N-[3-(triethoxysilyl)propyl]ethylenediamine

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2002-05-10 to 2002-07-18

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP guideline study but the pH range is over the recommended pH range between 6-9, the hightest pH is 9.62.

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 0(Control), 0.464, 1.00, 2.15, 4.64, 10.0, 21.5, 46.4 and 100 mg/L.

- Sampling method: An aliquot of test medium from all test concentrations at the start of the test before filling the test vessels. A combined aliquot was collected from the test media from all four exposure vessels of all test concentrations at the end of the test (48 hours).

- Sample storage conditions before analysis: All samples were stored at -20ºC prior to analysis.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION

- Method: A 100 mg/L stock solution was prepared by adding 100 mg of the test substance to 1 L of dilution water and stirring intensely for 30 minutes. The other test concentrations were prepared by adding appropriate volumes of the stock solution to dilution water.

- Controls: Dilution water

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM

- Source: IRChA, France

- Age at study initiation (mean and range, SD): 6-24 hours

- Method of breeding: Laboratory stock culture

- Feeding during test: None

ACCLIMATION

- Acclimation period: At least 7 days

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

- Type and amount of food: Unicellular algae (Scenedesmus subspicatus) and a small amount of aerated sewage.

- Feeding frequency: no data

- Health during acclimation (any mortality observed): no data

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

250 mg/l as CaCO3

Test temperature:

20 +/-1ºC

pH:

6.99-9.62

Dissolved oxygen:

≥80% ASV

Nominal and measured concentrations:

Nominal concentrations: 0(Control), 0.464, 1.00, 2.15, 4.64, 10.0, 21.5, 46.4 and 100 mg/L.

Measured DOC concentrations were within+/-20% of the theoretical values at the start and end of the test. The test results are therefore presented and interpreted with reference to the nominal concentrations.

Details on test conditions:

TEST SYSTEM

- Test vessel:

- Type: no data

- Material, size: glass, 50 mL

- Aeration: none

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

- No. of organisms per vessel: 5

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

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

- Biomass loading rate: 1 daphnid/10 mL


TEST MEDIUM / WATER PARAMETERS

- Source/preparation of dilution water: Reconstituted fresh water prepared by adding salts to demineralised water.

- Alkalinity: 0.8 mmol/L

- Ca/mg ratio: 4:1

- Culture medium different from test medium: no

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


OTHER TEST CONDITIONS

- Adjustment of pH: no

- Photoperiod: 16 hours light, 8 hours dark

- Light intensity:500 lux (+/-20%)


EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Mobility after 24 and 48 hours


TEST CONCENTRATIONS

- Spacing factor for test concentrations: 2.2

- Range finding study: no

Reference substance (positive control):

no

Key result

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

but exposure is to hydrolysis products

Basis for effect:

mobility

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

23 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

but exposure is to hydrolysis products

Basis for effect:

mobility

Key result

Duration:

48 h

Dose descriptor:

EC0

Effect conc.:

1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

but exposure is to hydrolysis products

Basis for effect:

mobility

Details on results:

- Immobilisation of control: 5% (average of two sets of controls used in the test)

Reported statistics and error estimates:

The 48-h EC50 value was calculated by linear regression analysis incorporating probit analysis. (Probit Program Version 1.5 , U.S. Emvironmental Protection Agency, 1992).

The 24-h EC50 value and the EC0 and NOEC values were determined directly from the raw data.

Table 1. Test results

Nominal test substance concentration (mg/L)	Mean percentage immobilisation after 24 hours	Mean percentage immobilisation after 48 hours
0 (Control)	0	5
0.464	0	0
1.00	5	10
2.15	20	30
4.64	5	20
10.0	10	25
21.5	20	25
46.4	15	85
100	45	85

Table 2. Results of analysis of test media

Nominal test substance concentration (mg/L)	Theoretical DOC concentrations (mg/L)	Actual DOC concentration after 48 hours (mg/L)
0.464	0.2	0.5
1.00	0.5	0.5
2.15	1.1	1.3
4.64	2.3	2.2
10.0	5.0	5.4
21.5	10.7	9.9
46.4	23.2	19
100	50.0	53

Conclusions:

A 48-h EC50 value of 23 mg/L and a NOEC of 0.464 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.

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2002-01-23 to 2002-01-25

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

no

Vehicle:

yes

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION

- Method: A 1.0 mg/ml stock solution was prepared by placing 2.450 ml (2.5186g based on a density of 1.028 g/ml) of aminosilane in a 3.8-litre glass jar and diluting with 2500 ml of dilution water containing 0.250 ml dimethylformamide (DMF, CAS # 68-12-2). The solution was stirred for approximately 5 minutes with a magnetic stir bar and stir plate. Each test concentration was prepared by adding the appropriate amount of the 1.0 mg/ml stock solution to an intermediate vessel and diluting to 1000 ml with dilution water.

Test organisms (species):

Daphnia magna

Details on test organisms:

- Source, supplier, any pretreatment, breeding method: Springborn Smithers culture facility. Daphnids were cultured in 1.0-L glass vessels containing 0.80 L of water.

- Culture medium: Water used to culture the daphnids was be prepared in the same manner and has the same characteristics as the dilution
water.

- Feeding: Daphnids were fed a unicellular green algae, Ankistrodesmus falcatus (4 x 107 cells/mL) and YCT (yeast, cereal leaves and flaked fish food) suspension, daily, at a rate of 1 mL algae and 0.5 mL YCT solution per vessel per day.

- Test organisms: Daphnids were obtained by removing all immature daphnids from the culture vessel, thus isolating mature gravid daphnids #24 hours prior to initiating the test. Young produced by these organisms were subsequently pipetted into the test beakers.

- Age of test organisms at study initiation: < 24 hours

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

The dilution water had a total hardness and alkalinity as CaCO3 of 170 mg/l and 120 mg/l, respectively

Test temperature:

20 to 21 °C

pH:

pH measured in the dilution water and solvent control vessels was 8.0 and 7.9 respectively, at test initiation and 7.9 and 8.0 respectively, at test termination.

Dissolved oxygen:

The dilution water and solvent control vessels had a measured DO concentration of 8.9 and 8.7 mg/l respectively, at test initiation and 8.2 and 8.3 mg/l respectively, at test termination.

Salinity:

Not applicable

Nominal and measured concentrations:

Nominal test concentrations: 0 (Control), 0 (Solvent control) 63, 130, 250, 500 and 1000 mg/l

Details on test conditions:

Test vessels: The toxicity test was conducted in 250-ml glass beakers, each containing 200 ml of test solution.

- Replication: Four replicate test vessels were established for each treatment level and a dilution water and solvent control. Twenty daphnids were
impartially selected and distributed to each concentration and the controls (five daphnids per replicate vessel).

- Aeration: No aeration was provided to the test vessels.

- Dilution water source: Fortifying well water based on the formula for hard water (U.S. EPA, 1975).

- Dilution water chemistry (hardness, alkalinity, pH, TOC, TSS, salinity, Ca/Mg ratio, Na/K ratio): The dilution water had a total hardness and alkalinity as CaCO3 of 170 mg/l and 120 mg/l, respectively, a pH of 7.8 and a specific conductivity of 500 μmhos/cm. The TOC concentration of the dilution water source was 0.60 mg/l for the month of January 2002.

- Lighting (quality, intensity, and periodicity): The test area was illuminated with Sylvania Octron® fluorescent bulbs at an intensity range of 70 to 90 footcandles at the solutions' surface. The test area received a regulated photoperiod of 16 hours of light and 8 hours of darkness. Sudden transitions from light to dark and vice versa were avoided. Light intensity was measured once during the test.

- Element (unit) basis (i.e., immobilization): Immobilization

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

90 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: 77-110 mg/L

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

< 63 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

but exposure is to hydrolysis products

Basis for effect:

mobility

Details on results:

- Control response; No immobilization or adverse effects were observed in daphnids exposed to the control or solvent control.

- Cumulative immobilization in the treated media: 10, 90, 100, 100 and 100% immobilization was observed among daphnids exposed to the 63, 130, 250, 500, and 1000 mg/l treatment level, respectively.

Reported statistics and error estimates:

The 48-hour EC50 for aminosilane and daphnids was calculated using probit analysis. The NOEC was determined directly from the raw data.

Table 1. Test results

 

Nominal concentration (mg/l)	Mean percentage immobilisation after 24 hours	Mean percentage immobilisation after 48 hours
0 (Control)	0	0
0 (Solvent control)	0	0
63	5	10
130	30*	90**
250	100	100
500	100	100
1000	100	100

*All surviving daphnids were observed to be lethargic

** All surviving daphnids were observed to be lethargic and swimming on the bottom of the test vessel.

Validity criteria fulfilled:

yes

Conclusions:

A 48-hour EC50 value of 90 mg/l and NOEC of <63 mg/l have been determined for the effects of the test substance on mobility of Daphnia magna. The results are expressed relative to nominal concentrations of the test substance. However the substance is subject to rapid hydrolysis and under the test conditions it is therefore likely that exposure will have been to its hydrolysis products (methanol and trisilanols).

Reference 3

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1995-01-17 to 1995-01-19

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:

Test substance concentration determined in the stock solution used to prepare the test media.

Test substance concentration was determined in all treatments at the start and end of the test.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION

- Method: A 1000 mg/l stock solution was prepared by mixing for 18 hours followed by filtration. The other treatments were prepared by dilution of the stock solution. The measured DOC concentration in the stock solution was 427 mg/l which was equivalent to 986 mg/l of the test substance.

- Controls: Dilution water

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 was 2.5 mmol

Test temperature:

20 +/-1ºC

pH:

8.0 - 8.3

Dissolved oxygen:

8.0 - 8.4 mg/l

Salinity:

not applicable

Nominal and measured concentrations:

Nominal: 0(Control), 20, 35, 59, 108 and 197 mg/l

Measured concentration in stock solution used to prepare test media: 986 mg/l

Measured concentration in treatments at the start of the test: 0, 26, 36, 59, 106 and 194 mg/l

Measured concentration in treatments at the end of the test: 0, 19, 33, 58, 105 and 156 mg/l

The test results are interpreted with reference to nominal concentrations.

Details on test conditions:

TEST SYSTEM

- Test vessel:

- Type: open

- Material, size, headspace, fill volume: glass 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: Immobilization after 24 and 48 h exposure

TEST CONCENTRATIONS

- Spacing factor for test concentrations: 1.7

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

81 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: 59-108 mg/L

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

35 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

but exposure is to hydrolysis products

Basis for effect:

mobility

Details on results:

- Mortality of control: 10%

- Other adverse effects control: none reported

Results with reference substance (positive control):

48-h EC50: >1.0, <2.0 mg/l

Reported statistics and error estimates:

The EC50 and its confidence interval were determined by Probit analysis. The NOEC value was obtained directly from the raw data.

Table 1. Test results

Nominal test concentration (mg/l)	Mean percentage immobilisation after 24 hours	Mean percentage immobilisation after 48 hours
0 (Control)	0	10
20	0	0
35	0	0
59	10	15
108	50	80
197	90	90

Validity criteria fulfilled:

yes

Conclusions:

A 48 hour EC50 value of 81 mg/l and a NOEC of 35 mg/l have been determined for the effects of the test substance on mobility of Daphnia magna. The results are expressed relative to nominal concentrations of the test substance. However the substance is subject to rapid hydrolysis and under the test conditions it is therefore likely that exposure will have been to its hydrolysis products (methanol and trisilanols).

Reference 4

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

Please refer to the attached justification for grouping of substances in IUCLID Section 13.

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

81 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:

Remarks:

Hüls, 1995

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

90 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

but exposure is to hydrolysis products

Basis for effect:

mortality

Remarks on result:

other: 77-110 mg/L

Remarks:

Springborn Smithers, 2002

Description of key information

EC50 (48 h)= 23 mg/L (OECD 202)

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

23 mg/L

Additional information

One study is available for N-[3-(triethoxysilyl)propyl]ethylenediamine (CAS 5089-72-5) with an EC50 of 23 mg/L (2003), the pH at the concentration around the EC50 was 8.5 up to 9.6, and therefore higher than the recommended range in the guideline but the study was considered valid for assessment.

Two supporting read across from the analogue substance, N-(3-(trimethoxysilyl)propyl)ethylenediamine (CAS 1760-24-3) was deemed acceptable for assessment. A 48 h EC50 value of 81 mg/l and NOEC of 35 mg/l have been determined for the effects of the test substance on mobility of Daphnia magna (1994). The results are expressed relative to nominal concentrations of the test substance. However the substance is subject to rapid hydrolysis under the tested conditions, it is therefore likely that exposure will have been to its hydrolysis products (methanol and N-(3-(trihydroxysilyl)propyl)ethylenediamine).

The 48-h EC50 value of the second available read across study (2002) was found to be 90 mg/l.