2-Propenamide, N-(2,2-dimethoxyethyl)-

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:

2009-10-27 to 2010-04-07

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-(2,2-dimethoxyethyl)prop-2-enamide

EC Number:

610-472-5

Cas Number:

49707-23-5

Molecular formula:

C7 H13 N1 O3

IUPAC Name:

N-(2,2-dimethoxyethyl)prop-2-enamide

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 1 ( 100 mg/L)
- Sampling method: no data
- Sample storage conditions before analysis: yes., storage < -10° C

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: according to OECD 202 a limit test was conducted (dissolving 41.5mg of the test item into 415mL test water by intense stirring for 20 minutes).
- Controls: In the control, test water was used without addition of the test item
- Evidence of undissolved material (e.g. precipitate, surface film, etc): no evidende, acc. to water solubitlity the test item is fully miscible with water

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Water flea
- Strain: Clone 5
- Source: The Daphnia were bred in the laboratories of the testing facility under similar temperature and light conditions as used in the test. The test organisms were not first brood progeny.
- Age at study initiation (mean and range, SD): From 5.5 to 21.75 hours old
- 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:

7.9 at test start;
7.8 at test end; and thus the pH-value did not vary by more than 1.5 units

Dissolved oxygen:

8.7 - 8.8 mg/L at test start;
8.6 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: 80 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): not applicable

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: no data
- Photoperiod: 16/8 l/d
- Light intensity: 330 - 550 lux

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

TEST CONCENTRATIONS
- Spacing factor for test concentrations: not applicable
- 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:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Duration:

48 h

Dose descriptor:

LOEC

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 3

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/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 1.374 mg/L (48 h)

Reported statistics and error estimates:

not applicable due to no observed immobility

Any other information on results incl. tables

Nominal Concentration	No. of Daphnia tested	No. of immobilized Daphnia after		% of immobilized Daphnia after
[mg test item/L]		24 h	48 h	24 h	48 h
Control	20	0	0	0	0
100	20	0	0	0	0

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The toxic effect of the test item N-(2,2-Dimethoxyethyl)acrylamide (NAAADA) to Daphnia magna was assessed in a static limit-test. The 48-hour NOEC was determined to be => 100 mg test item/L. The 48-hour EC50 value was calculated to be > 100 mg test item/L.

Executive summary:

After 48 hours of exposure no immobilisation of the test animals was observed in the control and the only test item concentration of nominal 100 mg/L.All validity criteria were met.

 

In the most recent test with the reference item potassium dichromate performed in January 2010 (study code 48399220) the EC₅₀after 24 hours was determined to be 1.59 mg test item/L indicating that the sensitivity of the Daphnia was consistent with the level proposed by the OECD 202 guideline (EC₅₀-24 h between 0.6 and 2.1 mg potassium dichromate/L).

The toxic effect of the test item N-(2,2-Dimethoxyethyl)acrylamide (NAAADA) to Daphnia magna was assessed in a static limit-test. The 48-hour NOEC was determined to be => 100 mg test item/L. The 48-hour EC50 value was calculated to be > 100 mg test item/L.