Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
toxicity to soil microorganisms
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1995-07-31 to 1995-08-04
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 100, 180, 350, 550 and 1000 mg/L and the fresh stock solutions used to prepare the test media.

- Sampling method: Concentrations of test substance hydrolysis products determined in fresh media at all concentrations after preparation and again before renewal after 24 hours. The concentrations of the fresh stock solutions used to prepare the test media was also determined.

- Sample storage conditions before analysis: not reported
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION

- Method: Test media prepared by dilution of a 1000 mg/L stock solution. Stock solutions were prepared by stirring for 18 h followed by filtration. TOC concentration of stock solution determined and used as the basis for determining the nominal test concentrations.

- Differential loading: Five nominal test concentrations 100, 180, 350, 550 and 1000 mg/L

- Controls: Dilution water
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM

- Common name: Zebrafish

- Source: West aquarium, Bad Lauterberg, Germany

- Length at study initiation (length definition, mean, range and SD): 3.0 cm +/-0.5 cm

- Feeding during test: none

ACCLIMATION

- Acclimation period: at least 14 days

- Acclimation conditions (same as test or not): yes

- Type and amount of food: TetraMin® at 1% of body weight

- Feeding frequency: Daily

- Health during acclimation (any mortality observed): The fish exhibit normal behaviour and are free from visible signs of disease at the start of the test.
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
≈ 12ºdH
Test temperature:
20 - 22ºC
pH:
8.0 - 8.4
Dissolved oxygen:
84 - 111%
Salinity:
not applicable
Nominal and measured concentrations:
Nominal concentrations: 100, 180, 350, 550 and 1000 mg/L.

Initial measured concentrations: 100, 157, 334, 502 and 1005 mg/L.

Concentrations in media prior to replacement after 24 hours: 109, 156, 327, 514 and 929 mg/L.

Geometric mean measured concentrations (0-24h): 104, 156, 330, 508 and 968 mg/L.

The test results are presented and interpreted with reference to nominal concentrations.
Details on test conditions:
TEST SYSTEM

- Test vessel:

- Type (delete if not applicable): open aquarium

- Material, size, headspace, fill volume: 20 L

- Aeration: Continuous

- Renewal rate of test solution (frequency/flow rate): Daily

- No. of organisms per vessel: 10

- No. of vessels per concentration (replicates): 1

- No. of vessels per control (replicates): 1

- Biomass loading rate: 0.49 g/L


TEST MEDIUM / WATER PARAMETERS

- Source/preparation of dilution water: Potable water from Gelsenwasser AG


OTHER TEST CONDITIONS

- Adjustment of pH: None

- Photoperiod: 16 h light/8 h dark


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mortality after 24, 48, 72 and 96 h


TEST CONCENTRATIONS

- Spacing factor for test concentrations: 1.8
Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
350 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
but exposure is to hydrolysis products
Basis for effect:
mortality (fish)
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
439 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
but exposure is to hydrolysis products
Basis for effect:
mortality (fish)
Remarks on result:
other: Concentrations bounding LC50: 350 - 550 mg/l
Key result
Duration:
72 h
Dose descriptor:
LC50
Effect conc.:
451 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
but exposure is to hydrolysis products
Basis for effect:
mortality (fish)
Key result
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
486 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
but exposure is to hydrolysis products
Basis for effect:
mortality (fish)
Key result
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
742 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
but exposure is to hydrolysis products
Basis for effect:
mortality (fish)
Details on results:
- Mortality of control: Zero
Reported statistics and error estimates:
LC50 determined by graphical interpolation
Sublethal observations / clinical signs:

Table 1. Test results

 Nominal test substance concentration (mg/L)  Percentage mortality after 24 hours Percentage mortality after 48 hours  Percentage mortality after 72 hours  Percentage mortality after 96 hours 
 0 (Control)  0  0  0  0
 100  0  0  0
 180  0  0  0  0
 350  0  0  0  0
 550  0  70  90  100
 1000  100  100  100  100
Validity criteria fulfilled:
yes
Conclusions:
A 96-h LC50 value of 439 mg/L and NOEC of 350 mg/L have been determined for the effects of the test substance on mortality of Brachydanio rerio based on nominal concentrations of the substance. The test substance hydrolyses in water and it is therefore likely that the test organisms were primarily exposed to the hydrolysis products of the substance.
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1995-09-26 to 1995-09-28
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 0.64, 1.3, 2.7, 5.4, 11, 21 and 43 mg/L and the fresh stock solution used to prepare the test media.

- Sampling method: Concentrations of test substance hydrolysis products determined in fresh media at all concentrations after preparation and again before renewal after 24 hours. The concentrations of the fresh stock solution used to prepare the test media was also determined.

- Sample storage conditions before analysis: not reported
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION

- Method: Test media prepared by dilution of a 1000 mg/L stock solution prepared by mixing for 18 h followed by filtration. TOC concentration of stock solution determined and used as the basis for determining the nominal test concentrations.

- Test concentrations (Nominal): Control, 0.64, 1.3, 2.7, 5.4, 11, 21 and 43 mg/L
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM

- Common name: Daphnia magna

- Strain: Clone 5

- Source: Stock culture

- Age at study initiation (mean and range, SD): <24 h

- Method of breeding: Parthenogenetic reproduction

- Feeding during test: None

ACCLIMATION

- Acclimation conditions (same as test or not): yes

- Type and amount of food: sufficient to be consumed each day leaving no residue

- Feeding frequency: daily
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
The sum of the Ca2+ and Mg2+ ions: 2.5 mmol
Test temperature:
20 +/-1 degree C
pH:
7.5 - 7.9
Dissolved oxygen:
8.8 - 9.6 mg/L
Salinity:
not applicable
Nominal and measured concentrations:
- Test concentrations (Nominal): Control, 0.64, 1.3, 2.7, 5.4, 11, 21 and 43 mg/L

- Test concentrations (at start of test): Control,
- Test concentrations at end of test: Control,
- The measured concentrations that were >LOD were within +/-20% of nominal. The results are therefore presented and interpreted with reference to nominal concentrations.
Details on test conditions:
TEST SYSTEM

- Test vessel: glass cylinder

- Type: open

- Material, size, headspace, fill volume: cylinder containing 10 ml of test medium

- Aeration: none

- No. of organisms per vessel: 5

- No. of vessels per concentration (replicates): 4

- No. of vessels per control (replicates): 4


TEST MEDIUM / WATER PARAMETERS

- Source/preparation of dilution water: Elendt M4 medium

- Intervals of water quality measurement: end of test


OTHER TEST CONDITIONS

- Photoperiod: Dark


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Immobilization after 24 and 48 h exposure


TEST CONCENTRATIONS

- Spacing factor for test concentrations: 2
Reference substance (positive control):
yes
Remarks:
Potassium dichromate
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
6.7 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
but exposure is to hydrolysis products
Basis for effect:
mobility
Remarks on result:
other: 4.9 - 9.1
Key result
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
20 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
but exposure is to hydrolysis products
Basis for effect:
mobility
Remarks on result:
other: 12 - 36
Key result
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
2.7 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
but exposure is to hydrolysis products
Basis for effect:
mobility
Results with reference substance (positive control):
- Results with reference substance valid?

- EC50/LC50: >1 mg/L, <2.0 mg/L
Reported statistics and error estimates:
EC50 and confidence interval determined by Probit analysis

Table 1. Results of analysis of test media

 Nominal test concentration (mg/L)  Measured concentration at start of test (mg/L)  Measured concentration at end of test (mg/L)
 0 (Control)  -  -
 0.64  <LOD  <LOD
 1.3  <LOD  <LOD
 2.7  Unreliable value  2.3
 5.4  Unreliable value  6.3
 11  12.4  9.7
 21  20.9  20.4
 43  37.7  39.8

Table 2. Test results

 Nominal test concentration (mg/L)  Mean percentage immobilisation after 24 hours  Mean percentage immobilisation after 48 hours
 0 (Control)  5  5
 0.64  0  0
 1.3  0  0
 2.7  0  5
 5.4  15  50
 11  50  85
 21  40  90
 43  70  95
Validity criteria fulfilled:
yes
Conclusions:
A 48-h EC50 value of 6.7 mg/L and a NOEC of 2.7 mg/L have been determined for the effects of the test substance on mobility of Daphnia magna based on nominal concentrations of the substance. The test substance hydrolyses in water and it is therefore likely that the test organisms were primarily exposed to the hydrolysis products of the substance.
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Endpoint:
toxicity to aquatic algae and cyanobacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1995-07-03 to 1995-07-06
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method C.3 (Algal Inhibition test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 10, 20, 40, 80, 160, 319 and 639 mg/L and the fresh stock solution used to prepare the test media.

- Sampling method: Concentrations of test substance hydrolysis products determined in fresh media at all concentrations after preparation and again before renewal after 24 hours. The concentrations of the fresh stock solution used to prepare the test media was also determined.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION

- Method: Seven nominal concentrations 10, 20, 40, 80, 160, 319 and 639 mg/L. Test media prepared by dilution of a 1000 mg/l stock solution prepared by mixing for 18 h followed by filtration. TOC concentration of stock solution determined and used as the basis for determining the nominal test concentrations.

- Controls: Dilution water (algal growth medium)
Test organisms (species):
Desmodesmus subspicatus (previous name: Scenedesmus subspicatus)
Details on test organisms:
TEST ORGANISM

- Strain: 86.81.SAG

- Source (laboratory, culture collection): Institute for Water, Ground and Air Hygiene, Berlin (Germany)

- Age of inoculum (at test initiation): 3 days

- Method of cultivation: A pre-culture is produced from an original culture by super-inoculation three days before the test begins. From this culture the test cultures are inoculated at a density of about 20000 cells/ml.
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
72 h
Hardness:
not reported
Test temperature:
23.0 - 23.3 degrees C
pH:
8.2 - 8.7 at start of test

7.6 - 9.3 at end of test
Dissolved oxygen:
not reported
Salinity:
not applicable
Nominal and measured concentrations:
Nominal test concentrations: Control (0), 10, 20, 40, 80, 160, 319 and 639 mg/L.

Measured test concentrations at start of test: 0, 9.8, 19, 38, 76, 150, 332 and 596 mg/L.

Measured test concentrations at end of test: 0, 9.2, 19, 38, 73, 147, 296 and 577 mg/L.

The measured concentrations were with +/-20% of nominal. The results are therefore presented and interpreted with reference to nominal concentrations.
Details on test conditions:
TEST SYSTEM

- Test vessel: Erlenmeyer flasks

- Type: open

- Material, size, headspace, fill volume: glass

- Aeration: none

- Initial cells density: 1260000 cells/mL

- Control end cells density: 20000 cells/mL

- No. of vessels per concentration (replicates): 5

- No. of vessels per control (replicates): 8

GROWTH MEDIUM

- Standard medium used: yes

TEST MEDIUM / WATER PARAMETERS

- Culture medium different from test medium: no

- Intervals of water quality measurement: start and end of test

OTHER TEST CONDITIONS

- Sterile test conditions: yes

- Adjustment of pH: no

- Photoperiod: continuous

- Light intensity and quality: 8000 Lux

EFFECT PARAMETERS MEASURED:

- Determination of cell concentrations: spectrophotometer (absorption at 685 nm)

TEST CONCENTRATIONS

- Spacing factor for test concentrations: 2
Reference substance (positive control):
no
Key result
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
931 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
but exposure is to hydrolysis products
Basis for effect:
growth rate
Remarks on result:
other: the concentration exceeds the highest treatment level in the test
Key result
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
267 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
but exposure is to hydrolysis products
Basis for effect:
biomass
Key result
Duration:
72 h
Dose descriptor:
EC10
Effect conc.:
92 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
but exposure is to hydrolysis products
Basis for effect:
growth rate
Key result
Duration:
72 h
Dose descriptor:
EC10
Effect conc.:
36 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
but exposure is to hydrolysis products
Basis for effect:
biomass
Key result
Duration:
72 h
Dose descriptor:
NOEC
Effect conc.:
40 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
but exposure is to hydrolysis products
Basis for effect:
growth rate
Details on results:
- Exponential growth in the control (for algal test): yes
Reported statistics and error estimates:
The area under the growth curve (biomass) and growth rate parameters were calculated from the cell concentration data in accordance with the description of the test method.

ECx values were determined by probit analysis (Cavalli-Sforza, 1972. Biometrie. Gustav Fischer Verlag, Stuttgart).

NOEC values were determined directly from the raw data.

Table 1. Results of analysis of test media

 Nominal test substance concentration (mg/L)  Measured concentration at start of test (mg/L)  Measured concentration at end of test (mg/L)
 0 (Control) - -
 10 9.8 9.2
 20 19  19
 40  38 38
 80  76 73
 160 150 147
 319 332 296
 639  596 577

Table 2. Test results

 Nominal test substance concentration (mg/L)  Mean cell concentration at start of test (cells/ml)  Mean cell concentration after 24 hours (cells/ml) Mean cell concentration after 48 hours (cells/ml)  Mean cell concentration after 72 hours (cells/ml) 
 0 (Control)  20000  90000  350000  1260000
 10  20000  80000  260000  1020000
 20  20000  100000  350000  1290000
 40  20000  90000  300000  1040000
 80  20000  90000  310000  920000
 160  20000  100000  270000  610000
 319  20000  90000  200000  350000
 639  20000  100000  170000  260000
Validity criteria fulfilled:
yes
Conclusions:
A 72-h EC50 value of 931 mg/L and a NOEC of 40 mg/L have been determined for the effects of the test substance on growth rate of Scenedesmus subspicatus based on nominal concentrations of the substance. The test substance hydrolyses in water and it is therefore likely that the test organisms were primarily exposed to the hydrolysis products of the substance.
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Endpoint:
activated sludge respiration inhibition testing
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
other: EG-Nr. L 133/118 from 30.5.1988
GLP compliance:
yes
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Direct addition
Test organisms (species):
activated sludge of a predominantly domestic sewage
Details on inoculum:
- Source of inoculum/activated sludge (e.g. location, sampling depth, contamination history, procedure): Marl-Ost municipal sewage treatment plant.

- Preparation of inoculum for exposure: Centrifuged.

- Suspended solids: 3.6 g/l; (1.44 g/l when used in test).
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
3 h
Post exposure observation period:
Oxygen consumption evaluated over a time period of at most 10 minutes.
Test temperature:
19.0 - 20.7°C
Nominal and measured concentrations:
Nominal:207.6 mg/l; 157.4 mg/l; 101 mg/l; 51.2 mg/l; 20 mg/l
Details on test conditions:
TEST SYSTEM
- Material, size, headspace, fill volume: 500 ml

- Type (delete if not applicable): closed

- Aeration: Yes
Reference substance (positive control):
yes
Remarks:
3,5-Dichlorophenol
Key result
Duration:
3 h
Dose descriptor:
EC50
Effect conc.:
463 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
inhibition of total respiration
Remarks:
respiration rate
Key result
Duration:
3 h
Dose descriptor:
EC10
Effect conc.:
32.6 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
inhibition of total respiration
Remarks:
respiration rate
Results with reference substance (positive control):
EC50 6.9 mg/l

Table 1: Controls, reference substance (3, 5-dichlorophenol) and test substance: oxygen consumption and percentage inhibition of the respiration rate.

Flask

Nominal concentration (mg/l)

Oxygen consumption rate

(mg O2/l/hour)

% Inhibition

respiration rate

Inoculum control

-

23.93

-

Inoculum control

-

24.23

-

 

Test substance

207.6

14.84

38.4

Test substance

157.4

16.47

31.6

Test substance

101

19.73

18.1

Test substance

51.2

21.04

12.6

Test substance

20

22.50

6.6

 

Reference substance

5

13.92

42.4

Reference substance

7

11.94

50.4

Reference substance

10

9.98

58.6

 

Validity criteria fulfilled:
yes
Conclusions:
A 3-hour ASRI EC50 value of 463 mg/l and EC10 value of 32.6 mg/l were determined in a reliable study conducted according to an appropriate test protocol, and in compliance with GLP.
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Endpoint:
toxicity to soil macroorganisms except arthropods: short-term
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1996-02-29 to 1996-03-14
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The study was conducted according to an EU method, and in compliance with GLP, however no analytical monitoring was undertaken.
Qualifier:
according to guideline
Guideline:
EU Method C.8 (Toxicity for Earthworms: Artificial Soil Test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
no
Vehicle:
no
Test organisms (species):
Eisenia fetida
Animal group:
annelids
Details on test organisms:
TEST ORGANISM

- Common name: Earthworm, Eisenia foetida foetida

- Source: Eisenia GmbH und Co, Wiesbaden, Germany

- Age at test initiation (mean and range, SD): 2 months

- Weight at test initiation (mean and range, SD): 300 - 600 mg
Study type:
laboratory study
Substrate type:
other: quartz sand
Limit test:
yes
Total exposure duration:
14 d
Test temperature:
20 +/-2 ºC
pH:
5.7
Moisture:
40%
Details on test conditions:
TEST SYSTEM

- No. of organisms per container (treatment): 10

- No. of replicates per treatment group: 4

- No. of replicates per control: 4

SOURCE AND PROPERTIES OF SUBSTRATE (if soil)

- Composition (if artificial substrate): Quartz sand

OTHER TEST CONDITIONS

- Photoperiod: Daylight

- Light intensity: ca. 400 Lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mortality after 7 and 14 days exposure

VEHICLE CONTROL PERFORMED: no

TEST CONCENTRATIONS

- Limit test at 1000 mg/kg
Nominal and measured concentrations:
Nominal: 1000 mg/kg
Reference substance (positive control):
no
Key result
Duration:
14 d
Dose descriptor:
LC50
Effect conc.:
> 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Key result
Duration:
14 d
Dose descriptor:
NOEC
Effect conc.:
>= 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- Mortality at end of exposure period: 0
Reported statistics and error estimates:
No toxic effects on survival and growth were observed in the test and therefore statistical analysis of the results was not required.
Validity criteria fulfilled:
yes
Conclusions:
A reliable 14-day LC50 of >1000 mg/kg dry weight has been reported for the test substance to Eisenia foetida. A NOEC of ≥1000 mg/kg dry weight was also determined in the test.

Data source

Materials and methods

Test material

Constituent 1
Chemical structure
Reference substance name:
3-trimethoxysilylpropane-1-thiol
EC Number:
224-588-5
EC Name:
3-trimethoxysilylpropane-1-thiol
Cas Number:
4420-74-0
Molecular formula:
C6H16O3SSi
IUPAC Name:
3-trimethoxysilylpropane-1-thiol

Results and discussion

Applicant's summary and conclusion