1-(3-sulphonatopropyl)-2-vinylpyridinium

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:

2017-11-21 - 2017-11-23

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

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 Immobilisa-tion Test”, adopted 30. May 2008

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: OECD guidance document no. 23, GUIDANCE DOCUMENT ON AQUATIC TOXICITY TESTING OF DIFFICULT SUBSTANCES AND MIXTURES, adopted 14. Dec. 2000

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

1-(3-sulphonatopropyl)-2-vinylpyridinium

EC Number:

229-565-3

EC Name:

1-(3-sulphonatopropyl)-2-vinylpyridinium

Cas Number:

6613-64-5

Molecular formula:

C10H13NO3S

IUPAC Name:

3-(2-vinylpyridinium-1-yl)propane-1-sulfonate

Test material form:

solid: particulate/powder

Remarks:

light beige

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: sponsor

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: The test item was stored dark and dry in a closed vessel at room temperature (15.8 - 22.5°C).

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 0, 4.6, 10, 22, 46, 100 mg/l
- Sampling method: 500 µL of samples in aqueous media were mixed with 500 µL acetonitrile in a vial each. Filtration using 0.45 µm Nylon filters is possible.

Test solutions

Vehicle:

yes

Remarks:

dilution water

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A solution containing 101 mg/L in dilution water was prepared. The solution was used as highest treatment and for preparation of lower concentrations by dilution with dilution water.
- Controls: yes, concurrent dilution water (negative control)
- 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: water flea
- Strain/clone: Daphnia magna STRAUS Berlin
- Source: Origin: Umweltbundesamt Berlin, In-house breeding since 27. September 2007
- Feeding during test: no

- Type and amount of food under culturing conditions: unicellular green algae (Desmodesmus subspicatus)

METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES:
Selection of Daphnia
23 hours before the start of the test, the adult animals were separated from the young. 40 minutes before test start, the adults were caught with the help of a glass tube, and the newborn daphnia, aged between 0 and 22 hours 20 minutes, were sieved from the medium and immediately placed into a beaker containing dilution water. After a settling-in period of 40 minutes, animals which showed no apparent damage were used for the test.
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:

no

Total exposure duration:

48 h

Post exposure observation period:

none

Test conditions

Hardness:

2.502 mmol/l / 250 mg CaCO3/l

Test temperature:

19.7 - 20.9°C

pH:

7.8

Dissolved oxygen:

After preparation, the dilution water was aerated; 8.5 - 9.1 mg/l

Nominal and measured concentrations:

Nominal: 0, 4.6, 10, 22, 46, 100 mg/l
Measured, at 0h: 0, 4.84, 10.20, 21.90, 45.38, 98.38 mg/l
Measured, at 48h: 0, 4.48, 10.31, 23.12, 48.92, 107.77 mg/ml
The concentrations to be tested are based on the result of a non-GLP pre-test.

Details on test conditions:

TEST SYSTEM
- Test vessel: Beakers, glass, nominal volume 50 mL, containing each 20 ± 5 mL test solution
- Type (delete if not applicable): open
- Aeration: dilution water was aerated
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Chlorine: 293.80 mg/l CaCl2*2H2O, 5.80 mg/l KCl
- Ca/mg ratio: 293.80 mg/l CaCl2*2H2O, 123.30 mg/l MgSO4*7H2O
- 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) : mobility daily, pH, oxygen content at 0 and 48h

VEHICLE CONTROL PERFORMED: yes

Reference substance (positive control):

yes

Results and discussion

Effect concentrations

Effect concentrations 1

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

95.94 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

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 3

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

46 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 4

Duration:

48 h

Dose descriptor:

LOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

- Mortality of control: none
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: none
- Effect concentrations exceeding solubility of substance in test medium: none

Results with reference substance (positive control):

The 24h-EC50 value was determined as 1.6 mg/L.
The value was within the requested range for the 24h-EC50 between 0.6 - 2.1 mg/L of potassium dichromate K2Cr2O7 as specified in the OECD guideline. Since the fits showed sufficient statistical correspondence of the data with the dose-response-equation, this reference study can be considered valid.

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 SPV towards daphnids.
The toxicity against Daphnia magna was tested in a static test design using 5 concentrations ranging from 4.6 to 100 mg/L. The analytical determinations of the test item showed very good correlation between nominal and measured concentrations and very good recovery rates. Therefore, the test item 1-(3-Sulfopropyl)-2-vinyl-pyridinumbetain (SPV) can be stated as stable under the test condition and the determination of the results was based on the nominal concentrations.
Only in the highest concentration 60% immobilisation was observed, the EC50 was determined to be 95.94 mg/l. Based on the obtained results, SPV does not need to be classified as acutely toxic to the environment, but as it is not biodegradable it should be classified as hazardous to the aquatic environment Cat. 3 (chronic) according to the Regulation (EC) No. 1272/2008.

Executive summary:

The study was conducted under GLP according to OECD guideline 202 and EU method C.2 on the registered substance itself.

One valid experiment was performed.

The study was performed using 5 concentrations ranging from 4.6 to 100 mg/L. For each test concentration, 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.

Only in the highest concentration 60% immobilisation was observed. None of the animals was immobilised in the blank control.

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-UV-determination. The concentrations determined at the start of the test were in a range from 98.38 to 105.17% of the nominal concentration. At the end of the test the determined concentrations were between 97.3 and 107.77% of the nominal concentration. The analytical determinations of the test item showed very good correlation between nominal and measured concentrations and very good recovery rates. Therefore, the test item 1-(3-Sulfopropyl)-2-vinyl-pyridinumbetain (SPV) can be stated as stable under the test conditions. Therefore, the determination of the results was based on the nominal concentrations.

The following results were determined for the test item 1-(3-Sulfopropyl)-2-vinyl-pyridinumbetain (SPV) (species: Daphnia magna):

48h-NOEC = 46 mg/L

48h-LOEC = 100 mg/L

24h-EC50 > 100 mg/L

48h-EC50 = 95.94 mg/L

SPV should be classified as hazardous to the aquatic environment Cat. 3 (chronic) according to Regulation (EC) No. 1272/2008.