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TITLE/COVER PAGE 

ABIOTIC DEGRADATION: HYDROLYSIS AS A FUNCTION OF pH 

(PRELIMINARY TEST) 

Sponsor Research Laboratory 

Huntingdon Life Sciences, Ltd. 

Woolley Road 

Alconbury 

Huntingdon 

Cambridgeshire 

PE28 4HS 

ENGLAND 

Final: 2 April 2008 
: 2 : 

TABLE OF CONTENTS 

Page 

TITLE/COVER PAGE........................................................................................................ 1 

TABLE OF CONTENTS.................................................................................................... 2 

COMPLIANCE WITH GOOD LABORATORY PRACTICE STANDARDS ................. 3 

QUALITY ASSURANCE STATEMENT ......................................................................... 4 

CONTRIBUTING SCIENTISTS........................................................................................ 5 

SUMMARY ........................................................................................................................ 6 

INTRODUCTION............................................................................................................... 7 

TEST SUBSTANCE........................................................................................................... 8 

ABIOTIC DEGRADATION: HYDROLYSIS AS A FUNCTION OF pH 

(PRELIMINARY TEST) .................................................................................................... 9 

FIGURE 

1. Standard Calibration for by HPLC.......................................................... 12 

TABLES 

1. Standard Calibration for by H 13 

2. Preliminary Test Results sis of 14 

3. pH Change During Preliminary Hydrolysis 15 

PROTOCOL DEVIATIONS............................................................................................... 16 

MAINTENANCE OF RECORDS...................................................................................... 16 

REFERENCES.................................................................................................................... 17 

APPENDICES 

1. Eye Research Centre GLP Compliance Statement 2005.............................................. 18 

2. Eye Research Centre GLP Compliance Statement 2008.............................................. 20 

3. Certificate of Analysis.................................................................................................. 22 

4. Study Protocol .............................................................................................................. 24 
COMPLIANCE WITH GOOD LADORA TORY PRACTICE STANDARDS 

Abiotic Degradation: Hydrolysis as a Function of pH 

(Preliminary Test) 

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 2004110/EC of 11 February 2004. 

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

ENV /MC/CHEM(98) 17. 

The OECD 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 . 

............. !!.:.¥~······················ 

P. Sydney, B.Sc., M.Sc. 

Study Director 

Huntingdon Life Sciences Ltd. 

.. ~ ... 6-f..r:-.:' ... ~.~~ ............ . 

Date 

: 3: 
QUALITY ASSURANCE STATEMENT 

Abiotic Degradation: Hydrolysis as a Function of pH 

(Preliminary Test) 

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

Study Phase 

Protocol Audit 

Report Audit 

Date(s) oflnspection 

17 May2007 

14-16 October 2007 

Date of Reporting to Study 

Director and Management 

18 May2007 

16 October 2007 

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 

Hydrolysis 

Date(s) oflnspection 

26 September 2007 

Date of Reporting to 

Management 

28 September 2007 

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. 

Vrt:ffiflKVIanager 

Department of Quality Assurance, 

Huntingdon Life Sciences Ltd. 

:4: 

... ~.l:f.e.-:~~;-:-.. ~~'.( ........ . 

Date 
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CONTRIBUTING SCIENTISTS 

Abiotic Degradation: Hydrolysis as a Function of pH 

(Preliminary Test) 

The following staff member has reviewed this report. 

A. L. Comb, B.Sc., Ph.D. 

(Scientific Manager, Product Chemistry) 

The following staff were responsible for the conduct of the work and reporting of the results. 

P. Sydney, B.Sc., M.Sc. 

(Study Director, Product Chemistry) 

C. Steil, B.Sc. 

(Scientist, Product Chemistry) 
: 6 : 

SUMMARY 

A study was performed to determine the rate of hydrolysis of as a function of 

pH. The study was performed in accordance with the prelimi described in the 

Annex to EEC Directive 92/69/EEC, Method C.7, and the OECD Guidelines for the Testing 

of Chemicals, Method 111. 

The preliminary study showed that at pH 4, 7 and 9 and 50 ± 0.5oC, less than 10% hydrolysis 

had occurred after 120 hours (5 days), equivalent to a half-life of greater than 1 year under 

environmental conditions (25°C); therefore, no further testing was necessary. 

 was determined to be hydrolytically stable under acidic (pH 4), neutral (pH 7) 

H 9) conditions.
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INTRODUCTION 

This study was designed to determine the rate of hydrolysis of as a function of 

pH. Determination of the rate of hydrolysis of a test subs in predicting its 

environmental fate. 

The study was conducted in compliance with the requirements of the Annex to EEC Directive 

92/69/EEC, Method C.7, and the OECD Guidelines for the Testing of Chemicals, 

Method 111. 

The protocol was approved by the Study Director and Huntingdon Life Sciences 

Management on 15 May 2007, by the Study Monitor for the Sponsor on 17 May 2007 and by 

the Sponsor’s Representative on 31 May 2007. 

The experimental start and completion dates were 15 August 2007 and 23 August 2007, 

respectively. 

Location of study : Huntingdon Life Sciences, Ltd. 

 Eye Research Centre 

 Eye 

 Suffolk 

 IP23 7PX 
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TEST SUBSTANCE 

Identity: 

Chemical name: 

Molecular formula: 

Molecular weight: 

CAS number: 

Lot number: 

Expiry date: 14 May 2008 

Purity: 

Appearance: 

Storage conditions: Ambient temperature in a dark environmentally 

controlled area 

Date of sample receipt: 31 July 2006 

Source: 

Structure: 
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ABIOTIC DEGRADATION: HYDROLYSIS AS A FUNCTION OF pH 

(PRELIMINARY TEST) 

METHOD 

The test was performed in accordance with the preliminary test as described in Method C.7 

(92/69/EEC) and OECD Guideline 111. 

DEFINITION AND UNITS 

Hydrolysis refers to a reaction of a chemical RX with water. This reaction may be 

represented by the net exchange of the group X with OH: 

 RX + HOH → ROH + HX 

The concentrations can be expressed in units such as milligrams per litre or moles per litre. 

PROCEDURE 

Preparation of buffer solutions 

Buffer solutions were prepared as follows, using sterile, purified water: 

pH 4.0 : Potassium dihydrogen orthophosphate (3.00 g) and disodium hydrogen 

orthophosphate dodecahydrate (6.42 g) were dissolved in water (950 ml), and the 

pH was adjusted to 4.0 ± 0.05 with orthophosphoric acid. The volume was then 

adjusted to 1000 ml with water. 

pH 7.0 : Potassium dihydrogen orthophosphate (6.82 g) was dissolved in water (950 ml), 

1M sodium hydroxide (30 ml) was added and the pH was measured as 7.0 ± 0.05. 

The volume was then adjusted to 1000 ml with water. 

pH 9.0 : Disodium tetraborate decahydrate (16.6 g) and potassium dihydrogen 

orthophosphate (1.80 g) were dissolved in water (950 ml) and the pH was 

measured as 9.0 ± 0.05. The volume was then adjusted to 1000 ml with water. 

Preliminary test 

The following procedure was carried out in duplicate at each of pH 4, 7 and 9: 

An aliquot (1 ml) of a stock solution of (approximately 50 mg/l in methanol) 

was added to a 100-ml volumetric flask co ffer solution (100 ml), which had been 

purged with nitrogen and pre-equilibrated at test temperature (50°C). The sample, of nominal 

concentration 0.5 mg/l, was placed in a 50°C water bath in the dark (the sample was 

foil-wrapped) until sampling was required (after a short incubation period of approximately 

5 minutes, and then after 2.4 and 120 hours). At each sampling time, an aliquot (5 ml) was 

diluted to volume (10 ml) with methanol for analysis by high performance liquid 

chromatography (HPLC). 
: 10 : 

Sample pH and incubation temperature were monitored over the period of the test using a 

Fisher Scientific Hydrus 400 pH meter and calibrated mercury-in-glass thermometer, 

respectively. 

HPLC CONDITIONS 

Instrument: 

Column: 

Column temperature: 

Mobile phase composition: 

Flow rate: 

Injection volume: 

Detector: 

Retention time: 

PREPARATION OF CALIBRATION 

A stock calibration solution of concentration 2.5 g/l was prepared by weighing test substance 

(approximately 120 mg) into a 50 ml volumetric flask and dissolving in and diluting to 

volume with methanol. 

Calibration solutions in the range 0.05 to 0.5 mg/l were prepared by dilutions of the stock 

solution with mobile phase. 

CALCULATIONS 

The concentration of in the analysed solution (CA) was calculated from 

standards introduced b fter samples (bracketing standards) by the following 

equation: 

CA (mg/l) = 

standards bracketing of areapeak mean 

concentrat standard x areapeak sample (mgion l)

The concentration of in each test solution (CB) was then determined thus: 

CB (mg/l) = CA (mg/l) x dilution factor 

where the dilution factor was 2 for all samples tested. 
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RESULTS 

Validation 

Using the conditions described, the calibration of was found to be linear over 

the concentration range 0 to 0.5 mg/l, with sion coefficient of 1.0000 

(Figure 1, Table 1). 

The analytical method used was sufficiently precise and sensitive to detect a reduction of 

10% of the initial test concentration. 

Recoveries of from fortified control samples in each medium were found to be 

quantitative an orrection was necessary to the determined sample concentrations. 

No significant interfering peaks were evident in blank control solutions. 

Preliminary test 

Results from th ry test showed that there was no significant change in the 

concentration of when incubated in pH 4, 7 and 9 buffer solutions at 50 ± 0.5oC 

(Table 2). Less hydrolysis had occurred after 120 hours (5 days) under these 

conditions, equivalent to a half-life of greater than 1 year under environmental conditions 

(25°C); therefore, no further testing was necessary. 

pH of test solutions 

The pH values of test solutions over the period of the test are presented in Table 3. The 

results show that there were no significant changes in pH with time. 

CONCLUSION 

 was determined to be hydrolytically stable under acidic (pH 4), neutral (pH 7) 

H 9) conditions. 
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FIGURE 1 

Standard Calibration for by HPLC 

y = 263.8x - 0.4848

r = 1.0000

0

255075

100125150

0.00 0.10 0.20 0.30 0.40 

Concentration (mg/l)

Peak area
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TABLE 1 

Standard Calibration for by HPLC 

Standard concentration (mg/l) Peak area 

0.4918 129.72 

0.3934 103.09 

0.2951 77.225 

0.1967 51.088 

0.09835 25.233 

0.04918 12.492 

Linear regression: y = 263.8x - 0.4848 

(including x = 0, y = 0) r = 1.0000 

x = concentration 

y = peak area 
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TABLE 2 

Preliminary Test Results for Hydrolysis of 

Ct (mg/l) 

pH t0h t2.4h t120h

 Measured Mean Measured Mean Measured Mean 

4 0.47, 0.48 0.48 0.50, 0.48 0.49 0.48, 0.48 0.48 

7 0.48, 0.48 0.48 0.48, 0.48 0.48 0.47, 0.47 0.47 

9 0.48, 0.48 0.48 0.48, 0.48 0.48 0.47, 0.47 0.47 

Where Ct is the concentration of in solution at time th (in hours) 
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TABLE 3 

pH Change During Preliminary Hydrolysis Tests 

Nominal pH Mean Initial pH (t0h) Mean Final pH (t120h) 

4 4.1 4.1 

7 7.0 7.0 

9 9.0 9.1 
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PROTOCOL DEVIATIONS 

Blank control solutions were run at each pH during the course of method development work 

and no significant interfering peaks were evident. Such controls were not, however, run on 

each occasion of analysis as specified in the protocol. 

This minor deviation was not considered to have any impact on the integrity of the study. 

MAINTENANCE OF RECORDS 

All raw data, samples and specimens (if appropriate) generated at Huntingdon Life Sciences 

during the course of this study, together with a copy of the final report, will be retained by 

Huntingdon Life Sciences in its archive for a period of five years from completion of the 

study, or until the Sponsor provides instructions for their delivery to the Sponsor’s designated 

archiving facility. After such time, the Sponsor will be contacted and advice sought on the 

return, disposal or further retention of the materials. Types of sample and specimen which are 

unsuitable, by reason of instability, for long term retention and archiving may be disposed of 

after the periods stated in Huntingdon Life Sciences Standard Operating Procedures and after 

contacting the Sponsor. Under no circumstances will any item be discarded without the 

Sponsor’s consent. 

Huntingdon Life Sciences will retain the Quality Assurance records relevant to this study and 

a copy of the final report in its archive indefinitely. 
: 17 : 

REFERENCES 

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

amended by Statutory Instrument 2004 No. 994). 

OECD Principles of Good Laboratory Practice (as revised in 1997), ENV/MC/CHEM(98)17. 

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

Directive 92/69/EEC, Official Journal No. L383A, 29.12.1992, Method C.7, Abiotic 

Degradation, Hydrolysis as a Function of pH. 

OECD Guideline 111 - Hydrolysis as a Function of pH, Adopted by the Council on 13 April 

2004. 
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APPENDIX 1 

EYE RESEARCH CENTRE GLP COMPLIANCE STATEMENT 2005
: 19 : 
: 20 : 

APPENDIX 2 

EYE RESEARCH CENTRE GLP COMPLIANCE STATEMENT 2008 
: 21 : 

j nli) Department 

~ ofHealth 

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 

IP23 7PX 

DATE OF INSPECTION 

28th January 2008 

TEST TYPE 

Analytical Chemistry 

Ecosystems 

Environmental Fate 

Environmental Toxicity 

Mutagenicity 

Phys/Chem Testing 

Toxicology 

A general inspection for compliance with the Principles of Good Laboratory Practice 

was carried out at the above test facility as part of the UK GLP Compliance Programme. 

At the time of inspection no deviations were found of sufficient magnitude to affect 

the validity of non-clinical studies performed at these facilities . 

• Dr. Andrew J. Gray 

Head, UK GLP Monitoring Authority 
: 22 : 

APPENDIX 3 

CERTIFICATE OF ANALYSIS
: 23 : 
: 24 : 

APPENDIX 4 

STUDY PROTOCOL
: 25 : 

Study Number: 

Enquiry Number: 

CONFIDENTIAL 

PROTOCOL 

Huntingdon 

Life Sciences 

ABIOTIC DEGRADATION: HYDROLYSIS AS A FUNCTION OF pH 

(PRELIMINARY TEST) 

Sponsor 

Total number of pages: 10 

Final Protocol 

Research Laboratory 

Huntingdon Life Sciences Ltd 

Woolley Road 

Alconbury 

Huntingdon 

Cambridgeshire 

PE28 4HS 

ENGLAND 

Page i 

Huntingdon Life Sciences Ltd, registered in England No: 1815730 
: 26 : 

Study Number: 

Enquiry Number: Huntingdon 

Life Sciences 

PROTOCOL APPROVAL 

ABIOTIC DEGRADATION: HYDROLYSIS AS A FUNCTION OF pH 

(PRELIMINARY TEST) 

p:·s;.fu~1:~··· ·············· ············· Study Director 

Huntingdon Life Sciences Ltd 

................ ~.W- .. ~.L ... Lt ...................... A. L. Comb, ~G~~. Ph.D. , 

Management 

Huntingdon Life Sciences Ltd 

t? /J/ . ........ :1; ... .,1............ . ..... A. I. Nikiforov, Ph.D. 

Study Monitor for the Sponsor 

Toxicology/Regulatory Services, Inc. 

!. f./~·7!· ?:E.!. ..... . Date 

}:.(.; ....... !'J.~ .... /.~v "{ 

Date 

/1. ...... 1.J6Y.. ... 2-o OfDate l--

Please sign both copies of this page, retain one for your records and return one to the Study Director at 

Huntingdon Life Sciences. 

Final Protocol Page ii 
: 27 : 

Study Number:

Enquiry Number: 

Study number: 

Study title: 

Test substance 

Identity: 

Chemical name: 

Molecular formula: 

CAS number: 

Lot number: 

Expiry date: 

Purity: 

Appearance: 

Storage conditions: 

Date of sample receipt: 

Source: 

Sponsor: 

Sponsor's Representative: 

Study Monitor for the Sponsor: 

Study Director: 

Person acting in the temporary 

absence of the Study Director: 

Location of study: 

Proposed study dates 

Experimental start: 

Experimental completion: 

Audited draft report: 

Huntingdon 

Life Sciences 

STUDY DETAILS PAGE 

Abiotic Degradation: Hydrolysis as a Function of pH (Preliminary 

Test) 

To be included in the raw data when available 

Ambient temperature in a dark envirorunentally controlled area 

31 July 2006 

Andrey I. Nikiforov, Ph.D., TRS, Inc., 2365 Hunters Way, 

Charlottesville, VA 22911, U.S.A. 

P. Sydney 

In the temporary absence of the Study Director, routine duties and 

scientific queries will be attended to by A. L. Comb, Scientific 

Manager, Product Chemistry. Formal GLP responsibilities will be 

assumed by Management. Decisions made during the temporary 

absence of the Study Director pertaining to this study will be ratified 

by the Study Director upon return. 

Department of Product Chemistry, Eye Research Centre, Eye, Suffolk, 

IP23 7PX 

September 2007 

October 2007 

October 2007 

The actual dates will be documented in the fmal report. 

Final Protocol Page iii 
: 28 : 
: 29 : 
: 30 : 

Study Number: 

Enquiry Number: 

2. EXPE~ENTALPROCEDURES 

2.1 Method 

Huntingdon 

Life Sciences 

The test will be performed in accordance with the preliminary test as described in Method C.7 

(92/69/EEC) and OECD Guideline 111. 

The test will be performed at 50± 0.5°C at three pH values: 4, 7 and 9. A sufficient number of 

measurements will be made in order to be able to estimate whether the half-life time (t.,) is lower 

than 2.4 hours, or whether less than 10% hydrolysis is observed after 5 days. These values 

correspond respectively to half-life times lower than 1 day or higher than 1 year respectively, 

under conditions more representative of the environment {25°C). 

2.2 Definition and units 

Hydrolysis refers to a reaction of a chemical RX with water. This reaction may be represented by 

the net exchange of the group X with OH: 

RX + HOH ~ ROH + HX 

The concentrations can be expressed in units such as milligrams per litre or moles per litre. 

2.3 Procedure 

The test will be carried out in duplicate at pH 4, 7 and 9, using reagent grade chemicals and 

purified, sterile water. The test solutions will be contained in stoppered 100 m1 volumetric flasks 

and pH measurements will be made with a Corning Model 250 pH meter or a suitable alternative. 

The test substance will be dissolved in the buffer solution at a concentration not exceeding 0.01 M 

or half the saturation concentration, whichever is the lower. The composition of the buffer 

solutions employed may depend on the nature of the· test substance and the analytical procedure 

used. The concentration of the test substance in solution will be determined by a suitable 

analytical procedure at various time points which will include as a minimum 0 hours, 2.4 hours 

and 5 days. Full details of the analytical method will be documented in the study records. 

The tests will be carried out using a water bath fitted with a thermostatic heater at 50 ± 0.5°C. 

The water bath temperature will be monitored with a calibrated mercury-in-glass thermometer. 

Precautions will be taken to exclude oxygen by bubbling nitrogen through the buffer solution for a 

minimum of 5 minutes before preparation of the test solution. Light will be excluded from the test 

vessels by covering the flasks in aluminium foil. 

Depending on the test concentrations used, the test solutions will be analysed in either of two 

ways: 

1) Dilution of an accurately measured subsample with solvents compatible with the mobile phase 

being used; or 

2) Extraction of an accurately measured subsample with a water immiscible solvent with a high 

solvation capacity for the test substance. Note - if necessary; for reasons of low sensitivity or 

high test substance reactivity, the whole of the test solution may be used. 

Final Protocol Page 3 
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Study Number: 

Enquiry Number:

3. REPORTING 

3.1 Hydrolysis 

Huntingdon 

Life Sciences 

The test report should, if possible, include but not necessarily be limited to the following 

information: 

• test substance identity and impurities; 

• detailed test procedure including the temperature, pH and buffer for each set of 

experiments; 

• detailed analytical method used, including detailed method of extraction and 

recovery data if an extraction method is used to separate the chemical from the 

aqueous phase; 

• all concentration-time data points for each test; and 

• all information relevant for the interpretation of the results, especially with regard to 

impurities and physical state of the substance. 

3.2 General reporting requirements 

A summary of the test results will be sent to the Study Monitor for the Sponsor on completion of 

the experimental work. 

An audited draft report and a copy of the study raw data package will be provided to the Study 

Monitor for the Sponsor before the final report is issued. Unless otherwise requested, this draft 

report will be issued electronically (Microsoft Word format). Unless otherwise requested, one 

unbound and one electronic copy (PDF format) of the final report will be issued. 

In the absence of ongoing communications, Huntingdon Life Sciences reserves the right to 

finalise, sign and issue the final report from this study six months after issue of the draft. In such 

an event, all materials will be transferred to the archive. Any subsequent requests for 

modifications, corrections or additions to the final report will be the subject of a formal report 

amendment (or new study, as appropriate) and will be subject to additional charge. 

The authorised final report will include the information and data required by Good Laboratory 

Practice standards and relevant guideline reporting requirements. 

Corrections or additions to a final report will be in the form of an amendment by the Study 

Director. The amendment will clearly identify that part of the final report that is being added to or 

corrected, the reasons for the correction or addition and the impact the correction or addition will 

have on the study, and will be signed and dated by the Study Director and the Study Monitor for 

the Sponsor. 

Final Protocol Page 5 
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Study Number:

Enquiry Number: Huntingdon 

Life Sciences 

4. QUALITY ASSURANCE PROCEDURES AND RECORDS TO BE MAINTAINED 

4.1 Quality assurance 

The following will be inspected or audited in relation to this study. 

Protocol Audit The protocol and any amendments specific to this study will 

be audited. 

Process based inspections 

Report Audit 

Routine and repetitive procedures will be inspected on 

representative studies, not necessarily on this study. 

The draft report and study data will be audited before issue 

of the draft report to the Sponsor's Representative. 

QA findings will be reported to the Study Director and Company Management promptly on 

completion of each action, except for process based inspections which will be reported to 

appropriate Company Management only. 

4.2 Health & safety 

In order for Huntingdon Life Sciences to comply with the Health and Safety at Work Act 1974, 

and the current Control of Substances Hazardous to Health Regulations, it is a condition of 

undertaking the study that the Sponsor shall provide Huntingdon Life Sciences with all 

information available to it regarding known or potential hazards associated with the handling and 

use of any substance supplied by the Sponsor to Huntingdon Life Sciences. The Sponsor shall 

also comply with all current legislation and regulations concerning shipment of substances by 

road, rail, sea or air. 

4.3 Archiving 

All raw data, samples and specimens (if appropriate) generated at Huntingdon Life Sciences 

during the course of this study, together with the protocol and final report, will be retained by 

Huntingdon Life Sciences in its archive for a 'period of five years from completion of the study, 

unless the Sponsor provides instructions for their delivery to the Sponsor's designated archiving 

faciiity within this period. After such time, the Sponsor wiii be contacted and advice sought on 

the return, disposal or further retention of the materials. Types of sample and specimen which are 

unsuitable, by reason of instability, for long term retention and archiving may be disposed of after 

the periods stated in Huntingdon Life Sciences Standard Operating Procedures and after 

contacting the Sponsor. Under no circumstances will any item be discarded without the Sponsor's 

consent. 

Huntingdon Life Sciences will retain the Quality Assurance records relevant to this study and a 

copy of the final report in its archive indefinitely. 

Final Protocol Page6 
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