Poly(oxy-1,2-ethanediyl), α,α'-(iminodi-2,1-ethanediyl)bis[.omega.-hydroxy-, N-[3-(C10-16-alkyloxy)propyl] derivs., di-Et sulfate-quaternized

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:

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:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Name: Poly(oxy-1,2-ethanediyl), .alpha.,.alpha.'-(iminodi-2,1-ethanediyl)bis[.omega.-hydroxy-, N-[3-(C10-16-alkyloxy)propyl] derivs., di-Et sulfate-quaternized
Product Description: C10-16-alkyletherpropylamine, ethoxylated, DES Quat
CAS No.: 70983-58-3
Physical state: yellowish to amber viscous liquid at 20 °C
Batch No.: PFS-755-173
Re-certification date of batch: 19 April 2018
Purity: 100 % (UVCB)
Color, Gardner 8.8
pH, 5% in water 5.76
Acid Value , mg KOH/g 20.1
Moisture, % 0.127
Total Amine, mg/g 11.18
Viscosity,cps, #4@60,25C 3280
Appearance @25C pass
Stability: stable under test conditions
Storage condition of test material: Room temperature, protected from light

Analytical monitoring:

yes

Details on sampling:

Chemical analysis of the test item concentrations in the test solutions was performed to determine exposure concentration and stability of the test item during exposure. Substance specific analysis was performed at the test site menal GmbH. The samples were filled into 10 mL glass vials and stored in the freezer (≤ -18 °C). The sampling was conducted according to the following specification:
After 0 h, 24 h and 48 h exposure, all replicates of NC, A (0.03 mg/l), B (0.1 mg/l), C (0.3 mg/l), D (0.9 mg/l) and E (2.7 mg/l) were sampled; one sample per replicate: 4 samples of 6 mL per treatment group.
Of each sampled treatment, one of the samples from 0 h, 24 h and 48 h was sent to the analytical laboratory at the test site menal GmbH. The remaining samples were stored as retain samples in the freezer (≤ -18 °C) until finalization of the study.

Vehicle:

no

Details on test solutions:

The stock solution was prepared by adding 2.7 mg test item to 1000 mL test medium and shaking for 1 h using an overhead shaker. This stock solution was used as highest test item concentration in the test.

Test organisms (species):

Daphnia magna

Details on test organisms:

The test organism Daphnia magna Straus originates from the clone breeding of the Federal Environment Agency, department IV 2.4, Berlin, and has been cultivated at Hydrotox GmbH since October 2012. The daphnids are cultured at 20 ± 2 °C with 16 h light : 8 h dark and placed into fresh M4 medium twice a week. They are kept at approx. 10 animals / 200 mL and fed on workdays with Desmodesmus subspicatus algae corresponding to 0.1 mg C × daphnid-1 × day-1. The test organisms used were 1.5 - 23.5 h old at the start of the test.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

The test was performed with M4 medium according to OECD 202 (2004).

Test temperature:

The temperature during the exposure was 20.4 – 21.2 °C (required 18 – 22 °C, constant within ± 1 °C).

pH:

After addition of the stock solutions, except the vitamin stock solution S23, the medium was aerated for 1.5 h to achieve oxygen saturation and the pH (8.6), oxygen concentration (7.5 mg/L) and conductivity (684 µS/cm) was determined.
The pH was 7.8 – 8.2 in the control and 7.8 – 8.3 in the test item treatments (required: 6 – 9).

Dissolved oxygen:

After addition of the stock solutions, except the vitamin stock solution S23, the medium was aerated for 1.5 h to achieve oxygen saturation and the pH (8.6), oxygen concentration (7.5 mg/L) and conductivity (684 µS/cm) was determined.
The dissolved oxygen concentration was 7.7 – 8.3 mg/L in the control and 7.7 – 8.4 mg/L in the test item treatment (required: ≥ 3 mg/L).

Salinity:

The test was performed with M4 medium according to OECD 202 (2004).

Conductivity:

After addition of the stock solutions, except the vitamin stock solution S23, the medium was aerated for 1.5 h to achieve oxygen saturation and the pH (8.6), oxygen concentration (7.5 mg/L) and conductivity (684 µS/cm) was determined.

Nominal and measured concentrations:

As the measured test item concentrations are not within ± 20 % of the nominal concentrations, according to OECD 202 (2004) and OECD 23 (2000), all results are given in relation to the analytically measured test item concentrations. Therefore, the geometric mean of all three measurement times (0 h, 24 h and 48 h) was calculated. For measurements which are < LOQ, the value of LOQ, i.e. 0.02 mg/L, was used for calculation.

Details on test conditions:

Test procedure

The test vessels were kept in an incubator (specified temperature 18 – 22 °C, constant within ± 1 °C) with 16 h light : 8 h dark. The swimming capability of the daphnids was determined after 24 h and 48 h exposure. Animals that did not swim within 15 s after gently moving the test vessel
were considered to be immobile. The pH as well as the O2-concentrations were measured at the start (0 h) and at the end of the test (48 h) and the temperature was measured continuously.

Criteria of validity

- Immobilisation of the test organisms in the control at the end of the test ≤ 10 %.
- Dissolved oxygen concentration in the control and the test item treatments at the end of the test
≥ 3 mg/L

Positive control

Quality assurance takes place at regular intervals by testing the sensitivity of the test organisms to the reference item potassium dichromate. The recent quality testing was performed in February 2017 with EC50 (24h) = 1.32 mg/L (CL 95 %: 1.24 – 1.41 mg/L), which is in the declared range of 0.6 – 2.1 mg/L (24 h) according to OECD 202.

Reference substance (positive control):

yes

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

0.54 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: CL: 0.36 – 0.79

Key result

Duration:

48 h

Dose descriptor:

EC10

Effect conc.:

0.18 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: CL: 0.07 – 0.29

Key result

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

0.02 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Key result

Duration:

48 h

Dose descriptor:

LOEC

Effect conc.:

0.15 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

1.2 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: CL: 0.51 – 4.82

Duration:

24 h

Dose descriptor:

EC10

Effect conc.:

0.54 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: CL: 0.04 – 1.06

Duration:

24 h

Dose descriptor:

LOEC

Effect conc.:

2.23 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

24 h

Dose descriptor:

NOEC

Effect conc.:

0.76 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Results with reference substance (positive control):

Quality assurance takes place at regular intervals by testing the sensitivity of the test organisms to the reference item potassium dichromate. The recent quality testing was performed in February 2017 with EC50 (24h) = 1.32 mg/L (CL 95 %: 1.24 – 1.41 mg/L), which is in the declared range of 0.6 – 2.1 mg/L (24 h) according to OECD 202.

Reported statistics and error estimates:

The effect occurrence after 24 h and 48 h exposure was calculated with the statistical software ToxRat Professional 3.2.1 (ToxRat Solutions GmbH, Alsdorf, Germany), ECx and LOEC/NOEC were determined.

The Daphnia magna acute immobilisation test was performed with five concentrations between 2 mg/L and 162 mg/L of the test item. As the measured test item concentrations are within ± 20 % of the nominal concentrations, according to OECD 202  (13 April 2004), all results are given in relation to the nominal test item concentrations. All validity criteria were fulfilled. The test is valid according to OECD Test Guideline 202 (13 April 2004).

The following results were obtained: EC50 (24 h): > 162 mg/l and EC50 (48 h): > 162 mg/l.

Validity criteria fulfilled:

yes

Conclusions:

The Daphnia magna acute immobilisation test was performed with five concentrations between 0.03 mg/L and 2.7 mg/L of the test item. As the measured test item concentrations are not within ± 20 % of the nominal concentrations, according to OECD 202 (2004) and OECD 23 (2000), all results are given in relation to the analytically measured test item concentrations. The test is valid according to OECD Test Guideline 202 (13 April 2004). The following results were obtained: EC50 (24 h) = 1.20 mg/l (CL 0.51 – 4.82) and EC50 (48 h) = 0.54 mg/l (0.36 – 0.79).

Executive summary:

The Daphnia magna acute immobilisation test was performed with five concentrations between 0.03 mg/L and 2.7 mg/L of the test item. As the measured test item concentrations are not within ± 20 % of the nominal concentrations, according to OECD 202 (2004) and OECD 23 (2000), all results are given in relation to the analytically measured test item concentrations. Therefore, the geometric mean of all three

measurement times (0 h, 24 h and 48 h) was calculated. All validity criteria were fulfilled. The test is valid according to OECD Test Guideline 202 (13 April 2004). The following results were obtained: EC50 (24 h) = 1.20 mg/l (CL 0.51 – 4.82) and EC50 (48 h) = 0.54 mg/l (0.36 – 0.79).

Description of key information

The Daphnia magna acute immobilisation test was performed with five concentrations between 0.03 mg/L and 2.7 mg/L of the test item. As the measured test item concentrations are not within ± 20 % of the nominal concentrations, according to OECD 202 (2004) and OECD 23 (2000), all results are given in relation to the analytically measured test item concentrations. Therefore, the geometric mean of all three

measurement times (0 h, 24 h and 48 h) was calculated. All validity criteria were fulfilled. The test is valid according to OECD Test Guideline 202 (13 April 2004). The following results were obtained: EC50 (24 h) = 1.20 mg/l (CL 0.51 – 4.82) and EC50 (48 h) = 0.54 mg/l (0.36 – 0.79).

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

0.54 mg/L