5H-1,2-oxathiole 2,2-dioxide

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material:
Supplier: Shijiazhuang Suntec-chem Co., Ltd.
Batch No.: 200301
- Purity, including information on contaminants, isomers, etc.:
Purity: 99.90%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
Ambient(21 to 29℃)
- Solubility and stability of the test material in the solvent/vehicle and the exposure medium:
soluble and stable


TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing (e.g. warming, grinding):
no
- Preliminary purification step (if any):
- Final concentration of a dissolved solid, stock liquid or gel:
not specified

Analytical monitoring:

yes

Remarks:

HPLC

Vehicle:

yes

Remarks:

reverse osmosis water

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method:
direct dissolution
- Chemical name of vehicle (organic solvent, emulsifier or dispersant):
reverse osmosis water
- Concentration of vehicle in test medium (stock solution and final test solution(s) or suspension(s) including control(s)):
not applicable
- Test concentration separation factor:
1.8

Test organisms (species):

Cyprinus carpio

Details on test organisms:

TEST ORGANISM
- Common name:
common carp
- Source:
Fisheries Research and Information Center (Inland), Hebbal, Bangalore, Karnataka, India.
- Age at study initiation (mean and range, SD):
not specified
- Length at study initiation (length definition, mean, range and SD):
2.8 to 3.9 cm
- Weight at study initiation (mean and range, SD):
not specified


ACCLIMATION
- Acclimation period:
9 days before used for the test
- Acclimation conditions (same as test or not):
same as test
- Type and amount of food during acclimation:
ad libitum with commercial feed pellets (Kijaro Grow).
- Feeding frequency during acclimation:
once a day
- Health during acclimation (any mortality observed):
no mortality

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

176 mg CaCO3/L

Test temperature:

22.0 to 22.9°C

pH:

7.09 to 7.52

Dissolved oxygen:

80.5 to 91.4%

Nominal and measured concentrations:

0, 0.55, 0.99, 1.78, 3.21, 5.78 and 10.40 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel:
Thoroughly cleaned rectangular glass aquaria having the water holding capacity of 50 liters was used as test vessels.
- No. of organisms per vessel:
7
- No. of vessels per concentration (replicates):
1
- No. of vessels per control (replicates):
1
- Biomass loading rate:
0.53 wet weight of fish/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:
Reverse osmosis purified tap water
- Total organic carbon:
0.8676 mg/L

OTHER TEST CONDITIONS
- Adjustment of pH:
7.09 to 7.52
- Photoperiod:
12 hours
- Light intensity:
580.2 to 668.8 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :

TEST CONCENTRATIONS
- Spacing factor for test concentrations:
1.8
- Range finding study
- Test concentrations:
1.0, 10.0, 50.0, 75.0 and 100.0 mg/L
- Results used to determine the conditions for the definitive study:
Mortalities of 28.6, 100, 100, 100 and 100% were observed at respective concentration.

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

3.01 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: with 95% confidence limits, lower limit of 2.61 mg/L and upper limit of 3.48 mg/L

Details on results:

During main study, no clinical signs of toxicity were observed in the control group and at the tested concentration of 0.55 mg/L during the 96 hours of exposure period.

Clinical sign of abnormal horizontal orientation was observed at 24 hours observation and continued up to 96 hours exposure period at the tested concentration of 0.99 mg/L.

Clinical signs of abnormal horizontal orientation and hypoactivity were observed at 24 hours observation and continued up to 96 hours exposure period at the tested concentration of 1.78 mg/L.

Clinical signs of abnormal horizontal orientation and hypoactivity were observed at 2 hours observation and continued up to 96 hours exposure period at the tested concentration of 3.21 mg/L.

Clinical sign of abnormal horizontal orientation was observed at 2 hours observation and continued up 96 hours exposure period and clinical sign of hypoactivity was observed at 2 hours observation period and continued up to 30 hours at the tested concentration of 5.78 mg/L.

Clinical signs of abnormal horizontal orientation was observed at 2 hours observation and continued up 78 hours observtaion period and clinical sign of hypoactivity was observed at 2 hours observation period and continued up to 54 hours observation period at the tested concentration of 10.40 mg/L.

No mortality was observed in control group and at the tested concentration of 0.55 mg /L during the 96 hours exposure period. Percent mortalities of 14.3, 28.6, 57.1, 71.4 and 100.0% were observed at the tested concentrations of 0.99, 1.78, 3.21, 5.78 and 10.40 mg/L of 1,3-Propene Sultone respectively during the 96 hours exposure period.

Results with reference substance (positive control):

not applicable

Sublethal observations / clinical signs:

TABLE 5.     summary of Test CONCENTRATION ANALYSIS DURING MAIN study

Day 0 (0 hours - Fresh)
Particulars	Nominal Conc. (mg/L)	Conc. Obtained for1,3-Propene Sultone (mg/L)	Recovery (%)
G1	0.00	BLOQ	BLOQ
G2	0.55	0.6516	118.47
G3	0.99	1.1052	111.64
G4	1.78	2.0204	113.51
G5	3.21	3.5289	109.94
G6	5.78	5.8941	101.98
G7	10.40	10.0900	97.02
Day 4 (96 hours Spent)
G1	0.00	BLOQ	BLOQ
G2	0.55	0.5992	108.95
G3	0.99	0.8545	86.31
G4	1.78	1.9427	109.14
G5	3.21	3.1600	98.44
G6	5.78	5.5982	96.85
G7	10.40	9.5168	91.51

BLOQ:Below Limit of Quantification; NA: Not applicable

Validity criteria fulfilled:

yes

Conclusions:

The 96 hours acute Fish Median Lethal Concentration LC50 value of 1,3-Propene Sultone is 3.01 mg/L.

Executive summary:

The test item 1,3-Propene Sultone received from Shijiazhuang Suntec-chem Co., Ltd.was evaluated for the Acute Toxicity on Fish as per OECD Guidelines for Testing of Chemicals (Section 2), Effects on Biotic Systems, Guideline No. 203, “Fish Acute Toxicity Test” adopted on 18 June 2019.

The freshwater fish Cyprinus carpio was exposed to test itemover a period of 96 hours to determine the 96 hours Median Lethal Concentration (LC₅₀).

Dose Range Finding Study

Range finding study was conducted with5 concentrations of 1.0, 10.0, 50.0, 75.0 and 100.0 mg/L1,3-Propene Sultone.

No clinical sign of toxicity were observed in control group during the 96 hours exposure period.

Clinical signs of abnormal horizontal orientation and hypoactivity was observed during the 96 hours exposure period at the tested concentrations of 1.0, 10.0, 50.0, 75.0 and 100.0 mg/L.

No mortality was observed at control group, percent mortalities of 28.6, 100.0, 100.0, 100.0 and 100.0% were observed at the tested concentration of 1.0, 10.0, 50.0, 75.0 and 100.0 mg/L respectively during the 96 hours observation period.

Main Study

Based on the results of dose range finding study, main study was conducted at the concentrations of 0.55, 0.99, 1.78, 3.21, 5.78 and 10.40 mg/L of1,3-Propene Sultone along with control group.

During main study, noclinical signs of toxicity were observed in the control group and at the tested concentration of 0.55 mg/L during the 96 hours of exposure period

Clinical signs of abnormal horizontal orientation and hypoactivity was observed at during the 96 hours exposure period at the tested concentrations of 0.99, 1.78, 3.21, 5.78 and 10.40 mg/L.

No mortality was observed in control group and at the tested concentration of 0.55 mg /L during the 96 hours exposure period. Percent mortalities of 14.3, 28.6, 57.1, 71.4 and 100.0% were observed at the tested concentrations of 0.55, 0.99, 1.78, 3.21, 5.78 and 10.40 mg/L of1,3-Propene Sultonerespectively during the 96 hours exposure period.

Analytical Measurements

During main study the Dose formulation samples of 1,3-Propene Sultone were analyzed for dose concentration by HPLC method and the results are reported. The dose samples of1,3-Propene Sultonewereanalyzed by HPLC method and the results are found to be within the acceptable range of ± 20% to the nominal concentration.

Conclusion

The 96 hoursacute Median Lethal ConcentrationLC₅₀value of1,3-Propene Sultone is 3.01 mg/L, with 95% confidence limits, lower limit of 2.61 mg/L and upper limit of 3.48 mg/L

Description of key information

The 96 hours acute Fish Median Lethal Concentration LC50 value of 1,3-Propene Sultone is 3.01 mg/L (measuredinitial concentration) (95% confidence limit: 2.61 – 3.48 mg·L^-1).

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

3.01 mg/L