Sodium (2-butoxyethoxy)acetate

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

04.10.2018 - 13.11.2018

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)

Version / remarks:

2004

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

TOXI-COOP ZRT., Arácsi út 97., 8230 Balatonfüred, Hungary

Analytical monitoring:

yes

Details on sampling:

For determination of the test item concentrations, four replicate samples (5 mL per replicate) were taken from the test solution (100 mg/L) and from the control at the start and at the end of the test. The analysis was performed by the analytical laboratory of TOXI-COOP ZRT.

Vehicle:

no

Details on test solutions:

The test solution was prepared by mechanical dispersion without using of any solubilising agent. An amount of 0.03 g test item was dissolved in 300 mL test medium (ISO Medium) resulting a nominal concentration of 100 mg/L. After the formulation procedure test animals were immediately introduced into the test solution or control.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Waterflea
- Strain: Straus
- Source: Laboratory of Hydrobiology (Central Agricultural Office, Directorate of Plant-, and Soil Protection), 2100 Gödöllő, Kotlán S. u. 3. Hungary
- Feeding during test: no

ACCLIMATION
- Acclimation period: 48h
- Acclimation conditions: same as test conditions
- Type and amount of food: concentrated algal suspension of Raphidocelis subcapitata during the holding
- Health during acclimation: no mortality

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

249 mg/L (as CaCO3)

Test temperature:

20.0 - 20.3°C

pH:

7.57 - 7.83

Dissolved oxygen:

7.28 - 7.41 mg/L

Nominal and measured concentrations:

Nominal concentration: 100 mg/L
Measured concentration: 106.2 mg/L (start); 109.6 mg/L (end)

Details on test conditions:

TEST SYSTEM
- Test vessel: glass beaker
- Material, size, fill volume: glass, 50 mL, 40 mL
- Aeration: no
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM PARAMETERS
- Preparation of dilution water: reconstituted water (ISO medium) according to OECD 202

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours of light and 8 hours dark cycle
- Light intensity: 1171 lux

EFFECT PARAMETERS MEASURED:
Each test vessel was observed for immobilized Daphnids at 24 and 48 hours after the beginning of the test.
The temperature, dissolved oxygen concentration and pH were measured in the test item treated and the control group at the start (before test solutions had been distributed into the test vessels) and in each test vessel at the end of the test. Additionally, the ambient temperature was measured continuously using a min/max thermometer in the climate chamber.

RANGE-FINDING STUDY
- Test concentrations: 0.1, 1.0, 10.0 and 100.0 mg/L
- Results used to determine the conditions for the definitive study: Yes, during range finding study no immobility was observed.

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

- Behavioural abnormalities:
- Observations on body length and weight: no
- Other biological observations: no
- Mortality of control: no
- Other adverse effects control: no
- Abnormal responses: no
- Any observations 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):

The date of the last study (Study Number: 392-202-4076) with reference item Potassium dichromate was: 20 – 21 September 2018.
The 24-h EC50: 1.48 mg/L, (95 % confidence limits: 1.21 – 1.71 mg/L).

Validity criteria fulfilled:

yes

Conclusions:

The 48-hour EC50 of the test item on Daphnia magna was determined to be >100 mg/L.

Executive summary:

The test item was evaluated for acute toxicity on Daphnia as per the OECD Guideline No. 202, “Daphina sp., Acute Immobilisation Test”. The acute toxicity study of the test item on Daphnia was performed to determine the 48 hours Effective Concentration (EC50) and to determine Lowest Observed Effect Concentration (LOEC) and No Observed Effect Concentration (NOEC). Daphnids were exposed to the test item by aqueous exposure under static condition. Daphnids were observed at 24 and 48 hours for signs of toxicity and immobility. Based on the results of the range finding study, a limit test was conducted as main study at the test concentration of 100.0 mg/L in the test medium along with a control. No clinical signs of toxicity were observed in control and in the tested concentration of 100 mg/L during the 48 hour observation period. During the main study, a sample from the test concentration was collected at the start and the end of the test and analyzed. Results showed that the test concentrations were within the acceptable range of ± 20% to the nominal concentrations. Therefore the results are based on the nominal concentration. Based on the results of the experiment it can be concluded that after 48 hours the EC50 of the test item on Daphnia is >100 mg/L. The No Observed Effect Concentration (NOEC) over the 48 hour exposure period is 100 mg/L, the and Lowest Observed Effect Concentration (LOEC) is >100 mg/L.

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

(Q)SAR

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification

Justification for type of information:

Please refer to QMRF and QPRF in the section "Attached justification"

Qualifier:

according to guideline

Guideline:

other: REACH guidance on QSAR R.6

Principles of method if other than guideline:

Calculation of acute toxicity in dapnia. Software used: ECOSAR 1.11 (EPISUITE) for chemical class "Neutral Organics-acid".

GLP compliance:

no

Remarks:

Not applicable for QSAR calculation

Specific details on test material used for the study:

SMILES: CCCCOCCOCC(=O)O

Analytical monitoring:

not required

Test organisms (species):

Daphnia sp.

Key result

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

15 293.602 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

ECOSAR v1.11 Class-specific Estimations

 

Not Related to an Existing ECOSAR Class Definition:

Estimates provided below use the Neutral Organics QSAR equations which represent baseline toxicity potential (minimum toxicity) assuming a simple non-polar narcosis model. Without empirical data on structurally similar chemicals, it is uncertain if this substance will present significantly higher toxicity above baseline estimates.                                 

 

NOTE: METAL ([Na], [Li] or [K]) HAS BEEN REMOVED FOR PROPER ESTIMATION.

SALTS SHOULD BE ENTERED IN ECOSAR AS THE NEUTRAL NON-SALT FORM OF THE MOLECULE CORRESPONDING TO EITHER THE FREE BASE OR CONJUGATE ACID.      

 

-> Acid moeity found: Predicted values multiplied by 10

 

Predicted ECOSAR Class	Organism	Duration	End Pt	mg/L (ppm)
Neutral Organics-acid	Daphnid	48-hr	LC50	15293.602

 

 

 

 

Validity criteria fulfilled:

yes

Conclusions:

Using ECOSAR v1.11 the short-term toxicity value for daphnia was calculated to be 15293.602 mg/L. The substance is within the applicability domain of the model.

Description of key information

The 48-hour EC50 of the test item on Daphnia magna was determined to be >100 mg/L.

Using ECOSAR v1.11 the short-term toxicity LC50 value for daphnia was calculated to be 15293.602 mg/L. The substance is within the applicability domain of the model.

Additional information

The test item was evaluated for acute toxicity on Daphnia as per the OECD Guideline No. 202, “Daphina sp., Acute Immobilisation Test”. The acute toxicity study of the test item on Daphnia was performed to determine the 48 hours Effective Concentration (EC50) and to determine Lowest Observed Effect Concentration (LOEC) and No Observed Effect Concentration (NOEC). Daphnids were exposed to the test item by aqueous exposure under static condition. Daphnids were observed at 24 and 48 hours for signs of toxicity and immobility. Based on the results of the range finding study, a limit test was conducted as main study at the test concentration of 100.0 mg/L in the test medium along with a control. No clinical signs of toxicity were observed in control and in the tested concentration of 100 mg/L during the 48 hour observation period. During the main study, a sample from the test concentration was collected at the start and the end of the test and analyzed. Results showed that the test concentrations were within the acceptable range of ± 20% to the nominal concentrations. Therefore the results are based on the nominal concentrations. Based on the results of the experiment it can be concluded that after 48 hours the EC50 of the test item on Daphnia is >100 mg/L. The No Observed Effect Concentration (NOEC) over the 48 hour exposure period is 100 mg/L, the and Lowest Observed Effect Concentration (LOEC) is >100 mg/L.

The short-term toxicity to aquatic invertebrates of the test substance was calculated using ECOSAR v.1.11 as part of EPISuite v4.11 from US Environmental Protection Agency. Using ECOSAR v1.11 the short-term toxicity LC50 value for daphnia was calculated to be 15293.602 mg/L (EPI Suite, 2014).