p.1 

Harcros Chemicals Inc. 

5200 Speaker Road 

Kansas City, KS 66106 

Telephone: 913/621-7747 

Fax: 913/621-7746 

E-mail: OrganicsCS@Harcros.com 

RECEIVED 

OPPT CBIC 

20I3JUL 25 AHIh 03 

Date 07/23/13 

Document Control Office (DCO) (7407M)

 CBI C

 Control Number 

Office of Pollution Control and Toxics (OPPT) *l*tQ 

U.S. Environmental Protection Agency (EPA) ww w 

1200 Pennsylvania Ave. NW 

Washington, D.C. 20460 (202-564-8930) 

Attn: TSCA Section 4 

40 CFR § 799.5087 (Docket # EPA-HQ-OPPT-2007-0531) 

•

Scanned & Processed in 

CIS by: SHARON 

RE: Physical/Chemical Properties Test Report for CASRN 31138-65-5 

To Whom It May Concern: 

In accordance with EPA's final rule, Testing of Certain High Production Volume Chemicals; Second 

Group of Chemicals, published in the Federal Register on January 7, 2011 at 76 fed. Reg. 1067, 

please find enclosed the final report for the Physical/Chemical Properties on D-gluco-Heptonic acid, 

monosodium salt, (2.xi.)- [CAS# 31138-65-5]. 

This study was conducted to fulfill the Physical/Chemical Property testing requirements of testing 

category A as set forth in Table 2 of 40 CFR 799.5087{j). 

If any further information is required, please do not hesitate to contact me at (913) 621-7802 or at 

asavi ni @harcros. com. 

Regards, 

Ann Marie Savini 

Harcros Chemicals Inc. 

Regulatory Specialist 

cc: Peter Radford 

James Grantham 

Randy Buckner 

John Miles 

File 
p. 2 

REPORT 

harlan 

Sodium Glucoheptonate (EC 250-480-2): 

Determination of General Physico-Chemical Properties 

Study Director: 

Test Facility: 

Sponsor: 

R E Butler 

Harlan Laboratories Ltd. 

Shardlow Business Park 

Shardlow 

Derbyshire 

DE72 2GD 

UK 

Harcros Chemicals Inc. 

3452 Corporate Drive 

Dalton GA 30720 

USA 

Harlan Study Number: 

Study Completion Date: 

41104686 

18 July 2013 

Page 1 of 22 
p. 3 

Harlan Study Number: 41104686 Report Page 2 

CONTENTS 

CONTENTS 2 

STUDY DIRECTOR STATEMENT OF GLP COMPLIANCE 3 

QUALITY ASSURANCE STATEMENT 4 

SUMMARY 5 

GENERAL INFORMATION 6 

Schedule 6 

Deviations from Study Plan 6 

Archiving 6 

1 INTRODUCTION AND PURPOSE 7 

1.1 Guidelines / Regulations 7 

2 TEST ITEM 8 

3 METHODS 9 

3.1 Melting/Freezing Temperature 9 

3.1.1 Test System 9 

3.1.2 Principle of the Test 9 

3.1.3 Procedure 9 

3.1.4 Calculation 9 

3.1.5 Results 10 

3.1.6 Conclusion 10 

3.2 Boiling Temperature 11 

3.2.1 Test System 11 

3.2.2 Principle of the Test 11 

3.2.3 Performance of the Test 11 

3.2.4 Data Handling 12 

3.2.5 Results 13 

3.2.6 Discussion 15 

3.2.7 Conclusion 15 

3.3 Water Solubility 16 

3.3.1 Test System 16 

3.3.2 Principle of the Test 16 

3.3.3 Performance of the Test 16 

3.3.4 Results 18 

3.3.5 Discussion 19 

3.3.6 Conclusion 19 

3.4 Moisture Content 20 

3.4.1 Test System 20 

3.4.2 Principle of the Test 20 

3.4.3 Performance of the Test 20 

3.4.4 Calculation 20 

3.4.5 Results 21 

3.4.6 Discussion 21 

3.4.7 Conclusion 21 

APPENDIX 22 

Monitoring Authority Statement of GLP Compliance 22 
p. 4 

Harlan Study Number: 41104686 Report Page 3 

STUDY DIRECTOR STATEMENT OF GLP COMPLIANCE 

Harlan Laboratories Ltd, Shardlow Business Park, Shardlow, Derbyshire, DE72 2GD, UK. 

This study was performed in compliance with UK GLP standards (Schedule 1, Good Laboratory 

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 of Directives 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 of the study or the validity of the data. 

Study Director: R E Butler 

Harlan Study Number: 

Study Title: 

41104686 

Sodium Glucoheptonate (EC 250-480-2): 

Determination of General Physico-Chemical Properties 

Date: 1 8 JUL 2013 
p. 5 

Harlan Study Number: 41104686 Report Page 4 

QUALITY ASSURANCE STATEMENT 

Harlan Study Number: 41104686 

Study Title: Sodium Glucoheptonate (EC 250-480-2): 

Determination of General Physico-Chemical Properties 

The general facilities and activities are inspected at least once a year and the results are reported 

to the relevant responsible person and management. 

Study-related procedures conducted at the test facility were audited and inspected. The details of 

these audits and inspections are given below. 

Dates and Types of QA Inspections 

Reported to the relevant 

Study Director and Test 

Facility Management 

Date of Inspection Type of Inspection Phase Inspected Report Date 

10 October 2011 General Study Plan 

Verification 

N/A 10 October 2011 

13 April 2012 Process - based Pour Point 13 April 2012 

05 March 2012 Process - based Boiling Temperature 05 March 2012 

21 March 2012 Process - based Water Solubility 21 March 2012 

21 March 2012 Study - based Water Content 21 March 2012 

03 April 2012 Study - based Loss on Drying 03 April 2012 

31 October 2012 Report Audit N/A 31 October 2012 

The complete study plan (including Study Specific Supplement) was verified for GLP 

compliance at report audit. 

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

Quality Assurance: 

1 8 JUL 2013 
p. 6 

Harlan Study Number: 41104686 Report Page 5 

SUMMARY 

The general physico-chemical properties of Sodium Glucoheptonate (EC 250-480-2) have been 

determined. The results are summarized below: 

Melting/Freezing Temperature. Less than -20 °C (< 253 K) using pour point method BS 2000: 

Part 15 (equivalent to ISO 3016), designed to be compatible with Method 102 of the OECD 

Guidelines for Testing of Chemicals, 27 July 1995 and Method 830.7200 of the OPPTS 

Guidelines, March 1998. 

Boiling temperature. The test item was determined to partially boil from 117 ± 1 °C (390 ± 1 K) 

at 102.9 kPa by differential scanning calorimetry using a procedure designed to be compatible 

with Method 103 of the OECD Guidelines for Testing of Chemicals, 27 July 1995 and Method 

830.7220 of the OPPTS Guidelines, August 1996. 

Water Solubility. The water solubility of the test item was determined to be in the range of 55.8 

to 58.1% w/w at 20 ± 0,5 °C by visual appraisal using a procedure based on the flask method, 

designed to be compatible with Method 105 of the OECD Guidelines for Testing of Chemicals, 

27 July 1995 and Method 830.7840 of the OPPTS Guidelines, March 1998. 

Moisture Content. The moisture content was determined to be 49.5% w/w (495 g/kg) using a 

procedure based on Method MT 17 of the CIPAC Handbook for the Analysis of Technical and 

Formulated Pesticides. 
p. 7 

Harlan Study Number: 41104686 Report Page 6 

GENERAL INFORMATION 

Schedule 

Experimental Starting Date: 

Experimental Completion Date: 

10 March 2012 

04 September 2012 

Deviations from Study Plan 

DeviationNo.l (18 July 2012) 

Preliminary assessment of the water content of the test item using Karl Fischer titration was 

unsuccessful. In error, a study plan amendment was not raised to amend the method of 

determination to a loss on drying procedure. The moisture content of the test item was 

determined gravimetrically using a procedure based on Method MT17 of the CIPAC Handbook 

for the Analysis of Technical and Formulated Pesticides. 

Archiving 

Unless instructed otherwise by the Sponsor, all original data and the final report will be retained 

in the Harlan Laboratories Ltd, Shardlow, UK archives for five 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. 
p. 8 

Harlan Study Number: 41104686 Report Page 7 

1 INTRODUCTION AND PURPOSE 

The purpose of this study is to evaluate the general physico-chemical properties of the test item. 

1.1 Guidelines / Regulations 

This study was designed to be compatible with the procedures indicated by the following 

internationally accepted guidelines and recommendations: 

• OECD Guidelines for Testing of Chemicals. 

• US EPA Office of Prevention, Pesticides and Toxic Substances, Series 830: Product 

Properties Test Guidelines. 

• Collaborative International Pesticides Analytical Council (CIPAC) Method MT 17 of 

the Handbook for the Analysis of Technical and Formulated Pesticides, 1995. 
p. 9 

Harlan Study Number: 41104686 Report Page 8 

2 TEST ITEM 

Information as provided by the Sponsor. 

Identification: 

Description: 

Batch: 

Purity: 

Expiry Date: 

Storage Conditions: 

Sodium Glucoheptonate (EC 250-480-2) 

Dark brown liquid 

921000100 

99% 

09 February 2015 

Room temperature in the dark 
p. 10 

Harlan Study Number: 41104686 Report Page 9 

3 METHODS 

3.1 Melting/Freezing Temperature 

3.1.1 Test System 

The determination was carried out using the pour point method BS 2000: Part 15 (equivalent to 

ISO 3016), designed to be compatible with Method 102 of the OECD Guidelines for Testing of 

Chemicals, 27 July 1995 and Method 830.7200 of the OPPTS Guidelines, March 1998. 

3.1.2 Principle of the Test 

The pour point method applies primarily to oily, waxy or resin-like test items, but may also be 

applied to mixtures or test items where a well-defined freezing temperature is not observed, or if 

a gradual but significant increase in viscosity is observed during cooling. 

3.1.3 Procedure 

A sample of test item was homogenized by heating at a nominal temperature of 105 °C. The 

cooled sample was then poured into a test jar which was then enclosed in a glass jacket. The 

sample was heated to 46 °C in a water bath set at 48 °C before being allowed to cool in air to 

35 °C. The sample was transferred to a ice/water bath maintained at -1 °C to 2 °C and cooled to 

10 °C, then transferred to a bath maintained at -18 °C to -15 °C and cooled to -7 °C, then finally 

transferred to a bath maintained at -35 °C to -32 °C. Starting at 46 °C and at intervals of 3 °C, 

the sample was tilted to a horizontal position for a period of 5 seconds, during which the sample 

was observed for signs of flow. 

3.1.4 Calculation 

The pour point was calculated using Equation 3.1. 

Equation 3.1 

P = S + 3 

where: 

P 

S 

pour point (°C) 

stationary point (°C) 
p. 11 

Harlan Study Number: 41104686 Report Page 10 

3.1.5 Results 

The measured stationary points are shown in the following table. 

Table 3.1 

Measurement Temperature (°C) 

Stationary point <-23 

Pour point <-20 

3.1.6 Conclusion 

The pour point of the test item has been determined to be less than -20 °C (< 253 K). 
p. 12 

Harlan Study Number: 41104686 Report Page 11 

3.2 Boiling Temperature 

3.2.1 Test System 

The determination was carried out by differential scanning calorimetry using a procedure 

designed to be compatible with Method 103 of the OECD Guidelines for Testing of Chemicals, 

27 July 1995 and Method 830.7220 of the OPPTS Guidelines, August 1996. 

3.2.1.1 Apparatus: 

Instrument: Differential Scanning Calorimeter DSC822e, Mettler 

Toledo incorporating ThemoHaake Cooler 

EK45/MT. 

Sample crucibles: Aluminium crucibles. Lids with defined perforations 

were used. 

Reference crucible: Empty aluminium crucible. 

Test conditions: The tests were performed in an air atmosphere. 

3.2.2 Principle of the Test 

A phase transformation, e.g. melting or evaporation, or a reaction, e.g. dissociation, usually is 

associated with a heat effect. In the calorimeter, two identical crucibles, one filled with the test 

item and the other empty (used as a reference), were heated at a constant rate. During the 

experiment, the heat effect, i.e. the difference in heat flow between the sample crucible and the 

reference crucible, is registered. 

3.2.3 Performance of the Test 

3.2.3.1 Calibration 

The temperature accuracy of the differential scanning calorimeter (DSC) was assessed using an 

indium reference standard (purity* 100%). The melting temperature was determined to be 

156.53 °C and within the defined tolerance (156.6 ± 0.5 °C). The DSC was therefore considered 

acceptable for use. 

* Value quoted by supplier 
p. 13 

Harlan Study Number: 41104686 Report Page 12 

3.2.3.2 Sample 

Aliquots (see following table) of test item were placed in pre-pierced aluminium crucibles. 

Before and after the test, the appearance of the samples was determined. 

Table 3.2 

Determination Mass Taken (g) 

1 0.0054 

2 0.0049 

The crucibles were heated up from 25 °C to 450 °C. 

3.2.4 Data Handling 

The standard boiling temperature is defined as the temperature at which the vapour pressure of a 

liquid is the same as the standard pressure (101.325 kPa). During thermal analysis the peak 

width of an endothermic reaction also depends on sample amount and heating rate. Therefore, 

the onset point of the relevant endothermic peak is usually stated as the boiling temperature. 

Where the endothermic peaks/effects are poorly defined, a range will be stated in the result 

section. 

Measured temperatures were converted from °C to K using Equation 3.2. 

Equation 3.2 

T = t + 273.15 

where: 

T = Thermodynamic temperature, Kelvin (K) 

t = Celsius temperature, degrees Celsius (°C) 

The boiling temperature depends on the atmospheric pressure. A correction to normalized 

pressure can be made, but the correction factor is a specific parameter for each test item and has 

to be determined individually. As this determination is beyond the scope of this study, no 

correction will be applied to the boiling temperature observed. The boiling temperature is stated 

with regard to the ambient pressure during measurement. 
p. 14 

Harlan Study Number: 41104686 Report Page 13 

3.2.5 Results 

Thermograms and thermographic data for determinations 1 and 2 are shown in Figure 3.1 and 

Figure 3.2 and in the following tables. 

Figure 3.1 Thermogram -Determination 1 

Method: PNT814 170784, 10.03.2012 11:05:19 

50 

mw 

System 147: METTLER STAR' SW 9.30 

Table 3.3 Thermographic Data - Determination 1 

Thermal Event Interpretation 

Temperature 

Thermal Event Interpretation 

°C K 

Onset of endotherm Start of boiling 118.12 391 

Atmospheric pressure: 102.9 kPa 
Harlan Study Number: 41104686 Report 

p. 15 

Page 14 

Figure 3.2 Thermogram - Determination 2 

Method; PdnSM 

dt 1.00 s 

25.0-450.0°C 20.00°C/mln 

Synchronization enabled 

170764,10.03.201211:36:59 

1707B4,4.9000 mg 

Integral -1329.27 rrJ 

Onset 115.80 °C 

Peak 124.38 *C 

Left Limit 102.0S "C 

Right Umlt 179.40 °C 

RESIDUE: dark brown Inside and outside of the crudble 

40 60 80 100 120 140 160 180 200 220 240 260 280 300 320 340 360 380 400 420 °C 

Hrr> 

JQ li u a 14 is is iz IB 19 20 min 

System 147: METTLER STAR8 SW 9.30 

Table 3.3 Thermographic Data - Determination 2. 

Thermal Event Interpretation 

Temperature 

Thermal Event Interpretation 

°C K 

Onset of endotherm Start of boiling 115.80 389 

Atmospheric pressure: 102,9 kPa 

Mean boiling temperature: Partial boiling from 117 ± 1 °C (390 ± 1 K) 
p. 16 

Harlan Study Number: 41104686 Report Page 15 

3.2.6 Discussion 

The appearance of dark brown residues both inside and outside of the crucible indicated partial 

boiling of the test item, most likely due to boiling of the aqueous portion of the test item leaving 

residues of non-volatile material. 

A visual determination demonstrated that the test item started to boil from approximately 110 °C 

which confirms the interpretation of the DSC thermograms. 

3.2.7 Conclusion 

The test item was determined to partially boil from 117 ± 1 °C (390± 1 K)at 102.9 kPa. 
p. 17 

Harlan Study Number: 41104686 Report Page 16 

3.3 Water Solubility 

3.3.1 Test System 

The determination was carried out using visual appraisal, using a procedure based on the flask 

method, designed to be compatible with Method 105 of the OECD Guidelines for Testing of 

Chemicals, 27 M y 1995 and Method OPPTS 830.7840 of the OPPTS Guidelines, March 1998. 

The test system consisted of glass double-distilled water. 

3.3.2 Principle of the Test 

To determine the water solubility of the test item, two different methods can be used: 

• the column elution method, for solubilities <10"2 g/L. 

• the flask method, for solubilities >10"2 g/L, or if the test item is not applicable to the 

column elution method, e.g. liquids. 

3.3.3 Performance of the Test 

The test item was homogenized by heating to approximately 100 °C for approximately 5 hours 

and then cooled to room temperature prior to testing. 

3.3.3.1 Preliminary Test 

Mixtures (see following table) of test item and glass double-distilled water were added to nine 

separate glass vessels. 

Table 3.4 

Sample 

Nominal Concentration 

(%w/w) Mass of Test Item (g) Mass of Water (g) 

1 10 1.0044 9.0956 

2 20 2.0549 8.0447 

3 30 3.0434 7.0744 

4 40 4.0478 6.0693 

5 50 5.0395 5.0100 

6 60 6.0189 4.0019 

7 70 7.0549 3.0179 

8 80 8.0489 2.0575 

9 90 9.0849 1.0598 
p. 18 

Harlan Study Number: 41104686 Report Page 17 

After preparation, the samples were shaken at approximately 30 °C for 19!4 hours. After 

standing at 20 °C for a period of 24 hours, the contents of the vessels were visually appraised. 

The pH of each solution was measured. 

3.3.3.2 Definitive Test 

Based on the result of the preliminary test, mixtures (see following table) of test item and glass 

double-distilled water were added to a further six separate glass vessels. 

Table 3.5 

Sample 

Nominal Concentration 

(%w/w) Mass of Test Item (g) Mass of Water (g) 

10 50 5.0199 5.0079 

11 52 5.2060 4.8094 

12 54 5.4200 4.6501 

13 56 5.5950 4.4290 

14 58 5.8302 4.2028 

15 60 5.9971 4.0039 

After preparation, the samples were shaken at approximately 30 °C for 72 hours. After standing 

at 20 °C for a period of 24 hours, the contents of the vessels were visually appraised. 

The pH of each solution was measured. 
p. 19 

Harlan Study Number: 41104686 Report Page 18 

3.3.4 Results 

3.3.4.1 Preliminary Test 

The sample concentrations, observations and solution pH's are shown in the following table: 

Table 3.6 

Sample 

Concentration 

(% w/w) Observations 

Solution 

pH 

1 9.95 Clear orange, homogenous, non-viscous solution. 9.8 

2 20.3 Clear dark orange/brown, homogenous, non-viscous solution. 9.8 

3 30.1 Clear dark brown, homogenous, non-viscous solution. 9.9 

4 40.0 Translucent dark brown, homogenous, non-viscous solution. 9.9 

5 50.1 Opaque black/brown, homogenous, non-viscous solution. 10.0 

6 60.1 Opaque black/brown, homogenous, non-viscous solution containing 

undissolved test item. 

10.1 

7 70.0 Opaque black/brown, homogenous, non-viscous solution containing 

undissolved test item. 

10.2 

8 79.6 Opaque black/brown, homogenous, non-viscous solution containing 

undissolved test item. 

10.4 

9 89.6 Opaque black/brown, non-viscous solution containing undissolved test item. 10.5 

Result: Water solubility in the range 50.1 to 60.1 %w/w at 20 ± 0.5 °C. 

3.3.4.2 Definitive Test 

The sample concentrations, observations and solution pH's are shown in the following table: 

Table 3.7 

Sample 

Concentration 

(% w/w) Observations 

Solution 

pH 

10 50.1 Opaque black/brown, homogenous, non-viscous solution. 9.7 

11 52.0 Opaque black/brown, homogenous, non-viscous solution. 9.7 

12 53.8 Opaque black/brown, homogenous, non-viscous solution. 9.7 

13 55.8 Opaque black/brown, homogenous, non-viscous solution. 9.7 

14 58.1 Opaque black/brown, non-viscous solution containing undissolved test item. 9.7 

15 60.0 Opaque black/brown, non-viscous solution containing undissolved test item. 9.7 

Result: Water solubility in the range 55.8 to 58.1 %w/w at 20 ± 0.5 °C. 
p. 20 

Harlan Study Number: 41104686 Report Page 19 

3.3.5 Discussion 

Due to the high level of water solubility of the test item, the test was performed by visual 

assessment. 

3.3.6 Conclusion 

The water solubility of the test item was determined to be in the range of 55.8 to 58.1% w/w at 

20 ±0.5 °C. 
p. 21 

Harlan Study Number: 41104686 Report Page 20 

3.4 Moisture Content 

3.4.1 Test System 

The moisture content was determined by a loss on drying technique based on procedures 

outlined in Method MT 17 of the CIPAC Handbook for the Analysis of Technical and 

Formulated Pesticides. 

3.4.2 Principle of the Test 

The sample is heated to constant weight in an oven at a specified temperature. 

3.4.3 Performance of the Test 

The test item was homogenized by heating at approximately 105 °C and then cooled to room 

temperature prior to testing. 

Aliquots (approximately 2 g) of test item were weighed, in triplicate (A, B and C) into 

previously dried and weighed loss bottles. 

The samples were placed in a vacuum oven at 40 °C at reduced pressure (approximately 

600 mbar) and dried for 6 days. The vacuum oven temperature was increased to 60 °C and the 

test item further dried overnight. 

The samples were transferred to an oven set at a nominal temperature of 105 °C and dried for a 

further 158 days. 

3.4.4 Calculation 

The moisture content was calculated using Equation 3.3. 

Equation 3.3 

Moisture Content (%) = 

b- c xlOO 

b - a 

where: 

c 

a 

b 

mass of loss bottle (g) 

mass of loss bottle and test item (g) 

mass of loss bottle and test item after drying (g) 
p. 22 

Harlan Study Number: 41104686 Report Page 21 

3.4.5 Results 

Sample A was lost prior to the end of testing and so only data from determinations B and C have 

been reported. 

Table 3.8 

Determination A Determination B 

a) Mass of loss bottle (g) 19.5975 18.0502 

b) Mass of loss bottle and test item (g) 21.6568 20.0875 

c) Mass of loss bottle and test item after drying (g) 20.6329 19.0846 

Moisture content (% w/w) 49.7 49.2 

Mean moisture content (% w/w) 49.5 

Mean moisture content (g/kg) 495 

3.4.6 Discussion 

The loss on drying was monitored over an extended period with multiple time points determined. 

These have been summarized in a plot of loss on drying versus time (days). It was observed that 

although a plateau and therefore constant weight had not been achieved, it was considered that 

sufficient data had been obtained to report a final end point after 165 days of drying. 

Figure 3.3 

Water Content 

S5.0 

50.0 

•j 45.0 jf****"^ 

— 40.0 JT 

g

 3 5 0 f 

J 30.0 / 

25.0 / 

20.0 \£-

0 20 40 60 80 100 120 140 160 180 

Time (days) 

3.4.7 Conclusion 

The moisture content of the test item was determined to be 49.5% w/w (495 g/kg). 
p. 23 

Harlan Study Number: 41104686 Report Page 22 

APPENDIX 

Monitoring Authority Statement of GLP Compliance 

DHj 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 TEST TYPE(S) 

Harlan Laboratories Ltd Analytical/Clinical 

DATE OF INSPECTION 

10 July 2012 

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). 

Shardlow Business Park 

London Road 

Shardlow 

Derby 

DE72 2GD 

Chemistry 

Environmental Toxicity 

Environmental Fate 

Mutagenicity 

Phys/Chem. Tests 

Toxicology 

•2,0/n I tZDr. Andrew J. Gray 

Head, UK GLP Monitoring Authority