofthePredictionThestructureofthetestitemwasassessedforchemicalgroupsthat implyexplosiveproperties.ExamplesofsuchgroupsareC-Cunsaturated,C-metal,N-metal,contiguousoxygenatoms,contiguousnitrogenatoms,N-halogens,0-halogens,N-0.Examplesofthesegroupsaregivenbelow.StructuralFeaturesC-CunsaturatedC-metal,N-metalContiguousoxygenatomsContiguousnitrogenatomsN-halogens0-halogensN-0ExamplesAcetylenes,acetylides,1,2-dienesGrignardreagents,organo-lithiwncompoundsPeroxides,ozonidesAzides,aliphaticazocompounds,diazoniumsalts,hydrazines,sulphonylhydrazidesChloramines,fluoroaminesChlorates,perchlorates,iodosylcompoundsHydroxylamines,nitrates,nitrocompounds,N-oxides,1,2-oxazolesFullstructuraldetailsaregiveninBretherick'sHandbookofReactiveChemicalHazards,7thEdition,AcademicPress,2007.3.2.3DataHandlingIftherearenostructuralalertswithinthestructurethentheexplosivepropertiescanbepredictednegative.3.2.4ResultsTherearenostructuralalertswithinthechemicalstructureofthetestitem.3.2.5ConclusionBasedonthechemicalstructureofthetestitemtheresultfortheexplosivepropertieshasbeenpredictednegative.I Study Number

: 4 1 3 01944
Report

Page 13 3.3 Auto-Ignition temperature (Liquids and Gases) 3.3.1 Test System The detennination
was carried out using

a procedure

2 designed

to be compatible with Method A15 Auto-Ignition

T e mperature (Liquid and Ga
s e s ) of Commission Regulation (EC) No 440

/ 2008 of 30 May 2008

. In s trument:

Carbolite flask heater 3.3.2 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 te st method. 3.3.3 Performance

of the Test The test flask was heated
in a flask heater

. Aliquots
of test item (test

e d as received

) were dropped into the flask which was observed for sign

s of ignition over

a 300

s econd period. This procedure was repeated, varying the sample

s ize,

a s necessary, until the lowe

s t temperature

at which ignition

, if any

, oc c urred within 300 second

s of insertion, was determined

. 3.3.4 Data Handling The auto-ignition

t e mperature

is the lowest temperature that will result in the igniti

o n of the test item. The room temperature
and atmospheric pressure

is recorded
for each day of the test. 2 B ased on, Anon (1987),

El ectrical Ap p aratus for Ex p losive Gas A tmosphe

r es.

P art
4 : Method
of Test fo r Ignitio

n Te m pera tur e. 1EC P ublications 79-4, Pl-19

.I Study Number: 41301944

R eport

Page 14 3.3.5 Results Re su lts of the auto-ignition temperature determination

are

s hown in the following table. Table 3.2 Test

Test Ignition Delay Observations Tempe

r ature (OC) Weigbt(g)

(s) 200 (clean flask)

0.2
>300

No ignition

. Grey fumes were emitted

. 250 (clean flask)

0.2
>300

No ignition. Grey fumes were emitted. 300 (clean flask)

0.2
>300

No ignition. Grey fumes were emitted

. 350 (clean flask)

0.1
>300

No ignition. Grey fumes were emitted. 400 (clean flask)

0.2

2

A yellow flame. Grey fumes were emitted. 380

0

. 2

2

A yellow flame. Grey fumes were emitted. 370

0.1
>300

No ignition. Grey fumes were emitted

. 3 7 6 (clean flask)

0

. 3

3

A yellow flame

. Grey fumes were emitted

. 372

0.3
>300

No ignition. Grey fumes were emitted

. 374

0

. 3 >300

No ignition. Grey fumes were emitted. 374 (clean flask)

0.2

2

A yellow flame. Grey fumes were emitted. 372 (clean flask)

0.2

7

A yellow

/ green flame. Grey fumes were emitted. 370 (clean flask)

0

. 2 >300

No ignition. Grey fumes were emitted

. 370 (clean flask)

0

. 1 >300

No ignition

. Grey fumes were emitted

. 37 0 (clean flask)

0 .3

5

A blue/green flame. Grey fumes were em

i tted

. 368 (clean flask)

0.2

2

A yellow/blue flame. Grey fumes were emitted. 366 (clean flask)

0

. 3

4

A yellow/blue flame. Grey fumes were emitted. 364 (clean flask)

0

. 3 >300

No ignition. Grey fumes were emitted. 364 (clean flask)

0.5
>300

No ignition. Grey fumes were emitted

. 364 (clean flask)

0

. 7

2

A yellow/blue flame. Grey fumes were emitted

. 362 (clean flask)

0

. 5 >300

No ignition

. Grey fumes were emitted. 36 2 (clean flask)

0.7
>300

No ignition

. Grey fumes were emitted. 362 (clean flask)

0

. 8

2

A yellow/blue flame. Grey fumes were emitted. 360 (clean flask)

0.8
>300

No ignition. Grey fumes were emitted. 360 (clean flask)

1.1

2

A yellow/blue flame. Grey fumes were emitted. 358 (clean flask)

0

. 8 >300

No ignition. Grey fumes were emitted.lstudyNumber: 41301944

Rep
o rt Table 3.2 (continued) Test

Test

Ign iti on Delay Observations Temperature
COC) Weight(g

)

(s ) 358 (clean flask)

1.1

2

A blue/yellow flame

. Grey fumes were emitted. 356 (clean flask)

1.1
>300

No ignition. Grey fumes were emitted

. 356 (c l ean fla sk )
1.4
>300

No ignition. Grey fumes were emitted

. 356 (clean flask)

1. 6 >300

No ignition. Grey fumes were emitted. 356 (clean flask)

1.8
>300

No ignition. Grey fume

s were emitted

. 356 (clean flask)

2.1
>300

No ignition. Grey fumes were emitted

. Room temperature:

19 to 21 °C Atmospheric pressure:101.0

to 102.1 kPa 3.3.6 Conclusion The test item has been determined

to have an auto-ignition temperature of358

± 5 °C. Page

1 5IStudyNumber:41301944ReportPage163.4OxidizingProperties(Liquids)3.4.1TestSystemThepredictionwasundertakenusingaproceduredesignedtobecompatiblewithMethodA21OxidisingProperties(Liquids)ofCommissionRegulation(EC)No440/2008of30May2008.3.4.2PerformanceofthePredictionThestructureofthetestitemwasassessedforchemicalgroupsthatwouldimplyoxidizingproperties.Examplesofsuchgroupsarenitrates,metaloxides,hypofluorites,difluoroaminopolynitroaryls,perchlorates,bromatesandiodites.FullstructuraldetailsaregiveninBretherick'sHandbookofReactiveChemicalHazards,7thEdition,AcademicPress,2007.3.4.3DataHandlingIftherearenostructuralalertswithinthestructurethentheoxidizingpropertiescanbepredictednegative.3.4.4ResultsTherearenostructuralalertswithinthechemicalstructureofthetestitem.3.4.5ConclusionBasedonthechemicalstructureofthetestitemtheresultfortheoxidizingpropertieshasbeenpredictednegative.I Study Number

: 41301944 

# APPENDICES Appendix

1 Compositional Information 

# . 

# .
. ••••• • 

## •••



# • ••• 

# ••••• • 

## •

• 

# . 

# [ [

Report

Page 17 

# ] ]IStudyNumber:41301944ReportAppendix2MonitoringAuthorityStatementofGLPComplianceioH)DepartmentofHealthTHEDEPARTMENTOFHEALTHOFTHEGOVERNMENTOFTHEUNITEDKINGDOMGOODLABORATORYPRACTICESTATEMENTOFCOMPLIANCEINACCORDANCEWITHDIRECTIVE2004/9/ECTESTFACILITYTESTTYPE(S)[]DATEOFINSPECTION10July2012Analytical/ClinicalChemistryEnvironmentalToxicityEnvironmentalFateMutagenicityPhys/Chem.TestsToxicologyAninspectionforcompliancewiththePrinciplesofGoodLaboratoryPracticewascarriedoutattheabovetestfacilityaspartoftheUKGoodLaboratoryPracticeComplianceMonitoringProgramme.Thisstatementconfirmsthat,onthedateofissue,theUKGoodLaboratoryPracticeMonitoringAuthorityweresatisfiedthattheabovetestfacilitywasoperatingincompliancewiththeOECDPrinciplesofGoodLaboratoryPractice.ThisstatementconstitutesaGoodLaboratoryPracticeInstrument(asdefinedintheUKGoodLaboratoryPracticeRegulations1999).Dr.AndrewJ.GrayHead,UKGLPMonitoringAuthorityPage18