DR. U. NOACK-LABORATORI

EN Art. 472166 (MAFS-92) Ready Biodegradability Manometric Respirometry Test 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 20Report Art. 472166 (MAFS-92) Ready Biodegradability

DR. U. NOACK-LABORATORI

EN Page
2 of 20 Manometric Respirometry Test ace. to OECD 301 F Project-No.

11 0317MS Study-No. ARE14275 Title Guideline Test Item Test Facility Statement
of GLP Compliance Art. 472166 (MAFS-92) Ready Biodegradability, Manometric Respirometry 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)Report Art. 472166 (MAFS-92) Ready Biodegradability

DR. U. NOACK-LABORATORI

EN Page
3 of 20 Manometric Respirometry Test ace. to OECD 301 F Project-No.

11 0317MS Study No. ARE14275 Statement
of the Quality Assurance Unit Title Guideline Test Item Study Director

Art. 472166 (MAFS-92) Ready Biodegradability, Manometric Respirometry Test 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:it** DR. U. NOACK-LABORATORIENDR. U. NOACK-LABORATORI

EN Report Art. 472166 (MAFS-92) Ready Biodegradability Manometric Respirometry Test ace. to OECD 301 F Personnel Involved Study Director:
Silke Fiebig Page
4 of 20 Project-No.

11 0317MS Study-No. ARE14275 (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)DR. U. NOACK-LABORATORI

EN 

### Report

Page
5 of 20 Art. 472166 (MAFS-92) 

### Ready Biodegradability Manometric Respirometry Test ace. to OECD 301 F Project-No.

11 0317MS Study-No. ARE 14275 

### 1 2 3 4 4.1 4.2 4.3 4.4 4.5 4.6 

### 5 6 7 

### 8 9


## Table of Contents Title Page Statement

of GLP Compliance 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 Page 

### 1 2 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

18Report Art. 472166 (MAFS-92) Ready Biodegradability

DR. U. NOACK-LABORATORI

EN Manometric Respirometry Test ace. to OECD 301 F 1 Summary

Page
6 of 20 Project-No.

11 0317MS Study-No. ARE 14275 The ready biodegradability

of the test item Art. 472166 (MAFS-92) (batch number: OF1 KS0340) was determined with
a non adapted activated sludge
in the Manometric Respirometry Test for a period of 28 days. The study was conducted from 2011-04-05

to 2011-05-03 according

to OECD 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 thepercentage 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.DR. U. NOACK-LABORATORI

EN Report Art. 472166 (MAFS-92) Ready Biodegradability Manometric Respirometry Test ace. to OECD 301 F
Page
7 of 20 Project-No.

11 0317MS Study-No. ARE 14275 Table
1: Biodegradation

of the Test Item Art. 472166 (MAFS-92)

in Comparison

to the Functional Control and Toxicity Control Biodegradation

[%] 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

# Report Art. 4721
6 6 ( MAFS

- 92 ) 

# Ready Biodegradability

DR

. U. NOACK-LABORATORI

EN 

# Page
8 of 20 Manometric Respirometry Test ace. to OECD 301 F

P r oject-No

. 1 1 0317MS Study-No

. ARE 14275 

# 2 Characterisation Data of the Test Item Expiry date Recommended storage Storage
at test facility Retention Identification parameter a t test facili

t y 2011-10

- 31 At +15 octo +25 oc in a tightly closed glass or p

l astic contai

n er

, protected from light and moisture Room temperature

, protected from light

, in origina

l container At least

1 g has been retained and stored at 6 ± 

# 2

° C
. N ame, batch number, state, consistency and colour The test item and the information concerning the test

i tem were provided by the sponsor.

# Report 

# Art. 472166 (MAFS-92) Ready Biodegradability

DR. U. NOACK-LABORATORI

EN 

# Page
9 of 20 Manometric Respirometry Test ace. to OECD 301 F Project-No.

11 0317MS Study-No. ARE14275 

# 3 Method GUIDELINE 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 OECD 301 F, Manometric Respirometry Test for Testing of Chemicals (adopted July 17, 1992) 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 C0 2 -free air for 4 days. 10 ml/L were used to initiate inoculation. 10

7 - 

# 1 0

8 

# 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/LReport Art. 472166 (MAFS-92) Ready Biodegradability

DR. U. NOACK-LABORATORI

EN Page 10 of 20 Manometric Respirometry Test ace. to OECD 301 F Project-No.

11 0317MS Study-No. ARE14275 TEST ITEM ThOD Test concentration ThOD
in the test vessel Pretreatment INOCULUM CONTROL TOXICITY CONTROL TEST METHOD Duration Application Test
v esse Is Test volume Test medium Temperature Dispersion treatment Photoperiod CHRONOLOGICAL TEST DESCRIPTION

Art. 472166 (MAFS-92) 0.91 mg 0 2 /mg test item 80 mg/L 72.8 mg 02/L 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-

### Report 

### Art. 472166 (MAFS-92) Ready Biodegradability

DR. U. NOACK-LABORATORI

EN 

### Page 11 of 20 Manometric Respirometry Test ace. to OECD 301 

### F Project-No.

11 0317MS Study-No. ARE14275 

### TYPE AND FREQUENCY OF MEASUREMENTS Equipment
lutions and 10 ml/L inoculum. The test item was weighed out and demineralised water was added. After ultrasonic treatment

it was transferred into the measuring flasks. The reference item was weighed out and transferred into the measuring flasks with demineralised water. 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 C0

2 . 

### The bottles were closed withOxiTop® 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 themeasuring 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 testsolutions 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

### Report Art. 472166 (MAFS-92) 

### Ready Biodegradability

DR. U. NOACK-LABORATORI

EN 

### Page 12 of 20 Manometric Respirometry Test ace. to OECD 301 F Project-No.

11 0317MS Study-No. ARE 14275 VALIDITY CRITERIA EVALUATION



### The percentage degradation

of the functional control must reach the pass level of 60 

### % by day 14. The oxygen depletion

in the inoculum control should be 20

- 30 mg 0 2 /L and not exceed 60 mg 02/L after 28 days. 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 wascalculated out of the difference

of the test and inoculum controlreplicates. 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.

### Report 

### Art. 472166 (MAFS-92) Ready Biodegradability

DR. U. NOACK-LABORATORI

EN 

### Page 13 of 20 Manometric Respirometry Test ace. to OECD 301 

### F Project-No.

11 0317MS Study-No. ARE14275 

### SOFTWARE DATES Study initiation Experimental starting Experimental completion Study completion 

### DEVIATIONS FROM THE GUIDELINE
Excel, MICROSOFT CORPORATION SigmaPiot {Windows), SPSS CORPORATION 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.

# Report 

# Art. 472166 (MAFS-92) Ready Biodegradability

DR. U. NOACK-LABORATORI

EN 

# Manometric Respirometry Test ace. to OECD 301 F 

# 4 Results 4.1 Theoretical Oxygen Demand

Page 14 of 20 Project-No.

11 0317MS Study-No. ARE 14275 The biodegradation in% was calculated based on the ThOD of 0.91 mg 

# 0 2 

# /mg test item. 

# 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 0

9 

# 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. Thebiodegradation 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

inFigure 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 itemreplicate
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.

### Report Art. 472166 (MAFS-92) 

### Ready Biodegradability

DR. U. NOACK-LABORATORI

EN 

### Manometric Respirometry Test ace. to OECD 301 F
Page 15 of 20 Project-No.

11 0317MS Study-No. ARE 14275 Table 2: Biological Oxygen Demand (BOD) of Inoculum Control, Functional Control, Test Item Art. 472166 (MAFS-92) and Toxicity Control Date 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

[d] 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 Inoculum 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 Functional 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 BOD [mg Oz/L] 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 Test Item 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 Toxicity Control 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 73.3Report Art. 472166 (MAFS-92) Ready Biodegradability

DR. U. NOACK-LABORATORI

EN Manometric Respirometry Test ace. to OECD 301 F
Page 16 of 20 Project-No.

11 0317MS Study-No. ARE 14275 Table 3: Biodegradation

[%] of the Test Item Art. 472166 (MAFS-92)

in Comparison to the Functional Control and Toxicity Control Biodegradation

[%] Date

[d] Functional
Test Item Toxicity Control 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

50ReportArt.472166(MAFS-92)ReadyBiodegradabilityDR.U.NOACK-LABORATORIENManometricRespirometryTestace.toOECD301F4.6pH-ValuesatTestStartandTestEndPage17of20Project-No.110317MSStudy-No.ARE14275ThepH-valuesofthesamplesweremeasuredatteststartandtestend.TheresultsareshowninTable4.Table4:pH-ValuesatTestStartandTestEndpH-ValueStartEnd1)7.52InoculumControl7.662)7.53FunctionalControl7.68 7.781)7.55TestItem7.652)7.56ToxicityControl7.65 7.831),2)=First,secondreplicate5ValidityCriteriaThestudywasperformedaccordingtoOECDGuideline301FandGLPprinciples.Thevaliditycriteriawerefulfilledaccordingtotheguideline:•Thepercentagedegradationofthefunctionalcontrolreachedthepasslevelof60%after2days(validitycriterion:60%after14days).•Theoxygendepletionintheinoculumcontrolwas.4.2mgoxygen/Londay28(validitycriterion:<60mgoxygen/L).•ThepH-valueofalltestreplicateswasintherangeof6.0-8.5attheendofthetest.•Thedifferenceofextremesofreplicatevaluesofremovalofthetestitemattheendofthetestwaslessthan20%.•Thepercentagedegradationofthetoxicitycontrolreachedthepasslevelof25%after1day(validitycriterion:25%after14days).

### Report Art. 472166 (MAFS-92) Ready Biodegradability

DR. U. NOACK-LABORATORI

EN 

### Manometric Respirometry Test ace. to OECD 301 F 

## 6 Literature

Page 18 of 20 Project-No.

11 0317MS Study-No. ARE 14275 (1) OECD-Guideline

No. 301 F for Testing of Chemicals (adopted July 17, 1992) 

## 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 FDR.U.NOACK-LABORATORIENReportPage19of20Art.472166(MAFS-92)ReadyBiodegradabilityProject-No.110317MSStudy-No.ARE14275ManometricRespirometryTestace.toOECD301F8CertificateofTestItemAnalysis))MerckKGa.AFrankfurterSir.250041293DarmstadtMERCKCentralAnalyticalServicesWL-ACP·8ANALYSENBERICHTTestreport,Rapportanalytique,BoleiiDdaanAlisisArllket-Nr.,Cat.No.472166Charae,Blotc•,LotOF1KS0340(FS-052-10)Ortd.Hentellung,PlaceormanutadureMerckKGaA,OC-OG1-KllilEnt-Analyse,FirstAnalysis0Nacbuntenucbung,CootrolAoalysisAppearance:Purity(LC-MS,wtt):Identity:Illlpurities:Released:Nextcontrolanalysis:Storage:!IJ.analy!\calttest•rXIO'tit."'Is.tt.dtesi0ICl••Se0thei-s.r\0:{!Vt1"ttt'-tlI'm.Roteaseount!!.--1...........·--------'Bezekhoua,DeslgaatlooMU'S-092HenteUuopdatum,Dateofmanufacture02.07.2010Cllar&euerillle,BatchJize255gAnalysendaten,.AoalytlcalDatawaxy,hygroscopicwhite-yellowsolid76.0UV-VIS-spectrum02102319IR-SpectrumA1006060conforms19F-NMR900212639439conforms13C-NMR900212639439conforms11.10.201031.10.2011at+l5°Cto+2S•cinatightlyclosedglass-orplasticcontainerprotectedfromlightandmoisture·Dr.Fichtner,LThiscertificateofanalysiswasprintedoutonOctober11,2010.DR.U.NOACK-LABORATORIENReportPage20of20Art.472166(MAFS-92)ReadyBiodegradabilityProject-No.110317MSStudy-No.ARE14275ManometricRespirometryTestace.toOECD301F9GLP-CertificateofDR.U.NOACK-LABORATORIENGewerbeaufsichtinNiedersachsenStaatlichesGewerbeaufsichtsamtHildesheimGuteLaborpraxis/GoodLaboratoryPracticeGLP-Bescheinigung/StatementofGLPCompliance(gema!Yaccordingto§19bAbs.1Chemikaliengesetz)EineGLP-InspektionzurOberwachungderEinhaltungderAssessmentofconformitywithGLPaccordingtoGLP-GrundsatzegemallChemikaliengesetzbzw.ChemikaliengesetzandDirective8813201EECat:Richtlinie88/3201EGwurdedurchgefilhrtin:181PrtlfeinrichtungITestfacilityCJPrUfstandortITestsiteDR.U.NOACK-LABORATORIENDR.U.NOACK-LABORATORIENKathe-Paulus-Str.1Kathe-Paulus-Str.1D-31157SarstedtD-31157SarstedtPrufungennachKategorien/AreasofExpertise(gema!YaccordingChemVwV-GLPNr.5.3/0ECDguidance)i1 -PrtlfungenzurBestimmungderphysikalisch-chemischenEigenschaftenundGehaltsbestimmungen4-CkotoxikologischePrUfungenzuBestimmungderAuswirkungenaufaquatischeundterrestrischeOrganismen5-PrOfungenzumVerhaltenimBoden,imWasserundinderLuft,PrtlfungenzurBioakkumulationundzurMetabolisierung6-PrUfungenzurBestimmungvonRUckstanden7-PrUfungenzurBestimmungderAuswirkungenaufMesokosmenundnaturlicheCkosysteme9-SonstigePrUfungen:-PrOfungenzurGentoxizitatundMutagenitatinvitro1 -Physical-chemicaltesting4 -Environmentaltoxicitystudiesonaquaticandterrestrialorganisms5 -Studiesonbehaviourinwater,soilandair,bioaccumulation6 -Residuestudies7 -Studiesoneffectsonmesocosmsandnaturalecosystems9 -Otherstudies:-StudiesofgenotoxicityandmutagenicityinvitroQrtlPlaceDatumderlnspektionIDateofInspection(Tag.Monat.JahrImonth.day.year)Sarstedt03.-06.November2009INov03rct-Nov061h,2009DiegenanntePrtlfeinrichtungbefindetsichimnationalenGLPOberwachungsverfahrenundwirdregelmalligaufEinhaltungderGLP-Grundsatzeuberwacht.AufderGrundlagedeslnspektionsberichteswirdhiermitbestatigt,dassindieserPrUfeinrichtungldiesemPrOf-standortdieobengenanntenPrtlfungenunterEinhaltungderGLP-GrundsatzedurchgefOhrtwerdenkonnen.Hildesheim,20.10.2010lmAuftrageStOber(Techn.-Angestellter)TheabovementionedtestfacilityisincludedinthenationalGLPComplianceProgrammeandisinspectedonaregularbasis.Basedontheinspectionreportitcanbeconfirmed,thatthistestfacilityItestsiteisabletoconducttheaforementionedstudiesincompliancewiththePrinciplesofGLP.