3-PPB 

Soil Adsorption 

HLS study number: 

Version 10: Final 

Issue date: 28 January 2014 

Page 1 of 18 
Huntingdon Life Sciences 

-- . --

Sponsor and Test Facility 

Sponsors 

Test facility 

Emerald Perfonnance Chemicals, LLC 

2020 Front Street, Suite 100 

Cuyahoga Falls 

OH44221 

USA 

Huntingdon Life Sciences 

Eye Research Centre 

Eye 

Suffolk 

IP23 7PX 

ENGLAND 

2 
Huntingdon Life Sciences 

Table of Contents 

Sponsor and Test Facility ...................................................................................................... 2 

Compliance with Good Laboratory Practice .......................................................................... 4 

Quality Assurance Statement. ............................................................................................... 5 

Contributing Scientists .......................................................................................................... 6 

Summary .............................................................................................................................. 7 

1. Introduction .................................................................................................................. 8 

1.1 Objective ........................................................................................................... 8 

1 .2 Regulatory compliance ..................................................................................... 8 

1.3 Study schedule ................................................................................................. 8 

1.4 Maintenance of records .................................................................................... 8 

1.5 Deviations from protocol ................................................................................... 8 

2. Test Substance ............................................................................................................ 9 

3. Soil Adsorption ........................................................................................................... 10 

3.1 Definition and units ......................................................................................... 10 

3.2 Method ........................................................................................................... 10 

3.3 Procedure ....................................................................................................... 10 

3.4 HPLC conditions ............................................................................................. 11 

3.5 Resutts ........................................................................................................... 12 

3.6 Conclusion ...................................................................................................... 12 

List of Annexes 

Annex 1 

Annex2 

Certificate of Analysis for 3-PPB .................................................................. 17 

Eye Research Centre GLP Compliance Statement 2012 ............................. 18 

3 
Huntingdon Life Sciences 

Compliance with Good Laboratory Practice 

3-PPB: Soli adsorption 

The study described in this report was conducted in compliance with the following Good 

Laboratory Practice standards and I consider the data generated to be valid. 

The UK Good Laboratory Practice Regulations (Statutory Instrument 1999 No. 3106, 

as amended by Statutory Instrument 2004 No. 994). 

EC Commission Directive 2004/10/EC of 11 February 2004. 

OECD Principles of Good Laboratory Practice (as revised in 1997), 

ENV/MC/CHEM(98)17. 

These principles of Good Laboratory Practice are accepted by the regulatory authorities of 

the United States of America and Japan on the basis of intergovernmental agreements. 

{J,·¥?· 

P Sydney BSc MSc 

Study Director 

Huntingdon Life Sciences 

Date 
Huntingdon Life Sciences 

' 

Quality Assurance Statement 

3-PPB: Soli adsorption 

The following inspections and audits have been carried out in relation to this study: 

Study Phase 

Protocol Audit 

Report Audit 

Date{s) of Inspection 

20Nov2013 

20 Jan2014 

Date of Reporting to Study 

Director and Management 

20Nov2013 

20Jan2014 

Process based Inspections: At or about the time this study was in progress inspections of 

procedures employed on this type of study were carried out. These were conducted and 

reported to appropriate Company Management as indicated below: 

Process Based Inspections 

Standard preparation/Sample 

preparation 

Results processing 

Analytical procedures 

Test item management: 

receipt of test items, disposal/ 

return of test items to 

Sponsor 

Study management and 

conduct 

Date{s) oflnspection 

02 Aug2013 

08 Aug2013 

04 Oct 2013, 07 Oct 2013 

03 Dec2013 

10Dec2013 

Date of Reporting to 

Management 

02Aug2013 

08Aug2013 

07 Oct2013 

03 Dec2013 

10 Dec 2013 

In addition, an inspection of the facility where this study was conducted was carried out on an 

annual basis. These inspections were promptly reported to Company Management. 

T Pullinger MRQA 

Group Manager 

Department of Quality Assurance 

Huntingdon Life Sciences 

Date 

5 
Contributing Scientists 

3-PPB: Soil adsorption 

Study management 

P Sydney BSc MSc 

Study Director 

Product Chemistty 

Huntingdon Life Sciences 

6 
Huntingdon Life Sciences 

Summary 

7 
Huntingdon Life Sciences 

1. Introduction 

1.1 Objective 

A study was perfurmed to estimate the adsorption coefficient (Ko,) of 3-PPB by HPLC. The 

adsorption coefficient is an important parameter in assessing the environmental distribution 

of a test substance. 

1.2 Regulatory compliance 

The method followed is amongst those described in Commission Regulation (EC) 

No. 440/2008 (Method C.19) and the OECD Guidelines for the Testing of Chemicals 

(Method 121). 

1.3 Study schedule 

Study initiation date 

Experimental start date 

Experimental completion date 

Study completion date 

1.4 Maintenance of records 

21 November 2013 

23 December 2013 

23 December 2013 

28 January 2014 

Primary data from the test, and a copy of the final report, are stored in the archives of 

Huntingdon Life Sciences. 

1.5 Deviations from protocol 

There were no deviations from the protocol. 

B 
-------------------

Huntingdon Life Sciences 

2. Test Substance 

Identity: 3-PPB 

Structure: 

Appearance: Clear, colourless liquid 

Storage conditions: Room temperature, under nitrogen 

Lot number: EH101912A 

Expiry date: 19 October 20 14 

Purity: 99.1% 

Date received: 22 October 2013 

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Huntingdon Life Sciences 

3. Soil Adsorption 

(EC Method C.19, OECD Method 121) 

10 
Huntingdon Life Sciences 

The following reference mixture was prepared in HPLC mobile phase. 

11 
Huntingdon Life Sciences 

3.5 Results 

12 
Table1 HPLC determination of log,.Ko, for 3-PPB 
Figure 1 log,.k versus log10K., calibration of standard runs A and B 
Figure 2 Chromatogram of standard materials wHh log10Koo between 1.3 and 5.6 
Figure 3 Chromatogram of 3-PPB 

":·.-· 
Annex 1 Certificate of Analysis for 3-PPB 

{ Em~ald Performance Materials'" 

~ Kalama Chemical 

Huntingdon Life Sciences 

CERTIFIC,\ TE OF f,NALYSIS 

F.meraid Kalar\1a Ch~mki:~l, LLC 

·!ZS5 ihir•:l S~el NcrlhWc;:;~ \(3!<;h1S, :WA-95615 

f:ho!1!:l: {~·~•OI !flS-2.."-.50 fi!;(: (313U) 673-155.:1 

PROOUCT: Kalama® K-Fiex®.613 Plasticizer 

This is lo:certi!'yth.at the product identified below has· been representatively sampled ami analyzed according to 

our quality control programs. It meets or exceeds the.speclfications for K-F.Iex 613. 

Lei! Number: 

Daie o!Manufacture: 

. CAS # 60045-26-l 

· .Appearance, visual 

Assay,% 

Acidity,% 

Calor,APHA 

Cherise Hylton 

Quality Manager 

EH101912A 

October 2012 

SPECIFICATIONS 

Clear and free of particulates 

99.0, Minimum 

0.3, Maximum 

1 00 .. Maximum 

Certificate-computer generated thus not requiring a signature. 

17 

ANALYSIS 

Pass 

99.1 

0.1 

42 
Huntingdon Life Sciences 

Annex2 Eye Research Centre GLP Compliance Statement 2012 

i nH) Department ~ ofHea/th 

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 FACILITY 

Huntingdon Life Sciences 

Eye Research Centre 

Oecoid 

Eye 

Suffolk 

IP237PX 

DATE OF INSPECTION 

18"'- 20 .. June-2012 

TEST TYPE(S) 

AnalyticaUCIInlcal 

Chemistry 

Environmental Fate 

Environmental Toxicity 

Ecosystems 

Phys.Chem. Testing 

Residue studies 

Mutagenicity 

Toxicology 

An Inspection for compliance with the Prtnclples of Good Laboratory Practice was 

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

Compliance Monltortng 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 ccinstltutes a Good Laboratory Practice Instrument (as defined In ihe 

UK Good Laboratory Practice Regulations 1999). 

Dr.AndrewJ. 

Head, UK GLP 

Gray 

Monitoring Auth0rtty 

~ 

~ 

18