Document jNQaMwbza9kjN2KrLQEd4kmaR
H IM -. 3X20
462
DR.U.NOACK-LABORATORIUM FR ANGEWANDTE BIOLOGIE
3&20
Terrestrial Plants Toxicity, Seedling Emergence
according to OECD Guideline 208 (Draft July 2000)
9 Sponsor Asahi Glass" Clariant Daikin Industries Ltd Dupont
Author Silke Fiebig
Test Facility Dr .U .N o ack-Laboratoriu m FOR ANGEWANDTE BIOLOGIE
Kthe-Paulus-Str. 1 D-31157 Sarstedt
Laboratory Project ID P ro ject-N o |M H H M Study-No. [TN C 841 l j p Study No. of the stuffy"plan^TNC8411-~~J
Page 1 of 51 Date
2003-05-02
DR.U.NOACK-LABORATORIUM FR ANGEWANDTE BIOLOGIE
acc. to OECD Guideline 208 (Draft July 2000)
Page 2 of 51
Project-No Study-No.
Statement of GLP Compliance
Title Guideline Test Item
Terrestrial Plant Toxicity, Seedling Emergence
OECD 208 (Draft document, July, 2000), Terrestrial (NonTarget) Plant Test, (Part A) Seedling Emergence
Test Facility
Dr.U.Noack-LaboratoriuI i fr angewandte Biologie Kthe-Paulus-Str.1, D-31157 Sarstedt Phone: (+49) 050 66 / 706 70, Fax: (+49) 050 66 / 706 789 E-mail: info@noack-lab.de
Deviations of GLP Regulations None
We declare that this study was conducted and reported in compliance with the actual OECD princi ples of Good Laboratory Practice and the national GLP regulations as specified in the law in force, except deviations mentioned above.
2003-05-02 (Date)
it.S i
(Silke Fiebig, Study Direci T)
2003-05-02 (Date)
(Dr. Udo Noack, Head of Testing Facility)
Sam1 Cotn>a ilif
Does not contain S C A B S '
DR.U.NOACK-LABORATORIUM FR ANGEWANDTE BIOLOGIE
Report
Sm SSrlai Plants Toxicity, Seedling Emergence acc. to OECD Guideline 208 (Draft July 2000)
--*----Page 3 of 51
Project-No Study-No.,
Statement of the Quality Assurance Unit
Title
Guideline Test Item Study Director
OECD 208 (Draft document, July, 2000), Terrestrial (NonTaget) Plant Test, (Part A) Seedling Emergence
Silke Fiebig
The study was verified as follows:
inspection study plan study based
report
dates
2002-11-13
2002-11-21
2003-02-19 2003-02-20 2003-02-21 2003-04-09 2003-04-11 2003-04-29
date of report
2002-11-13
2002-11-21
2003-02-20 2003-02-20 2003-02-21 2003-04-10 2003-04-11 2003-04-29
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.
2003-05-02
PP.... Gudrun Mohrmann-Kalabokidis TSCACBl
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DR.U.NOACK-LABRATORIUM FR ANGEWANDTE BIOLOGIE
acc. to OECD Guideline 208 (Draft July 2000)
Page 4 of 51
Project-No.jjjH H H H d P l
Study-No.
>
Study Director:
Personnel Involved
Silke Fiebig (Engineer, Biotechnologist)
Technical Staff:
Kirsten McVean Petra Makus Simone Pioch Barbara Wienker
? ;<*
Quality Assurance Unit:
Gudrun Mhrmann-Kalabokidis (Biologist)
Deputy:
Susanne Becker (Biologist)
Director of the Testing Facility:
Dr. Udo Noack (Biologist)
Sarw
m
DR.U.NOACK-LABORATORIUM FR ANGEWANDTE BIOLOGIE
lerrestrial Plants Toxicity, Seedling Emergence acc. to OECD Guideline 208 (Draft July 2000)
Page 5 of 51
Project-No Study-No.
Title Page
Table of Content
Page 1
Statement of GLP Compliance
2
Statement of the Quality Assurance Unit
3
Personnel Involved
4
Table of content
5
List of Tables
6
List of Figures
7
1 Summary
8
2 Characterisation Data of the Test Item
10
3 Method
11
4 Results
20
4.1 Visual Phytotoxicity
20
4.2 Shoot Height
22
4.3 Fresh Weight (Biomass)
23
4.4 Emerged Seedlings
25
4.5 Effect Levels
26
4.5.1
Inhibition of Shoot Height, Fresh Weight and Number of Emerged Seedlings 26
4.5.2
EC25, EC50and NOEC Values
27
5 Graphs
28
6 Conclusions
29
7 Validity Criteria
29
8 Literature 9 Biological Data 9.1 Observation Parameter 9.2 Emerged Seedlings on Day 7
30
3231
31
9.3 Emerged Seedlings on Day 14
33
9.4 Emerged Seedlings on Day 21
35
9.5 Visual Phytotoxicity on Day 7
36
9.6 Visual Phytotoxicity on Day 14
38
9.7 Visual Phytotoxicity on Day 21
39
9.8 Shoot Height
40
9.9 Fresh Weight (Biomass) Day 21
47
10 Certificate of Test Item Analysis
50
11 GLP Certificate of Dr.U.Noack-Laboratorium
51 TSCA CBl
CotnPan^
DR.U.NOACK-LABORATORIUM FR ANGEWANDTE BIOLOGIE
acc. to OECD Guideline 208 (Draft July 2000)
Page 6 of 51
Project-No.j Study-No.
Table 1: Table 2: Table 3:
Table 4: Table 5: Table 6: Table 7: Table 8: Table 9: Table 10 Table 11 Table 12 Table 13 Table 14 Table 15 Table 16 Table 17 Table 18 Table 19 Table 20 Table 21 Table 22 Table 23 Table 24 Table 25 Table 26 Table 27 Table 28 Table 29 Table 30 Table 31 Table 32 Table 33
List of Tables
Shoot Height: NOEC, EC25 and EC50 Values with Confidence Range (p) Fresh Weight: NOEC, EC25 and EC50 Values with Confidence Range (p) Number of Emerged Seedlings: NOEC, EC25 and EC50 Values with Confidence Range (p) Oats: Phytotoxic Effects and Rate of Emergence after 21 Days Rape: Phytotoxic Effects and Rate of Emergence after 21 Days Soybean: Phytotoxic Effects and Rate of Emergence after 21 Days Inhibition of Shoot Height Inhibition of Fresh Weight Inhibition of Emerged Seedlings Oats: Emerged Seedlings on Day 7 Rape: Emerged Seedlings on Day 7 Soybean: Emerged Seedlings on Day 7 Oats: Emerged Seedlings on Day 14 Rape: Emerged Seedlings on Day 14 Soybean: Emerged Seedlings on Day 14 Oats: Emerged Seedlings on Day 21 Rape: Emerged Seedlings on Day 21 Soybean: Emerged Seedlings on Day 21 Oats: Visual Observations and Number of Dead Plants on Day 7 Rape: Visual Observations and Number of Dead Plants on Day 7 Soybean: Visual Observations and Number of Dead Plants on Day 7 Oats: Visual Observations and Number of Dead Plants on Day 14 Rape: Visual Observations and Number of Dead Plants on Day day 14 Soybean: Visual Observations and Number of Dead Plants on Day 14 Oats: Visual Observations and Number of Dead Plants on Day 21 Rape: Visual Observations and Number of Dead Plants on Day 21 Soybean: Visual Observations and Number of Dead Plants on Day 21 Oats: Shoot Height [cm] Pooled Control, 10 and 32 mg/kg DW Oats: Shoot Height [cm] 100, 320 and 1000 mg/kg DW Rape: Shoot Height [cm] Pooled Control, 6.25 and 12.5 mg/kg DW Rape: Shoot Height [cm] 25, 50 and 100 mg/kg DW Soybean: Shoot Height [cm] Pooled Control, 10 and 32 mg/kg DW Soybean: Shoot Height [cm] 100, 320 and 1000 mg/kg DW
Page 9 9
9 20
21
21 26 27 27 32 32 33 33 34 34 35 35 36 36 37 37 38 38 39 39 40 40 41 42 43 44 45
,anW*e d,O o eS
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DR.U.NOACK-LABORATORIUM FR ANGEWANDTE BIOLOGIE
. Report
i errestnai Plants loxicity, seedling Emergence acc. to OECD Guideline 208 (Draft July 2000)
Page 7 of 51
i Project-No
Study-No.
Table 34: Table 35: Table 36:
Oats: Fresh Weight on Day 21 Rape: Fresh Weight on Day 21 Soybean: Fresh Weight on Day 21
List of Figures
Figure 1: Oats: Shoot Heiaht after 21 Davs (Mean SD1 in Relation to the Test Item Concentration in Soil
Figure 2: Raoe: Shoot Heiaht after 21 Davs (Mean SDI in Relation to the Test Item Concentration in Soil
Figure 3: Sovbean: Shoot Heiaht after 21 Davs (Mean SD1 in Relation to the Test Item Concentration in Soil
Figure 4: Oats: Fresh Weiaht after 21 Davs (Mean SD1 in Relation to the Test Item Concentration in Soil
Figure 5: Raoe: Fresh Weiaht after 21 Davs (Mean SD1 in Relation to the Test Item Concentration in Soil
Figure 6: Sovbean: Fresh Weiaht after 21 Davs (Mean SD1 in Relation to the Test Item Concentration in Soil
Figure 7: Oats: Emeraed Seedlinas after 21 Davs (Mean SD) in Relation to the Test Item Concentration in Soil
Figure 8: Raoe: Emeraed Seedlinas after 21 Davs (Mean SD1 in Relation to the Test Item Concentration in Soil
Figure 9: Sovbean: Emeraed Seedlinas after 21 Davs (Mean SD1 in Relation to the Test Item Concentration in Soil
Figure 10: Rape: Shoot Heiqht after 21 d
Figure 11: Rape: Fresh Weiaht after 21 d
47 48 49
Page 22 22 23 23 24 24 25 25 26 28 28
potnpany
,,rtco n U fctS C A C B I
DR.U.NOACK-LABORATORIUM FR ANGEWANDTE BIOLOGIE
acc. to OECD Guideline 208 (Draft July 2000)
Page 8 o f 51
Project-Ncc & m m m l Study-No.
1 Summary
a s e e d im ^ m e rg e n c e test over a period of 21 days, from November 21, 2002 to February 07, 2003 (for detailed test periods see test conditions) according to OECD 208 Draft document, July 2000 at the Dr.U.Noack-Laboratorium fr angewandte Biologie, Sarstedt, Germany.
The test was conducted with the nominal concentrations
10.0 - 32.0 - 100 - 320 - 1000 soil dry weight (DW) (oats and soybean) 6.25 - 12.5 - 25.0 - 50.0 - 100 mg/kg soil dry weight (DW) (rape)
selected on the basis of a preliminary phytotoxicity test.
To reach a sorption equilibrium the application of the test medium was performed 24 h be fore the seeds were sown.
Test systems were one monocotyledon (oats (Gramineae)) and two dicotyledons (rape (Brassicaceae) and soybean (Leguminosae)). The test containers were bottom watered with nutrient solution as needed.
A solvent control without test item (quartz sand only spiked with ferf.-buthyl-methyl-ether) was tested under the same conditions as the test groups. To exclude effects of the solvent ferf.-buthyl-methyl-ether a second control without solvent was tested. The solvent ferf.buthyl-methyl-ether caused no inhibitory effects in shoot height, biomass growth, and rate of emergence. No statistically significant differences were found between the control and the solvent control. For rape, enhanced growth was observed for the solvent control relative to the control. This promotion was not significant for this study. Therefore for calculations the replicates of the control and solvent control were summarized in a pooled control group.
The toxic effects of the test item were determined on day 7, 14 and 21 by visual observa tions (number of emerged seedlings, phytotoxic effects and number of dead plants) and on day 21 by shoot height and shoot fresh weight determination.
Shoot height, fresh weight and number of emerged seedlings were checked for statistically significant differences relative to the controls and the NOEC, the EC25- and EC50-values were calculated (Table 1-3).
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DR.U.NOACK-LABORATORIUM FR ANGEWANDTE BIOLOGIE
emergence acc. to OECD Guideline 208 (Draft July 2000)
Page 9 of 51
Project-N Study-No.
Table 1: Shoot Height: NOEC, EC25 and EC50 Values with Confidence Range (p)
Species
I NOEC*
EC25
p = 95%
EC50
p = ,95% i
I [mg/kg DW] [mg/kjjg DW] [mg/kg DW] [mg/kg DW] [mg/kg DW]
oats
J 1000
>1000
- > 1000
-
rape
I 50.0
80.2 65.6 - 97.9
> 100
-
soybean
J 1000
> 1000
- > 1000
-
Table 2 : Fresh Weight: NOEC, EC25 and EC50 Values with Confidence Range (p)
Species
NOEC*
EC2s
p = 95%
EC50
p = 95%
[mg/kg DW] [mg/kg DW] [mg/kg DW] [mg/kg DW] [mg/kg DW]
oats
1000 > 1000
- > 1000
-
rape
25.0
51.7 44.0-60.8
73.7 62.6 - 86.7
soybean
320 > 1000
- > 1000
-
Table 3: Number of Emerged Seedlings: NOEC, EC25 and EC50 Values with Confidence Range (p)
Species
NOEC'
EC25
p = 95%
EC5 O
p = 95%
[mg/kg DW] [mg/kg DW] [mg/kg DW] [mg/kg DW] [mg/kg DW]
oats rape soybean
1000 100 1000
> 1000 > 100 > 1000
-
> 1000 > 100 > 1000
-
- not determinable
* The highest tested concentration o f the test item at which no statistically significant effect is observed relative to control
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Page 10 o f 51
Project-N Study-No
2 Characterisation Data of the Test item
TEST ITE
Batch Nui CAS RN Chemical
Purity
Appearance Water solubility
Stability in water Density
C8-perfluoroalkylethanol: 99.8 % (a/a), sum perfluoroalkylethanol 99.9 % (a/a)
Yellowish solid wax
134 pg/L at 12 degree C, Std 29 pg/L, n=8 (DuPont, 2002) 137 pg/L at 25 degree C, Std 53 pg/L, n=17 (DuPont, 2002)
Stable at test conditions
Ca. 1.7 g/cm3
Expiry date Recommended storage Storage at testing facility Retention Identification parameter at testing facility
Unlimited if stored under the recommended conditions. Room temperature (20 C), protected from moisture. Room temperature, protected from moisture and light. At least 1 g has been retained.
Name, batch number and colour.
The test Item and the information concerning the test item were provided by the sponsor.
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DR.U.NOACK-LABORAtORIUM FR ANGEWANDTE BIOLOGIE
Tcity, aee'Cf1ing~t:mergence acc. to OECD Guideline 208 (Draft July 2000)
Page 11 of 51
Project-N Study-No.
3 Method
GUIDELINE
OECD 208 (Draft document, July 2000), Terrestrial (NonTarget) Plants Testing, (Part A) Seedling Emergence
TYPE AND PURPOSE OF THE STUDY Principle of the test
TEST SYSTEMS
Reason for the selection of the test systems Origin
Storage
Determination of toxic effects of soil incorporated chemicals on the emergence of seedlings and the early stages of growth of three terrestrial plant species.
4 ; The test item was incorporated into the soil in which the seeds were sown. During the test period the number of seedlings emerged were counted every 7 days. The seedlings also were observed for visual phytotoxic symptoms. After 21 days the plants were harvested and shoot height and shoot fresh weight were measured.
Three plant species of different families were tested:
Monocotyledonae: Avena sativa (oats)1, Fiamingsstern
Gramineae
Dicotyledonae: Glycine max (soybean)2, Jutro Brassica napus (rape)3, Pollen
Leguminosae Brassicaceae
The species are recommended species according to the test guideline.
1 Lochow Petkus GmbH, Postfach 1197, D-29296 Bergen 2S0dwestsaat Gbr., Im Rheinfeld 1-13, D-76437 Rastatt 3 GrOtzner Pflanzenzucht GmbH & Co. KG, Margaretenbof
23, D-22397 Hamburg
The seeds were stored at the test facility at room temperature (20 5 "C) and protected from light and moisture until use.
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iciioou iai n a iiw iwyvn./iiy, VJCCUIU'y u iio iy w iv acc. to OECD Guideline 208 (Draft July 2000)
Page 12 of 51
Project-No Study-No.
TEST ITEM
Pretreatment
The test item was heated to 50 C, weighed out, dissolved in ferf.-methyl-buthyl-ether and mixed with quartz sand. After the solvent had volatilised out of the quartz sand, the quartz sand was mixed with test soil to provide the test treatments.
Test concentration
Oats, soybean: 1000 - 320 - 100 - 32 - 10 mg/kg soil dry weight (DW) (factor V10) Rape: 100 - 50 - 25 - 12.5 - 6.25 mg/kg soil dry weight (DW) (factor 2)
Vehicle
Max. 1 % Quartz sand
Solvent
fe /t-m ethyl-buth yl-e ther
Stock solutions for oats study
The soil test concentrations of 10 - 100 mg/kg DW were made using two freshly prepared stock solutions dissolved in ferf.-methyl-butyl-ether having test concentrations of 25 and 10 g/L. Appropriate stock solution volumes were mixed with quartz sand and finally with the soil to give specified soil con centrations (see table below). The test concentrations 320 and 1000 mg/kg DW were prepared by adding directly weighed quantities of the test item to measured quantity of solvent (ferf.-methyl-butyl-ether) (see table below). The volume of stock solution mixed with quartz sand is given below.
Soil test con Amount Amount of Cone, of Stock Direct weighing Stock Solvent
centration of DW soil
[mg/kg DW] 1000 320
100 32 10
[kg'] 10.5 10.5 15.81) 10.5 10.5
quartz sand (1 %) [g] 105.2 105.2
157.8 105.2 105.2
Test Item Stock
solution
[g/L]
- -- ---
solution volume*
[mL]
nominal actual
[g] [g] 10.521 10.5213 3.367 3.3671
solution volume prepared
[mL]
'[mL] 35 20
- - - --25 63.1 2.5 2.4996 100 -25 13.6
10 11.0 0.5 0.5003 50
* Volum e of stock solution (ferf.-m ethyl-butyl-ether) mixed with quartz sand DW = dry weight Cone. = concentration 1) = larger amount of D W soil prepared because rape tested additionally
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rerrestrial Plants Toxicity, Seedling Emergence acc. to OECD Guideline 208 (Draft July 2000)
Page 13 o f 51
Project-N Study-No.
Stock solutions for soybean study
The soil test concentrations of 10 - 100 mg/kg DW were made using two freshly prepared stock solutions dissolved in ferf.-methyl-butyl-ether having test concentrations of 50 and 5 g/L. Appropriate stock solution volumes for the concentrations 32 and 100 mg/kg DW were mixed with quartz sand and finally with the soil to give specified soil concentrations (see table below). The test concentrations 320 and 1000 mg/kg ,DW were prepared by adding directly weighed quantities of the test item to measured quantity of solvent (ferf.-methyl-butyl-ether) (see table below). The stock solution for the concentration 10 mg/kg DW was prepared by 1:10 dilution of the stock solution 50 g/L (see ta ble below). The volume of stock solution mixed with quartz sand is given below.
Soil test con centration
[mg/kg DW] 1000 320 100 32 10
Amount Amount of Cone, of
of DW quartz Test Item
soil
sand
Stock
(1 %) solution
[kg] [fl] [g/L]
5.2 51.9
-
5.2 51.9
-
5.2 51.9
50
5.2 51.9
50
5.2 51.9
5
Stock solution volume'
[mL]
-
10.4 3.4 10.0
Direct weighing Stock Solvent
solution nominal actual volume
prepared
[g] [g] [mL] [mL]
5.186 5.1863
-
30
1.659 1.6591 -
25
2.5 2.4998 50
-
--
--
-
-
-
* Volum e of stock solution (ferf.-m ethyl-butyl-ether) mixed with quartz sand DW = dry weight Cone. = concentration
Stock solutions for rape study
A stock solution f o i | ^ ^ ^ ^ lor soil concentrations
1 0 - 1000 mg/kg~DW (57.8 g/L; .nominal: 2.89 g, actual: 2.8901 g dissolved in 50 mL of ferf.-methyl-butyl-ether) was freshly prepared. The soil test concentrations 6.25 - 50 mg/kg DW were pre pared by 1:2 dilution of the stock solution with a final volume of 50 mL each. 10 mL of the appropriate stock solution was mixed with quartz sand.
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DR.U.NOACK-LABORATORIUM FR ANGEWANDTE BIOLOGIE
Report
Terrestrial Plants i oxicity, seeming Emergence acc. to OECD Guideline 208 (Draft July 2000)
.MPage 14 of 51
Project-N Study-No.
REFERENCE ITEM CONTROL SOLVENT CONTROL
TEST CONDITIONS Duration
Soil test concen Amount of
tration
DW soil
[mg/kg DW]
100 50 25 12.5 6.25
[kg] 5.8 5.8 5.8 5.8 5.8
Amount of Stock solu quartz sand tion volume*
(1 %)
fe] [mL] 57.8 10 57.8 10 57.8 10 57.8 10 57.8 10
Cone, of Test Item Stock solu
tion [g/L] 57.8 28.9 14.5 7.2 3.6
* Volume of stock solution (ferf.-m ethyt-butyl-ether) mixed with quartz sand DW = dry weight Cone. = concentration
No reference item is recommended for this test according to the test guideline.
8 replicates applied with quartz sand.
8 replicates applied with quartz sand and ferf.-methyl-buthyl-
ether.
Amount solvent added per treatment:
oats:
63.1 mL
soybean:
30 mL
rape:
10 mL
A: oats
Incorporation of the quartz sand into the soil: 2002-11-21
Sowing of the seeds:
2002-11-22
Completiondate:
2002-12-13
B:soybean
Incorporation of the quartz sand into the soil: 2002-11-28
Sowing of the seeds:
2002-11-29
Completiondate:
2002-12-20
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4MPage 15 of 51
Project-N Study-No.
Number of replicates Number of seeds Test medium
Test container Sowing Application Application technique
C: rape
Incorporation of the quartz sand into the soil: 2003-01-16
Sowing of the seeds:
2003-01-17
Completion date:
2003-02-07
8 replicates per dose level, solvent control and control were tested in a randomized block design.
5 seeds were sown per replicate.
2/3 certified LUFA soil No. 2.2 and 1/3 quartz sand (Non-GLP data)
Overall carbon content:
1.31 %
Certified LUFA soil No. 2.2
(batch-no. Sp 223302 / 224602) (Non-GLP data)
Soil type:
loamy sand (DIN)
Grain size:
< 2 mm
Carbon content:
2.3 0.2 %
pH value
5.6 0.4
The soil has been stored at the test facility at green house conditions until use.
Origin: Landwirtschaftliche Untersuchungs- und Forschungsanstalt Speyer (LUFA), Obere Langgasse 40, D-67346 Speyer.
Plastic containers (standard flower pots) with a diameter of 12 cm were used.
Test containers were filled with 700 g treated soil each (see below) and seeding holes were made with a seeding pistil. One seed was placed in every hole and covered with soil. Dur ing cultivation the test containers were bottom watered and fertilized as necessary.
The control, solvent control and test item were applied once at the beginning of the study.
To reach a sorption equilibrium the test item was incorporated into the soil 24 h prior to test start. The concentrations of the test item are expressed in terms of the dry weight of the soil.
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Terrestrial Plants i oxicity, seedling Emergence acc. to OECD Guideline 208 (Draft July 2000)
Page 16 o f 51
Project-N Study-No.
The test item was weighed out and dissolved in ferf.-buthylmethyl-ether to produce a number of stock solutions. A speci fied amount of the appropriate test item stock solution was mixed with quartz sand. After the solvent had volatilised out of the quartz sand, the treated quartz sand was mixed with the soil. The soil was mixed carefully with a hand-mixer (Krups) to insure a homogeneous distribution of the test item in the soil. The amount of quartz sand added was the same for each test concentration (1 %). After 24 h the treated soil was placed in the test container and the seeds were sown (see above).
ENVIRONMENTAL CONDITIONS
Source of light Watering / Fertilisation Nutrient solution
nominal Oats Soybean Rape
Temperature [C]
20 10 16-24 16-24 17-26
Relative humidity [%]
>60 68-100 70-100 74 -100
Photoperiod [h] 16 16 16 16
Illumination (lx]
>3500 3600 1100 5300 1400 3400 1100
Special-fluorescent tube Fluora (Art-No. 25414925) Special-fluorescent tube Daylight (Art.-No. 25414922) Origin: Hoklatherm GmbH, Postfach 206, D-26687 Apen
Bottom watering of the test containers with nutrient solution as necessary.
Flory 9 hydro (0.5 %o) Origin: Grtnereibedarf Asperg e .G., Niederlassung Han nover, Ringstrasse 7, D-30457 Hannover
Nutrient
Concentration [mg/L]
Ammonium nitrogen Nitrate nitrogen p2o5 Potassium oxide Magnesium oxide Boron Iron (Chelate) Copper Manganese Molybdenum Zinc
50 100 70 220 60
0.3 1.2 0.02 0.5 0.05 0.1
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DR.U.NOACK-LABORATORIUM FR ANGEWANDTE BIOLOGIE
ieeanng Emergence acc. to OECD Guideline 208 (Draft July 2000)
iiiPPage 17 of 51
Project-N Study-No.
TYPE AND FREQUENCY OF MEASUREMENTS AND OBSERVATIONS
The room temperature and relative humidity were recorded continuously throughout the test with a thermohygrograph.
During the observation period the replicates were observed every 7 days for number of emerged seedlings, number of dead plants and visual phytotoxic effects.
Observations included all variations, either inhibitory or stimu latory, between the treated replicates and the pooled controls. Such variations were phytotoxic symptoms (e.g. chlorosis, ne crosis, wilting), formative effects and growth and development rates.
At the end of the study the number of emerged seedlings, number of dead plants and phytotoxic effects were determined and shoot height and shoot fresh weight were measured.
TEST DESCRIPTION
Day -1:
Start (day 0): Every working day: Day 7, 14, 21: Test end:
A preliminary NON-GLP test was performed with 3 soil concentrations (10 - 100 - 1000 mg/kg DW), and additionally for rape a single concentration of 1 mg/kg DW was tested. Based on the results of the preliminary test, the main study was performed with five concentrations from 10 to 1000 mg/kg DW with a factor of Vi 0 (oats and soybean) and from 6.25 to 100 mg/kg DW with a factor of 2 (rape).
The test medium was heated to 50 C, weighed out, dissolved in fe/t-buthyl-methyl-ether and mixed with quartz sand. After the solvent had volatilised out of the quartz sand (ca. 1 h), the treated quartz sand was mixed with the soil.
The treated soil was placed in the test containers and the seeds were sown.
Test containers were bottom watered and fertilised as needed.
The plants were observed for number of emerged seedlings, visual phytotoxic effects and number of dead plants.
Final shoot heights and fresh weight measurements were done.
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rw e s tria l Plants i oxicity, seedling Emergence acc. to OECD Guideline 208 (Draft July 2000)
Page 18 o f 51
Project-Noi Study-No.
STATISTICS AND CALCULATIONS
NOEC of biomass/ be emerged seedlings
One Way Analysis of Variance (ANQVA) and Dunnett's Test were carried out for the determination of statistically signifi cant differences compared to pooled control replicates. When running a One Way Analysis of Variance a Normality Test and an Equal Variance Test were done first. P-values for both Normality and Equal Variance Test are 0.05. The a-value for ANOVA and Dunnett's Test (acceptable probability of incorrectly concluding that there is a difference) is a=0.05.
No statistically significant differences were found between the control and the solvent control. Therefore for calculations the replicates of the control and solvent control were summarized in a pooled control group.
All dead plants were measured and weighed and included in calculations if possible according to the guideline.
EC-values and confidence Intervaly of growth
Calculations were carried out via probit analysis. Probit values were taken from Weber (1986). Confidence intervals were calculated according to a standard procedure (Breitig & TOmpling 1982).
Software
SigmaPiot (windows) rei. 6.0 (2000), SPSS Incorporation SigmaStat (windows) rel. 2.03 (1997), SPSS Incorporation Excel rel. 9.0 (2000), Microsoft Corporation
VALIDITY CRITERIA
The following validity criteria must be found in the control rep licates:
a minimum of 65 % emergence the mean seedling growth should not exhibit visible phytotoxic effects the mean survival of the plants is at least 90 % at the end of the test
DEVIATIONS FROM THE GUIDELINE
None
s a i
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Terrestrial Plants Toxicity, Seedling Emergence acc. to OECD Guideline 208 (Draft July 2000)
Page 19 o f 51
Project-N Study-No
DEVIATIONS FROM THE STUDY PLAN
REPORTING
ARCHIVING
The final report is issued as paper copy (5 originals) and an electronic record (1 original).
The following was retained in the archive of the test facility for the period as specified in the operative national GLP regula tions: ail raw data study plan (Original 1 of 2) final report paper copy (Original i of 5) all records performed by the quality assurance programme
including master schedules sample of test item
Microfilms will be retained in a safe-deposit by Volksbank Sarstedt, D-31157 Sarstedt.
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Page 20 o f 51
Project-No Study-No.
4 Results
No statistically significant differences were found between the control and the solvent con trol. Therefore for calculations the replicates of the control and solvent control were summarized in a pooled control group.
4.1 Visual Phytotoxicity
The plants were observed on day 7, 14 and 21 for visual phytotoxic effects, number of dead plants and emerged seedlings. Observations are given in Table 1 9 - 2 1 (day 7), Table 22 24 (day 14) and Table 25 - 27 (day 21). Number of emerged seedlings is given in Table 10 12 (day 7), 13 - 15 (day 14) and 16 - 18 (day 21). Phytotoxic effects and rate of emergence after 21 days are given in Table 4 - 6 .
Table 4: Oats: Phytotoxic Effects and Rate of Emergence after 21 Days
Phytotoxic effects
Cone. Phytotoxic effects
Replicate
[mg/kg DW]
1234567 8
Pooled control
10 32 100 320 1000
-
-
-
- -------
- ----- - -
- -------
- -------
- ------ -
- --
----
- -------
Cone. = Concentration = not occurred
Rate of Emergence
[%] 88
88 90 85 68 78
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Page 21 o f 51
Project-N Study-No.. TNCBTT
Table 5: Rape: Phytotoxic Effects and Rate of Emergence after 21 Days
Phytotoxic effects
Cone. Phytotoxic effects*
Replicate
[mg/kg DW]
123456
Pooled
-
- -----
control
- -----
6.25 -
- -----
12.5 (E) - - - - - -
25 - - - - - - -
50 - - - - - - -
100 (2.1) ++ ++ + ++ ++
Rate of Emergence
78
[%]
--
99
--
--
95
-1
98
--
95
-+ ++
95 98
Table 6: Soybean: Phytotoxic Effects and Rate of Emergence after 21 Days
Phytotoxic effects
Cone. Phytotoxic effects*
Replicate
Rate of Emergence
[mg/kg DW]
1234 5678
[%]
Pooled (E) - - - - 1 1 - -
control
- -------
10 (E) - - - 1 - - - -
32 (E) - - - - 1 - - -
100 - - - - - - - - -
320 - - - - - - - - -
1000
- - -------
93
93 85 90 95 80
Cone. = Concentration
* The numbers in brackets correspond to the observations as follows:
(2 .1 ): Decrease in length
(E) : Dead plant
- = not occurred
+ /- = slight effect
+ = medium effect
++ = strong effect
tozed. Do* n n f
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Project-No Study-No.
4.2 Shoot Height
The shoot height was determined on day 21. Test item related statistically significant inhibition (marked with *) of the shoot heights was found at the concentration 100 mg/kg DW for rape (Figure 2). No test item related inhibition was determined in the tested concentration range of 10 - 1000 mg/kg DW for the plant species oats and soybean (Figure 1, 3).
42
concentration img/kg DW]
Figure 1: Oats: Shoot Height after 21 Days (Mean SD) in Relation to the Test Item Concentration in Soil
12
concentration (mg/kg DW)
Figure 2: Rape: Shoot Height after 21 Days (Mean SD) in Relation to the Test Item Concentration in Soil
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Page 23 of 51
Project-N Study-No
25
20
E
S.
15
'x2og>:>
1 10
wJZ
5
0
Figure 3: Soybean: Shoot Height after 21 Days (Mean SD) in Relation to the Test Item Concentration in Soil
4.3 Fresh Weight (Biomass)
The biomass was determined as fresh weight on day 21. Test item related statistically significant inhibition (marked with *) of the fresh weight was found at concentrations > 50 mg/kg DW for rape and at the concentration 1000 mg/kg DW for soybean (Figure 5, 6). No test item related statistically significant inhibition of the fresh weight was determined in the tested concentration range 10 - 1000 mg/kg DW for the plant species oats (Figure 4).
Figure 4:
concentration [mg/kg DW]
Oats: Fresh Weight after 21 Days (Mean SD) in Relation to the Test Item Concentration in Soil
Company Sanitized. Does not contain TSC CBJ
DR.U.NOACK-LABORATORIUM FR ANGEWANDTE BIOLOGIE
^ oNeoW'-
50i>0 ^00.0
concentration [mg/kg DW]
Figure 5: Rape: Fresh Weight after 21 Days (Mean SD) in Relation to the Test Item Concentration in Soil
2100
concentration [mg/kg DW]
Figure 6: Soybean: Fresh Weight after 21 Days (Mean SD) in Relation to the Test Item Concentration in Soil
Company Sanifiatetf. o es not contain TSCA CBI
DR.U.NOACK-LABORATORIUM FR ANGEWANDTE BIOLOGIE
I errestriai Plants I oxicify, Seedling Emergence acc. to OECD Guideline 208 (Draft July 2000)
C^r!BP!^Page 25 of 51
Project-N Study-No
4.4 Emerged Seedlings
No statistically significant decrease was found for the plant species oats and soybean at the concentration range 10 - 1000 mg/kg DW and for the plant species rape at the concentration range 6.25 - 100 mg/kg DW (Figure 7 - 9).
Figure 7: Oats: Emerged Seedlings after 21 Days (Mean SD) in Relation to the Test Item Concentration in Soil
/ """V
Figure 8: Rape: Emerged Seedlings after 21 Days (Mean SD) in Relation to the Test Item Concentration in Soil
JS P M V Saniieect o *
ft f e n tw t 8 e A m i
DR.U.NOACK-LABORATORIUM FR ANGEWANDTE BIOLOGIE
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Project-No Study-No.
concentration [mg/kg DWJ
Figure 9: Soybean: Emerged Seedlings after 21 Days (Mean SD) in Relation to the Test Item Concentration in Soil
4.5 Effect Levels 4.5.1 Inhibition of Shoot Height, Fresh Weight and Number of Emerged Seedlings
The tabulated results represent rounded results calculated on the exact raw data.
Table 7:
Inhibition of Shoot Height
Concentration [mg/kg DW] Oats
Pooled control 34.4
10 37.0
32 35.4
100 34.7
320 34.2
1000
32.4
Shoot height [crn]
Inhib. Soy [%] bean
- 20.2 -8 21.8
-3 20.6
-1 21.2
0 20.6
6 19.1
Shoot height
Concentration
[crn]
Inhib. [mg/kg DW] Rape Inhib.
[%] * pooled control 10.2
t%] -
-8 6.25 10.8 -6
-2 12.5 9.8 4
-5 25
10.7 -5
-2 50
9.4 8
6 100
6.4* 37
Inhib. = Inhibition negative values = enhanced growth * Significantly different, P < 0.05, A N O V A a =JJ.05
>es cm tah r SC4 c e i
/*"V
DR.U.NOACK-LABORATORIUM FR ANGEWANDTE BIOLOGIE
I rrestrial Plants l oxicity, Seedling Emergence acc. to OECD Guideline 208 (Draft July 2000)
Page 27 of 51
Project-No Study-No.
Table 8: Inhibition of Fresh Weight
Concentration [mg/kg DW]
Oats
Pooled control 10 32
100 320 1000
816 979 917 795 759 718
Fresh weight [mg]
Inhib. Soy [%] bean - 1792
-20 1737
-12 1614
3 1750
7 1553
12 1452
Concentration Inhib. [mg/kg DW]
Fresh weight
[mg] Rape Inhib.
[%] [%]
- pooled control 1035
-
3 6.25 1081 -4
10 12.5 975 6
2 25 1001 3
13 50
798* 23
19* 100
287* 72
Table 9: Inhibition of Emerged Seedlings
Concentration [mg/kg DW]
Pooled control
Eoerged seedlings
Oats
[7] Inhib. Soy
[%] bean
Inhib. [%]
88 - 93 -
Ernerged Concentration seedlings [%] [mg/kg DW] Rape Inhib.
[%]
pooled control 99
-
10 88 0 93 0
6.25 95 4
32 90 -2 85 9 12.5 98 1
100
85
3 90
3
25
95 4
320 68 23 95 -2
50
95 4
1000
78 11 80 14
100
98 1
Inhib. = Inhibition negative values =-enhanced growth * Significantly different, P < 0.05, ANOVA a = 0.05
4.5.2 EC25, ECsoand NOEC Values
EC25 and EC50 values with confidence range of shoot height, fresh weight and emerged seedlings were calculated out of percentage inhibition. Results were presented in Table 1-3.
NOEC values were calculated using One Way Analysis of Variance ( A n o v a ) and D u n n e t t 's test. Results were also presented in Table 1-3.
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Project-N Study-No.
5 Graphs
Figure 10:
Figure 11:
Rape: Fresh Weight after 21 d
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lerrestrial Plants Toxicity, Seedling Emergence
Project-N
acc. to OECD Guideline 208 (Draft July 2000)____________________Study-No.
6 Conclusions
After 21 days no test item related phytotoxic effects were observed for the plant species oats and soybean at the tested concentration range 10 - 1000 mg/kg DW. For rape decrease in length was observed at the concentration 100 mg/kg DW as medium to strong effect. For details see Table 25 - 27.
The EC50-value fo r sh o o t height was not calculable in the tested concentration range for the tested plant species because no test item related inhibition occurred. The EC50- values for shoot height were > 100 mg/kg DW for rape and > 1000 mg/kg DW for oats and soybean, respectively (Table 1). Significant differences in comparison to the control were determined at the concentration 100 mg/kg for rape.
The ECS0- values fo r fresh w eight was determined for the plant species rape at 73.7 mg/kg DW (Table 2). The EC50- values for fresh weight were > 1000 mg/kg DW for oats and soybean (Table 2). Significant differences in comparison to the control were determined at the concentration 50 and 100 mg/kg for rape and at the concentration 1000 mg/kg for soybean.
The EC50- value fo r seedling emergence was not calculable in the tested concentration range for the tested plant species. The EC50- values for seedling emergence were > 100 mg/kg DW for rape and > 1000 mg/kg DW for oats and soybean, respectively (Table 3).
7 Validity Criteria
The control treatment validity criteria according to the test guideline were fullfilled: a minimum of 65 % emergence the mean seedling growth exhibited no visible phytotoxic effects the mean survival of the plants was at least 90 % at the end of the test
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Project-No Study-No.
8 Literature
(1) Breitig & T mpling (1982): Methoden der Wasseruntersuchungen Bd.II, VEB Gustav Fischer Verlag, Jena.
(2) DuPont, Determination of physio-chemical parameters of Perfluorooctylethanol, CAS No. 678-39-7, Unpublished results, Update Feb. 15, 2002
(3) Fll C., Jung S. und C. Schulte (1999): Prfanforderungen des Umweltbundesamtes zur Bewertung der Auswirkungen von Pflanzenschutzmitteln auf terrestrische Pflan zen. UWSF - Z. Umweltchem. kotox. 11 (3) 145-149
(4) OECD 208 (draft document, July, 2000), Terrestrial (Non-Target) Plant Testing, Part A Seedling Emergence Test
(5) W eber. E.: Grundri der biologischen Statistik, 9. Auflage (1986).
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rerrestrial Plants Toxicity, Seedling Emergence
Abr IPage 31 of 51
Project-NoJ
acc. to OECD Guideline 208 (Draft July 2000)
Study-No. TNC841 \ TM
9 Biological Data
9.1 O bservation Parameter
(2) Disturbance of growth (2.1) Decrease In length
(2.2) Promoted growth
(3) (3.1) (3.2) (3.3) (3.4)
Alteration of form and appearance (deformation) Curling / twisting / sticking or other deformation of the leafs Change of appearance Shoot deformations Wilting
(4) (4.1) (4.3)
(4.4)
Discolouration of the leafs
Lighter green
(4.2)
Chlorosis
(4.3.1)
(4.3.2)
(4.3.3)
(4.3.4)
Loss of colour or discolouration
darker green spots marginal of the veins between the veins
(5) (5.1)
Alteration of the leaf cells Necrosis
(5.1.1) (5.1.2) (5.1.3) (5.1.4) (5.1.5)
spots marginal apical between the veins of the whole leaf
(E) Dead plant
Assessment of the effects:
- = no effects observed +/- = slight effects + = medium effects + 4- = strong effects
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Project-No Study-No.
9.2 Emerged Seedlings on Day 7
Table 10: Oats: Emerged Seedlings on Day 7
Emerged seedlings
Concentration Emergence
Replicate
[mg/kg DW]
t%]
12 345 67 8
Pooled control
10 32 100 320 1000
85
83 90 85 65 70
54 54 3 4 3 4 5545354 5 554 4534 3 554 534 5 5 53533555 43442 153 34 333 25 5
Table 11: Rape: Emerged Seedlings on Day 7
Emerged seedlings
Concentration Emergence
Replicate
[mg/kg D W ]
[%]
12 34 5 6 7 8
Pooled control
6.25 12.5 25 50 100
96
93 95 95 95 95
54 5 5 5 5 5 5 55555535 534 55 55 5 55 5554 54 5554 5 4 55 455 55 4 5 5 555 54 554
oes not com*" TSCA C M
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Project-No Study-No. NC8411
Table 12: Soybean: Emerged Seedlings on Day 7
Emerged seedlings
Concentration Emergence
Replicate
[mg/kg DW]
[%]
12 34 567 8
Pooled control 83
4 3 5 54 5 5 4 34 3 35 54 4
10 83 5 4 5 4 4 1 5 5 32 80 2 5 4 3 5 5 4 4
100 83 4 5 4 5 4 3 4 4
320 90 5 3 4 5 5 5 5 4
1000
78 4 3 2 5 4 5 5 3
9.3 Emerged Seedlings on Day 14
Table 13: Oats: Emerged Seedlings on Day 14
Emerged seedlings
Concentration Emergence
Replicate
[mg/kg DW]
[%]
12 3 4 5 6 7 8
Pooled control 85
54 5 4 3 4 3 4 554 53 54 5
10 88 5 5 4 4 5 4 4 4 32 90 5 5 4 5 3 4 5 5 100 85 5 3 5 3 3 5 5 5
320 68 4 3 4 4 2 2 5 3
1000
78 4 4 3 4 3 3 5 5
Z'*'*'''*'
Deas not contain TSC CBI
DR.U.NOACK-LABORATORIUM FR ANGEWANDTE BIOLOGIE
Terrestrial Plants Toxicity, Seedling Emergence acc. to OECD Guideline 208 (Draft July 2000)
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Project-No1 Study-No.
Table 14: Rape: Emerged Seedlings on Day 14
Emerged seedlings
Concentration Emergence
Replicate
[mg/kg DW]
[%]
1234 5 678
Pooled control
6.25 12.5 25 50 100
98
95 98 95 95 98
55555555 55555535 53555555 555554 55 5554 54 55 45555455 55 55 5 5 54
Table 15: Soybean: Emerged Seedlings on Day 14
Emerged seedlings
Concentration Emergence
Replicate
[mg/kg DW]
[%]
12 34 567 8
Pooled control
1 32 100 320 1000
91
93 85 90 95 80
44 555554 45455544 54 5 5 5 3 5 5 25435555 55 4 5 54 4 4 54 4 5 5 5 5 5 44 2 5 4 5 5 3
fSCACBl SanSSze&. Dees p ic e n i s tu p a s
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rerrestrial Plants Toxicity, Seedling Emergence acc. to OECD Guideline 208 (Draft July 2000)
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Project-Nc Study-No. TNC8411
9.4 Emerged Seedlings on Day 21
Table 16: Oats: Emerged Seedlings on Day 21
Concentration Emergence Sig.
Enrlerged seedli igs Rep icate
[mg/kg DW] [%] Dif. 1 2 3 4 5 6 7 8
Pooled control
10 32 100 320 1000
88
88 90 85 68 78
- 54 5 4 34 34 55 5 5 3 5 5 5
No 5 5 4 4 5 4 4 4 No 5 5 4 5 3 4 5 5 No 5 3 5 3 3 5 5 5 No 4 3 4 4 2 2 5 3 No 4 4 3 4 3 3 5 5
Table 17: Rape: Emerged Seedlings on Day 21
Errlerged seedli ngs
Concentration Emergence Sig.
Rep icate
[mg/kg DW] [%] Dif.s 1 2 3 4 5 6 7 8
Pooled control
6.25 12.5 25 50 100
99
95 98 95 95 98
- 5555 5555 55555545
No 5 3 5 5 5 5 5 5 No 5 5 5 5 5 4 5 5 No 5 5 5 4 5 4 5 5 No 4 5 5 5 5 4 5 5 No 5 5 5 5 5 5 5 4
Significantly different, ANOVA, a = 0.05
,,rta a T S C fcC S i p o m pan SanM IM d. D o K>S
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Terrestrial Plants Toxicity, Seedling Emergence acc. to OECD Guideline 208 (Draft July 2000)
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Project-Nc Study-No. TNC8411
Table 18: Soybean: Emerged Seedlings on Day 21
Emerged seedlings
Concentration Emergence Sig.
Replicate
[mg/kg DW]
[%]
Dif. 1 2 3 4 5 6 7 8
Pooled control 93
44 555554 4 54 55554
10 93 No 5 4 5 5 5 3 5 5
32 85 No 2 5 4 3 5 5 5 5
100 90 No 5 5 4 5 5 4 4 4
320 95 No 5 4 4 5 5 5 5 5
1000
80 No 4 4 2 5 4 5 5 3
Significantly different, ANOVA, a = 0.05
9.5 Visual Phytotoxicity on Day 7
Table 19: Oats: Visual Observations and Number of Dead Plants on Day 7
Phytotoxic effects
Concentration Phytotoxic
Rep icate
[mg/kg DW] effects 1 2 3 4 5 6 7 8
Pooled control -
--------
-- - - - - - -
10 - - - - - - - - 32 - - - - - - - - -
100 - - - - - - - - 320 - - - - - - - - -
1000
--
------
- = not occurred
CSWOP*"
no*>lconfcal 1 S C A .C B I
DR.U.NOACK-LABORATORIUM FR ANGEWANDTE BIOLOGIE
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Project-N Study-No.. TNC84113"
Table 20: Rape: Visual Observations and Number of Dead Plants on Day 7
Phytotoxic effects
Concentration Phytotoxic
Replicate
[mg/kg DW] effects 1 2 3 4 5 6
Pooled control -
6.25 12.5 25 50 100
-
----------------- -- - ----------------
7
-
8
-
Table 21 : Soybean: Visual Observations and Number of Dead Plants on Day 7
Phytotoxic effects
Concentration Phytotoxic
Rep icate
[mg/kg DW] effects 1 2 3 4 5 6 7
Pooled control
10 32 100 320 1000
-
-
-------------------------------------------
- = not occurred
8
-
C0rP*W
not contata T8CA CBI
Dow
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terrestrial Plants Toxicity, Seedling Emergence acc. to OECD Guideline 208 (Draft July 2000)
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Project-N Study-No TNC84113
9.6 Visual Phytotoxicity on Day 14
Table 22: Oats: Visual Observations and Number of Dead Plants on Day 14
Phytotoxic effects
Concentration Phytotoxic
Replicate
[mg/kg DW] effects 1 2 3 4 5 6
Pooled control -
------
-----10 - - - - - - -
32 - - - - - - 100 - - - - - - -
320 1000
- ------ ----- -
7
-
8
-
Table 23: Rape: Visual Observations and Number of Dead Plants on Day day 14
Concentration Phytotoxic
[mg/kg DW] effects
Pooled control
--
6.25 12.5 25 50 100
-
1
-
Phytotoxic effects Rep icate
234 56
----------------- - - - ---- -----
7
-
- = not occurred
8
-
Does no. oonu-n TSCA CBI
DR.U.NOACK-LABORATORIUM FR ANGEWANDTE BIOLOGIE
Terrestrial Plants Toxicity, Seedling Emergence acc. to OECD Guideline 208 (Draft July 2000)
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Project-No Study-No.
Table 24: Soybean:,Visual Observations and Number of Dead Plants on Day 14
Phytotoxic effects
Concentration Phytotoxic
Replicate
[mg/kg DW] effects* 1 2 3 4 5 6 7
Pooled control (E)
10 32 100 320 1000
(E) -
- - - - 11--------- --- - - - - 1- -- - - -- --- --- --- - -- -
8
-
9.7 Visual Phytotoxicity on Day 21
Table 25: Oats: Visual Observations and Number of Dead Plants on Day 21
Concentration Phytotoxic [mg/kg DW] effects Pooled control -
10 32 100 320 1000
-
1
-
Phytotoxic effects Rep cate
234 56
------ --- - - ------ '- - - -- ---- - --
* The numbers in brackets correspond to the observations as follows: ( E ) : Dead plants
- = not occurred
7
-
8
-
GontP" *
not contain TSCA.CBI
D eS
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Project-No( Study-No. TNC8411
Table 26: Rape: Visual Observations and Number of Dead Plants on Day 21
Concentration Phytotoxic
[mg/kg DW] effects*
Pooled control
--
6.25 12.5 25 50 100
(E) (2.1)
1
++
2
++
Phytotoxic effects
Rep cate
34 56
-------- --
---- --+ ++ ++
-
7
+
8
1 ++
Table 27: Soybean: Visual Observations and Number of Dead Plants on Day 21
Phytotoxic effects
Concentration Phytotoxic
Rep icate
[mg/kg DW] effects* 1 2 3 4 5 6
Pooled control (E)
10 32 100 320 1000
(E) (E) -
- - - - 11 -- - - - - - - 1- -- - - 1----- ----- -- - - - -
* The numbers in brackets correspond to the observations as follows:
(2.1) : Decrease in length
(E) :
Dead plant
- = not occurred
+/- = slight effect
+ = medium effect
++ = strong effect
7
-
8
-
9.8 Shoot Height
Statistical analysis was carried out using ANOVA and DUNNETT's Method if applicable (ANOVA a = 0.05). Multiple Comparisons vs. Control Group were done. Results see table 28 - 33.
GO1****
s a t"
noi
DR.U.NOACK-LABORATORIUM FR ANGEWANDTE BIOLOGIE
Terrestrial Plants Toxicity, Seedling Emergence acc. to OECD Guideline 208 (Draft July 2000)
'` Page 41-of 51
Project-N Study-No
Table 28 : Oats: Shoot Height [cm] Pooled Control, 10 and 32 mg/kg DW
Repl.
1
2
3
4
5
6
7
8 Mean SD Sig. Dif. P< 0.05
Pooled control
Control
Solvent control
Height
Height
[cm] Mean SD [cm] Mean SD
4.9 37.4 40.6 37.0 37.5 31.2 14.9 38.4 36.1 3.4 38.4 37.7 34.8 30.2 38.7 38.5 36.2 41.3 32.9 36.9 3.0 36.0 37.7 2.8 39.7 38.7
33.9
37.0 37.5 39.8 39.8 33.6 39.6 4.5 39.0 30.5 15.4 43.6 32.6 44.2 3.4 42.2 38.4 35.6 33.6 34.8 37.8 3.3 35.4 34.8 2.2 38.4 33.4
33.3
37.7 37.8
31.5 40.6 35.0 34.7 3.1 34.1 37.5 3.3
_-
_-
32.5 35.3 36.0 35.1 1.8 36.4
-
36.1 37.1 39.4 37.0 2.2
38.6 33.9
36.1 35.4 33.9 35.1 1.1
_
..
29.9 37.9 17.4 27.5 8.6 24.7
3.6 29.8 32.0 27.9 14.0 37.9 36.3 32.0
32.6 27.0 31.9 2.9 33.5 34.6
34.5 3.6
Height [cm]
Concentration [mg/kg DW]
10 32 Height
Mean SD [cm] Mean SD
42.9 3.4
38.6 35.6 36.7 38.7 2.6 38.8 29.8 14.9
39.1 38.0
36.3 33.4
37.8 35.1
43.0 37.7 40.4 39.0 2.7 36.6 35.7 1.4
36.8 34.5
36.8 34.5
38.3 35.5
37.4 33.4
39.6 38.4 0.9 32.7 34.8 2.1
38.4 37.4
--
48.7 41.8
46.7 43.6
39.5 44.4 4.1 41.5 41.1 4.1
42.6 34.1
- 44.4
33.8 33.7
32.6 36.7
39.0 36.7 3.8 41.0 37.1 3.7
41.9 -
36.0 -
9.3 34.3
35.8 36.1 41.3 32.5 15.8 37.1
37.8 4.1
43.5 43.6
-*
16.7 36.3
38.1 34.1
41.6 33.2 11.2 29.6 34.2 2.7
36.2 35.9
* 35.0
7.3 39.7
38.4 34.9
43.3 32.9 17.2 32.9 33.0 + 8.1
42.4 38.1
- 19.3
37.0 4.1
35.4 3.4
No No
- not emerged Sig. Dif. = Significantly different
tscacbi S a n itized Doe not e
DR.U.NOACK-LABORATORIUM FR ANGEWANDTE BIOLOGIE
acc. to OECD Guideline 208 (Draft July 2000)
Page 42 of 51
Project-N Study-No.
Table 29 : Oats: Shoot Height [cm] 100, 320 and 1000 mg/kg DW
Repl. 1 2 3 4 5
Concentration [mg/kg DW]
I
100 320 1000
Height
Height
Height
[cm] Mean SD [cm] Mean SD [cm] Mean SD
34.0 36.3 32.5 33.4 2.4 30.0 34.4 42.8 29.3 38.2 36.8 6.9
:
31.4 34.9 32.0 25.9 28.8 32.5 3.8 35.3 37.9 32.2
- '-
35.1 38.0 32.2 36.7 33.2 33.5 1.5 35.9
30.6 :
32.1 4.3 35.3 3.3
35.8 36.0 39.2
35.2 37.0 32.7
36.9 35.7 3.3 39.2 36.6 2.0 33.7
30.9 34.3
-
39.9
-
-
35.1 31.4 27.4
33.1 33.1 38.1
35.6 34.6 1.3 33.3 32.8 0.9 26.9
33.3 34.8 ;
35.2 3.5 31.8 5.5
32.7 34.8 38.2 35.2 2.8
37.1 36.7
36.9 0.3 -
35.9 31.8 17.9
28.5 9.4
6
7
8 Mean SD Sig. Dif. P< 0.05
34.3 33.0 36.0 34.1 1.6 32.0 35.0 36.6 36.1 25.6 32.9 5.3 37.3 . 29.1 38.6 34.1 39.6 34.6 5.1 33.9 26.7
34.7 1.3
No
- not emerged Sig. Dif. = Significantly different
26.4 35.7
-
-
-
37.9 30.0 35.1 36.3 37.4 35.4 34.0 36.0
-
31.1 6.6 35.3 3.2 35.1 1.0
"
34.2 2.1
No
33.6 27.6 29.3
-
-
35.7 39.8 29.4 35.7 32.9 32,8 19.2 35.2 37.0 33.6 I
30.2 3.1 34.7 3.9 31.6 7.1
32.4 2.5
No
Company Sanitized. Does not contain TSC CBl
DR.U.NOACK-LABORATORIUM FR ANGEWANDTE BIOLOGIE
rerrestrial Plants Toxicity, Seedling Emergence acc. to OECD Guideline 208 (Draft July 2000)
Page 43 o f 51
Project- N o |_ Study-No. TNC84113"
Table 30 : Rape: Shoot Height [cm] Pooled Control, 6.25 and 12.5 mg/kg DW
Repl.
1
2
3
4
5
6
7
8 Mean SD Sig. Dif. P< 0.05
Pooled control
Control
Solvent control
Height
Height
[cm] Mean SD [cm] Mean SD
11.5 10.8 8.7 8.9 9.9 9.0 2.1 10.4 10.4 0.9 5.7 10.7 9.4 11.3
9.4 12.0 9.3 9.4 11.2 8.4 3.4 12.2 11.3 1.2 9.5 12.1 2.5 10.7 13.5 10.3 10.8 13.3 10.2 10.9 1.6 11.6 11.0 1.5 10.9 9.7 9.1 10.0 11.3 13.2 9.2 12.9 9.1 10.1 1.0 12.6 12.2 1.1 10.0 10.4 10.8 11.8 10.3 11.2
10.9 11.5 8.1 9.0 2.7 11.1 11.6 0.9 10.9 13.1 4.7 11.1 8.6 10.8 7.6 10.8 8.5 8.6 0.7 11.1 10.4 1.1 9.5 10.9 8.6 8.4
10.5 11.9 9.4 13.0 9.2 10.1 0.8 10.5 9.7 4.3 10.1 3.4
11.1 8.3 11.2 9.3 11.5 9.9 9.2 1.1 11.6 11.2 0.4 7.8 10.5 10.5 11.2
10.2 1.1
Concentration [mg/kg DW]
6.25 12.5
Height
Height
[cm] Mean SD [cm] Mean SD
11.6 10.7
12.0 10.8
11.3 11.4 0.5 9.6 10.3 0.5
11.4 10.2
10.7 10.3
11.6 11.6
11.9 13.4
9.2 10.9 1.5 10.9 11.9 1.0
- 11.1
- 12.3
9.7 9.7
11.9 11.8
12.4 9.8 3.5
9.8 10.1 1.1
3.9 8.9
11.2 10.5
11.3 7.4
11.0 11.1
11.1 11.2 0.3 9.8 9.6 1.3
11.6 9.7
10.8 9.8
14.1 8.9
10.6 9.0
11.0 11.3 1.8 10.1 9.5 0.9
11.6 8.9
9.3 10.8
11.7 8.4
11.4 11.2
9.2 10.7 1.0 8.7 9.4 1.3
10.5 9.4
10.5 -
11.7 10.9
10.2 10.6
10.8 11.0 0.6 10.8 10.7 0.3
1T2 11.1
11.2 10.2
11.3 2.5
7.8 9.1
10.2 10.0 1.3 5.4 6.5 2.6
10.6 8.2
10.1 7.4
10.8 0.6
9.8 1.5
No No
- not emerged Sig. Dif. = Significantly different
Company Sanitized. Does not contain TSCA CBI
DR.U.NOACK-LABORATORIUM FR ANGEWANDTE BIOLOGIE
acc. to OECD Guideline 208 (Draft July 2000)
Page 44 o f 51
Project-No, Study-No.
Table 31 : Rape: Shoot Height [cm] 25, 50 and 100 mg/kg DW
I Repl.
1
2
3
4
5
6
7
8 Mean SD Sig. Dif. P< 0.05
Concentration [mg/kg DW]
25 50 100
Height
Height
Height
[cm] Mean SD [cm] Mean SD [cm] Mean SD
10.3 5.2 11.0 12.4 7.3
11.4 12.6 10.1 12.8 12.9
11.0 10.7 9.8 9.5 10.3 11.3 11.3 11.0 12.2
-
11.5 10.2 10.6 10.8 10.6 12.0 11.4 10.9 10.0
-
9.3 10.4 9.8 10.8 11.2 11.5 12.4 10.3 9.5 9.9
9.2 2.9 12.0 1.2 10.3 0.6 11.5 0.5 10.7 0.5 11.1 0.8 10.3 0.8 10.7 1.2
10.8 7.6 9.6 9.3
-
10.8 11.0 7.0 11.5 8.0
8.7 10.9 11.1 10.5 10.3
8.3 7.4 8.8 9.3 6.5 11.7 9.2 10.3 9.0 10.0
8.5 11.0 11.1 9.3
-
10.0 9.4 9.2 5.5 9.5 10.2 8.7 10.3 10.8 6.1
9.3 1.3 9.7 2.0 10.3 0.9 8.1 1.1 10.0 1.1 10.0 1.3 8.7 1.8 9.2 1.9
5.1 6.3 7.5 4.5 5.5
8.1 3.2 5.5 7.1 3.7
7.4 4.7 9.4 8.1 6.1
3.8 4.9 5.5 6.1 4.9
8.7 6.8 7.2 8.3 4.1
7.9 5.0 5.7 7.5 4.4
8.7 6.3 7.2 8.9 7.7 6.6 6.6 7.7 5.3
-
5.8 1.2 5.5 2.1 7.1 1.8 5.0 0.9 7.0 1.8 6.1 1.5 7.8 1.1 6.6 1.0
10.7 0.8
9.4 0.7
6.4 0.9
No No Yes
- not emerged Sig. Dif. = Significantly different
Com parti Sanitized. Does not contain TSCA CBS
DR.U.NOACK-LABORATORIUM FR ANGEWANDTE BIOLOGIE
Terrestrial Plants Toxicity, Seedling Emergence acc. to OECD Guideline 208 (Draft July 2000)
Page 45 o f 51
Project-N Study-No. TNC84113
Table 32 : Soybean: Shoot Height [cm] Pooled Control, 10 and 32 mg/kg DW
Repl.
1
2
3
4
5
6
7
8 Mean SD Sig. Dif. P< 0.05
Pooled control
Control
Solvent control
Height
Height
[cm] Mean SD [cm] Mean SD
20.6 22.3 19.2 25.6 22.1 21.3 1.7 18.8 21.2 3.5 23.2 18.0
_18.7
21.6 22.5 18.9 4.4 12.7
-
23.5 23.1 24.7 23.2 1.3 23.7 21.1
19.5 22.7
21.2 8.7
24.1 21.4 3.5 9.8 16.0 7.8
25.5 22.7
16.7
-
4.0 4.5
4.5 11.1
22.8 15.4 10.2 24.4 17.4 9.2
23.8 25.2
21.7 21.9
12.0 8.5
24.0 21.7
22.7 20.8 5.9 23.1 19.4 6.3
24.5 19.7 * 23.8
25.8 22.7 24.3 3.2 23.1 24.2 1.2 22.1 18.6 8.7 23.6 23.9
* 21.1
24.4 24.0
23.6 23.0
23.9 23.6 0.8 22.3 20.9 4.6
23.8 22.2
22.3
_6.2
23.6 25.3 20.1 9.3 25.1
12.8 23.7 23.9 24.2 21.9 4.0
15.9
-
20.3 2.5
Height [cm]
Concentration [mg/kg DW]
10 32 Height
Mean SD [cm] Mean SD
12.0 16.8
23.8 21.3
20.9 19.7 4.8
- 19.1 3.2
18.5 -
23.1 -
-21.5 16.9
18.1 15.1 21.4 20.7 1.7 22.0 20.1 3.8
21.6 23.8
22.6
25.2 22.2
15.5 20.3
27.0 22.1 4.7 22.0 21.9 1.1
23.4 22.9
19.2
23.0 24.5
23.5 22.2
25.6 24.9 2.1 23.5 23.4 1.2
27.5
*
25.9 3.2 24.4 2.9 18.8 23.3 2.7 25.5 15.6 11.5 23.9 24.2 23.4 22.4 16.1 20.6 16.7 22.3 23.3 18.7 4.0 23.3 22.1 1.7
- 20.1 - 24.0
17.9 24.4 22.6 24.6 24.3 22.7 2.9 23.5 21.9 4.6 23.4 23.3 25.3 13.7 21.4 21.8
24.7 11.9 21.6 22.6 1.8 20.1 20.5 5.2 24.2 23.6 20.9 25.2
21.8 2.0
20.6 2.4
No No
* not determ inable, plant decomposed - not emerged Sig, Dif. = Significantly different
tsca cbi
DR.U.NOACK-LABORATORIUM FR ANGEWANDTE BIOLOGIE
acc. to OECD Guideline 208 (Draft July 2000)
Page 46 o f 51
Project-N Study-No.
Table 33 : Soybean: Shoot Height [cm] 100,320 and 1000 mg/kg DW
Repl. 1 2 3
Concentration [mg/kg DW]
100
320 |
1000
Height
Height
8 Height
[cm] Mean SD [cm] Mean SD I [cm] Mean SD
3.9 25.6 23.1 19.7 8.9 22.7 23.2
7.7 23.8 20.9 19.4 6.6 22.5 22.1
23.1 21.9 21.1 22.4 1.1 23.4
22.0 24.6 22.2 22.7 1.4 23.7 21.1
19.8 20.4 20.3 20.7 1.1 22.4
-
17.0 7.4 22.2 16.3 6.3 18.7
18.4 20.3 11.5 21.5
-
16.7 22.1 15.4 21.1
-
22.8 21.4
-
-
17.9 4.5 18.8 3.3 22.1 1.0
4
5
6
7
8 Mean SD Sig. Dif. P< 0.05
25.5 23.4 24.4 24.7 25.5
24.4 24.0 16.2 20.8 22.8
10.0 15.1 13.1 25.0
-
20.4 22.8 22.6 23.0
-
23.2 22.6 24.5 23.6
-
24.7 0.9 21.6 3.3 15.8 6.5 22.2 1.2 23.5 0.8
21.2 2.8
No
21.3 20.1 23.9 15.0 23.1
21.9 20.7 23.9 26.2 23.7 4.1 24.0 22.0 20.3 23.7 21.5 23.3 17.8 22.7 22.9
18.9 22.8 23.3 18.4 19.5
20.7 3.5
23.3 2.1
18.8 8.4
21.6 2.2 -
20.6 2.3
20.6 2.2
No
21.0 21.6 19.3 19.5 11.8 22.0 19.2 19.0 22.1
-
21.8 10.9 21.9 19.6 17.0 23.9 18.8 22.8 22.6 22.1
2.6 21.0 20.7
-
-
18.6 3.9 20.6 1.7 18.2 4.6 22.0 1.9 14.8 10.5
19.1 2.4
No
* not determinable, plant decomposed - not emerged
Slg. Dif. = Significantly different
not contain tSCA CB l
Sanitized- Does Cotnps0^
DR.U.NOACK-LABORATORIUM FR ANGEWANDTE BIOLOGIE
acc. to OECD Guideline 208 (Draft July 2000)
Page 47 of 54 ^
Project-No Study-No. TNC84113
9.9 Fresh Weight (Biomass) Day 21
Table 34: Oats: Fresh Weight on Day 21
Cone. Repl. Number of Fresh
[mg/kg DW]
No.
plants per replicate*
weight mean
value per
replicate
[mg]
ou. Oco L_ oo TD O ~Q Q_ coo c > CO 10
32
1 2 3 4 5 6 7 8
1 2 3 4 5 6 7 8
1 2 3 4 5 6 7 8 1 2 3 4 5 6 7 8
5 4 5 4 3 4 3 4 5 5 5 5 3 5 5 5
5 5 4 4 5 4 4 4
5 5 4 -5 3 4 5 5
765 1017 1092 1086 783 907 823 509
926 748 834 787 747 1002 572 465
1057 831 980 1318 1001 850 766 1030 795 858 879 1256 985 1054 757 749
Fresh weight mean value SD
[mg]
817 189
979 172
917 174
Signif. Diff.
Cone. Number Of
[mg/kg DW]
plants per replicate*
Fresh weight mean value per replicate
[mg]
100
I 320
-
1000
No
5 3 5 3 3 5 5 5 4 3 4 4 2 2 5 3
4 4 3 4 3 3 5 5
628 896 901 815 798 702 843 780 614 828 886 572 1134 601 630 804
576 790 1071 787 530 517 837 633
No
* num ber of plants per replicate Included in calculations
Cone. = Concentration SD = Standard deviation
Signif. Diff. = Significantly different, ANOVA, a = 0.05.
Fresh weight mean value SD [mg]
795 93
759 193
718 190
Signif. Diff.
No No No
Company Sanitized. Does not c o n ta in T S G A C B l
DR.U.NOACK-LABORATORIUM FR ANGEWANDTE BIOLOGIE
acc. to OECD Guideline 208 (Draft July 2000)
Page 48 of 51
Project-Nc Study-No. TNC84113
Table 35: Rape: Fre?h Weight on Day 21
Cone. RepI. Number of Fresh
[mg/kg DW]
No.
plants per weight replicate* mean
value per
replicate
ImgJ
o Oco oo o o "5 Cl coo c > CO 6.25
12.5
1 2 3 4 5 6 7 8
1 2 3 4 5 6 7 8
1 2 3 4 5 6 7 8
1 2 3 4 5 6 7 8
5 5 5 5 5 5 5 5
5 5 5 5 5 5 4 5
5 3 5 5 5 5 5 5
5 5 5 5 5 4 5 5
871 830 1160 1118 995 863 1339 848
918 1287 1103 1052 1202 817 1081 1071 1254 1259 1036 1232 1142 826 1022 878 965 1414 1031 765 1030 950 1232 416
Fresh weight mean value SD
[mg]
1035 166
1081 169
975 298
Signif. Diff.
-
No
Cone. Number of
[mg/kg DW]
plants per replicate*
25 5 5 5 4 5 4 5 5
50 4 5 5 5 5 4 5 5
100 5 5 5 5 5 5 5 4
Fresh weight mean value per replicate
[mg]
885 1227 857 1184 907 1016 715 1213
768 950 834 459 829 1096 655 796 154 292 461 208 280 275 394 228
No
* num ber of plants per replicate included in calculations
Cone. = Concentration
SD = Standard deviation
Signif. Diff. = Significantly different, ANOVA, a = 0.05.
Fresh weight mean value SD
[mg]
1001 191
798 189
287 100
Signif. Diff.
No Yes Yes
com p ^ Sim'" 2 e d D o a s
TSCACB
DR.U.NOACK-LABORATORIUM FR ANGEWANDTE BIOLOGIE
R rre stria m a n ts T o x ic ity , Seedling Emergence acc. to OECD Guideline 208 (Draft July 2000)
Page 49 of 51
Project-Nc Study-No. TNC8411
Table 36: Soybean: Fresh Weight on Day 21
Cone. Repl. Number of Fresh
[mg/kg DW]
No.
plants per replicate*
weight mean
value per
replicate
[mg]
_. o u_ co o
o "O CooL o
o c _> <o/) 10
32
1
2 3 4 5 6 7 8 1 2 3 4 5 6 7 8 1 2 3 4 5 6 7 8
1 2 3 4 5 6 7 8
4 4 5 5 5 5 5 4
4 5 4 5 5 5 5 4
5 4 5 5 5 3 5 5 2 5 4 3 5 5 5 5
1755 1657 1701 1477 1393 1743 2003 1988
1856 2359 1441 1833 1747 1728 1952 2032
1792 1496 1838 1765 1703 1556 1745 2004 1414 1290 1332 2174 1234 1811 1908 1746
Fresh weight mean value SD
[mg]
1792 246
1737 159
1614 343
Signif. Diff.
-
No
Cone. Number of
[mg/kg DW]
plants per replicate*
100 320 1000
5 5 4 5 5 4 4 4
5 4 4 5 5 5 5 5 4 4 2 5 4 5 5 3
Fresh weight mean value per replicate
[mg]
1616 1433 1921 1715 1720 1433 1910 2251 1656 1477 1252 1435 2075 1493 1671 1368
1146 1502 1755 1492 1624 1293 1579 1225
No
* number o f plants per replicate Included In calculations
Cone. = Concentration
SD = Standard deviation
Signif. Diff. = Significantly different, ANOVA, a = 0.05.
Fresh weight mean value SD
[mg]
1750 274
1553 252
1452 211
Signif. Diff.
No No Yes
COWP^ San'
.D oes,olc o n ta i
DR.U.NOACK-LABORATORIUM FOR ANGEWANDTE BIOLOGIE
errestrlal Plants Toxicity, Seedling Emergence acc to OECD Guideline 208 (Draft July 2000)
Page 50 of 51
Project-NoJ Study-No.
10 Certificate of Test Item Analysis
CUriut GmbH. Werk Gendarf CQG / Quili(2Uiaaaagemer)l D-84504 Surgkirchen Fax: + + 4 9 8679 / 2 6 7 6
C la ria n t
1
Inspeccin
certificate
a c co rd in g co EN10204-3.13
Date: 13.11.2001 Page: 1 / 1
Or; tn e b a te .-., o f w ni :r. r.iva ro n e sg n m e n t i s a p a r t , t h e f o l l o w i n g v a l u e s
're
s fe t.a r T .ir .iu . r-.ey c o n tu/, .t t o to, a g r e e d p r o d u c t s p e c i f i c a t i o n .
I n s p e c t io n - - . ar a. - " er v j , - m e t h o d S p e c x fic a t io r i
R esu lt
The above p a r t ic u la r s do not r e le a s e th e custom er from th e o b lig a t io n
c a r r y o u t an in sp e c tia n o : roods receiv ed .
to
Ma. P au m gartn er - W er< s in s p e c to r
Company Sanitized. Does noi conta 1 3 CA CB1
DR.U.NOACK-LABORATORIUM FR ANGEWANDTE BIOLOGIE
Terrestrial Plants Toxicity, Seedling Emergence acc. to OECD Guideline 208 (Draft July 2000)
Page 51 of 51
Project-Nc Study-No. TNC84113
11 GLP Certificate of Dr.U.Noack-Laboratorium
n
Ntedarschsisches Umwaltministerium
Gute Laborpraxis/Good Laboratory Practice
GLP-Bescheinigung/Statement of GLP Compliance
5(gematt/aocording to 19 b Abs.1 Chemikaliengesetz)
Eine GLP-Inspektton zur berwachung der
Einhaltung der GLP-Grundstze gem Chemikaliengesetz bzw. Richtlinie SB/320/EG wurde durchgefhrt In:
Assessment of conformity with GLP according to Chemlkallengesetz end Directive 8B20/EEC at:
X Prfeinrichtung/Test facility
Dr. U. NOACKLABORATORIUM
f r angewandte Biologie Kthe-Paulus-Str. 1 D-31157 Sarstedt
O Prfstandort /T e s t site
Dr. U. NOACKLABORATORY
o f applied biology Kthe-Paulus-Str. 1 D-31157 Sarstedt
{Unverwechselbare Bezeichnung und Adresse/Unequtvocal name end address)
Prfungen nach Kategorien/Areas of Expertise
(gem JS/according ChemVwV-GLP N r. 6.3/OSCD guidance)
1 - Prfungen zur Bestimmung der physikalisch-chemischen Eigenschaften und Gehaltsbestimmungen 3 - Prfungen zur Bestimmung der erbgutverndemden Eigenschaften (in vitro und in vivo) 4 - Umwelttoxikologische Prfungen zu Auswirkungen auf aquatische und terrestrische Organismen 5 - Prfungen zum Verhalten im Boden, im Wasser und in der Luft. Prfungen zur Bioakkumulation und
. zur Metabolisierung Bi- Prfungen zur Bestimmung von Rckstnden 7 'f Prfungen zur Bestimmung der Auswirkungen auf Mesokosmen und natrliche kosysteme
Datum dar Inspektion / Date of Inspection
(Tag.MonatJahr / day.momh.year)
25. - 27. Juni 2001 / June 25" - 27" , 2001 29. August und 21. September 2001 / August 29" and September 2 1 " , 2001
Die genannte Prfeinrichtung/P er ge nonntoPrtifctandort
b e fin d e t
sich
fm
nationalen
GLP*
berwachungsverfahren und wird regelmig auf
Einhaltung der GLP-Grundstze berwacht.
A uf der Grundlage des Inspektlonsberfchtss wird hiermit besttigt, dass in dieser Prfeinrichtung/iesem Pffcfcmdort die oben genannten Prfungen unter Einhaltung der GLP-Grundstze durchgefQhrt werden knnen.
T he above mentioned test facility / test site is included in the national G LP Com pliance Programme and is inspected on a regular basis.
Based o n the inspection report it can be confirmed, that this test facility / tost- cito is able to conduct the aforementioned studies in compliance with die Principles of GLP.
11. Mrz 2002 Im Auftrge
ts
Dr. Braedt
not contain tSGACBl
S a m te d -DoeS C o ttiP any
