N-(2-aminoethyl)-N'-[3-(trimethoxysilyl)propyl]ethylenediamine

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key 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.

Reference 2

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:

22°C in water bath (mean and ranges not documented)

pH:

Test initiation (t = 0 h): mean 7.4 (range 7.4-7.5)

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 3 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	-

 

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).

Reference 3

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 below and the overall justification for grouping of substances attached in IUCLID Section 13.

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

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)

Remarks on result:

other:

Remarks:

Source: Hüls, 1994

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

213 other: ppm

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

but exposure is to hydrolysis products

Basis for effect:

mortality (fish)

Remarks on result:

other: 151-270 ppm

Remarks:

Source: Dow Corning, 1978

Conclusions:

Two studies are available for the source substance CAS 1760-24-3. 96 hour LC50 values of 597 mg/L and 213 ppm have been determined for the effects of the test substance on the mortality of Danio rerio. As detailed in the attached justification, similar effects are expected by the target substance.

Description of key information

LC50 (96 h) = 597 mg/L (geom. mean meas., Danio rerio, EU Method C.1) based on read across from CAS 1760-24-3

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

597 mg/L

Additional information

Experimental data on the toxicity of N-(2-aminoethyl)-N’-[3-(trimethoxysilyl)propyl]ethylenediamine (CAS 35141-30-1) towards fish are not available. Therefore, in accordance with the Regulation (EC) No. 1907/2006 Annex XI, 1.5 “Grouping of substances and read across” and the read across assessment framework (RAAF, ECHA 2017) a read across from the analogue substance N-(2-aminoethyl)-3-aminopropyltrimethoxysilane (CAS 1760-24-3) has been performed. Details on the read-across justification can be found in the attached justification in the respective target entry and in the overall justification for grouping of substances attached in IUCLID Section 13.

In an acute fish toxicity test (1994) according to the EU Method C.1 and GLP standards, the test organism Brachydanio rerio was exposed in a semi-static testing regime to nominal test item concentrations of 110, 190, 330, 580 and 1000 mg/L and a control. Analytical monitoring was performed via DOC measurement. The recovery of the measured concentrations was >80%. The study resulted in an LC50 (96 h) of 597 mg/L (geom. mean meas.).

A supporting study is available with the analogue substance (1978). The study was conducted according to EPA-660/3-75-009 (USEPA 1975) but not in line with GLP standards. The test organism Oncorhynchus mykiss was exposed in a static testing regime to nominal test item concentrations of 56, 180, 320, 560 and 1000 ppm and a control for 96 h. Analytical monitoring was not performed. The study resulted into a LC50 (96 h) of 213 ppm.

Since the substance hydrolysis rapidly it is assumed that the test organisms were mainly exposed to the hydrolysis products.

Based on the findings of the read across substance and as explained in the read across justification attached in the target entry, no toxicity to fish is expected from N-(2-aminoethyl)-N'-[3-(trimethoxysilyl)propyl]ethylenediamine (CAS 35141-30-1) up to concentrations of 100 mg/L.