Ethylene carbonate

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:

1992-06-09 to 1992-06-11

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP, limited details on methods provided.

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

other: EPA/600/4-85/013

Deviations:

no

GLP compliance:

no

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material:
N/A

Analytical monitoring:

no

Details on sampling:

N/A

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Weighed 8.02 g of test substance and diluted to 1 L

Test organisms (species):

Ceriodaphnia dubia

Details on test organisms:

TEST ORGANISM
- Common name: Water flea
- Source: In-house culture
- Age at study initiation (mean and range, SD): < 24 h

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Post exposure observation period:

None

Hardness:

37 mg/L

Test temperature:

19-21 C

pH:

7.3-7.5

Dissolved oxygen:

7.8-8.2 mg/L

Salinity:

N/A

Nominal and measured concentrations:

Nominal- Control, 250, 500, 1000, 2000, 4000, 8000 mg/L.

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: 50 ml beaker
- Aeration: No
- 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: Bee Tree Lake
-Chlorine-Total Residual- below detection
- Conductivity: 105 umhos
- Culture medium different from test medium: no
- Intervals of water quality measurement: 24 h


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mortality, 24 hr


TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2

Reference substance (positive control):

no

Key result

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

5 900 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: 95% confidence limits 5200-6800 mg/L

Details on results:

N/A

Results with reference substance (positive control):

N/A

Reported statistics and error estimates:

LC50 value calculated via Trimmed Spearman-Karber method. The 1000 mg/L concentration mortality data was not used in the statistical evaluation, as the slight increase in mortality was not monotonically proportional with the other dilutions.

Validity criteria fulfilled:

not specified

Conclusions:

A Klimisch 2 study (Mackenzie, 1992) on ethylene carbonate reported a 48-h LC50 value of 5900 mg/L.

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

27 Sep 2001 - 05 Feb 2002

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Name of test substance: ethylene carbonate
- Chemical name: 1,3-dioxolan-2-on
- Batch number: out of continuous production
- Substance number: 00/0884-1
- Date of production: EC-campaign 10/2000
- Product number: 81266
- CASn°: 96-49-1
- Aggregate state: solid
- Colour: colourless-yellowish
- Homogeneity: yes (at 50°C)

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage conditions: under N2, ambient
- Stability: The stability of the test substance is given for at least 2 years in a closed container (until 10/2002)

Analytical monitoring:

yes

Details on sampling:

Capillary gas chromatography after SPME (= solid phase micro extraction), evaluation by the internal standard metho d

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test substance was heated up to about 50 C° for about 1 hour. The test substance was stirred in M4 medium for about 10 minutes at 20 +/- 2°C. The nominal concentration of the stock solution was 100 mg/l. By diluting this stock solution with M4 medium, nominal concentrations (mg/l) of 0 (control), 100, 50, 25, 12.5 were prepared.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna
- Strain/clone: STRAUS 1820
- Source: Institut National de Recherche Chimique Appliquée, France, in 1978. From this date on this clone was cultured and bred continuously in the Laboratory Experimental Toxicology and Ecology of BASF AG in Ludwigshafen .
- Age of parental stock (mean and range, SD): Age of stock animals: 2-4 weeks; Age of the animals at the begin of exposition: 2- 24 h(starting with the 3rd breed of parent animals)
- Feeding during test: no

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

2.39 mmol/l

Test temperature:

18 - 22 °C (max . temperature difference 2°C )

pH:

The pH was found to be between 7.9-8 during the test period

Dissolved oxygen:

The oxygen content was found to be 8.4 to 8.6 mg/l during the test period

Conductivity:

603 uS/cm

Nominal and measured concentrations:

nominal: control, 12.5, 25, 50, 100 mg/L
measured: < 5-8, 8-10, not measured, not measured 86-92 mg/L
Within the precision of the analytical method the analytically determined values of the samples correspond to 64 - 92 % of the nominal ones.

Details on test conditions:

TEST SYSTEM
- Test temperature:18 - 22 °C (max . temperature difference 2°C )
- Test vessel: Test tubes with flat bottom
- Material, size, headspace, fill volume: glass (nominal volume 20 ml)
- Test volume: 10ml
- Loading (animals/ml): 0.5
- Number of animals/vessel: 5
- Total number of animals/conc.: 20
- Number of replicates/conc.: 4
- Number of replicates/control: 4
- Number of replicates for the measurement of pH and oxygen: 1
- Number of parallels without animals: 1 (parallel 5) per test concentration and control for measurement of the pH and oxygen content at the beginning of the exposition. This parallel was thrown away after measurement . 4 per test concentration and control for concentration control analysis.

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: A synthetic fresh water was used for culture and test purposes. This water was prepared on the basis of an ultrapure, demineralized water with a conductivity < 0.05 NS/cm. For the composition of this M4 medium see ISO 10706. After preparation the M4 medium is aerated for approximately 24 h until saturation with oxygen is reached.

- Properties of this medium :
* Total hardness: 2,20 - 3,20 mmol/L
* Alkalinity up to pH 4 .3: 0,80 - 1,00 mmol/L
* Molar ratio Ca:Mg : about 4:1
* pH value: 7,5 - 8,5
* Conductivity: 550 - 650 NS/cm

OTHER TEST CONDITIONS
- Illumination: Artificial light, type warm white (e.g . OSRAM L58 W31) day:night rhythm = 16 : 8 h
- Light intensity: About 1- 8 NE/(m^2•s) at a wave length of 400 - 750 nm
- Test parameter: Swimming ability of the test animals
- Check of the study and recording (swimming ability): Visually after 0, 24 and 48 h
- Measurement of temperature: Continuously during the whole test period in a separate vessel close the test vessels.
- Measurement of pH and oxygen: After Oh in an additional replicate without daphnids and after 48h in replicate 1 of each tested concentration.

Reference substance (positive control):

no

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Details on results:

Analytically measured relative minimum and maximum concentrations of the test substance in the test solutions in terms of nominal concentrations (mg/l) without stocked daphnids:
at 0h minimum 80% and maximum 89%
at 48h minimum 64% and maximum 92%

- 48h EC0: >= 100 mg/L
- 48 h EC 100: > 100 mg/L

Results with reference substance (positive control):

The EC50(24h) of the control substance potassium dichromate (non-GLP) was 0,92 mg/l
(Date of the last control experiment (non-GLP): 18 Sep 2001, project number : 97/0242/50/66) .

Reported statistics and error estimates:

Due to the results of the test no statistical evaluation of the data was performed.

Number of mobile daphnids in different test concentrations

Conc.	Parallel 1  (h)			Parallel 2  (h)			Parallel 3  (h)			Parallel 4  (h)			∑ (h)	∑ (h)
(mg/l)	0	24	48	0	24	48	0	24	48	0	24	48	24	48
control	5	5	5	5	5	5	5	5	5	5	5	5	20	20
100	5	5	5	5	5	5	5	5	5	5	5	5	20	20
50	5	5	5	5	5	5	5	5	5	5	5	5	20	20
25	5	5	5	5	5	5	5	5	5	5	5	5	20	20
12,5	5	5	5	5	5	5	5	5	5	5	5	5	20	20

Validity criteria fulfilled:

yes

Conclusions:

For both 24h and 48h timelines, the EC0 value was >= 100 mg/L whereas the EC50 and EC100 values were also > 100 mg/L with 95% confidence limits.

Description of key information

A Klimisch 2 study (Mackenzie, 1992) on ethylene carbonate reported a 48-h LC50 value of 5900 mg/L. Additionally, the Klimisch 2 study from Hisgen (2002) indicates the EC50 value to be > 100 mg/L. As the study from Hisgen resulted in an unbound value, the 48-h LC50 value of 5900 mg/L derived by Mackenzie was considered as the key value for this endpoint and for the PNEC derivation.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

5 900 mg/L

Additional information

The acute daphnia study of Mackenzie (1992) was used as key study for the PNEC derivation. The 48-h test was conducted according to EPA/600/4-85/013. The static test was performed at pH 7.3-7.5 at 19-21 °C. The nominal test concentrations were 0, 250, 500, 1000, 2000, 4000 and 8000 mg/L. A 48-h LC50 of 5900 mg/L for Cerodaphnia dubia was obtained in this study.