Sodium 1,4-bis(1,3-dimethylbutyl) sulphonatosuccinate

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Guideline and GLP compliant study

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: 0 (control), 100 mg test item /L
- 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 stability samples, the contents of the respective replicates were combined prior to sampling.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test medium was prepared by dissolving 50.1 mg of test item completely in 500 mL of test water using ultrasonic treatment for 15 minutes and intense stirring for 15 minutes at room temperature. The test medium was prepared just before introduction of the daphnids (i.e. start of the test).
- Eluate: no
- Differential loading: no
- Controls: dilution water only
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): no vehicle used
- Concentration of vehicle in test medium (stock solution and final test solution): not applicable
- Evidence of undissolved material (e.g. precipitate, surface film, etc): no, recoveries of freshly prepared and aged test solutions were 88% at both sampling times, indicating that no significant precipitation could have been occured.

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.
- Method of breeding: During breeding, daphnids are generally fed three times a week with an algal suspension of the green algae Desmodesmus subspicatus CHODAT, Strain No. 86.81 SAG, supplied by the Collection of Algal Cultures (SAG, Institute for Plant Physiology, University of Göttingen, 37073 Göttingen / Germany) and cultivated at Harlan Laboratories under standardized conditions or a mixture of this algal suspension and a commercial fish diet (Tetra Min® Hauptfutter, supplied by TETRA-Werke, 49304 Melle / Germany).
- Feeding during test: no
- Food type: NA
- Amount: NA
- Frequency: NA

ACCLIMATION
- Acclimation period: The test was conducted in AAP Medium. The parental daphnids are cultivated in water of the same quality (in respect to pH, main ions, and total hardness). Reconstituted test water (AAP medium) was prepared according to OECD Test Guideline No 201
- Acclimation conditions (same as test or not): Yes
- Type and amount of food: During breeding, daphnids are generally fed three times a week with an algal suspension of the green algae Desmodesmus subspicatus CHODAT, Strain No. 86.81 SAG, supplied by the Collection of Algal Cultures (SAG, Institute for Plant Physiology, University of Göttingen, 37073 Göttingen / Germany) and cultivated at Harlan Laboratories under standardized conditions or a mixture of this algal suspension and a commercial fish diet (Tetra Min® Hauptfutter, supplied by TETRA-Werke, 49304 Melle / Germany).
- Feeding frequency: three times a week
- Health during acclimation (any mortality observed): no health problems reported

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

15 mg/L as CaCO3

Test temperature:

The water temperature during the test was between 20 - 21 °C.

pH:

The pH values of the test medium and control were 7.0

Dissolved oxygen:

At the beginning and end of the test period, the dissolved oxygen concentration in the test medium and control was at least 7.4 mg/L.

Nominal and measured concentrations:

nominal concentrations: 0 (control), 100 mg test item/L
measured concentrations Control < LOQ, 100 mg/L: 88 mg/L in the freshly prepared and aged test solutions

Details on test conditions:

TEST SYSTEM
- Test vessel: 100-mL glass beakers filled with 50 mL of test medium
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- Biomass loading rate: 1 daphnia/10 mL

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: The test was conducted in AAP Medium. The parental daphnids are cultivated in water of the same quality (in respect to pH, main ions, and total hardness). Reconstituted test water (AAP medium) was prepared according to OECD Test Guideline No 201.
- Culture medium different from test medium: No
- Intervals of water quality measurement: start and termination of the exposure.

OTHER TEST CONDITIONS
- Photoperiod: A 16-hour light to 8-hour dark cycle with a 30-minute transition period was used. Light intensity during the light period was approximately between 390 and 560 Lux.
- Light intensity: Light intensity during the light period was approximately between 390 and 560 Lux.

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : NOEC, EC10, EC50 at 48 hours

TEST CONCENTRATIONS
- Spacing factor for test concentrations: NA since limit test
- Range finding study: performed but results were not reported.

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Duration:

48 h

Dose descriptor:

EC0

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: immobilization

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: immobilization

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: immobilization

Details on results:

- Behavioural abnormalities: none
- Other biological observations: not reported
- 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
- Effect concentrations exceeding solubility of substance in test medium: no

Results with reference substance (positive control):

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:

Since no immobilization was observed, the NOEC, EC0, EC50 and EC100 were determined directly from the raw data.

Table 1     Effect of Sodium di(1.3-dimethylbutyl) sulfosuccinate on the Mobility of Daphnia magna

Nominal test item concentration	No. of daphnids tested	Immobilized daphnids after 24 hours		Immobilized daphnids after 48 hours
[mg/L]		No.	[%]	No.	[%]
Control	20	0	0	0	0
100	20	0	0	0	0

 

 

Validity criteria fulfilled:

yes

Conclusions:

48-hour-EC50 to daphnids: >100 mg/L.

Executive summary:

In the Klimisch 1 GLP study from Kimmel (2013) the acute toxicity of Sodium di(1.3-dimethylbutyl) sulfosuccinate to Daphnia magna was determined in a static limit test according to EEC C.2 and OECD 202. The test was started with a control and a nominal concentrations of 100 mg test item. The concentrations were analyzed by HPLC analyses. The mean measured concentrations were 0 (control) and 88 mg/L for the nominal concentration of 100 mg/L at the start and end of the exposure. Since all values were > 80 % the results were based on nominal concentrations. For each test concentration and the control, 4 replicates with 5 daphinds each were set up in 100 mL vessels filled with 50 mL test solution. After 48 hours of exposure no immobilization was observed in the control and the 100 mg/L test solution. The corresponding 48 h EC10 and EC50 value are > 100 mg test item/L.

This study is considered to be acceptable for the risk assessment.

Description of key information

Daphnia 48-h: EC50 > 100 mg/L

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Dose descriptor:

EC50

Effect concentration:

100 mg/L

Additional information

In the Klimisch 1 GLP study from Kimmel (2013) the acute toxicity of Sodium di(1.3-dimethylbutyl) sulfosuccinate to Daphnia magna was determined in a static limit test according to EEC C.2 and OECD 202. The test was started with a control and a nominal concentrations of 100 mg test item. The concentrations were analyzed by HPLC analyses. The mean measured concentrations were 0 (control) and 88 mg/L for the nominal concentration of 100 mg/L at the start and end of the exposure. Since all values were > 80 % the results were based on nominal concentrations. For each test concentration and the control, 4 replicates with 5 daphinds each were set up in 100 mL vessels filled with 50 mL test solution. After 48 hours of exposure no immobilization was observed in the control and the 100 mg/L test solution. The corresponding 48 h EC10 and EC50 value are > 100 mg test item/L.

This study is considered to be acceptable for the risk assessment.