Sodium 1,4-diisodecyl sulphonatosuccinate

Long-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Guidline compliant study according to most recent guideline.

Qualifier:

according to guideline

Guideline:

OECD Guideline 211 (Daphnia magna Reproduction Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: Control, 0.042, 0.084, 0.17, 0.34, 0.67 and 1.3 mg sulfosuccinate/L. Based on the biological results, samples from the nominal concentrations of 0.55 to 2,2 mg/L and the Control were analyzed.

- Sampling method: For determination of the test item concentrations, samples were taken from the freshly prepared test media of all test concentrations and from the control at one treatment period of the first, second and last week of the test (Day 0, 7 and 16, respectively). To determine the maintenance of the test item concentrations in the test media, stability samples were taken at the end of two test medium renewal periods of 48 hours (Days 2 and 9) and at the end of one renewal period of 72 hours (Day 19).
The following stability samples were taken in duplicate:
a) Samples taken from the actual test by combining the contents of all replicate test beakers after the end of the test medium renewal period.
b) Samples incubated during the renewal periods under the test conditions, without food and daphnids.
For each sampling time point and concentration level, one set of duplicate samples (10 mL) was taken without further dilution and one set of samples (8 mL) was directly diluted with methanol by a factor of 1.25. Subsequently, all samples were stored deep-frozen (at about -20 °C) until analysis was performed
The concentration of the test item Butanedioic acid, sulfo-, 1,4-diisodecyl ester, sodium salt was determined in one of the duplicate test media samples stored without further dilution and in one of the duplicate test media samples diluted with methanol before storage. From the overall six test concentrations only the four highest were analyzed. The two lowest test concentrations were below the NOEC determined in this test and thus, they were not relevant for the interpretation of the biological results.

- Sample storage conditions before analysis:
All samples were stored deep-frozen (at about –20 °C) till date of analysis.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Prior to the start of the test and prior to each test medium renewal, a stock solution of nominal 22 mg test item/L was freshly prepared by completely dissolving 22 mg of the test item (dosed in the range of 22.0 to 22.27 mg) in 1000 mL of test water using ultrasonic treatment for 15 minutes and stirring for 15 minutes at room temperature. This intensively stirred stock solution was used in a series of dilutions to prepare the test media of all test item concentrations.
- Controls: Dilution water
- Evidence of undissolved material (e.g. precipitate, surface film, etc): not reported

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna Straus
- Strain/clone: 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 this date, the clone is successfully bred at Harlan Laboratories in culture medium identical to the medium used for the test.
- Age of parental stock (mean and range, SD): at least 14 days but not older than 4 weeks.
- Feeding during test: yes
- Food type: The test animals were fed daily with a food mixture containing a suspension of green algae of the species Desmodesmus subspicatus (freshly grown at Harlan Laboratories) and a fish food suspension. The fish food suspension was prepared by dispersing 10 g of powdered commercial fish diet (TETRA MIN Hauptfutter, obtained from TETRA-Werke, 49304 Melle / Germany) in 500 mL of test water. The suspension was allowed to stand for 4 hours. Then, 400 mL of the supernatant were taken, diluted 1:1 with test water and boiled. The suspension was stored deep frozen in small quantities until use.
- Amount: The carbon contents of the algal and fish food suspensions were determined using a Shimadzu TOC 5000A Analyzer. The food amount (based on the measured concentrations of the total organic carbon (TOC) in the food suspensions) was 0.20 mg TOC per Daphnia and day.
- Frequency: daily

ACCLIMATION
- Acclimation period: not needed
- Acclimation conditions (same as test or not): similar conditions as in test, Each stock animal was maintained separately in a 100 mL glass beaker filled with about 80 mL culture medium and was transferred twice a week to fresh medium. The condition of the stock animals was frequently checked. No signs of stress were observed and the brood stock was healthy.
- Type and amount of food: see description of test conditions

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

21 d

Hardness:

2.5 mmol/L (= 250 mg/L as CaCO3)

Test temperature:

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

pH:

7.6 to 7.9

Dissolved oxygen:

at least 8.2 mg/L

Nominal and measured concentrations:

Nominal: Control, 0.042 (n.a.), 0.084 (n.a.), 0.17 (0.052), 0.34 (0.15), 0.67 (0.40) and 1.3 (0.76) mg sulfosuccinate/L. The biological results are based on mean measured sulfosuccinate concentrations (calculated as the time-weighted means over all measurements per test concentration with food). The mean measured values are presented in brackets behind the nominal concentrations.

n.a.: not analysed since the concentration was below the NOEC.

Details on test conditions:

TEST SYSTEM
- Test vessel: The test was performed in 100 mL glass beakers containing 80 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: fill volume 80 mL
- Aeration: no
- Renewal rate of test solution (frequency/flow rate): every 48 or 72 hours
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10
- Biomass loading rate: 1 daphnia / 80 mL

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water (Elendt M7 medium)
- Culture medium different from test medium: no
- Intervals of water quality measurement: At the beginning and end of each test medium renewal period, the pH and dissolved oxygen concentrations were measured in one replicate of each test concentration and of the control. At the same time, the water temperature was measured in one of the control replicates. Additionally, the room temperature was continuously monitored. The appearance of the test media was visually inspected and recorded at the beginning and end of each test medium renewal period.


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

VEHICLE CONTROL PERFORMED: no

Reference substance (positive control):

no

Duration:

21 d

Dose descriptor:

EC10

Effect conc.:

0.31 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality

Key result

Duration:

21 d

Dose descriptor:

EC10

Effect conc.:

0.15 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

reproduction

Duration:

21 d

Dose descriptor:

EC10

Effect conc.:

> 0.4 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

growth

Remarks on result:

other: No adverse effect > 5 % observed, hence the EC10 is > 0.76 mg/L

Details on results:

- Mortality of parent animals: yes, used for EC10 calculation. In the control and at the lower mean measured concentrations up to and including 0.15 mg sulfosuccinate/L, the survival of the test animals at the end of the test was at least 90% or higher. At the mean measured concentration of 0.40 mg sulfosuccinate/L, the survival was 60%. At the highest test concentration of 0.76 mg sulfosuccinate/L, all test animals were dead at observation on Day 1. Mortality up to 20% is regarded as natural and tolerated by the test guideline. Thus, the survival of Daphnia magna after 21 days was reduced at the mean measured concentrations of 0.40 and 0.76 mg/L.. The EC10 for mortality was calculated to be at 0.31 mg/L.
- Body length and weight of parent animals: The mean body length of the daphnids in the control was 4.06 ± 0.09 mm (mean ± standard deviation). At any test concentration up to and including the mean measured concentration of 0.15 mg sulfosuccinate/L, the mean body length was not significantly smaller compared to the control (Williams t-test, one-sided smaller, alpha = 0.05). First at the next higher mean measured concentration of 0.40 mg/L, the mean body length of surviving daphnids was statistically significantly reduced to in the mean 97% compared to the control. Hence, the EC10 is greater than 0.76 mg/L
- Type and number of morphological abnormalities: no visible abnormalities were observed at the test animals during the test
- Type and number of behavioural abnormalities: no visible abnormalities were observed at the test animals during the test
- Effect concentrations exceeding solubility of substance in test medium: none

- Analytical results:The measured test item concentrations in the freshly prepared test media of the nominal test concentrations of 0.28 to 2.2 mg/L were between 45 and 81% of the nominal values. In the aged test media samples without food, the measured concentrations were in the range of 17 to 67% of the nominal values. In the aged test media samples including food particles the mean test item concentrations were slightly lower than in the aged test media samples without food, 22 to 49% of the nominal values. The biological results are based on mean measured sulfosuccinate concentrations (calculated as the time-weighted means over all measurements per test concentration with food)

Reported statistics and error estimates:

The mean reproduction rates and mean body lengths of the daphnids at the test concentrations were both compared to the control by multiple Williams t-tests, one-sided smaller, alpha = 0.05. Additionally, the EC10 for the inhibition of the reproduction rate and the immobility after 21 days was calculated by Probit Analysis using linear maximum likelihood regression.

After 21 days 0, 0, 0, 0, 10 and 60% mortality was observed in the control and at nominal test concentrations of 0.1375, 0.275, 0.55, 1.1 and 2.2 mg/L, respectively.

The reproduction per parent daphina was 124.6 (10), 145.6 (10), 126.9 (10), 131.7 (10), 127.0 (10), and 98.6 (10) living offspring per parental animal

(number of parental daphinds used to calculate the mean are given in brackets) in the control and 0.1375, 0.275, 0.55, 1.1 and 2.2 mg/L, respectively

.

Summary of the results after 21 days of exposure of the test animals

 

 

	Control	Nominal (mean measured) concentration of sulfosuccinate [mg/L]
		0.042 (n.a.)	0.084 (n.a.)	0.17 (0.052)	0.34 (0.15)	0.67 (0.40)	1.3 (0.76)
Mortality [%] after 21 days of exposure	10^#	0	0	0	0	40^##	100^##
Mean reproduction rate (living offspring per adult)	109.4	112.0	108.3	128.2	75.7*	74.8*	0*
Mean reproduction rate in % of control	100.0	102.3	99.0	117.1	69.2	68.3	0
Mean body length of the adults [mm]	4.06	4.05	4.07	4.08	4.10	3.92**	n.ap.
Mean body length of the adults in % of control	100.0	99.9	100.3	100.5	101.0	96.6	n.ap.

 

*:        statistically significantly lower than the control value, results of an U-test, one-sided smaller,a= 0.05

**:      statistically significantly lower than the control value, results of a Williams t-test, one-sided smaller,a= 0.05

^#:         Mortality is regarded as biologically not relevant and the calculation is based on the surviving adults only.

^##:        Mortality is regarded as a toxic effect of the test item and the calculation is based on all adults (independently of their survival).

n.a.:    not analyzed

n.ap.: not applicable since all adult test animals were dead at observation on Day 1

 

The biological results can be summarized as follows (on the basis of mean measured concentrations of the test item

Parameter	Inhibition of reproduction rate	Immobility	Inhibition of growth
	(21 days)	(21 days)	(21 days)
EC10  [mg/L]	0.15	0.31	>0.40

 

Validity criteria fulfilled:

yes

Conclusions:

21-day EC10: 0.15 mg/L

Executive summary:

In the Klimisch 1 GLP study from Eckenstein (2015) the chronic toxicity of Butanedioic acid, sulfo-, 1,4-diisodecyl ester, sodium salt on Daphnia magna was determined in an 21 day semi-static test according to OECD 211. The test was performed with Control, 0.042 (n.a.), 0.084 (n.a.), 0.17 (0.052), 0.34 (0.15), 0.67 (0.40) and 1.3 (0.76) mg sulfosuccinate/L. The biological results are based on mean measured sulfosuccinate concentrations (calculated as the time-weighted means over all measurements per test concentration with food). The mean measured values are presented in brackets behind the nominal concentrations.

Ten replicates with 1 Daphnia each were set up. After 21 days 0, 0, 0, 0, 0, 40 and 100% mortality was observed in the control and at nominal test concentrations of 0.042 (n.a.), 0.084 (n.a.), 0.17 (0.052), 0.34 (0.15), 0.67 (0.40) and 1.3 (0.76) mg sulfosuccinate/L, respectively. The mean measured values are presented in brackets behind the nominal concentrations.

The reproduction per parent Daphnia was 109.4 (9), 112.0 (10), 108.3 (10), 128.2 (10), 75.7 (10), and 74.8 (10) living offspring per parental animal (number of parental daphinds used to calculate the mean are given in brackets) in the control and 0.042 (n.a.), 0.084 (n.a.), 0.17 (0.052), 0.34 (0.15), 0.67 (0.40) mg sulfosuccinate/L, respectively. The mean measured values are presented in brackets behind the nominal concentrations. Due to 100 % mortality at 1.3 (0.76) mg/L until day 1, there was no reproduction in the highest test concentration group.

 

The biological results were based on time weighed mean measured concentrations.

 

The EC10 for mortality is 0.31 mg/L, the EC10 for reproduction is 0.15 mg/L, the EC10 for growth is > 0.40 mg/L. For the risk assessment, the more conservative EC10, i.e., the EC10 for reproduction was used.

 

The result is considered relevant and reliable for the risk assessment.

Description of key information

21-d EC10 (reproduction): 0.15 mg/L

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Dose descriptor:

EC10

Effect concentration:

0.15 mg/L

Additional information

In the Klimisch 1 GLP study from Eckenstein (2015) the chronic toxicity of Butanedioic acid, sulfo-, 1,4-diisodecyl ester, sodium salt on Daphnia magna was determined in an 21 day semi-static test according to OECD 211. The test was performed with Control, 0.042 (n.a.), 0.084 (n.a.), 0.17 (0.052), 0.34 (0.15), 0.67 (0.40) and 1.3 (0.76) mg sulfosuccinate/L. The biological results are based on mean measured sulfosuccinate concentrations (calculated as the time-weighted means over all measurements per test concentration with food). The mean measured values are presented in brackets behind the nominal concentrations.

Ten replicates with 1 Daphnia each were set up. After 21 days 0, 0, 0, 0, 0, 40 and 100% mortality was observed in the control and at nominal test concentrations of 0.042 (n.a.), 0.084 (n.a.), 0.17 (0.052), 0.34 (0.15), 0.67 (0.40) and 1.3 (0.76) mg sulfosuccinate/L, respectively. The mean measured values are presented in brackets behind the nominal concentrations.

The reproduction per parent Daphnia was 109.4 (9), 112.0 (10), 108.3 (10), 128.2 (10), 75.7 (10), and 74.8 (10) living offspring per parental animal (number of parental daphinds used to calculate the mean are given in brackets) in the control and 0.042 (n.a.), 0.084 (n.a.), 0.17 (0.052), 0.34 (0.15), 0.67 (0.40) mg sulfosuccinate/L, respectively. The mean measured values are presented in brackets behind the nominal concentrations. Due to 100 % mortality at 1.3 (0.76) mg/L until day 1, there was no reproduction in the highest test concentration group.

 

The biological results were based on time weighed mean measured concentrations.

 

The EC10 for mortality is 0.31 mg/L, the EC10 for reproduction is 0.15 mg/L, the EC10 for growth is > 0.40 mg/L. For the risk assessment, the more conservative EC10, i.e., the EC10 for reproduction was used.

 

The result is considered relevant and reliable for the risk assessment.