1,3,2-dioxathiolane 2,2-dioxide

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:

Study initiation: 2012.02.09 Study completion: 2012.03.29

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)

GLP compliance:

yes

Specific details on test material used for the study:

Substance name: ESA
Chemical name: 1,3,2-Dioxathiolane, 2,2-dioxide
Receipt date: 2011.12. 26.
Term of Validity: 2013. 10.
Purity: 99.1 %
Appearance: Lemon yellow solid
Storage condition: Room temperature

Analytical monitoring:

yes

Details on sampling:

Stability test of test substance: Check was carried out by collecting 0.5 ml of test solution in each high·middle·low position at 0 hour, 24 hours and 48 hours after start of test.
Analysis of test substance: Samples were collected of 0.5 ml in each high·middle·low position of flask according to each concentration at 0 hour, 24 hours (before and after replacement of test solution) and 48 hours after start of test

Vehicle:

yes

Remarks:

Methyl Alcohol

Details on test solutions:

Test concentration was set up to 10.0 mg/L. The maximum test concentration was set up on the basis of maximum solubility (100,000 mg/L) of test substance for organic solvent (methyl alcohol). Nominal concentration was set up on the basis of results of range-finding test carried out for active ingredients of test substance (1.00, 5.00 and 10.00 mg/L). Immobilisation was not observed in control group, solvent control group and test substance treatment group 1.00, 5.00 and 10.00 mg/L for range-finding test.


Preparation of test solutions
Stock solution (100,000 mg/L, based on 99.1 % of active ingredients) was prepared by putting 1,009.1 mg of test substance into volumetric flask of 10 ml after measurement with analytical balance (sartorius CPA224S), and adding methyl alcohol up to marked line.
In solvent control group, 1.000 ml was prepared by adding test water after putting 0.1 ml of methyl alcohol in volumetric flask of 1,000 ml. 1,000 ml of test solution were prepared by adding test water after putting 0.010, 0.018, 0.032, 0.056 and 0.100 ml of stock solution into volumetric flask of 1,000 ml respectively.
In test solution, 100 ml was put into beaker by making 4 replicates per each nominal concentration (nominal concentrations of each flask were 1.0, 1.8, 3.2, 5.6 and 10.0 mg/L).
Stock solution and test solution were prepared on the day that the test started and test solution was replaced(at 24 hours). M4 medium was used for the control group.

Test organisms (species):

Daphnia magna

Details on test organisms:

Supplier
Name: Green Chemistry Team, Korea Environment Corporation
Address: Environmental Research Complex, Kyungseo-dong, Seo-gu, lncheon, Korea
Age of the test organisms: Juvenile daphnids. less than 24 hours old and from the third brood or above of that of healthy adults
Selection of the test species: Daphnia magna are the recommended species by the OECD guidelines for the testing of chemicals, Test No. 202: Daphnia sp., Acute Immobilisation Test(Adopted: 13 April 2004) and National Institute of Environmental Research Notification No. 2010-29(16 August 2010). This species was selected for this test because there is adequate comparative toxicological data available for evaluation of results.

Breeding condition
Breeding environment: The daphnia were bred in a 1 L cylindrical water bath. During breeding the temperature of the breeding water was 18 - 22 ºC and the photo-period was
16-hour light and 8-hour darkness. Food was supplied once per day in the afternoon; Pseudokirchnerie//a subcapitata.
Monitoring of breeding conditions: The photo-period for the breeding room was controlled by automatic lighting system. The temperature of daphnia breeding water was recorded once every day.
No alterations effecting the test were observed during monitoring .
Breeding water: The breeding water was prepared following OECD guidelines for the testing of chemicals, Test No. 202: Daphnia sp. Acute immobilisation test Annex 3 Elendt
M7 and M4 medium (Adopted: 13 April 2004) and aerated for more than 24 hours.

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

175 mg CaCO3 / L.

Test temperature:

20.33 °C (min 20.3 - max 20.4 °C)

pH:

7.88 (min 7.45 - max 8.22)

Dissolved oxygen:

7.82 mg/L (min 7.35 - max 8.18 mg/L)

Nominal and measured concentrations:

The nominal concentrations were 1.00, 1.80, 3.20, 5.60 and 10.00 mg/L (geometric series 1.78).
Measured concentrations
At 0 hour, the concentrations of EPA in the:t est solutions were 0.716, 1.440, 2.726, 4.960 and 11.310 mg/ L (71.6, 80.0, 85.2, 88.6 and 113.1 % of nominal
concentrations)
At 24 hours (before replacement for the new test solutions), the concentrations were 0.898, 1.548, 2.589, 4.735 and 10.963 mg/L (89.8, 86.0, 80.9, 84.6 and 109.6 % of nominal concentrations)
At 24 hours (after replacement for the new test solutions). the concentrations were 1.322, 2.464, 3.931. 6.752 and 12.598 mg/L (132.2, 136.9, 122.8, 120.6 and 126.0 % of nominal concentrations)
The concentrations of test solutions at 48 hours were 1.502, 2.794, 4.540, 8.520 and 14.948 mg/ L (150.2, 155.2, 141.9, 152.1 and 149.5 % of nominal concentrations)

The geometric means of concentrations (0 - 24 hours) were 0.082, 1.493, 2.657, 4.846 and 11 .135 mg/L (80.2, 82.9, 83.0, 86.5 and 111.4 % of nominal concentrations).
The geometric means of concentrations were 1.102, 2.058, 3.440, 6.215 and 12.429 mg/L (110.5, 114.4, 107.5, 11 1.0 and 124.3 % of nominal concentrations) during the test period (0 - 48 hours).

Details on test conditions:

Exposure conditions
20 daphnis less than 24 hours old, where divided into 4 groups of 5 animals each. 100 ml of test solutions was added to a 150 ml cylindric glass bath (85 mm H. x 60 mm ¢). The same expqsure condition as breeding condition was maintained. Feeding was not supplied during the test. Exposure was carried out in the semi-static system that test solution was replaced every 24 hours for 48 hours.

Control
M4 medium was used for control. Methyl Alcohol was used for solvent control.

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 12.429 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

> 11.135 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

Immobility and abnormal behaviors
Immobilisation was not observed in control group, solvent control group and test substance treatment group during the test period.

Results with reference substance (positive control):

24-hour acute toxicity study in daphnia magna was carried out with potassium dichromate (K2Cr2O7, Sigma- Aldrich Inc., Lot No. 05406KJ) on 17-19 January 2012.
24-hour EC50 was 1.117 mg/L (95% confidence limits: 0.956 - 1.313 mg/L). The result of the reference test was within the ranges of the OECD Guideline (0.6 - 2.1 mg/L).

Validity criteria fulfilled:

yes

Conclusions:

In the results that daphnia acute toxicity test of ESA was carried out in semi-static system, 48-hour EC50 was more than 12.429 mg/L (24- hour EC50 was more than 11.135 mg/L).
Determination of EC50 was based on mean measured concentrations. During the test period there was no disturbance which influenced test results.

Executive summary:

Results of acute immobilisation test that observe immobilisation and abnormal behaviors, by exposing Daphnia magna to test substance ESA under the semi-static (24-hour) system for 48 hours are as follows.

The test was carried out according to OECD guidelines for the testing of chemicals, Test No. 202: Daphnia sp., Acute Immobilisation Test (Adopted: 13 April 2004) and National Institute of Environmental Research Notification No. 2010-29 (16 August 2010) Regulations on designation of test institute for examination of toxicity of chemicals, etc. annex 5 chapter 2 clause 2 Daphnia sp., Acute Immobilisation Test.

The test was performed using a control, a solvent control and concentrations of 1.00, 1.80, 3.20, 5.60 and 10.00 mg/L (nominal concentration, geometric series 1. 78). Each geometric mean of test substance during the test period (0 - 48 hours) was 1.102, 2.058, 3.440, 6.215 and 12.429 mg/L (110.5, 114.4, 107.5, 111.0 and 124.3 % of nominal concentrations).

The test results are as follows:

Observation time	EC50 * (mg/L)	95 % confidence limits
24 hours	> 11.135	-
48 hours	> 12.429	-

*Median Effect Concentration, Based on Mean Measured Concentration

Immobilisation and abnormal behaviors were not observed in control group, solvent control group and test substance treatment group during the test period.

The mean of the temperature was 20.33 °C (min 20.3 - max 20.4 °C).

The mean of the pH was 7.88 (min 7.45 - max 8.22).

The mean of Dissolved Oxygen during exposure was 7 .82 mg/L (min 7 .35 - max 8.18 mg/L).

Description of key information

Results of acute immobilisation test that observe immobilisation and abnormal behaviors, by exposing Daphnia magna to test substance ESA under the semi-static (24-hour) system for 48 hours are as follows.

The test was carried out according to OECD guidelines for the testing of chemicals, Test No. 202: Daphnia sp., Acute Immobilisation Test (Adopted: 13 April 2004) and National Institute of Environmental Research Notification No. 2010-29 (16 August 2010) Regulations on designation of test institute for examination of toxicity of chemicals, etc. annex 5 chapter 2 clause 2 Daphnia sp., Acute Immobilisation Test.

The test was performed using a control, a solvent control and concentrations of 1.00, 1.80, 3.20, 5.60 and 10.00 mg/L (nominal concentration, geometric series 1. 78). Each geometric mean of test substance during the test period (0 - 48 hours) was 1.102, 2.058, 3.440, 6.215 and 12.429 mg/L (110.5, 114.4, 107.5, 111.0 and 124.3 % of nominal concentrations).

The test results are as follows:

Observation time	EC50 * (mg/L)	95 % confidence limits
24 hours	> 11.135	-
48 hours	> 12.429	-

*Median Effect Concentration, Based on Mean Measured Concentration

Immobilisation and abnormal behaviors were not observed in control group, solvent control group and test substance treatment group during the test period.

The mean of the temperature was 20.33 °C (min 20.3 - max 20.4 °C).

The mean of the pH was 7.88 (min 7.45 - max 8.22).

The mean of Dissolved Oxygen during exposure was 7 .82 mg/L (min 7 .35 - max 8.18 mg/L).

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Dose descriptor:

EC50

Effect concentration:

> 12.43 mg/L