### 3-PPB Soil Adsorption

HLS study number: Version 10: Final Issue date: 28 January 20 14
Page 1 of 18Huntingdon Life Sciences



### -- .-- 

## Sponsor and Test Facility Sponsors

Test facility 

### Emerald Perfonnance Chemicals, LLC 2020 Front Street, Suite 100 CuyahogaFalls OH44221 USA Huntingdon Life Sciences Eye Research Centre Eye Suffolk IP23 7PX ENGLAND

2Huntingdon 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 ofrecords ....................................................................................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 ofAnalysis 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 

### considerthe data generatedto be

### valid. The UK 

### Good Laboratory Practice Regulations (Statutory Instrument 1999 No. 3106, as amended by Statutory Instrument 2004No. 994). EC Commission Directive 2004/10/EC of11 February2004. OECD Principles of Good Laboratory Practice (as revised 

### in 1997), ENV/MC/CHEM(98)17. These principles ofGood Laboratory Practice are accepted by 

### the regulatory authorities of theUnited States ofAmerica and Japan onthe basis ofintergovernmental agreements. 

# {J,·¥?· P Sydney BScMSc Study Director 

### Huntingdon Life Sciences DateHuntingdon Life Sciences ' 

## Quality Assurance Statement 3-PPB: Soli adsorption The following inspections and audits have been 

### carried out in relation to

### this study: StudyPhase Protocol Audit Report Audit Date{s) ofInspection 20Nov2013 20 Jan2014 

### Date ofReporting to Study Director andManagement 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 Standardpreparation/Sample preparation Results processing Analytical 

### procedures 

### Testitem management: receipt of

### test items, disposal/ 

### return of testitems to Sponsor Studymanagementand conduct Date{s) oflnspection 02 Aug2013 08 Aug2013 04 Oct 2013, 07 Oct2013 03 Dec2013 10Dec2013 

### Date ofReporting to Management 02Aug2013 08Aug2013 07 Oct2013 03 Dec2013
10 Dec 2013


### In 

### addition, an inspection ofthe 

### facility where 

### this study was conductedwas carried outon an 

### annual basis. These inspections werepromptly reported to CompanyManagement.

T

### PullingerMRQA Group Manager Department ofQuality 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

6Huntingdon Life Sciences 

## Summary

7Huntingdon Life Sciences 

## 1. Introduction 1.1 Objective A study was perfurmed to estimate the adsorption coefficient 

### (Ko,) of3-PPB by HPLC. The adsorption coefficient is an important parameter in assessing the environmental distribution ofa 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 ofthe 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, undernitrogen Lot number: EH101912A Expiry date: 19 October 20 14 Purity: 99.1% Date received: 22 October 2013

9Huntingdon Life Sciences 

## 3. Soil Adsorption (EC Method C.19, OECD Method 121)

10Huntingdon Life Sciences 

### The following reference mixture was prepared in 

### HPLC mobile phase.

11Huntingdon Life Sciences 

### 3.5 Results

12Table1 HPLC determination of log,.Ko, for 3-PPBFigure 1 log,.k versus log10K., calibration of standard runs A and BFigure 2 Chromatogram ofstandard materials wHh log10Koo between 1.3 and 5.6Figure 3 Chromatogram of3-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.atthe product identified below has·been representatively sampled amianalyzed according to our quality control programs. It meetsor 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 42Huntingdon 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. Gray


## ~ Head, UK GLP Monitoring Auth0rtty


### ~

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