according to OECD Guideline 301 F for Testing of Chemicals (1992) 

Sponsor 

MERCK KGAA 

HPC: U009/1 01 

Frankfurter Str. 250 

64293 Darmstadt 

Germany 

Author 

Sil ke Fiebig 

Test Facility 

DR. U. NOACK-LABORATORIEN 

Kathe-Paulus-Stral1e 1 

D-31157 Sarstedt 

Laboratory Project ID 

Project-No. 11 0317MS 

Study-No. ARE14275 

Date 

2 9. II. 1_1 

Page 1 of 20 
Guideline 

Test Item 

Test Facility 

y 

g

y, 

p

o

etry Test 

OECD 301 F for Testing of Chemicals (adopted 1992-07-17) 

Art. 472166 (MAFS-92) 

(Batch number: OF1 KS0340) 

DR.U.NOACK-LABORATORIEN 

Kathe-Paulus-Str.1, D-31157 Sarstedt 

Phone: (+49) 050 66 I 706 70, Fax: (+49) 050 66 I 706 789 

E-mail: info@noack-lab.de 

We declare that this study was conducted and reported in compliance with the present OECD, 

EC and German principles of Good Laboratory Practice. 

cP..L;.:.~.-~.1..~ 

(Date) 

(Date) 
Guideline 

Test Item 

Study Director 

p

y 

OECD 301 F for Testing of Chemicals (adopted 1992-07-17) 

Art. 472166 (MAFS-92) 

(Batch number: OF1 KS0340) 

Silke Fiebig 

The study was verified and reported to the study director and test facility management as 

follows. The inspection(s) of the experimental phase of this study type are part of a processbased inspection programme. The next date(s) with respect to the experimental phase of this 

study is (are) reported. 

Inspected study phase Inspection date Date of report 

Study plan 2011-04-01 2011-04-01 

Acclimatisation test system 2011-02-25 2011-02-25 

Experimental 

phase Test system 2011-02-25 2011-02-25 

Environmental conditions 2011-03-04 2011-03-04 

2011-06-23 2011-06-23 Report 2011-06-24 2011-06-24 

It is confirmed that the reported results accurately and completely reflect the raw data of the 

study. Also methods, procedures, and observations are accurately and completely described in 

the report. 

The accordance of the study with its study plan and the principles of Good Laboratory Practice 

is guaranteed. 

17 }/ I 

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

-G•£'eL~olied.~J?Jsc- .. · · · · · · · · 

- dJ;ity Assuran~lJ:itDR. U. NOACK-LABORATORIEN 
Study Director: Silke Fiebig 

(Engineer, Biotechnologist) 

Deputy 

Technical Staff: 

Quality Assurance Unit: 

Test Facility 

Management: 

Dr. Katharina Klee 

Nadine Mendel 

Gwendolin Kraetzig 

(Biologist) 

Dr. lnes Stanetzek 

(Chemist) 

Dr. Udo Noack 

(Biologist) 
1 

2 

3 

4 

4.1 

4.2 

4.3 

4.4 

4.5 

4.6 

5 

6 

7 

8 

9 

Statement of Quality Assurance Unit 

Personnel Involved 

Table of Contents 

List of Tables and Figures 

Summary 

Characterisation Data of the Test Item 

Method 

Results 

Theoretical Oxygen Demand 

Colony Forming Units of the Inoculum 

Results of the Functional Control 

Results of the Toxicity Control 

Course and Stages of Biodegradation of Functional Control and Test Item 

pH-Values at Test Start and Test End 

Validity Criteria 

Literature 

Graph 

Certificate of Test Item Analysis 

G LP-Certificate of DR. U. NOACK-LABORATORIEN 

List of Tables and Figures 

Table 1: Biodegradation of the Test Item Art. 472166 (MAFS-92) in Comparison to the 

3 

4 

5 

5 

6 

8 

9 

14 

14 

14 

14 

14 

14 

17 

17 

18 

18 

19 

20 

Functional Control and Toxicity Control 7 

Table 2: Biological Oxygen Demand (BOD) of Inoculum Control, Functional Control, 

Test Item Art. 472166 (MAFS-92) and Toxicity Control 15 

Table 3: Biodegradation [%] of the Test Item Art. 472166 (MAFS-92) in Comparison 

to the Functional Control and Toxidty Control 16 

Table 4: pH-Values at Test Start and Test End 17 

Figure 1: Biodegradation over a Period of 28 Days ace. to OECD 301 F 18 
guideline 301 F at DR.U.NOACK-LABORATORIEN, D-31157 Sarstedt. The test item concentration 

selected as appropriate was 80 mg/L, corresponding to a ThOD of 72.8 mg 02/L per test vessel. 

The oxygen was depleted by the respiration of bacteria and the degradation was followed by 

measuring the oxygen concentration. The biodegradation rate is therefore expressed as the percentage BOD (biological oxygen demand) and was calculated for each study day. 

The mean oxygen depletion in the inoculum control was 4.2 mg 0 2/L on day 28. 

In order to check the activity of the test system sodium benzoate was used as functional control. 

The pass level > 60 % was reached after 2 days. The biodegradation rate came to a maximum 

of 93 % on day 24. 

In the toxicity control containing both test and reference item 49 % degradation occurred within 

14 days. After 28 days the biodegradation came to 50 %. The degradation of the reference item 

was not inhibited by the test item. 

The biodegradation of the test item is shown in Table 1 and graphically indicated in Figure 1 in 

comparison to the readily degradable functional control and the toxicity control. The test item 

replicate 1 did not reach the 10 % level (beginning of biodegradation). The test item replicate 2 

reached the 10 % level after 9 days. The 60 % pass level was not reached within 28 days. After 

28 days the mean biodegradation was 6 %. 

The validity criteria of the guideline are fulfilled. 

The test item is classified as 

not readily biodegradable 

in the 1 0-d-window and after 28 days. 
Study Day [ d] 

Replicate 7 14 21 28 

Test Item 1 0 6 6 4 

80 mg/L 2 6 12 12 8 

Functional Control 

45 mg/L 81 86 92 90 

Toxicity Control 

80 mg/L Test Item + 44 49 50 50 

45 m g/L Reference Item 
Expiry date 

Recommended storage 

Storage at test facility 

Retention 

Identification parameter 

at test facility 

2011-10-31 

At +15 octo +25 oc in a tightly closed glass or plastic container, 

protected from light and moisture 

Room temperature, protected from light, in original container 

At least 1 g has been retained and stored at 6 ± 2 °C. 

Name, batch number, state, consistency and colour 

The test item and the information concerning the test item were provided by the sponsor. 
TYPE AND PURPOSE 

OF THE STUDY 

TEST SYSTEM 

Source 

Reasons for the selection 

of the test system 

Pretreatment 

Colony forming units 

in the test vessels 

FUNCTIONAL CONTROL 

Batch number 

CAS No. 

Purity 

Expiry date 

Test concentration 

ThOD 

ThOD in the test vessel 

Testing of ready biodegradability over a period of 28 days with 

a non adapted activated sludge in order to check the rate of 

biodegradation in % by oxygen depletion. 

Inoculum of the aqueous phase of non adapted activated sludge. 

Municipal sewage treatment plant, D-31137 Hildesheim 

Activated sludge from the sewage plant at Hildesheim is well 

suited as it receives predominantly municipal sewage and hardly 

any industrial chemical waste. 

The activated sludge was washed twice with autoclaved tap water. 

After the second washing the settled sludge was filled up with 

mineral salts medium and was maintained in an aerobic condition 

by aeration for 4 hours. Thereafter the sludge was homogenized 

with a blender. The supernatant was decanted and maintained in 

an aerobic condition by aeration with C02-free air for 4 days. 

10 ml/L were used to initiate inoculation. 

107 - 1 08 CFU/L 

Sodium benzoate (FLUKA) 

1434477 

532-32-1 

100.0% 

2012-01-29 

45 mg/L 

1 .67 mg 02/mg 

75.2 mg 02/L 
Pretreatment 

INOCULUM CONTROL 

TOXICITY CONTROL 

TEST METHOD 

Duration 

Application 

Test v esse Is 

Test volume 

Test medium 

Temperature 

Dispersion treatment 

Photoperiod 

CHRONOLOGICAL 

TEST DESCRIPTION 

Ultrasonification for 5 min at room temperature 

Test medium without test and/or reference item 

Test item and reference item in test concentration 

28 days 

Once at test start 

Brown glass bottles (volume 500 ml) 

250 ml 

Mineral salts medium according to OECD 301 F 

20.5 - 21.5 oc 

Continuous stirring 

Dark, in an incubator 

Based on the calculated oxygen demand, the test concentration 

of 80 mg/L corresponding to an oxygen demand of 72.8 mg 02/L 

in the vessel was selected. 

The following brown glass bottles were prepared as incubation 

vessels: 

• two for the test item (P1; P2) 

• one for the functional control (R1) 

• one for the tax icity control (T 1) 

• two for the inoculum control (C1, C2) 

All test solutions were prepared in measuring flasks in demineralised water with the required amounts of mineral medium stock so-
TYPE AND FREQUENCY 

OF MEASUREMENTS 

Equipment 

g 

250 ml measuring flasks were used to place 250 ml of the test 

solutions in the brown glass bottles. 

A rubber sleeve with soda lime was hung into the opening of the 

bottles to absorb evolved C02 . The bottles were closed with OxiTop® measuring heads and the measuring system was activated. 

The temperature in the incubator was documented continuously 

throughout the test by a hygrothermograph. 

At test start the pH-values of the prepared solutions in the measuring flasks (inoculum control before dividing, functional control) 

and the separate replicates (test item, toxicity control), respectively, were determined. At test end the pH-values of the test solutions in the brown glass bottles were determined. 

The oxygen consumption was determined continuously from the 

pressure in the incubation vessels by OxiTop® measuring system 

at 360 measuring points (every 112 minutes) during the 28 d 

incubation period. 

OxiTop® OC11 0 controller, WTW 

OxiTop® measuring heads, WTW 

Stirring platform, WTW 

Incubator, RUBARTH 

pH-Meter, Multi 350i,WTW 

Thermohygrograph, LUFFT 

Ultrasonic bath, SONOREX, Bandelin 

Ana!ytica! balance, SARTORIUS 

Balance, EW 3000-2M, KERN 
EVALUATION 

The difference of extremes of replicate values of removal of the 

test item at the end of the test, at the plateau or at the end of the 

1 0-d-window as appropriate must be less than 20 %. 

The pH-value should be in the range of 6.0 - 8.5 at the end of the 

test. 

If in the toxicity control, containing both test item and reference 

item, less than 25 % degradation (based on BOD) occurred within 

14 days, the test item can be considered to be inhibitory. 

Calculation of the theoretical oxygen demand (ThOD) of the test 

item and functional control according to formula (1 ): 

16 · ( 2c + 1/2 · ( h - cl - 3n ) + 3s + 5/2p + 1 /2na - o ) 

ThOD = ------------------------------------ ( 1) 

Molecular weight 

Concerning the OECD-guideline 301 the index of the atoms of the 

item CcHhCiciNnNanaOoPpSs was used for the calculation of the 

ThO D. 

The oxygen depletion of the test and reference item was calculated out of the difference of the test and inoculum control replicates. 

The biodegradation of the test and reference item was calculated 

out of the BOD in relation to the ThOD according to formula (2): 

Biodegradation [%] = ---------. 100 (2) 

ThOD [mg 02/L] 

BOD = biological oxygen demand 

ThOD =theoretical oxygen demand 

The tabulated results represent rounded results calculated on the 

exact raw data. 
Study initiation 

Experimental starting 

Experimental completion 

Study completion 

DEVIATIONS FROM 

THE GUIDELINE 

2011-04-05 

2011-04-05 

2011-05-03 

Please refer to page 1 

None 

DEVIATIONS FROM None 

THE STUDY PLAN 

ARCHIVING The following will be retained in the archive of the test facility for 

at least 15 years: 

• all raw data 

• study plan 

• final report 

• all records performed by the quality assurance programme 

including master schedules 

• samples of test and reference items 

Additionally, microfilms will be retained in a safe-deposit by 

Volksbank Sarstedt, D-31157 Sarstedt. 
4.2 Colony Forming Units of the Inoculum 

Colony forming units (CFU) of the inoculum were determined at test start by standard dilution 

plate count: 

2.3 X 1 09 CFU/L 

4.3 Results of the Functional Control 

The pass level of a biodegradation > 60% was reached after 2 days. The validity criterion that 

the degradation should be > 60 % after 14 d was fulfilled. 

4.4 Results of the Toxicity Control 

In the toxicity control the biodegradation achieved 49 % after 14 days (Table 3, Figure 1 ). After 

28 days the biodegradation came to 50 %. The validity criterion that the test item should not 

inhibit the biodegradation of the reference item was fulfilled. 

4.5 Course and Stages of Biodegradation of Functional Control and Test Item 

In case of the functional control, the adaptation phase changed to degradation phase after 

1 day (degradation> 10 %). The pass level > 60% was reached after 2 days. The biodegradation rate came to a maximum of 93 % on day 24 {Table 3, Figure 1 ). 

The biodegradation of the test item is shown in Table 1 and 3 and graphically indicated in Figure 1 in comparison to the readily degradable functional control and the toxicity control. The test 

item replicate 1 did not reach the 10% level (beginning of biodegradation). The test item replicate 2 reached the 10% ievei after 9 days. The 60% pass ievei was not reached within 28 days. 

After 28 days the mean biodegradation was 6 %. 

The test item is classified as not readily biodegradable in the 1 0-d-window and after 28 days. 
2011-04-06 

2011-04-07 

2011-04-08 

2011-04-09 

2011-04-10 

2011-04-11 

2011-04-12 

2011-04-13 

')I'H 1 J\A_1 A L.V I I -v-r- I --y 

2011-04-15 

2011-04-16 

2011-04-17 

2011-04-18 

2011-04-19 

2011-04-20 

2011-04-21 

2011-04-22 

2011-04-23 

2011-04-24 

2011-04-25 

2011-04-26 

2011-04-27 

2011-04-28 

2011-04-29 

2011-04-30 

2011-05-01 

2011-05-02 

2011-05-03 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

Control 

mean 

0.7 

2.1 

4.9 

0.0 

0.0 

0.0 

0.0 

0.0 

0.0 

0.7 

0.7 

1.4 

1.4 

2.8 

2.8 

3.5 

3.5 

3.5 

3.5 

3.5 

2.8 

4.2 

4.9 

4.9 

5.6 

4.9 

4.2 

4.2 

Control 

45 mg/L 

gross 

38.0 

50.7 

56.4 

56.4 

57.8 

59.2 

60.6 

60.6 

62.0 

64.8 

64.8 

66.2 

66.2 

67.6 

67.6 

69.0 

70.5 

70.5 

71.9 

71.9 

71.9 

73.3 

73.3 

74.7 

74.7 

74.7 

71.9 

71.9 

R1 

net 

37.3 

48.6 

51.5 

56.4 

57.8 

59.2 

60.6 

60.6 

62.0 

64.1 

64.1 

64.8 

64.8 

64.8 

64.8 

65.5 

67.0 

67.0 

68.4 

68.4 

69.1 

69.1 

68.4 

69.8 

69.1 

69.8 

67.7 

67.7 

gross 

0.0 

1.4 

2.8 

0.0 

0.0 

0.0 

0.0 

2.8 

4.2 

7.0 

7.0 

7.0 

7.0 

7.0 

7.0 

7.0 

7.0 

7.0 

7.0 

8.5 

7.0 

8.5 

8.5 

8.5 

8.5 

8.5 

7.0 

7.0 

p1 

80 mg/L 

net 

-0.7 

-0.7 

-2.1 

0.0 

0.0 

0.0 

0.0 

2.8 

4.2 

6.3 

6.3 

5.6 

5.6 

4.2 

4.2 

3.5 

3.5 

3.5 

3.5 

5.0 

4.2 

4.3 

3.6 

3.6 

2.9 

3.6 

2.8 

2.8 

gross 

1.4 

1.4 

2.8 

1.4 

2.8 

2.8 

4.2 

5.6 

7.0 

9.9 

9.9 

11.3 

9.9 

11.3 

11.3 

11.3 

11.3 

11.3 

11.3 

11.3 

11.3 

11.3 

12.7 

12.7 

12.7 

12.7 

9.9 

9.9 

Pz 

net 

0.7 

-0.7 

-2.1 

1.4 

2.8 

2.8 

4.2 

5.6 

7.0 

9.2 

9.2 

9.9 

8.5 

8.5 

8.5 

7.8 

7.8 

7.8 

7.8 

7.8 

8.5 

7.1 

7.8 

7.8 

7.1 

7.8 

5.7 

5.7 

80 mg/L Test 

Item+ 45 mg/L 

Reference Item 

gross 

40.9 

50.7 

57.8 

59.2 

62.0 

63.4 

64.8 

64.8 

66.2 

69.0 

70.5 

71.9 

73.3 

74.7 

74.7 

76.1 

76.1 

76.1 

77.5 

77.5 

76.1 

77.5 

77.5 

78.9 

78.9 

78.9 

76.1 

77.5 

T1 

net 

40.2 

48.6 

52.9 

59.2 

62.0 

63.4 

64.8 

64.8 

66_2 

68.3 

69.8 

70.5 

71.9 

71.9 

71.9 

72.6 

72.6 

72.6 

74.0 

74.0 

73.3 

73.3 

72.6 

74.0 

73.3 

74.0 

71.9 

73.3 
Control 80 mg/L 80 mg/L Test 

45 mg/L Item + 45 mg/L 

Reference Item 

R1 p1 p2 T1 

2011-04-05 0 0 0 0 0 

2011-04-06 1 50 0 1 27 

2011-04-07 2 65 0 0 33 

2011-04-08 3 68 0 0 36 

2011-04-09 4 75 0 2 40 

2011-04-10 5 77 0 4 42 

2011-04-11 6 79 0 4 43 

2011-04-12 7 81 0 6 44 

2011-04-13 8 81 4 8 44 

2011-04-14 9 82 6 10 45 

2011-04-15 10 85 9 13 46 

2011-04-16 11 85 9 13 47 

2011-04-17 12 86 8 14 48 

2011-04-18 13 86 8 12 49 

2011-04-19 14 86 6 12 49 

2011-04-20 15 86 6 12 49 

2011-04-21 16 87 5 11 49 

2011-04-22 17 89 5 11 49 

2011-04-23 18 89 5 11 49 

2011-04-24 19 91 5 11 50 

2011-04-25 20 91 7 11 50 

2011-04-26 21 92 6 12 50 

2011-04-27 22 92 6 10 50 

2011-04-28 23 91 5 11 49 

2011-04-29 24 93 5 11 50 

2011-04-30 25 92 4 10 50 

1'\nA A 1"\,- 1"'\A 1"\,. "'"' "" !=I"\ LV I 1-UO-U I LO 0 I I vv 

2011-05-02 27 90 4 8 49 

2011-05-03 28 90 4 8 50 
Table 4: pH-Values at Test Start and Test End 

pH-Value 

Start End 

1) 7.52 

Inoculum Control 7.66 

2) 7.53 

Functional Control 7.68 7.78 

1) 7.55 

Test Item 7.65 

2) 7.56 

Toxicity Control 7.65 7.83 

1 ), 2) = First, second replicate 

5 Validity Criteria 

The study was performed according to OECD Guideline 301 F and GLP principles. The validity 

criteria were fulfilled according to the guideline: 

• The percentage degradation of the functional control reached the pass level of 60 % 

after 2 days (validity criterion: 60 % after 14 days). 

• The oxygen depletion in the inoculum control was. 4.2 mg oxygen/L on day 28 (validity 

criterion: < 60 mg oxygen/L). 

• The pH-value of all test replicates was in the range of 6.0- 8.5 at the end of the test. 

• The difference of extremes of replicate values of removal of the test item at the end of 

the test was less than 20 %. 

• The percentage degradation of the toxicity control reached the pass level of 25 % after 

1 day (validity criterion: 25 % after 14 days). 
7 Graph 

Figure 1: 

0 2 4 6 8 1 0 12 14 16 18 20 22 24 26 28 

Day 

• Reference item, 45 mg/L 

.., Test item, 1st replicate, 80 mg/L 

1:::. Test item, 2nd replicate, 80 mg/L 

o Toxicity control, 45 mg/L + 80 mg/L 

Biodegradation over a Period of 28 Days ace. to OECD 301 F 
) 

) 

ANAL YSENBERICHT 

Test report, Rapport analytique, BoleiiD da anAl isis 

Arllket-Nr., Cat. No. 

472166 

Charae, Blotc•, Lot 

OF1KS0340 (FS-052-10) Ort d. Hentellung, Place or manutadure 

Merck KGaA, OC-OG1-K 

llil Ent-Analyse, First Analysis 

0 Nacbuntenucbung, Cootrol Aoalysis 

Appearance: 

Purity (LC-MS, wtt) : 

Identity: 

Illlpurities: 

Released: 

Next control analysis: 

Storage: 

!IJ. analy!\cal t test• rX IO'tit."'I s.tt.dtes 

i 0 

I Cl ••Se 0 the i-s. r\0: 

{ !V t1"ttt'-tl 

I' m . Roteaseo unt!! .-- 1 . . . . . ..... . 

·- -------' 

Bezekhoua, Deslgaatloo 

MU'S-092 

HenteUuopdatum, Date of manufacture 

02 . 07 . 2010 

Cllar&euerillle, Batch Jize 

255g 

Analysendaten,.Aoalytlcal Data waxy, hygroscopic white-yellow 

solid 

76 .0 

UV-VIS-spectrum 02102319 

IR-Spectrum A1006060 conforms 

19F-NMR 90021 2639439 conforms 

13C- NMR 900212639439 conforms 

11.10.2010 

31.10 .2011 

at +l5°C to +2S•c in a tightly 

c l osed glass-or plasti c container 

protected from light and moisture · 

Dr.Fichtner, L 

This certificate of analysis was printed out on October 11 , 2010. 
Gewerbeaufsicht 

in Niedersachsen 

Staatliches Gewerbeaufsichtsamt 

Hildesheim 

Gute Laborpraxis/Good Laboratory Practice 

GLP-Bescheinigung/Statement of GLP Compliance 

(gema!Yaccording to § 19 b Abs.1 Chemikaliengesetz) 

Eine GLP-Inspektion zur Oberwachung der Einhaltung der Assessment of conformity with GLP according to 

GLP-Grundsatze gemall Chemikaliengesetz bzw. Chemikaliengesetz and Directive 8813201EEC at: 

Richtlinie 88/3201EG wurde durchgefilhrt in: 

181 Prtlfeinrichtung I Test facility CJ PrUfstandort I Test site 

DR. U. NOACK- LABORATORIEN DR. U. NOACK- LABORATORIEN 

Kathe-Paulus-Str. 1 Kathe-Paulus-Str. 1 

D- 31157 Sarstedt D- 31157 Sarstedt 

Prufungen nach Kategorien/Areas of Expertise (gema!Yaccording ChemVwV-GLP Nr. 5.3/0ECD guidance) 

1 - Prtlfungen zur Bestimmung der physikalisch- i 

chemischen Eigenschaften und Gehaltsbestimmungen 

4 - Ckotoxikologische PrUfungen zu Bestimmung der 

Auswirkungen auf aquatische und terrestrische 

Organism en 

5- PrOfungen zum Verhalten im Boden, im Wasser 

und in der Luft, Prtlfungen zur Bioakkumulation und 

zur Metabolisierung 

6 - PrUfungen zur Bestimmung von RUckstanden 

7- PrUfungen zur Bestimmung der Auswirkungen auf 

Mesokosmen und naturliche Ckosysteme 

9- Sonstige PrUfungen: 

- PrOfungen zur Gentoxizitat und Mutagenitat 

in vitro 

1 - Physical-chemical testing 

4 - Environmental toxicity studies on aquatic and 

terrestrial organisms 

5 - Studies on behaviour in water, soil and air, 

bioaccumulation 

6 - Residue studies 

7 - Studies on effects on mesocosms and natural 

ecosystems 

9 - Other studies: 

-Studies of genotoxicity and mutagenicity 

in vitro 

Qrtl Place Datum der lnspektion I Date of Inspection 

(Tag.Monat.Jahr I month.day.year) 

Sarstedt 03. - 06. November 2009 I Nov 03rct- Nov 061h, 2009 

Die genannte Prtlfeinrichtung befindet sich im nationalen GLPOberwachungsverfahren und wird regelmallig auf Einhaltung der 

GLP-Grundsatze uberwacht. 

Auf der Grundlage des lnspektionsberichtes wird hiermit bestatigt, 

dass in dieser PrUfeinrichtungldiesem PrOf-standort die oben 

genannten Prtlfungen unter Einhaltung der GLP-Grundsatze 

durchgefOhrt werden konnen. 

Hildesheim, 20.10.2010 

lmAuftrage 

StOber 

(Techn.- Angestellter) 

The above mentioned test facility is included in the 

national GLP Compliance Programme and is inspected 

on a regular basis. 

Based on the inspection report it can be confirmed, that 

this test facility I test site is able to conduct the 

aforementioned studies in compliance with the Principles 

ofGLP.