1-Propanaminium, 3-amino-N-ethyl-N,N-dimethyl-, N-rape-oil acyl derivs., Et sulfates

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:

From October 31, 2017 to November 03, 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:

equivalent or similar to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

not applicable

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPPTS 850.1010 (Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids)

Deviations:

not applicable

Qualifier:

equivalent or similar to guideline

Guideline:

other: EPA-600-4-91-002 (Short-term methods for estimating the chronic toxicity of effects and receiving water to freshwater organisms)

Version / remarks:

1994

Deviations:

not applicable

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Remarks:

High-performance liquid chromatography (HPLC) method

Details on sampling:

At the start of the test additional sacrificial vessels with dispensed test solution were taken for whole sample analysis and at the end of the test, replicate vessels of the dilution water control and each test concentration was taken for whole sample analysis.

Vehicle:

yes

Remarks:

Elendt's M4 culture medium

Details on test solutions:

Preparation of test solutions
The study was run with a dilution water control and nominal exposure concentrations of 0.03125, 0.0625, 0.125, 0.25, 0.5 and 1.0 mg/L. A primary stock concentrate of test substance, with a nominal concentration of 10 mg/L, was prepared by adding a nominal 0.01 g of test substance to 1000 mL of culture medium. The resultant stock was observed to be clear and colourless with bubbles on the surface and was used to prepare the test solutions. This was achieved by the direct addition of the appropriate amount of concentrate to dilution water in a volumetric flask. The control consisted of culture medium only. All test solutions were clear and colourless.

Test organisms (species):

Daphnia magna

Details on test organisms:

Test organism
The test organism was the fresh water crustacean, Daphnia magna (<24 h old), obtained from continuous laboratory cultures held at Scymaris. The stock cultures of D. magna were maintained in a reconstituted water medium, the same as the test dilution water, at a temperature of 20 ± 2°C. The cultures were maintained in 2 L glass vessels with a working volume of 1.6 L. A photoperiod of 16 h’ light:8 h dark, with 20-minute transition periods was provided. The D. magna cultures were fed on a mixed algae diet of Chlorella vulgaris, strain CCAP 211/12 and Pseudokirchneriella subcapitata, strain CCAP 278/4. The D. magna cultures were fed daily ad libitum depending on age and density of the culture. Culture conditions were such that the D. magna reproduction was by diploid parthenogenesis. D. magna <24 h old, obtained from two culture vessels, were used for testing. The parent animals were 14 ± 1 d old and had been maintained with a twice weekly renewal of reconstituted water medium since birth. The test organisms and the cultures from which they were obtained showed no evidence of disease before the test period.

Test type:

static

Water media type:

other: Elendt's M4 D. magna medium

Limit test:

no

Total exposure duration:

48 h

Hardness:

Total hardness as CaCO3 (mg/L): 214.7

Test temperature:

20 ± 1°C

pH:

7.47 to 7.84

Dissolved oxygen:

9.13 to 9.33 mg/L

Nominal and measured concentrations:

1 mg/L highest concentration (Based on non-GLP range-finding study)
0, 0.03125, 0.0625, 0.125, 0.25, 0.5 and 1.0 mg/L (nominal)
0, 0.012, 0.029, 0.070, 0.13, 0.25 and 0.51 mg/L (measured)

Details on test conditions:

Apparatus
Glass beakers of 250 mL nominal capacity were used as test vessels, with four replicates per test concentration. Each vessel contained 200 mL of test solution providing a depth of approximately 60 mm. The beakers were covered with loose fitting glass lids. The positions of the treatments were randomly allocated within the test area.

Reference substance (positive control):

no

Key result

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

ca. 0.34 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat. (dissolved fraction)

Basis for effect:

mobility

Remarks on result:

other: 95% Confidence limits: 0.20 - 0.41

Remarks:

Linear interpolation (ICPIN)

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

ca. 0.24 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat. (total fraction)

Basis for effect:

mobility

Remarks on result:

other: 95% Confidence limits: 0.18 - 0.40

Remarks:

Linear interpolation (ICPIN)

Key result

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

ca. 0.13 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat. (total fraction)

Basis for effect:

mobility

Key result

Duration:

48 h

Dose descriptor:

LOEC

Effect conc.:

ca. 0.25 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat. (total fraction)

Basis for effect:

mobility

Analytical data

The limit of quantification of test substance in thisstudy was 0.02 mg/L. All analytical values are quoted to two significant figures and percentages to the nearest integer. The measured concentrations at the start of the study were 60-78% of nominal and at the end were 0-41% of nominal.Analytical calibrations were constructed using a minimum of 5 calibration levels, with a minimum R² value of 0.99. The maximum percentage difference from nominal concentration for standards at the LOQ is less than 30% and less than 20% at levels greater than the LOQ. On the basis of the analytical data the mean measured concentrations were used for the calculation and reporting of results.

Biological data

The results obtained (based on mean measured concentrations of test substance) were:

Time	EC50	95% confidence limits	Calculation method
24 h	0.34 mg/L	0.20-0.41 mg/L	Linear interpolation (ICPIN)
48 h	0.24 mg/L	0.18-0.40 mg/L	Linear interpolation (ICPIN)

Based on immobility compared to the control (p <0.05) the 48 h No Observed Effect Concentration (NOEC) was determined to be 0.13 mg/L and the Lowest Observed Effect Concentration (LOEC) was 0.25 mg/L. There was no immobility observed in the dilution water control. No other symptoms of toxicity were observed.

Validity criteria

The OECD 202 Test Guideline details the following performance criteria for the test validity:

- In the control, no more than 10% of the daphnids should have been immobilised or show other signs of stress;

- The dissolved oxygen concentration at the end of the test should be ≥3 mg/L in control and test vessels.

As no immobility or other signs of stress were observed in the control and dissolved oxygen concentration remained at ≥3 mg/L this test has satisfied all validity criteria.

Validity criteria fulfilled:

yes

Conclusions:

Under study conditions, the 48 h EC50 and NOEC value of the test substance in Daphnia magna was determined to be 0.24 mg/Land 0.13 mg/L(measured), respectively.

Executive summary:

A study was conducted to determine the acute toxicity of test substance, ‘C18-unsatd and C22-unsatd. AAP EDM-ES (active: 104%)' to Daphnia magna, according to OECD Guideline 202, in compliance with GLP. Twenty test organisms were exposed to each nominal test substance concentrations of 0, 0.03125, 0.0625, 0.125, 0.25, 0.5 and 1.0 mg/L for 48 h, under static conditions. The concentrations of test substance in the test vessels were measured using HPLC method of analysis. The mean measured concentrations of test substance were determined to be0, 0.012, 0.029, 0.070, 0.13, 0.25 and 0.51 mg/Lrespectively. Immobilisation was recorded at 24 and 48 h and compared with control values. Based on immobility compared to the control (p <0.05), the 48 h NOEC and LOEC were determined to be0.13 mg/Land0.25 mg/L(measured). No other symptoms of toxicity were observed. Based on the study results, the 48 h EC50 was calculated to be 0.24 mg/L(measured). As no immobility or other signs of stress were observed in the control and dissolved oxygen concentration remained at ≥3 mg/L, the test was considered to have satisfied all the validity criteria. Under study conditions, the 48 h EC50 and NOEC value of the test substance in Daphnia magna was determined to be 0.24 mg/Land 0.13 mg/L(measured), respectively (Scymaris, 2017).

Description of key information

Based on the results of the study, the 48 h EC50 value of the test substance for toxicity to aquatic invertebrates was determined to be 0.24 mg/L (measured).

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

0.24 mg/L

Additional information

A study was conducted to determine the acute toxicity of test substance, ‘C18-unsatd and C22-unsatd. AAP EDM-ES (active: 104%)' to Daphnia magna, according to OECD Guideline 202, in compliance with GLP. Twenty test organisms were exposed to each nominal test substance concentrations of0, 0.03125, 0.0625, 0.125, 0.25, 0.5 and 1.0 mg/Lfor 48 h, under static conditions. The concentrations of test substance in the test vessels were measured using HPLC method of analysis. The mean measured concentrations of test substance were determined to be0, 0.012, 0.029, 0.070, 0.13, 0.25 and 0.51 mg/Lrespectively. Immobilisation was recorded at 24 and 48 h and compared with control values. Based on immobility compared to the control (p <0.05), the 48 h NOEC and LOEC were determined to be0.13 mg/Land0.25 mg/L(measured). No other symptoms of toxicity were observed. Based on the study results, the 48 h EC50 was calculated to be0.24 mg/L(measured). As no immobility or other signs of stress were observed in the control and dissolved oxygen concentration remained at ≥3 mg/L, the test was considered to have satisfied all the validity criteria. Under study conditions, the 48 h EC50 and NOEC value of the test substance for toxicity to Daphnia magna was determined to be 0.24 mg/Land 0.13 mg/L(measured), respectively (Scymaris, 2017).