1,2-Ethandiylbis(oxy-2,1-ethandiyl)-dimethansulfonat

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:

8 - 11 February 2022

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2022

Report date:

2022

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

13 April 2004

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Version / remarks:

30 May 2008

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2-[2-(2-hydroxyethoxy)ethoxy]ethanol,methanesulfonic acid

Cas Number:

80322-82-3

Molecular formula:

C8H18O8S2

IUPAC Name:

2-[2-(2-hydroxyethoxy)ethoxy]ethanol,methanesulfonic acid

impurity 1

Reference substance name:

Water

EC Number:

231-791-2

EC Name:

Water

Cas Number:

7732-18-5

Molecular formula:

H2O

IUPAC Name:

Oxidane

impurity 2

Reference substance name:

1,2-Ethandiylbis(oxy-2,1-ethandiyl)-monomethanesulfonat

IUPAC Name:

1,2-Ethandiylbis(oxy-2,1-ethandiyl)-monomethanesulfonat

Test material form:

liquid

Details on test material:

Appearance: Dark yellow liquid
Batch No.: 01110008
Storage: -5 – 40 °C, container tightly closed, protected from light

Specific details on test material used for the study:

Batch no.: 01110008
Storage conditions: 2–8°C, protected from light

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

Samples were taken from all test media at the start of the test as well as after 24 hours in the fresh and old media and after 48 hours of exposure. At the start of the test, the samples were taken from the freshly prepared single test solution as well as from the pure test water serving as control. For all subsequent sampling time points, aliquots from the respective replicates were pooled per treatment before sampling.

All samples were diluted with acetonitrile to obtain a composition of sample:acetonitrile (6:4; v:v). Subsequently, the samples were stored deep-frozen (at about -20 °C) until analysis. In non-GLP preliminary experiments, the test item proved to be stable under these storage conditions.

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
The following test vessels were set up:
- Test solution (Tn); containing test water with test item (four replicates with five Daphnia each)
- Blank control (Bn); containing pure test water (four replicates with five Daphnia each)
- Since the test item is soluble, the single test solution was prepared by adding 100 mg/l of test item to test water in glassware and stirring it for ten minutes until dissolution.


The test vessels were filled with 50 ml of the respective test medium. Daphnia, aged less than 24 hours and already acclimatised to the test water, were introduced into the test media and the vessels were covered with a glass plate. The Daphnia were not fed during the test and the test vessels were not aerated.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISMS
- Test organism: Daphnia magna Straus, supplied by IES Ltd., 4108 Witterswil, Switzerland
- Breeding: The daphnids are cultivated in Elendt M4 medium at 18–22 °C, controlled at ±1 °C
- Illumination: 16 h per day, about 550-1100 lux, source: overhead white fluorescent tubes
- Medium: Reconstituted water (Elendt M4 medium)
- Feed: Suspension of Desmodesmus subspicatus in reconstituted water with an optical density at 680 nm of about 12 units. This results in a final concentration of about 0.1 units from Monday to Thursday
and 0.4 units on Fridays in the culture vessel.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test conditions

Hardness:

Hardness: 2.5 mM (based on the sum of Ca2+ and Mg2+), Carbonate Alkalinity: 0.8 mM

Test temperature:

18–22 °C, controlled at ±1 °C

pH:

7.5 to 7.8

Dissolved oxygen:

The minimum dissolved oxygen concentration in the controls and the test vessels was >=8.1 mg O2/l (required >=3 mg O2/l).

Salinity:

not reported

Conductivity:

not reported

Nominal and measured concentrations:

Since no significant effects were observed in the non-GLP range-finding test, the definitive test was performed as a limit-test at a nominal test item concentration of 100 mg/l.

The concentrations of Triethylene glycol dimethanesulfonate in the test media were determined by HPLC with UV detection in the samples from the test start as well as in the samples after 24 and 48 hours of exposure.
These analyses showed that the test item was correctly dosed and remained within 80–120% of the nominal concentration over the exposure period. Therefore, the effective concentrations ECx were assessed based on the nominal concentration of the test item.

Details on test conditions:

TEST SYSTEM
- Test vessel: 100 ml beakers, all-glass, with 50 ml of test medium, covered with a glass plate to avoid evaporation and contamination of the test solutions with dust
- Test medium: Elendt M4 medium; prepared with ultra-pure water (conductivity <1.5 µS/cm)
- Number of Daphnia: 20 individuals per test concentration, five per vessel
- Age: Less than 24 h
- Light: 16 hours photoperiod per day, about 550–1100 lux, supplied by overhead white fluorescent tubes
- Temperature: 18–22 °C, controlled at ±1 °C
- pH: 6 to 9. The pH should normally not vary by more than 1.5 units in one test.
- Feed: The Daphnia are not fed during the test
- Test type: Static exposure conditions
- Test duration: 48 h


RANGE-FINDING STUDY
Prior to the definitive test a non-GLP range finding test with nominal concentrations of 1, 10 and 100 mg/l of the test item was performed (two replicates for each of the test concentration and the control; five daphnids per replicate).


EFFECT PARAMETERS MEASURED
Observed immobility (inability to swim) of the daphnids: Observations of immobile Daphnia were made after 24 and 48 h of exposure. Any abnormal behaviour or appearance was reported.

Reference substance (positive control):

yes

Remarks:

Acute reference test with potassium dichromate conducted twice a year.

Results and discussion

Effect concentrations

Effect concentrations 1

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 2

Key result

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 3

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 4

Duration:

24 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

During the first 24 hours of the test, no immobilised test organisms were determined in the control and in the single test item concentration of 100 mg/l. Thus, the 24-hour EC50 was greater than 100 mg/l.

The no observed effect concentration (NOEC) after 24 hours was determined to be 100 mg/l.

After 48 hours of exposure, no immobilised test organisms were determined in the control and the single test item concentration of 100 mg/l. Thus, the 48-hour EC50 was greater than 100 mg/l.

The no observed effect concentration (NOEC) after 48 hours was determined to be 100 mg/l.

Results with reference substance (positive control):

Acute ref. test with K2Cr2O7 conducted twice a year. The EC50 value for the control of sensitivity for 24 h of exposure with K2Cr2O7 was estimated to be 1.6 mg/l (September 2021), which lies within the recommended range of 0.6–2.1 mg/l acc. to OECD Guideline 202.

Reported statistics and error estimates:

The effective concentration EC50 for 24 and 48 hours was estimated based on the concentration tested and immobilisation observed.

The no observed effect concentration (NOEC) is the highest test concentration for which the test item is observed to have an immobilisation rate not exceeding 10%. Thus, immobilisation rates >10% are considered to be significant.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Remarks:

All validity criteria i.e. immobilization in the controls <=10% and O2 concentrations at the end of the test >=3 mg/L were fulfilled.

Conclusions:

The acute toxicity of Triethylene glycol dimethanesulfonate (CAS no. 80322-82-3) to Daphnia magna was investigated according to the OECD guideline 202 under static exposure conditions over a period of 48 hours.

The median effect concentrations (EC50) of Triethylene glycol dimethanesulfonate on Daphnia magna were estimated to be >100 mg/l each nominal concentration after 24 and 48 h of exposure, respectively. The NOEC values were determined to be 100 mg/l each nominal concentration after 24 and 48 h of exposure, respectively. The results of the test can be considered reliable without restriction.

Executive summary:

The acute toxicity of Triethylene glycol dimethanesulfonate (CAS no. 80322-82-3) to Daphnia magna was investigated according to the OECD guideline 202 under static exposure conditions over a period of 48 hours.

The test item is liquid, 94.3% (area) pure and soluble in test water (Elendt M4 medium) up to at least 100 mg/l. The single nominal concentration tested was 100 mg/l.

The concentrations of Triethylene glycol dimethanesulfonate in the test media were determined by HPLC with evaporative light scattering detection in the samples from the test start as well as in the samples after 24 and 48 hours of exposure. These analyses showed that the single test concentration was correctly dosed and remained stable within 80–120% of the nominal value. Therefore, the effective concentrations ECx were assessed based on the nominal concentration of the test item.

In the control and at the test concentration of 100 mg/l, no immobilised test organisms were determined in the control and in the single test item concentration of 100 mg/l over the whole exposure period of 48 hours.

The biological test results of Triethylene glycol dimethanesulfonate to Daphnia magna after 24 and 48 hours of exposure are summarised in the following table based on nominal concentrations:

 

Parameter	Immobilisation (0-24 h) [mg/l]	Immobilisation (24-48 h) [mg/l]
EC50	>100	>100
NOEC	100	100

 

In conclusion, Triethylene glycol dimethanesulfonate (CAS no. 80322-82-3) had no acute toxic effects on Daphnia magna up to the nominal concentration of 100 mg/l under the conditions of the test.

All validity criteria were fulfilled.