Registration Dossier

Diss Factsheets

Ecotoxicological information

Short-term toxicity to fish

Currently viewing:

Administrative data

Link to relevant study record(s)

Referenceopen allclose all

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions. The study was not conducted under GLP and exposure concentrations were not measured.
Qualifier:
according to guideline
Guideline:
other: EPA-660/3-75-009 (USEPA 1975)
GLP compliance:
no
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION

- Method: Test substance (CAS No. 1760-24-3) was added directly to exposure vessels and 4.2 ml of methanol added to controls because methanol is released on hydrolysis of test substance. Manner of addition of test substance to dilution water not documented. Test solutions for range-finding study were prepared 30 minutes prior to addition of fish. Time of test solution preparation and time of fish addition were not recorded for the definitive study.
Test organisms (species):
Lepomis macrochirus
Details on test organisms:
·Test organisms: Juvenile bluegill sunfish having a mean total length of 3.4 cm (range 3.0-4.2 cm); fish were acclimated to laboratory conditions for a minimum of two weeks before testing; loading rate of 10 fish per exposure vessel; total of 80 fish
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
40 to 48 mg CaCO3/l
Test temperature:
22°C in water bath (mean and ranges not documented)
pH:
Test initiation (t = 0 h): mean 7.2 (range 7.2-7.3)

48 h observation: mean 8.5 (range 7.5-9.4)
Dissolved oxygen:
Test initiation (t = 0 h): mean 13.4 mg/L (range 13.0-13.5 mg/l)

Test termination (t = 96 h): mean 8.4 mg/L (range 8.0-8.5 mg/l)
Salinity:
Not applicable
Nominal and measured concentrations:
Nominal concentrations: 0 (methanol control), 10, 100, 180, 320, 560 and 1000 ppm
Details on test conditions:
TEST SYSTEM

- Design: static exposure, no solution renewal

- Dilution water: reconstituted soft-water prepared fromglass-distilled water, EPA-660/3-75-009 (USEPA 1975). Water chemistry not documented, except for pH and dissolved oxygen. Based on EPA-660/3-75-009, the expected hardness would be 40 to 48 mg CaCO3/L, expected alkalinity 30 to 35 mg CaCO3/L, and expected pH 7.2 to 7.6. Measured pH at test initiation ranged from 7.2 to 7.3 (mean 7.2). Hardness and alkalinity were not measured. Total organic carbon (TOC) was not measured but expected to be insignificant.

- Test substance stability: test substance not stable in aqueous solutions; measured hydrolysis half-life is 1.5 to 6.0 min at 25ºC over the pH range of 4 to 7.

- Exposure vessel: polyethylene-lined vessels containing 10 L of dilution water; vessels aerated prior to study initiation but not during study.

- Replication: duplicate controls and single exposure concentrations

- Observations: 0, 24, 48, 72, 96 h after study initiation

- Photo-period: not specified
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
100 other: ppm
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
but exposure will be to the hydrolysis products
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LOEC
Effect conc.:
180 other: ppm
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
but exposure will be to hydrolysis products
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
200 other: ppm
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
but exposure will be to hydrolysis products
Basis for effect:
mortality (fish)
Remarks on result:
other: 157-258 ppm
Details on results:
No mortality observed in controls. The one mortality observed in the 100 ppm exposure (NOEC) at 24 hour observation was not considered dose
related (no additional mortality was observed and results were identical to the 180 ppm exposure). Sublethal efects, if any, were not recorded.
Reported statistics and error estimates:
ECx values were determined by Probit analysis (Finney, 1952). The NOEC was obtained directly from the raw data.
Sublethal observations / clinical signs:

Table 1. Test results

 

Nominal concentration (ppm)

Number alive at 0 hours

Number alive at 24 hours

Number alive at 48 hours

Number alive at 72 hours

Number alive at 96 hours

0 (Control)

20

20

20

20

20

10

10

10

10

10

10

100

10

9

9

9

9

180

11

9

9

9

9

320

10

2

1

1

0

560

10

0

0

0

0

1000

10

0

0

0

0

 

Validity criteria fulfilled:
yes
Conclusions:
A 96-hour LC50 value of 200 ppm and a NOEC of 100 ppm have been determined for the effects of the test substance on mortality of Lepomis macrochirus. 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).
Endpoint:
short-term toxicity to fish
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 provided in IUCLID Section 13.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
200 other: ppm
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
but exposure will be to hydrolysis products
Basis for effect:
mortality (fish)
Remarks on result:
other: 157-258 ppm
Remarks:
Source: Dow Corning 1978_1
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
213 other: ppm
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
but exposure will be to hydrolysis products
Basis for effect:
mortality (fish)
Remarks on result:
other: 151-270 ppm
Remarks:
Dow Corning 1978_2
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
597 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: Source: Hüls 1994
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
Not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions. The study was not conducted under GLP and exposure concentrations were not measured.
Qualifier:
according to guideline
Guideline:
other: EPA-660/3-75-009 (USEPA 1975)
GLP compliance:
no
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION

- Method: The test substance was added directly to the exposure vessels (polyethylene-lined containers with 10 litres of dilution water), a carrier solvent was not used. Manner of addition of test substance to dilution water was not documented. Test solutions were prepared 10 minutes prior to addition of fish.
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
No details provided
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
40 to 48 mg CaCO3/l
Test temperature:
12°C in water bath (mean and ranges not documented)
pH:
Test initiation (t = 0 h): mean 7.7 (range 7.5-8.1)

Test initiation (t = 96 h): 8.4 (range 7.3-10.0)
Dissolved oxygen:
Test initiation (t = 0 h): mean 11.6 mg/l (range 11.5-12.0 mg/l)

Test termination (t = 96 h): mean 6.4 mg/l (range 4.5-7.5 mg/l)
Salinity:
Not applicable
Nominal and measured concentrations:
Nominal concentrations: 0 (Control), 56, 180, 320, 560, and 1000 ppm
Details on test conditions:
TEST SYSTEM

- Design: static exposure, no solution renewal

- Dilution water: reconstituted soft water following guideline EPA-660/3-75-009 (USEPA 1975). Hardness, alkalinity, and total organic carbon (TOC) were not measured. Based on EPA-660/3-75-009, the expected hardness would be 40 to 48 mg CaCO3/L, expected alkalinity 30 to 35 mg CaCO3/L, and expected pH 7.2 to 7.6.

- Test substance stability: This material is sensitive to hydrolysis, which may occur during preparation of the dosing solutions and/or during the testing. Rapid hydrolysis of this material produces methanol and trisilanols..

- Exposure vessel: polyethylene-lined vessels containing 10 L of dilution water; vessels aerated prior to study initiation but not during study.

- Replication: Single replicates per treatment comprising of 10 fishations

- Observations: 0, 24, 48, 72, 96 h after study initiation

- Photo-period: not specified
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
56 other: ppm
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
but exposure will be to the hydrolysis products
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LOEC
Effect conc.:
180 other: ppm
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
but exposure will be to hydrolysis products
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
213 other: ppm
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
but exposure will be to hydrolysis products
Basis for effect:
mortality (fish)
Remarks on result:
other: 151-270 ppm
Details on results:
No data
Reported statistics and error estimates:
ECx values were determined by Probit analysis (Finney, 1952). The NOEC was obtained directly from the raw data.
Sublethal observations / clinical signs:

Table 1. Test results

 

Nominal concentration (ppm)

Number alive at 0 hours

Number alive at 24 hours

Number alive at 48 hours

Number alive at 72 hours

Number alive at 96 hours

0 (Control)

10

10

10

10

10

56

10

10

10

10

10

180

10

10

10

10

7

320

10

10

10

10

1

560

10

9

7

7

0

1000

10

7

1

0

0

 

Validity criteria fulfilled:
yes
Conclusions:
A 96-hour LC50 value of 213 ppm and a NOEC of 56 ppm have been determined for the effects of the test substance on mortality of Oncorhynchus mykiss. 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).
Endpoint:
short-term toxicity to fish
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
1994-09-26 to 1994-09-30
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:
Samples of test medium were taken at the start of the test and then after 24 hours in the old medium prior to renewal. Samples of freshly prepared medium were taken again when the tst medium was renewed after 24, 48 and 72 hours.
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 h followed by filtration. The other treatments were prepared by dilution of the stock solution.
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 t
est. Mortalities in the 7 days pruior to the test were ≤5%
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
11.3 ºdH
Test temperature:
20 - 21ºC
pH:
7.7 - 9.6
Dissolved oxygen:
83 - 103% ASV
Nominal and measured concentrations:
Nominal concentrations: 0 (Control), 110, 190, 330, 580 and 1000 mg/l

Mean measured concentrations over test: 0 (Control), 116, 194, 344, 676 and 1130 mg/l

The results are interpreted with reference to mean measured concentrations.
Details on test conditions:
TEST SYSTEM

- Test vessel: 20 litre aquarium

- Type (delete if not applicable): open

- Aeration: Yes, continuous

- Renewal rate of test solution: daily

- No. of organisms per vessel: 10

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

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


TEST MEDIUM / WATER PARAMETERS

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


OTHER TEST CONDITIONS

- Adjustment of pH: No

- Photoperiod: 16 hours light, 8 hours dark


EFFECT PARAMETERS MEASURED: Daily mortalities


TEST CONCENTRATIONS

- Spacing factor for test concentrations: 1.7
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
597 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Remarks:
but exposure is to hydrolysis products
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
344 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Remarks:
but exposure is to hydrolysis products
Basis for effect:
mortality (fish)
Details on results:
- Mortality of control: 0
Reported statistics and error estimates:
The LC50 was determined by graphical interpolation. The NOEC was obtained directly from the raw data.
Sublethal observations / clinical signs:

Table 1. Test results

 

Nominal concentration (mg/L)

Mean measured 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

110

116

0

0

0

0

190

194

0

0

0

0

330

344

0

0

10

10

580

676

0

0

10

60

1000

1130

10

90

100

100

 

Validity criteria fulfilled:
yes
Conclusions:
A 96-h LC50 value of 597 mg/l and NOEC of 344 mg/l have been determined for the effects of the test substance on mortality of Brachydanio rerio. It is likely that the test organisms were exposed to the hydrolysis products of the substance.

Description of key information

key study: A 96-hr LC50 of 200 ppm and NOEC of 100 ppm (Lepomis macrchirus, EPA 660/3-75-009), RL2
supoorting study 1: A 96-hr LC50 of 213 ppm and NOEC of 56 ppm (Oncorhynchus mykiss, EPA 660/3-75-009), RL2
supoorting study 2: A 96-hr LC50 of 596 mg/l and NOEC 344 mg/l (Brachydanio rerio (new name: Danio rerio), RL2

Key value for chemical safety assessment

Additional information

Measured data was not available for N-[3-(dimethoxymethylsilyl)-2-methylpropyl]ethylenediamine (CAS 023410-40-4), therefore read across from the comparable substance, N-(3-(trimethoxysilyl)propyl)ethylenediamine (CAS 1760-24-3) was deemed acceptable for assessment.

In the key study, according to EPA 660/3-75-009 a 96-hour LC50value of 200 ppm and a NOEC of 100 ppm have been determined for the effects of the test substance on mortality of Lepomis macrochirus (Dow Corning Corporation, 1978).

In the supporting study , according to EPA 660/3 -75 -009 a 96-hour LC50value of 213 ppm and a NOEC of 56 ppm have been determined for the effects of the test substance on mortality of Oncorhynchus mykiss (Dow Corning Corporation, 1978).

In the supporting study, according to EU Method C.1 a 96-h LC50value of 597 mg/l and NOEC of 344 mg/l have been determined for the effects of the test substance on mortality of Brachydanio rerio (Hüls AG, 1994a).

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.