Registration Dossier

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

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:
2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Version / remarks:
OECD 202 (2004)
Deviations:
not specified
GLP compliance:
yes (incl. certificate)
Specific details on test material used for the study:
- Name of test material: 1,3,2-dioxathiane 2,2-dioxide
- IUPAC name: 1,3,2-Dioxathiane 2,2-dioxide
- Molecular formula: C3H6O4S
- Molecular weight: 138.14 g/mol
- Substance type: Organic
- Physical state: Solid
Vehicle:
not specified
Details on test solutions:
The primary stock solution used in the range-finding test was prepared by dissolving 10 mg of the test substance in 40 mL of dilution water – M4 and the total volume was completed to 100 mL, resulting in a concentration of 100 mg.L-1. To assist solubilization, the solution was stirred for 20 minutes in a magnetic stirrer and 5 minutes of ultrasonic dispersion was also applied. The secondary stock solutions of the 10 and 1 mg.L-1 were prepared by dilutions of the primary stock solution.

The stock solution used in the definitive test was prepared by dissolving 50 mg of the test substance in 40 mL of dilution water – M4 and the total volume was completed to 500 mL, resulting in a concentration of 100 mg.L-1. To assist solubilization, the solution was stirred for 20 minutes in a magnetic stirrer and 5 minutes of ultrasonic dispersion was also applied.
Test organisms (species):
Daphnia magna
Details on test organisms:
The test system used for this study is described below, according to Straus (1820):

Kingdom: Animalia
Phylum: Arthropoda
Subphylum: Crustacea
Class: Branchiopoda
Order: Cladocera
Family: Daphniidae
Genus: Daphnia
Species: Daphnia magna

Young Daphnia magna ≤ 24 hours old were obtained from the culture kept at the Ecotoxicology Laboratory, maintenance and cultivation records are archived at BIOAGRI.
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Hardness:
185.2 mg.L-1 CaCO3
Test temperature:
20.0 to 20.1 °C
pH:
7.7
Dissolved oxygen:
8.0 to 8.1 mg.L-1
Nominal and measured concentrations:
In the range-finding test the exposure conditions were: control; 0.1; 1; 10 and 100 mg.L-1
In the definitive test the exposure conditions were: control; 3.3; 6.5; 13; 25 and 50 mg.L-1
Details on test conditions:
TEST SYSTEM
Test vessel: 30 mL glass beakers

In the range-finding test the exposure conditions were:

a) Total number of organisms per each tested concentration or control: 10;
b) Number of replicates per each tested concentration and control: 2;
c) Number of organisms per test container: 5;
d) Volume: 15 mL of test solution per test container, 3 mL to each Daphnia;
e) The organisms were distributed randomly in the test container. Firstly, three organisms were placed in each test container and, finally, two organisms were added to the container;
f) Nominal used concentrations: control; 0.1; 1; 10 and 100 mg.L-1;
g) Temperature of the test solutions: 20.1 to 20.3°C;
h) Photoperiod: 16 hours of light and 8 hours of dark;
i) Parameters evaluated: immobility after 24 and 48 hours; and still animals were considered unable to swim for a period of 15 seconds of observation after mild agitation of the flasks.

In the definitive test the exposure conditions were:

a) Total number of organisms per each tested concentration or control: 20;
b) Number of replicates per each tested concentration and control: 4;
c) Number of organisms per test container: 5;
d) Volume: 15 mL of test solution per test container, 3 mL to each Daphnia;
e) The organisms were distributed randomly in the test container. Firstly, three organisms were placed in each test container and, finally, two organisms were added to the container;
f) Nominal used concentrations: control; 3.3; 6.5; 13; 25 and 50 mg.L-1;
g) Temperature of the test solutions: 20.0 to 20.5°C;
h) Photoperiod: 16 hours of light and 8 hours of dark;
i) Parameters evaluated: immobility after 24 and 48 hours; and still animals were considered unable to swim for a period of 15 seconds of observation after mild agitation of the flasks;
j) Analytical determination: content dissolved oxygen, pH of the test solutions and the test substance concentration were determined at the beginning of the test and after 48 hours.


TEST MEDIUM / WATER PARAMETERS
Source/preparation of dilution water: M4 (OECD 202)
pH: 7.7
Hardness: 185.2 mg.L-1 CaCO3
Dissolved oxygen: 8.0 to 8.1 mg.L-1
Temperature: 20.0 to 20.1°C

Reference substance (positive control):
yes
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
ca. 18.01 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Remarks:
95% confidence limits = 14.53 to 22.32 mg.L-1
Basis for effect:
not specified
Key result
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
ca. 38.56 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Remarks:
95% confidence limits = 29.64 to 50.16
Basis for effect:
not specified
Key result
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
ca. 3.3 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
other: immobility
Key result
Duration:
48 h
Dose descriptor:
LOEC
Effect conc.:
ca. 50 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
other: immobilization
Results with reference substance (positive control):
- Results with reference substance valid? yes
- EC50 (24 h): 1.03 mg/L (95% confidence limits = 0.91 to 1.17 mg.L-1).
Validity criteria fulfilled:
yes
Conclusions:
The 48-hours EC50 value of 1,3,2-Dioxathiane, 2,2-dioxide was 18.01 mg.L-1 (95% confidence limits = 14.53 to 22.32 mg.L-1).
Executive summary:

Assessing the toxicity to aquatic invertebrates, Daphnia magna was exposed to 1,3,2-dioxathiane 2,2-dioxide for 48 hours. The experiment was conducted according to OECD Guideline 202 (2004). The test gave a 48-h EC50 value of 18.01 mg.L-1 (95% confidence limits = 14.53 to 22.32 mg.L-1).

Description of key information

Study carried out according to guideline and with GLP compliance.

Key value for chemical safety assessment

EC50/LC50 for freshwater invertebrates:
18.01 mg/L

Additional information

In a static test conducted according to OECD 202 guideline an EC50 of 18.01 mg/L after 48 h based on mean measured concentration has been determined.