1-Propanaminium, 3-amino-N-ethyl-N,N-dimethyl-, N-lanolin 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 24, 2017 to October 27, 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

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 were 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 test substance exposure concentrations of 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 present 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:

7.89 to 8.12

Dissolved oxygen:

8.99 to 9.22 mg/L

Conductivity:

Conductivity (µS/cm): 559

Nominal and measured concentrations:

1 mg/L highest concentration (Based on non-GLP range-finding study)
0, 0.0625, 0.125, 0.25, 0.5 and 1.0 mg/L (nominal)
0, 0.047, 0.11, 0.21, 0.42 and 0.79 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.:

> 0.79 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat. (dissolved fraction)

Basis for effect:

mobility

Remarks on result:

other: >0.758 mg/L a.i.

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

ca. 0.56 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat. (dissolved fraction)

Basis for effect:

mobility

Remarks on result:

other: 95% Confidence interval: 0.48 - 0.62

Remarks:

0.538 a.i.

Key result

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

ca. 0.42 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat. (dissolved fraction)

Basis for effect:

mobility

Remarks on result:

other: 0.403 mg/L a.i.

Key result

Duration:

48 h

Dose descriptor:

LOEC

Effect conc.:

ca. 0.79 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat. (dissolved fraction)

Basis for effect:

mobility

Remarks on result:

other: 0.758 mg/L a.i.

Analytical data

The nominal and measured concentrations of test substance determined in the test solutions were 0, 0.0625, 0.125, 0.25, 0.5, 1.0 mg/L and 0, 0.047, 0.11, 0.21, 0.42, 0.79 mg/L respectively. The limit of quantification of test substance in this study was 0.02 mg/L. All analytical values were quoted to two significant figures and percentages to the nearest integer. The measured concentrations at the start of the study were 77-88% of nominal and at the end were 72-84% of nominal. 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	>0.79	-	ICPIN
48 h	0.56	0.48 – 0.62	ICPIN

Based on immobility compared to the control (p <0.05), the 48 h No Observed Effect Concentration (NOEC) was determined to be 0.42 mg/L and the Lowest Observed Effect Concentration (LOEC) was 0.79 mg/L. There was one immobile D. magna observed in the dilution water control. One D. magna was on the surface of the test solution in 0.0625 mg/L Rep D and 0.125 mg/L Rep A at 48 h. 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 5% immobility and no 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 the study conditions, the 48 h EC50 of test substance was determined to be 0.56 mg/L (0.538 mg a.i./L).

Executive summary:

A study was conducted to determine the acute toxicity of the test substance, 'iso and anteiso C10-40 AAP EDM-ES' (active: 96%) to Daphnia magna, according to the OECD Guideline 202 method, in compliance with GLP. A 1 mg/L test substance concentration was selected as the highest concentration based on the toxicity demonstrated in a non-GLP range-finding study. Twenty test organisms (four replicates per test concentration, 5 daphnids per test vessel, i.e., 20 daphnids per test concentration) were exposed to each nominal test substance concentrations of 0, 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 the high-performance liquid chromatography method. The mean measured concentrations of test substance were determined to be 0, 0.047, 0.11, 0.21, 0.42 and 0.79 mg/L. 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 No Observed Effect Concentration (NOEC) was determined to be 0.42 mg/L (measured) and the Lowest Observed Effect Concentration (LOEC) was 0.79 mg/L (0.758 mg/L a.i.). No other symptoms of toxicity were observed. Based on the study results, the 48 h EC50 was calculated to be 0.56 mg/L (0.538 mg a.i./L). As 5% immobility and no 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 the study conditions, the 48 h EC50 of the test substance, 'iso and anteison C10-40 AAP EDM-ES' was determined to be 0.56 mg/L (0.538 mg a.i./L) (Scymaris, 2017).

Description of key information

Based on the study results, the 48 h EC50 value of the test substance, 'iso and anteiso C10-40 AAP EDM-ES' for toxicity in Daphnia magna was determined to be 0.538 mg a.i./L (measured).

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

0.538 mg/L

Additional information

A study was conducted to determine the acute toxicity of the test substance, 'iso and antesio C10-40 AAP EDM-ES' (active: 96%) to Daphnia magna, according to the OECD Guideline 202 method, in compliance with GLP. A 1 mg/L test substance concentration was selected as the highest concentration based on the toxicity demonstrated in a non-GLP range-finding study. Twenty test organisms (four replicates per test concentration, 5 daphnids per test vessel, i.e., 20 daphnids per test concentration) were exposed to each nominal test substance concentrations of 0, 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 the high-performance liquid chromatography method. The mean measured concentrations of test substance were determined to be 0, 0.047, 0.11, 0.21, 0.42 and 0.79 mg/L. 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 No Observed Effect Concentration (NOEC) was determined to be 0.42 mg/L (measured) and the Lowest Observed Effect Concentration (LOEC) was 0.79 mg/L (0.758 mg/L a.i.). No other symptoms of toxicity were observed. Based on the study results, the 48 h EC50 was calculated to be 0.56 mg/L (0.538 mg a.i./L). As 5% immobility and no 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 of the test substance, 'iso and antesio C10-40 AAP EDM-ES' was determined to be 0.56 mg/L (0.538 mg a.i./L) (Scymaris, 2017).