Sodium 3-(2-propyn-1-yloxy)-1-propanesulfonate

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:

2018-10-16 - 2018-10-18 (experimental phase)

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

under GLP

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:

Commission Regulation (EC) No. 440/2008, Method C.2. “Daphnia sp. Acute Immo-bilisation Test”, adopted 30. May 2008

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 3-(2-propyn-1-yloxy)-1-propanesulfonate

EC Number:

608-454-7

Cas Number:

30290-53-0

Molecular formula:

C6H9O4NaS

IUPAC Name:

Sodium 3-(2-propyn-1-yloxy)-1-propanesulfonate

Test material form:

liquid

Specific details on test material used for the study:

The test item was stored in the test facility in a closed vessel at room temperature (20 ± 5°C).

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 0, 100 mg/L
- Sample storage conditions before analysis: no

Test solutions

Vehicle:

no

Remarks:

test medium was used

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A solution containing 100.4 mg/L in dilution water was prepared.
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): none

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Strain/clone: Daphnia magna STRAUS Berlin
- Source: Daphnia magna is bred in the laboratory throughout the year. The animals are kept for the use in toxicity tests. They multiply by parthenogenesis, thus being genetically identical. The husbandry is performed similar to the method described in the OECD guideline.
- Age of parental stock (mean and range, SD):
- Feeding during test: no
- Food type: green algae (Desmodesmus subspicatus)

METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES:
18 hours 15 minutes before the start of the test, the adult animals were separated from the young. 0.5 hours before test start, the adults were caught with the help of a glass tube, and the newborn daphnia, aged between 18 hours 15 minutes, were sieved from the me-dium and immediately placed into a beaker containing dilution water. After the settling-in period, 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:

yes

Total exposure duration:

48 h

Post exposure observation period:

none

Test conditions

Hardness:

Resulting hardness in mmol/L: 2.502
Resulting hardness in mg CaCO3/L: 250

Test temperature:

20.5 – 21.8 °C

pH:

7.8

Dissolved oxygen:

8.7 - 8.8 mg/L O2

Nominal and measured concentrations:

Nominal: 0 / 100 mg/L
Measured, t=0h: n.d. / 106.5 mg/L
Measured, t=72h: n.d. / 117.8 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: beakers
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: glass beakers, nominal volume 50 mL, tall shape, 20 ± 5 mL fill volume
- Aeration: The dilution water was aerated after preparation.
- Renewal rate of test solution (frequency/flow rate): no
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 5
- No. of vessels per control (replicates): 5
- No. of vessels per vehicle control (replicates): n/a

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16/8 hours
- Light intensity: not stated, neon tubes

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : immobility after 24 and 48 hours, pH and O2 after 0 and 48 hours.

RANGE-FINDING STUDY
The concentrations to be tested are based on the result of a non-GLP pre-test.

Reference substance (positive control):

yes

Remarks:

Potassium dichromate K2Cr2O7 (CAS No. 7778-50-9) was used as positive control in a current reference study.

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:

NOEC

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:

LOEC

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

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

Results with reference substance (positive control):

- Results with reference substance valid? yes
- Relevant effect levels: 24h EC50
- Limit test: no
- Dose-response test: yes
- ECx: The 24h-EC50i value was determined as 1.9 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.

Reported statistics and error estimates:

Since no toxicity has occurred, no statistical evaluation is performed.

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. Positive and negative controls gave the appropriate response. Hence, the results can be considered as reliable to assess the toxicity of POPS-Na towards aquatic invertebrates.
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 107 % of the nominal concentration. At the end of the test the determined concentrations were 118 % of the nominal concentration. Therefore, the determination of the biological results was based on the nominal concentration.
The study was performed as a limit test at 100 mg/L. For each test concentration and the blank control, 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.
No toxicity could be observed in the treatment. None of the animals was immobilised in the blank control. So the 48h NOEC was so determined to be ≥ 100 mg/L, the EC50 > 100 mg/L. Hence, POPS-Na does not need to be classified as hazardous to the environment according to Regulation 1272/2008 and amendments, neither acute nor chronic.

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 as a limit test at 100 mg/L. For each test concentration and the blank control, 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.

No toxicity could be observed in the treatment. 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 107 % of the nominal concentration. At the end of the test the determined concentrations were 118 % of the nominal concentration. Therefore, the determination of the biological results was based on the nominal concentration.

Since no toxicity has occurred, no statistical evaluation is performed.

The following results were determined for the test item Propargyl 3-sulfopropyl ether, sodium salt (POPS-Na) (species: Daphnia magna).

 

48h-NOEC = ≥ 100 mg/L
48h-LOEC = > 100 mg/L
24h-EC50 = > 100 mg/L
48h-EC50 = > 100 mg/L

 

POPS-Na does not need to be classified as hazardous to the environment according to Regulation 1272/2008 and amendments, neither acute nor chronic.