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Ecotoxicological information

Short-term toxicity to aquatic invertebrates

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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:
2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Guideline compliant GLP study with good documentation.
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
- Concentrations: The concentrations of the test item Sulfosuccinic (FA C12-18)E, 2Na were analyzed in one of the duplicate test media samples from the nominal concentrations of 6.25 to 25 mg/L from both sampling times (0 and 48 hours). The samples of the nominal test concentrations of 50 and 100 mg/L were not analyzed since the concentrations were above the 48 hour EC100 determined in this test and, thus, were not relevant for the interpretation of the biological results. From the control, one of the duplicate samples was analyzed per sampling time, too.

- Sampling method: For the determination of the actual test item concentrations, duplicate samples were taken from each treatment at the start and at the end of the test (after 48 hours). For the 48-hour samples, the contents of the respective replicates were combined prior to sampling.

- Sample storage conditions before analysis: All samples were stored deep-frozen (at about -20 °C) immediately after sampling.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test medium of the highest nominal concentration of 100 mg/L was prepared by completely dissolving 100.7 mg of test item in 1000 mL of test water using ultrasonic treatment for 15 minutes and intense stirring for 15 minutes at room temperature. Adequate volumes of this test medium were diluted with test water to prepare the lower concentrated test media. The test media were prepared just before introduction of the daphnids (i.e., start of the test).
- Controls: dilution water only
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): NA
- Concentration of vehicle in test medium (stock solution and final test solution): NA
- Evidence of undissolved material (e.g. precipitate, surface film, etc): Throughout the entire test duration, all test media were clear solutions. Only at the concentrations of 25, 50 and 100 mg/L the solutions were foamy at the start of the test. At the observations after 24 and 48 hours all test media were clear and no foam was observed any more.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna Straus
- Strain: clone 5
- Source: A clone of this species (defined by the supplier as clone 5) was originally supplied by the University of Sheffield / UK in 1992. Since that time, the clone has been bred at Harlan Laboratories in reconstituted water of the quality identical to the water quality used in the tests (in respect to pH, main ions, and total hardness) and under temperature and light conditions identical to those of the test.
- Age at study initiation (mean and range, SD): At the start of the test, the organisms used in the test were 6 - 24 hours old and were not first brood progeny.
- Feeding during test: None
- Food type: NA
- Amount: NA
- Frequency: NA

ACCLIMATION
- Acclimation period: Not needed since the cultures were kept under conditions similar to the testing conditions

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
15 mg/L as CaCO3 (nominal from medium)
Test temperature:
21 °C
pH:
7.1 to 7.4
Dissolved oxygen:
dissolved oxygen concentrations in the test media and control were at least 8.2 mg/L
Nominal and measured concentrations:
control and 6.25, 12.5, 25, 50 and 100 mg active substance/L, measured concentrations were within 100 and 105% of the nominal concentrations of the biologiocal relevant samples of 6.25 to 25 mg test item/L for the freshly prepared and aged test solutions, respectively.
Details on test conditions:
TEST SYSTEM
- Test vessel: 100-mL glass beakers filled with 60 mL of test medium
- Type (delete if not applicable): The test vessels were covered with glass plates to reduce the loss of water by evaporation and to avoid the entry of dust into the solutions.
- Material, size, headspace, fill volume: 100-mL glass beakers filled with 60 mL of test medium
- Aeration: none
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- Biomass loading rate: >= 10 mL/daphnia

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted test water (AAP Medium) prepared according to the test guideline OECD 201 was used for this study.
- Culture medium different from test medium: no, the parental daphnids were adapted to teh medium already, the daphnids showed normal reproduction behaviour in the AAP medium.
- Intervals of water quality measurement: start and end

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16-hour light to 8-hour dark cycle with a 30-minute transition period
- Light intensity: approximately between 390 and 560 Lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
immobilization at 0, 24, and 48 hours

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2
- Justification for using less concentrations than requested by guideline: NA
- Range finding study: not reported
- Test concentrations: not reported
- Results used to determine the conditions for the definitive study: not reported
Reference substance (positive control):
yes
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
13 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: Immobilization
Remarks on result:
other: 95% C.I.:11-15 mg as/L
Details on results:
- Behavioural abnormalities: not reported
- Other biological observations: none
- Mortality of control: none
- Other adverse effects control: none
- Abnormal responses: none
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: none. analytics confirmed the correct dosage and teh stability of the test item under test conditions
- Effect concentrations exceeding solubility of substance in test medium: none
Results with reference substance (positive control):
- Results with reference substance valid?
- Mortality: as expected
- EC50/LC50: 0.94 mg/L
- Other: For evaluation of the quality of the daphnia clone and the experimental conditions, potassium dichromate is tested as a positive control twice a year. The result of the latest positive control test in September 2012 (48-hour EC50: 0.94 mg/L, Harlan Laboratories Study D64333) showed that the sensitivity of the test organisms was within the internal historical range (48-hour EC50 from 2000 to 2012: 0.43 1.1 mg/L).
Reported statistics and error estimates:
The NOEC, EC0 and EC100 were determined directly from the raw data. The 24- and 48-hour EC50 and the 95% confidence limits were calculated by Weibull Analysis.
Validity criteria fulfilled:
yes
Executive summary:

In the Klimisch 1 GLP study from Kimmel (2013) the acute toxicity of Sulfosuccinic (FA C12-18)E, 2Na on Daphnia magna was determined in an 48 hour static test according to OECD 202 and EU method C.2. The test was performed with concentrations of 6.25, 12.5, 25, 50 and 100 mg test item/L and a blank control. Four replicates with 5 daphnids each were set up. After 48 hours 0, 0, 0. 50, 100 and 100 % immobilization was observed in the control and at test concentrations of 6.25, 12.5, 25, 50 and 100 mg test item /L, respectively. Analytical measurements confirmed that the test solutions were correctly dosed and statble throughour the exposure period. Therefore the data were evaluated based on nominal concentrations. The EC50 is 13 mg as/L, the NOEC and EC0 is 6.25 mg test item/L.

The results are considered relevant and reliable for the risk assessment.

Description of key information

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Dose descriptor:
EC50
Effect concentration:
13 mg/L

Additional information

In the Klimisch 1 GLP study from Kimmel (2013) the acute toxicity of Sulfosuccinic (FA C12-18)E, 2Na on Daphnia magna was determined in an 48 hour static test according to OECD 202 and EU method C.2. The test was performed with concentrations of 6.25, 12.5, 25, 50 and 100 mg test item/L and a blank control. Four replicates with 5 daphnids each were set up. After 48 hours 0, 0, 0. 50, 100 and 100 % immobilization was observed in the control and at test concentrations of 6.25, 12.5, 25, 50 and 100 mg test item /L, respectively. Analytical measurements confirmed that the test solutions were correctly dosed and statble throughour the exposure period. Therefore the data were evaluated based on nominal concentrations. The EC50 is 13 mg as/L, the NOEC and EC0 is 6.25 mg test item/L.

The results are considered relevant and reliable for the risk assessment.