Ethyl 2-methyl-1,3-dioxolane-2-acetate

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16 April 2013 to 16 May 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

Water samples were taken from the control and the 100 mg/L test vessel at 0 and 72 hours (fresh media) and at 24 and 96 hours (old media) and stored prior to quantitative analysis. Duplicate samples and samples at 24 (fresh media), 48 (old and fresh media) and 72 hours (old media) were taken and stored for further analysis if necessary. All samples were stored at approximately -20 °C.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
2000 mg of test material was dissolved in dechlorinated tap water and the volume adjusted to 500 mL to give a 4000 mg/L stock solution. The entire volume of the 4000 mg/L stock solution was then added to a final volume of 20 litres of dechlorinated tap water to give the 100 mg/L test concentration.
The media was stirred using a flat-bladed mixer to ensure adequate mixing and homogeneity.

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: Rainbow trout
- Age at study initiation: juveniles
- Length: at the end of the definitive test the fish had a mean standard length of 5.2 cm (sd = 0.3)
- Weight: at the end of the definitive test fish had a mean weight of 1.18 g (sd = 0.14)
- Feeding during test: No

ACCLIMATION
- Acclimation period: between 25 April to 7 May 2013.
- Acclimation conditions: Same as test (Fish were maintained in a glass fiber tank with a "single pass" water renewal system. The lighting cycle was controlled to give a 16 hours light and 8 hours darkness cycle with 20 minute dawn and dusk transition periods. The water temperature was controlled at approximately 14 °C with a dissolved oxygen content of greater than or equal to 10.0 mg O2/L. These parameters were recorded daily).
- Type and amount of food: The stock fish were fed commercial trout pellets which was discontinued approximately 24 hours prior to the start of the definitive test.
- Health during acclimation (any mortality observed): There was no mortality in the 7 days prior to the start of the test.

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

140 mg/L (as CaCO3)

Test temperature:

14 °C

pH:

8.0 - 8.5

Dissolved oxygen:

9.8 - 10.4 mg O2/L (96 - 101 % air saturation value)

Nominal and measured concentrations:

0 (control), 100 mg/L (nominal)

Details on test conditions:

TEST SYSTEM
- Test vessel: 20 L glass exposure vessels
- Type: closed (to reduce evaporation)
- Aeration: Yes, test vessels were aerated via narrow bore glass tubes
- Renewal rate of test solution: Test solutions were renewed daily to ensure that the concentrations of the test material remained near nominal and to prevent the build-up of nitrogenous waste products.
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: The mean weight value at the end of the definitive test gave a loading rate of 0.41 g bodyweight/litre (static volume).

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Laboratory tap water dechlorinated by passage through an activated carbon filter and partly softened.
- Total organic carbon: < 0.130 - 2.020 mg/L
- Pesticides: 0.000 - 0.027 µg/L
- Chlorine: 0.040 - 0.710 mg/L
- Conductivity: 315.000 - 486.000 µS/cm at 20 °C
- Culture medium different from test medium: No

OTHER TEST CONDITIONS
- Photoperiod: 16 hours light and 8 hours darkness with 20 minute dawn and dusk transition periods

EFFECT PARAMETERS MEASURED
Mortalities and sub-lethal effects of exposure were recorded at 3, 6, 24, 48, 72 and 96 hours after the start of exposure. The criteria of death were taken to be the absence of both respiratory movement and response to physical stimulation.

WATER QUALITY MEASUREMENT
The water temperature, pH and dissolved oxygen concentrations were recorded daily throughout the test. The measurements at 0 hours, and after each test media renewal at 24, 48 and 72 hours, represent those of the freshly prepared test preparations while the measurements taken prior to each test media renewal, and on termination of the test after 96 hours, represents those of the used or 24-hour old test preparations. The pH and oxygen were measured using a Hach HQ30d Flexi handheld meter and the temperature was measured using a Hanna Instruments HI 93510 digital thermometer.

TEST CONCENTRATIONS
- Range finding study
3 fish were added to each 20 L test and control vessels and maintained at 13 °C to 14 °C in a temperature controlled room with a photoperiod of 16 hours light and 8 hours darkness with 20 minute dawn and dusk transition periods for a period of 96 hours under static test conditions. Each vessel was covered to reduce evaporation. After 3, 6, 24, 48, 72 and 96 hours any mortalities or sub-lethal effects of exposure were determined by visual inspection of the test fish.
- Test concentrations: 0, 100 mg/L
- Results used to determine the conditions for the definitive study: Yes.

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

RANGE-FINDING TEST
The results showed no mortalities or sub-lethal effects at a test concentration of 100 mg/L. Based on this information, a single test concentration of 100 mg/L was selected for the definitive test.
Chemical analysis of the test preparations at 0 and 24 hours showed measured concentrations of 103 % and 100 % of nominal respectively, indicating that the test material was stable under test conditions.

DEFINITIVE TEST
- Mortality and Sub-Lethal Effects
There were no mortalities, or sub-lethal effects, in 7 fish exposed to a test concentration of 100 mg/L for a period of 96 hours. It was considered unnecessary and unrealistic to test at concentrations in excess of 100 mg/L.
- Test Solutions
The test solutions were observed to be a clear colourless for the duration of the test.
Analysis of the test preparations at 0, 24 and 96 hours showed measured test concentrations to range from 94% to 101% of nominal and so it was considered justifiable to estimate the LC50 values in terms of the nominal test concentrations only.

Validity criteria fulfilled:

yes

Conclusions:

Under the conditions of the study, the 96-hour LC50 was determined to be in excess of 100 mg/L.

Executive summary:

The short term toxicity to fish was investigated in a study which was conducted under GLP conditions and in accordance with the standardised guidelines OECD 203 and EU Method C.1.

Following a preliminary range-finding test, seven fish were exposed to an aqueous solution of test material, at a single concentration of 100 mg/L, for a period of 96 hours, under semi-static conditions. The number of mortalities and any sub-lethal effects of exposure in each test and control vessel were determined 3 and 6 hours after the start of exposure and then daily throughout the test until termination after 96 hours.

Under the conditions of the study, the 96-hour LC50 was determined to be in excess of 100 mg/L. Analysis of the test preparations at 0, 24 and 96 hours showed measured test concentrations to range from 94% to 101% of nominal and so it was considered justifiable to estimate the LC50 values in terms of the nominal test concentrations only.

Description of key information

96-hour LC50 > 100 mg/L (Oncorhynchus mykiss), OECD 203, EU Method C.1, Parr (2013)

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L

Additional information

The short term toxicity to fish was investigated in a study which was conducted under GLP conditions and in accordance with the standardised guidelines OECD 203 and EU Method C.1.

Following a preliminary range-finding test, seven fish were exposed to an aqueous solution of test material, at a single concentration of 100 mg/L, for a period of 96 hours, under semi-static conditions. The number of mortalities and any sub-lethal effects of exposure in each test and control vessel were determined 3 and 6 hours after the start of exposure and then daily throughout the test until termination after 96 hours.

Under the conditions of the study, the 96-hour LC50 was determined to be in excess of 100 mg/L. Analysis of the test preparations at 0, 24 and 96 hours showed measured test concentrations to range from 94% to 101% of nominal and so it was considered justifiable to estimate the LC50 values in terms of the nominal test concentrations only.

Since the study was conducted under GLP conditions and to standardised guidelines it was assigned a reliability score of 1 in line with the criteria of Klimisch (1997).