Dimethyl[2-[(2-methyl-1-oxoallyl)oxy]ethyl](3-sulphopropyl)ammonium hydroxide

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2017-04-25 - 2017-04-27 (experimental phase)

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

OECD Guideline for Testing of Chemicals No. 202, adopted 13. Apr. 2004: ”Daphnia sp., Acute Immobilisation Test“

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Version / remarks:

Council Regulation (EC) No. 440/2008, Method C.2. “Daphnia sp. Acute Immobilisation Test”, adopted 30. May 2008

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Dimethyl[2-[(2-methyl-1-oxoallyl)oxy]ethyl](3-sulphopropyl)ammonium hydroxide

EC Number:

222-860-8

EC Name:

Dimethyl[2-[(2-methyl-1-oxoallyl)oxy]ethyl](3-sulphopropyl)ammonium hydroxide

Cas Number:

3637-26-1

Molecular formula:

C11H21NO5S

IUPAC Name:

dimethyl[2-[(2-methyl-1-oxoallyl)oxy]ethyl](3-sulphopropyl)ammonium hydroxide

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: The test item was stored in a closed vessel at room temperature (20 ± 5°C), away from humidity

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 0, 100 mg/L

Test solutions

Vehicle:

no

Details on test solutions:

- Method: A test solution containing 101.4 mg/L test item in dilution water was prepared by direct addition, to prepare the limit test concentration of nominal 100 mg/L.
- Controls: Blank control were 4 vessels, each containing 20 ± 5 mL dilution water and 5 Daphnia
- Evidence of undissolved material (e.g. precipitate, surface film, etc): none stated

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna
- Strain/clone: Berlin (Origin: Umweltbundesamt Berlin)
- Source: Daphnia magna is bred in the LAUS GmbH throughout the year. The animals are kept for the use in toxicity tests. They multiply by parthenogenesis, thus being genetically identical.
- Age of parental stock (mean and range, SD): In-house breeding since 2007-09-27
- Husbandry: The husbandry is performed similar to the method described in EN ISO 6341
Vessels: preserving glasses, nominal volume 2 L
Medium: M4-Medium (recipe of ELENDT)
Food: unicellular green algae (Desmodesmus subspicatus)
Medium renewal: twice a week
Photo period: 16/8 hours, using neon tubes
Temperature: 20 ± 2 °C
- Feeding during test: no

ACCLIMATION
- Acclimation period: none
- Acclimation conditions (same as test or not): Not the same, but switching from M4-medium (husbandry) to Dilution water (test) has been shown not to cause any detrimental effects for test Daphnia.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Post exposure observation period:

no

Test conditions

Hardness:

2.502 mmol/L; 250 mg CaCO3/L

Test temperature:

19.8 – 21.1 °C

pH:

7.6 - 7.7 at test start
7.8 - 7.9 at test end

Dissolved oxygen:

8.5 - 8.9 at test start
8.4 - 8.5 at test end

Nominal and measured concentrations:

Nominal: 100 mg/L (The study was performed as a limit test because in a non-GLP pre-test at the concentrations 1 / 10 / 100 mg/L no toxicity was observed)
Measured: t0h = 98 mg/L, t48h = 107 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: glass beakers, nominal volume 50 mL, tall shape
- Type (delete if not applicable): open
- Aeration: no
- Medium renewal: none
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:
Dilution water specification:
Parameter Concentration in mg/L
CaCl2*2H2O 293.80
MgSO4*7H2O 123.30
NaHCO3 64.80
KCl 5.80
Deviations from the nominal weighted loads were less than 5%. Exact values ae recorded in the raw data. After preparation, the dilution water was aerated and the pH was meas-ured. The pH was 7.7.
- Culture medium different from test medium: yes

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16/8 hours, using neon tubes

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : After 24 and 48 hours, the immobilised Daphnia were counted. The pH and the concentration of dissolved oxygen were measured at the beginning and at the end of the test.

VEHICLE CONTROL PERFORMED: no

RANGE-FINDING STUDY
- Test concentrations: 0 / 1 / 10 / 100 mg/L
- Results used to determine the conditions for the definitive study: since no immobilisation was observed in the non-GLP range-finder the definitive study was performed as a limit test at 100 mg/L nominal.

Reference substance (positive control):

yes

Remarks:

Potassium dichromate K2Cr2O7 (CAS No. 7778-50-9) was used as positive control in a current reference study to assure that the test conditions are reliable.

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 3

Duration:

48 h

Dose descriptor:

LOEC

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 4

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

- Behavioural abnormalities: none stated
- Mortality of control: 0%
- Other adverse effects control: none stated
- Abnormal responses: none stated
- 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

Results with reference substance (positive control):

Potassium dichromate K2Cr2O7 (CAS No. 7778-50-9) was used as positive control in a current reference study (16102801R201). The 24h-EC50 value was determined to be 1.8 mg/L. The 24h-EC50 of K2Cr2O7 should lie between 0.6 and 2.1 mg/L.

Reported statistics and error estimates:

95% confidence interval could not be determined as no immobilisation occurred.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The study was conducted under GLP according to OECD guideline 202 and EU method C.2 on the registered substance itself. The method is to be considered scientifically reasonable with no deficiencies in documentation or deviations from the guidelines, the validity criteria were met. Hence, the results can be considered as reliable to assess the toxicity of SPE towards daphnids.
The toxicity against Daphnia magna was tested in a static limit test at a nominal test concentration of 100 mg/L. The concentrations showed no toxicity. None of the animals were immobilised neither in the treatment nor in the control.
Based on the obtained results, sodium N,N-Dimethyl-N-(2-methacryloyloxyethyl)-N-(3-sulfopropyl)-ammonium betaine; (SPE) does not need to be classified as hazardous to the aquatic environment according to the Regulation (EC) No. 1272/2008.

Executive summary:

The acute toxicity of N-[2-(methacryloyloxy)ethyl]-N,N-dimethyl-3-sulfopropan-1-aminium hydroxide was determined in a study according to OECD TG 202 under GLP.

Findings and Results:

One valid experiment was performed.

The study was performed as a limit test at the concentration 100 mg/L. 20 Daphnia were exposed to the test item for 48 hours in a static test system. After 24 and 48 hours, the immobilised Daphnia were counted.

The treatment showed no significant toxicity. None of the animals were immobilised in the blank control, only 1 animal (5 % total) was immobilised in the treatment.

Potassium dichromate K2Cr2O7 (CAS No. 7778-50-9) was used as positive control in a current reference study to assure that the test conditions are reliable.

At the beginning and at the end of the test, the content of the test item in the test solutions was determined using HPLC - determination. The measured concentration was 98 % and 107 % of the nominal concentration. Therefore, the determination of the biological results was based on the nominal concentration.

The following results were determined for the test item N,N-Dimethyl-N-(2 -methacryloyloxyethyl)-N-(3-sulfopropyl)-ammonium betaine; (SPE) (species: Daphnia magna).

48h-NOEC ≥ 100 mg/L

48h-LOEC > 100 mg/L

24h-EC50 > 100 mg/L

48h-EC50 > 100 mg/L