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

Toxicity to aquatic algae and cyanobacteria

Administrative data

Endpoint:

toxicity to aquatic algae and cyanobacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2009-10-22 to 2010-04-07

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-study, no deviation to current guideline, test item identical to the registered substance, test validity criteria fulfilled

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:

OECD Guideline 201 (Alga, Growth Inhibition Test)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.3 (Algal Inhibition 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: nominal: 0 - 1 - 3.2 - 10 - 32 - 100 mg/L
- Sample storage conditions before analysis: <-10 ° C

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: mixing test material (fluid) with pure water as stock solution (1 g/L) and dilution of the stock solution with test water (OECD Medium)
- Eluate: not necessary
- Controls: medium without test solution
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): no vehicle used
- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s)): no vehicle used
- Evidence of undissolved material (e.g. precipitate, surface film, etc): no

Test organisms

Test organisms (species):

Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)

Details on test organisms:

TEST ORGANISM
- Common name: Pseudokirchneriella subcapitata
- Strain: Strain No. 61.81 SAG
- Source (laboratory, culture collection): "Sammlung von Algenkulturen, Pflanzenphysiologisches Institut der Universität Göttingen", 37073 Göttingen, Germany
- Age of inoculum (at test initiation): breed at test institute, no further data
- Method of cultivation: standardised conditions according to the test guidelines

ACCLIMATION
- Acclimation period: no acclimatisation to test item
- Culturing media and conditions (same as test or not): yes
- Any deformed or abnormal cells observed: no

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

72 h

Post exposure observation period:

no

Test conditions

Hardness:

test water is Reconstituted water, prepared following OECD guideline 201: "original medium of OECD TG 201, also according to ISO 8692"; see 6.5

Test temperature:

0 h: 22
24 h: 23
48 h: 23
72 h: 23

pH:

start: 8.1
end: 8.8 - 9.0

Dissolved oxygen:

no data

Salinity:

see "hardness"

Nominal and measured concentrations:

see attached documents

Details on test conditions:

TEST SYSTEM
- Test vessel: 50 mL Erlenmeyer flasks, covered with glass dishes and incubated in a water bath
- Initial cells density: 5000
- Control end cells density: 87.066 * 10^4 cells/mL
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 6
- blank control per cencentration: 1


GROWTH MEDIUM
- Standard medium used: yes, OECD 201

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: RO-water
- Culture medium different from test medium: no


OTHER TEST CONDITIONS
- Sterile test conditions:no

- Photoperiod: continuous
- Light intensity and quality: Mean light intensity: 4870 lux (range: 4560 - 5170 lux)


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Determination of cell concentrations: spectrophotometer; microscopical evaluation


TEST CONCENTRATIONS
- Spacing factor for test concentrations: 3.2
- Range finding study: yes
- Results used to determine the conditions for the definitive study: no

Reference substance (positive control):

no

Remarks:

not in this study, historical data available

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

72 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth rate

Effect concentrations 2

Duration:

72 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

cell number

Effect concentrations 3

Duration:

72 h

Dose descriptor:

EC10

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth rate

Effect concentrations 4

Duration:

72 h

Dose descriptor:

EC10

Effect conc.:

> 74.71 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

cell number

Remarks on result:

other: 38.09 - 87.34

Effect concentrations 5

Duration:

72 h

Dose descriptor:

NOEC

Effect conc.:

32 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth rate

Effect concentrations 6

Duration:

72 h

Dose descriptor:

LOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth rate

Details on results:

- Exponential growth in the control (for algal test): yes
- Observation of abnormalities (for algal test): no
- Any stimulation of growth found in any treatment: 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: no

Any other information on results incl. tables

Parameter (0 - 72 h)	Growth rate [mg test item/L]	Yield [mg test item/L]
72-hour EC50	> 100	> 100
95 % conf. limits	n.d.	n.d.
72-hour EC10	> 100	74.71
95 % conf. limits	n.d.	38.09 - 87.34
72-hour NOEC	32	32
72-hour LOEC	100	100
n.d. = not determined

Values refer to nominal test concentrations

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The influence of N-(2,2-Dimethoxyethyl)acrylamide (NAAADA) on the growth of the freshwater green algae Pseudokirchneriella subcapitata was assessed in a static dose-response test. The 72-hour ErC50 and the 72-hour EyC50 were calculated to be > 100 mg test item/L. The 72-hour NOErC and the 72-hour NOEyC were determined to be 32 mg test item/L, respectively. The associated 72-hour LOErC and the associated 72-hour LOEyC is 100 mg test item/L.

Executive summary:

The 72-hour E_rC50 and the 72-hour E_yC50 were calculated to be > 100 mg test item/L. The 72-hour NOE_rC and the 72-hour NOE_yC were determined to be 32 mg test item/L, respectively. The associated 72-hour LOE_rC and the associated 72-hour LOE_yC is 100 mg test item/L.

The quantification of the test item was performed using liquid chromatography (HPLC-method).

At the start of the test 101 % of the nominal test concentrations were found (average of all test concentrations). After 72 hours test duration, 101 % of the nominal value was determined (average of all test concentrations). During the test the algae were exposed to a mean of 101 % of nominal. Therefore, all reported results refer to nominal concentrations.