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Ecotoxicological information

Short-term toxicity to aquatic invertebrates

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Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002-04-10 to 2002-07-10
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Guideline study. The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.
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), 2.15, 4.64, 10.0, 21.5, 46.4 and 100.0 mg/l.

- Sampling method: One aliquot from the freshly prepared test media of all test concentrations was taken at the start of the test. A further aliquot was taken from all test concentrations at the end of the test.

- Sample storage conditions before analysis: 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 stirring intensely for approximately 30 minutes. The other treatments were prepared by diluting appropriate volumes of the stock solution.

- 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 1 week

- Acclimation conditions: same as test

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

- Feeding frequency: not reported
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
250 mg/l as CaCO3
Test temperature:
19-21ºC
pH:
7.65-9.84
Dissolved oxygen:
=80% ASV
Salinity:
not applicable
Nominal and measured concentrations:
Nominal concentrations: 0(Control), 2.15, 4.64, 10.0, 21.5, 46.4 and 100 mg/l.

Measured concentrations in the 48 hour samples were within +/-20% of the nominal values. The samples taken at the start of the test were not analysed because it was considered that the results obtained for the 48 hour samples adequately demonstrated that the concentrations were stable and close to nominal.
Details on test conditions:
TEST SYSTEM

- Test vessel:

- Type: open

- Material, size, fill volume: 50 ml glass vessels with 50 ml of test medium

- Aeration: none

- Renewal rate of test solution: 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 of test medium


TEST MEDIUM / WATER PARAMETERS

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

- Alkalinity: 0.8 mmol/l

- Ca/mg ratio: 4:1

- Culture medium different from test medium: same as test medium

- Intervals of water quality measurement: start and end of test.


OTHER TEST CONDITIONS

- Adjustment of pH: no

- Photoperiod: 16 h light, 8 h dark

- Light intensity: 500 lux +/-20%


EFFECT PARAMETERS MEASURED: Immobility after 24 and 48 hours


TEST CONCENTRATIONS

- Spacing factor for test concentrations: 2.2

- Range finding study: yes

- Results used to determine the conditions for the definitive study: not reported
Reference substance (positive control):
no
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
2.15 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
but exposure is to hydrolysis products
Basis for effect:
mobility
Duration:
48 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
Details on results:
- Mortality of control: 2.5%
Reported statistics and error estimates:
Where appropriate ECx values were calculated by linear regression combined with probit analysis using Probit Program Version 1.5, U.S. Environmental Protection Agency, 1992). NOEC values were determined directly from the raw data.

Table 1. Results of the test

 Nominal concentration of test substance (mg/l)  Mean percentage immobilisation after 24 hours  Mean percentage immobilisation after 48 hours
 0 (Control)  0  2.5
 2.15  0  0
 4.64  15  15
 10.0  0  30
 21.5  5  20
 46.4  10  25
 100.0  25  50

Table 2. Results of analysis of test media

 Nominal concentration of test substance (mg/l)  Theoretical Dissolved Organic Carbon (DOC) concentration (mg/l)  Measured Dissolved Organic Carbon (DOC) concentration (mg/l)
2.15  1.0  1.5
4.64  2.2  2.1
10.0  4.7  4.7
21.5  10.0  9.6
46.4  21.6  22
100.0  46.6  49
Validity criteria fulfilled:
yes
Conclusions:
A 48-hour EC50 value of >100 mg/l and EC0 value of 2.15 mg/l have been determined for the effects of the test substance on mobility of Daphnia magna based on nominal concentration of the substance. However the test substance is susceptible to hydrolysis and it is therefore likely that the test organisms were primarily exposed to the hydrolysis products of the substance.

Description of key information

48 hour EC50: >100 mg/l, mobility Daphnia magna. The EC50 is equivalent to >86 mg/l when expressed in terms of the silanol hydrolysis product, N-[3-(dihydroxymethylsilyl)propyl]ethylenediamine.

Key value for chemical safety assessment

Additional information

A 48 hour EC50 value of >100 mg/l has been determined for the effects of the test substance on mobility of Daphnia magna based on nominal concentrations of the substance, verified by analysis of total organic carbon, in accordance with OECD TG 202 (LPT, 2003). The test substance is susceptible to very rapid hydrolysis and it is therefore likely that the test organisms were primarily exposed to the hydrolysis products of the substance, methanol and N-[3-(dihydroxymethylsilyl)propyl]ethylenediamine.

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.

The results may be expressed in terms of concentration of the silanol hydrolysis product, N-[3-(dihydroxymethylsilyl)propyl]ethylenediamine, by applying a molecular weight correction: (MW of silanol = 178.31 / MW of parent = 206.36) * [Concentration of parent = >100 mg/l] = >86 mg/l.

During the Daphnia toxicity test, at time 0, the pH of the test solution was higher than the OECD recommended maximum pH of 9 in the test concentrations of 10 mg/l and above. At the highest concentration of 100 mg/l, the pH remained above 9 for the duration of the test. It is therefore not possible to ascertain whether the observations made in the test are due to toxicity of the test substance or due to high pH. However, the EC50 was reported as >100 mg/l, indicating that the test substance is of low toxicity.

In addition to the measured data, supporting data have been read across from the structural analogue N-(3-(trimethoxysilyl) propyl)ethylenediamine (CAS 1760-24-3).

A 48-hour EC50 value of 81 mg/l has 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 N-(3-(trihydroxysilyl)propyl)ethylenediamine).

The results may be expressed in terms of concentration of the 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 = 81 mg/l] = 66 mg/l.