3-trimethoxysilylpropane-1-thiol

Toxicity to soil microorganisms

Administrative data

Endpoint:

toxicity to soil microorganisms

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Cross-reference

Cross-reference 1

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	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.

Cross-reference 2

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.

Cross-reference 3

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.

Cross-reference 4

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.

Cross-reference 5

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.

Materials and methods

Test material

Test material information

Constituent 1

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