Ethyl 2,4-dimethyl-1,3-dioxolane-2-acetate

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 March 2002 to 15 March 2002

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

The test item was analytically verified via DOC analysis. However. no further detail on analysis is provided in the study report.

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

1984

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Version / remarks:

1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Niedersächsisches Umweltministerium, Hannover, Germany (d.d. 2002-03-11)

Specific details on test material used for the study:

- Solubility in water: 71.70 g/L (at room temperature)
- pH value: 6.4 (20 °C)
- Storage at the test facility: Refrigerator 7 ± 2 °C, protected from light and moisture
- ThTOC: 56.64%
- Expiry date: 2002-08-31

Analytical monitoring:

yes

Details on sampling:

After 0 h (new media) and 48 h (old media).

Vehicle:

no

Details on test solutions:

- Stock solution: 100 mg/L, prepared with dilution water
- Dispersion treatment: Agitation
- Evidence of undissolved material: No, the test item was clearly dissolved throughout exposure.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Strain/clone: STRAUS (Clone 5)
- Source: Institut für Wasser-, Boden- und Lufthygiene des Bundesgesundheitsamtes, Corrensplatz, 14195 Berlin, Germany.
- Breeder: Dr.U.Noack-Laboratorium, 31157 Sarstedt, Germany.
- Cullture conditions: In 2-3 L glass vessels with approximatively 1.8 L culture medium (Elendt M4 modified to a total hardness of 160-180 mg CaCO3/L), at 21 °C (temperatures of 20-25 °C were tolerated), in an incubator, 16 h illumination, illumination strength max 20 µmol·m-2·s-1.
- Age of test organisms: 2 - 24 h old (obtained by removing the mother animals twice within 22 h)
- Food type/amount/frequency: 5x weekly ad libitum with a mix of Scenedesmus subspicatus and Chlorella vulgaris (algae cell density of >1.0E+06 cells/mL).
- Feeding during test: No

ACCLIMATION
- Acclimation period: 2 h
- Acclimation conditions: same as test

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

248 mg/L CaCO3 (dilution water)

Test temperature:

20 ± 1 °C.

pH:

- Start: 7.95 (limit concentration), 7.79 (control)
- End: 7.74 - 7.64 (limit concentration), 7.54 - 7.59 (control)

Dissolved oxygen:

- Start: 8.25 mg/L (limit concentration), 8.20 mg/L (control)
- End: 7.80 - 7.85 mg/L (limit concentration), 7.80 - 7.87 mg/L (control)

Conductivity:

659 µS/cm (dilution water)

Nominal and measured concentrations:

- Nominal test concentrations: 0 (control) and 100 mg/L.
- Measured test concentrations: Recovery was see 'Any other information on materials and methods incl. tables'.

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass beakers (5 cm ID x 8 cm H) with a nominal volume of 50 mL
- Fill volume: 20 mL
- Type (open / closed): not specified
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: According to EEC 92/69 L383A C.2.
- Physico-chemical parameters: Prior to the start of the test, the pH-value, dissolved oxygen concentration, temperature, conductivity and total hardness of the test medium were measured. At the start of the test, the pH-value and dissolved oxygen concentration were measured in one additional replicate per concentration and control. After 48 h the same water parameters were measured in all replicates per concentration and control. The temperature was recorded throughout the test with a thermohygrograph.

OTHER TEST CONDITIONS
- Illumination: Diffuse light, 16 h illumination strength max. 20 µmol·m-2·s-1 (corresponding to 1200 lux).
- Photoperiod: 16/8 h light/dark cycle
- Equipment used: Oxygen: Oximeter, Oxi 530 (WTW); pH value: pH-Meter inoLab pH Level 1 (WTW); Temperature: Hygro-thermograph (Lufft); Water hardness: Spectrophotometer Cadas 100 LPG 158 (Dr. Lange); DOC-analyzer: multi N/C 3000, Analytik Jena

EFFECT PARAMETERS MEASURED
Immobilisation of daphnia after 24 and 48 hours exposure.

RANGE-FINDING STUDY
- Test concentrations: 1, 10 and 100 mg/L (non-GLP)
- Results used to determine the conditions for the definitive study: Yes. No biologically significant effect (≤10%) was seen at the highest test concentration (nominal 100 mg/L) after 48 h of exposure.

Reference substance (positive control):

yes

Remarks:

potassium dichromate (Feb/March 2002)

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

Details on results:

There was no biologically significant effect (≤10%) neither in the tested limit concentration nor in the control group.

Results with reference substance (positive control):

- Results with reference substance valid? Yes
- Relevant effect levels: 24-h EC50 = 1.4 mg/L (C.L. 1.1 - 1.8 mg/L).

Reported statistics and error estimates:

EC50 values were only calculated for the reference item via probit analysis. Calculation of the confidence intervals was carried out using standard procedures according to BREMG & TÜMPLING (1982)

Validity criteria fulfilled:

yes

Remarks:

See 'Any other information on materials and methods incl. tables'.

Conclusions:

The 48-h EC50 is >100 mg/L in freshwater aquatic invertebrates (Daphnia magna) based on nominal concentration.

Executive summary:

The acute toxicity of the substance to aquatic invertebrates was determined in a limit test according to OECD TG 202 and in compliance with GLP criteria. Daphnids (Daphnia magna, 4 replicates of 5 ) were exposed to 100 mg/L test item and a blank control for 48 hours under static conditions. The test item was measured via DOC analysis at the start of the test and after 48 hours of exposure, and recovery was determined to be 96.8 % (based on ThTOC).

After 24 and 48 hours of exposure, no biologically significant effect (≤10% immobilization) was observed in the tested limit concentration nor in the control group. Based on these findings the 48-h EC50 value was determined to be >100 mg/L (based on nominal concentration). All the OECD validity criteria were met.

Description of key information

The acute toxicity of the substance to aquatic invertebrates was determined in a limit test according to OECD TG 202 and in compliance with GLP criteria (Dr Noack, 2002). Daphnids (Daphnia magna, 4 replicates of 5 ) were exposed to 100 mg/L test item and a blank control for 48 hours under static conditions. The test item was measured via DOC analysis at the start of the test and after 48 hours of exposure, and recovery was determined to be 96.8 % (based on ThTOC).

After 24 and 48 hours of exposure, no biologically significant effect (≤10% immobilization) was observed in the tested limit concentration nor in the control group. Based on these findings the 48-h EC50 value was determined to be >100 mg/L (based on nominal concentration). All the OECD validity criteria were met.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

100 mg/L