N-[3-(dimethoxymethylsilyl)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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Guideline study. The study was conducted according to an appropriate EU test method, and in compliance with GLP. However, pH limits were exceeded in the higher test concentrations therefore the study is considered reliability 2.

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:

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

Adequacy of study:

key study

Justification for type of information:

See Ecotoxicological Information discussion in IUCLID, Section 7 of the CSR, for justification of read-across.

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)

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)

Description of key information

96-h LC₅₀: 597 mg/l, mortality Danio rerio, read-across from CAS 1760-24-3. The LC₅₀ is equivalent to 484 mg/l when expressed in terms of the silanol hydrolysis product, N-(3-(trihydroxysilyl)propyl)ethylenediamine.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

484 mg/L

Additional information

There are no reliable short-term toxicity to fish data for the registered substance. However, a 96-hour LC₅₀ value of 597 mg/l has been determined for the effects of the read-across substance N-(3-(trimethoxysilyl)propyl)ethylenediamine (CAS 1760-24-3) on mortality of Danio rerio in accordance with EU Method C.1 (Hüls, 1994). The results are expressed relative to geometric mean measured DOC concentrations of the test substance.

The test 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 N-(3-(trihydroxysilyl)propyl)ethylenediamine).

The results may be expressed in terms of concentration of the silanol hydrolysis product, N-(3-(trihydroxysilyl)propyl)ethylenediamine, by applying a molecular weight correction: (MW of silanol = 180.28 / MW of parent = 222.36) * [Concentration of parent = 597 mg/l ] = 484 mg/l.

There is no basis to expect that methanol significantly influenced the results of the test. The toxicity of methanol is discussed further in Section 7.0 of the CSR and Section 6, ecotoxicological information overview endpoint summary (additional information), of IUCLID.

During the fish toxicity test, the pH of the test solution rose above the OECD recommended maximum pH of 8.5 in the higher test concentrations (194 mg/l and above). Toxicity was observed only at the high concentrations, therefore it is not possible to tell whether the effects were caused by toxicity of the test substance or high pH. The results should therefore be used with caution. However, the test does indicate that there are no effects on fish at a concentration of 100 mg/l.

Further information on read-across is given in the IUCLID Section 6 endpoint summary (CSR Section 7.0) and in the ecotoxicity RAAF attached in Section 13 of IUCLID.