N,N-bis(2-hydroxyethyl)undec-10-enamide

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August 09, 2017 to August 16, 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

At the start of the exposure (0 hours), sampling was carried out after preparation of the test substance concentrations. At the end of the exposure (48 hours), samples of the old media were taken from the test vessel.

Vehicle:

no

Details on test solutions:

Stock solution: the stock solution of 100 mg/L was prepared with dilution water prior to the start of the exposure (at 0 hours). The stock solution was mixed thoroughly by manual agitation.
Test concentrations: 5 test substance concentrations in a geometric series with a separation factor of 2 were prepared by dilution of the stock solution 100 mg/L with dilution water, as follows: 6.25 - 12.5 - 25.0 - 50.0 - 100 mg/L. The test concentrations are based on the results of a non-GLP preliminary range finding test.
Control: Dilution water without test substance incubated under the same conditions as the test groups.

Test organisms (species):

Daphnia magna

Details on test organisms:

Test system: Daphnia magna STRAUS (Clone 5),
Origin: Institut fur Wasser, Boden und Lufthygiene (WaBoLu), 14195 Berlin, Germany,
Breeder: Noack Laboratorien GmbH, Germany,
Culture: In glass vessels (2 - 3 L capacity) with approximately 1.8 L culture medium, at 20 ± 2 °C, in an incubator, 16 hours illumination; light intensity of max. 1500 lx,
Culture medium: Elendt M4, according to OECD 202, Annex 3 (2004), modified to a total hardness of 160 to 180 mg CaCO3/L,
Culture feeding: The culture daphnids were fed at least 5 times per week ad libitum with a mix of unicellular green algae, e.g. Pseudokirchneriella subcapitata and Desmodesmus subspicatus, with an algae cell density of > 10*E06 cells/mL. The algae were cultured at the test facility,
Origin of the food algae: Sammlung von Algenkulturen (SAG), Institut der Universitat Gottingen, Germany.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

total hardness of 160 to 180 mg CaCO3/L

Test temperature:

18 - 22 °C, constant within ± 1°C

pH:

7.45 - 8.08

Dissolved oxygen:

from 7.40 to 8.98 mg/L

Conductivity:

444 uS/cm

Nominal and measured concentrations:

- Nominal: 6.25, 12.5, 25.0, 50.0, 100 mg/L
- Measured: The measured concentrations of the test substance were in the range of 104 to 119 % of the nominal values at the start of the exposure (0 hours) and 99 to 119 % of the nominal values at the end of the exposure (48 hours). The measured test substance concentrations were all within ± 20 % of the nominal concentrations.

Details on test conditions:

Test vessels: Glass beakers (4 (ID) x 7 (H) cm), 50 mL capacity, loosely covered with watch glasses.
Test volume: 20 mL.
Number of daphnids and replicates: 20 daphnids, divided into 4 replicates, each with 5 daphnids, were used for each concentration level and the control.
Age of the organisms at the start of exposure: Less than 24 hours old daphnids from a healthy stock.

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

ca. 48 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: (95% CI: 26.4 - 87.2 mg/L)

Key result

Duration:

48 h

Dose descriptor:

EC10

Effect conc.:

ca. 45 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: (95% CI: 25.2 - 85.6 mg/L)

Key result

Duration:

48 h

Dose descriptor:

EC100

Effect conc.:

ca. 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Results with reference substance (positive control):

24 EC50: 1.90 mg/L; 95% CI: 1.43 - 2.69 mg/L.

Reported statistics and error estimates:

The EC10/50-values (after 24 and 48 hours of exposure) were calculated by sigmoidal dose-response regression with the software GraphPad Prism. The respective 95 % confidence limits were calculated from the standard error and the t-distribution. All calculations were carried out from the best-fit values with the software GraphPad Prism.

None.

Validity criteria fulfilled:

yes

Conclusions:

Under the study conditions, the nominal 48 h EC50 was determined to be 48.0 mg/L (equivalent to 43.5 mg a.i./L) (95% CI: 26.4 — 87.2 mg/L) and the 48 h EC10 was 45.0 mg/L (equivalent to 40.8 mg a.i./L) (95% Cl: 25.2 — 85.6 mg/L).

Executive summary:

A study was conducted to determine the toxicity of the test substance, C11-unsatd. DEA (90.6% active), to Daphnia magna according to OECD Guideline 202 and EU Method C.2, in compliance with GLP. Twenty daphnids (divided into 4 replicates with 5 daphnids each) were exposed to the test substance (directly diluted in water) in the range of 6.25 - 100 mg/L, prepared in a geometric series with a separation factor of 2 and including a control. Test substance concentrations were analytically verified via LC-MS/MS at the start and end of exposure in all dose groups and in the control. Measured concentrations were in the range of 104 - 119% of nominal values at test start and 99 - 119% of nominal values at test end, therefore results were based on nominal values. Under the study conditions, the nominal 48 h EC50 was determined to be 48.0 mg/L (equivalent to 43.5 mg a.i./L) and the 48 h EC10 was 45.0 mg/L (equivalent to 40.8 mg a.i./L) (Herrmann, 2017).

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

48 mg/L

Additional information

A study was conducted to determine the toxicity of the test substance, C11-unsatd. DEA (90.6% active), to Daphnia magna according to OECD Guideline 202 and EU Method C.2, in compliance with GLP. Twenty daphnids (divided into 4 replicates with 5 daphnids each) were exposed to the test substance (directly diluted in water) in the range of 6.25 - 100 mg/L, prepared in a geometric series with a separation factor of 2 and including a control. Test substance concentrations were analytically verified via LC-MS/MS at the start and end of exposure in all dose groups and in the control. Measured concentrations were in the range of 104 - 119% of nominal values at test start and 99 - 119% of nominal values at test end, therefore results were based on nominal values. Under the study conditions, the nominal 48 h EC50 was determined to be 48.0 mg/L (equivalent to 43.5 mg a.i./L) and the 48 h EC10 was 45.0 mg/L (equivalent to 40.8 mg a.i./L) (Herrmann, 2017).