N-(3-{1,1,1,5,5,5-hexamethyl-3-[(trimethylsilyl)oxy]trisiloxan-3-yl}propyl)prop-2-enamide

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010-09-03 to 2010-11-09

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study, study is performed according to OECD and EU guidelines, no deviation from study plan.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

N-(3-{1,1,1,5,5,5-hexamethyl-3-[(trimethylsilyl)oxy]trisiloxan-3-yl}propyl)prop-2-enamide

EC Number:

700-253-3

Cas Number:

115258-10-1

Molecular formula:

C15H37NO4Si4

IUPAC Name:

N-(3-{1,1,1,5,5,5-hexamethyl-3-[(trimethylsilyl)oxy]trisiloxan-3-yl}propyl)prop-2-enamide

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations: one: 29 µg/L (n = 4)
- Duplicate samples from the freshly prepared test medium of the only test concentration and the controls were taken at the start of the test.
- For the determination of the stability of the test item under the test conditions and of the maintenance of the test item concentration during the test period, duplicate samples from the test medium of the only test concentration and the controls were collected at the end of the test (after 48 hours).
- All samples were measured directly at the day of sampling

Test solutions

Vehicle:

yes

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method:acc. to OECD 23 with solvent
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Dimethylformaide
- Concentration of vehicle in test medium (stock solution and final test solution): stock soluition: 290 mg/L
- Evidence of undissolved material (e.g. precipitate, surface film, etc): no

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Water flea
- Strain: Clone 5
- Source:
- Age at study initiation (mean and range, SD): 2.5 to 18.75 hours
- Method of breeding: continous laboratory culture
- Feeding during test: no
- Food type: not applicable
- Amount: not applicable
- Frequency: not applicable

ACCLIMATION
- Acclimation period: not necessary, laboratory breed stock
- Acclimation conditions (same as test or not): see above
- Type and amount of food: Desmodesmus
- Feeding frequency: all working days
- Health during acclimation (any mortality observed): not applicable

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Post exposure observation period:

no

Test conditions

Hardness:

Reconstituted Water, (Elendt M4):
Water Hardness: 2.5 mmol/L (= 250 mg/L) as CaCO3
Alkalinity: 0.9 mmol/L

Test temperature:

20 to 21 °C at test start;
20 °C at test end

pH:

8.1 at test start;
7.6 to 7.7 at test end; and thus the pH-value did not vary by more than 1.5 units

Dissolved oxygen:

8.9 to 9.0 mg/L at test start;
8.3 mg/L at test end

Nominal and measured concentrations:

see block "additional information on results"

Details on test conditions:

TEST SYSTEM
- Test vessel: beaker, 100 ml

- Material, size, headspace, fill volume: 60 ml
- Aeration: no
- Type of flow-through (e.g. peristaltic or proportional diluter): not applicable
- Renewal rate of test solution (frequency/flow rate): no
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- No. of vessels per vehicle control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water
- Culture medium different from test medium: no
- Intervals of water quality measurement: no data

OTHER TEST CONDITIONS
- Adjustment of pH:
- Photoperiod: 16/8 l/d
- Light intensity: 330 - 400 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : immobility

TEST CONCENTRATIONS
- Spacing factor for test concentrations: not applicable
- Justification for using less concentrations than requested by guideline: low water solubility
- Range finding study: yes
- Test concentrations: 1-10-100 mg/L
- Results used to determine the conditions for the definitive study: yes

Reference substance (positive control):

no

Remarks:

historical data

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

>= 29 µg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Duration:

48 h

Dose descriptor:

LOEC

Effect conc.:

> 29 µg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 3

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 29 µg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

- Behavioural abnormalities: no
- Observations on body length and weight: no data
- Other biological observations: no
- Mortality of control: no
- Other adverse effects control: no
- Abnormal responses: no
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no
- Effect concentrations exceeding solubility of substance in test medium: yes, in the range fining test. Therefore a solvent and lower concentrations were used in the definite test

Results with reference substance (positive control):

- Results with reference substance valid, as determined by historical and regularily conducted study
- Mortality: control: 0
- EC50/LC50: 1.59 (24 h) and 1.37 mg/L (48 h)

Reported statistics and error estimates:

not applicable due to no observed immobility

Any other information on results incl. tables

Summary of Biological Results
Nominal Concentration	% of immobilised Daphnia after
[µg test item/L]	24 hours	48 hours
Control	0	0
Solvent Control	0	0
29	0	0
EC50[µg/L]:	> 29	> 29
95 % confidence values [µg/L]:	n.d.	n.d.
NOEC [µg/L]:	≥ 29	³29
LOEC [µg/L]:	> 29	> 29
Values refer to nominal test concentrations. n.d.: could not be determined NOEC and LOEC were determined directly from the raw data.

Analytical Results

sample description µg/L	geometric % of nominal	n
control	n.a.	2
29	48	4

At the start of the test 92 % of the nominal test concentration was found. After 48 hours test duration, 27 % of the nominal value was determined. All reported results refer to nominal concentrations.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The toxic effect of the test item N-[3-tris(trimethylsilyloxy) silylpropyl]prop-2-enamide to Daphnia magna was assessed in a static limit-test. The 48-hour NOEC was determined to be > 29 µg test item/L. The 48-hour LOEC was determined to be > 29 µg test item/L The 48-hour EC50 value was determined to be > 29 µg test item/L.

Executive summary:

The only concentration tested was nominal 29 µg test item/L(in 100 mg Dimethylformamide/L), a solvent control (100 mg Dimethylformamide/L) and a control. Additionally; a control was tested in parallel (test water without addition of the test item). Thus a limit test was performed in accordance with OECD Guideline 202 to demonstrate that the test item has no toxic effect on the test animals up to this concentration. No mortality or immobility was observed after 24 and the 48 h. In conclusion under test conditions no toxicity of the test item to freshly hatched daphnia was observed.