Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Ecotoxicological information

Long-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

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, 0.1375, 0.275, 0.55, 1.1 and 2.2 mg Sulfosuccinic (FA C12-18)E, 2Na /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 timepoint and concentration level, one set of duplicate samples (8 mL) were directly diluted with methanol by a factor of 1.25 and another set of duplicate samples (10 mL) was taken without further dilution as backup. Subsequently, all samples were stored deep-frozen (at about -20 °C) until analysis was performed.
For all test and control samples, the concentration of the test item Sulfosuccinic (FA C12-18)E, 2Na was determined in one of the duplicate test media samples diluted with methanol before storage. To confirm the initially obtained analytical results for the stability samples from day 2/48 h, the duplicate test media samples diluted with methanol before storage as well as one of the backup samples were (re)analyzed.

- 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 30 mg/L was freshly prepared by completely dissolving 30 mg of the test item (dosed in the range of 29.98 to 30.12 mg) in 1000 mL of test water using 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): none, dose verification indicated correct dosage and stability of the test solutions.
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 maintained at 21 °C
pH:
7.6 to 8.0
Dissolved oxygen:
at least 8.3 mg/L
Nominal and measured concentrations:
Nominal: Control, 0.1375, 0.275, 0.55, 1.1 and 2.2 mg Sulfosuccinic (FA C12-18)E, 2Na/L, the biological data were based on nominal concentrations.
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
Key result
Duration:
21 d
Dose descriptor:
EC10
Effect conc.:
1.1 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality
Remarks on result:
other: 95%CI 0.27 – 1.49 mg/L
Duration:
21 d
Dose descriptor:
EC10
Effect conc.:
1.6 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
reproduction
Remarks on result:
other: 95% CI 0.38 - 1.86 mg/L
Duration:
21 d
Dose descriptor:
EC10
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
growth
Remarks on result:
other: No adverse effect observed
Details on results:
- Mortality of parent animals: yes, used for EC10 calculation.In the control and up to and including the test concentration of 0.55 mg/L, the survival of the test animals at the end of the test was 100%. In the two highest test concentrations mortality was observed, 10% at 1.1 mg/L and 60% at 2.2 mg/L.
- No. of offspring produced per day per female:The mean reproduction rate of the daphnids in the control was 125 ± 24 living offspring per reproductive adult (mean ± standard deviation.No statistically significant inhibitory effect of the test item on the mean reproduction rate was determined up to and including the highest test concentration of 2.2 mg/L. The EC10 for the mean reproduction rate was calculated to be at 1.6 mg/L (confidence limits: 0.38-1.86 mg/L).
- Body length and weight of parent animals: The mean body length of the daphnids in the control was 4.1 ± 0.04 mm (mean ± standard deviation). No statistically significant inhibitory effect of the test item on the mean body length was determined up to and including the highest test concentration of 2.2 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: In the biologically relevant dose groups, the measured test item concentrations in the freshly prepared test media of the nominal concentrations of 0.55 to 2.2 mg/L were between 89 and 112% of the nominal values at the start of the test medium renewal periods. In the aged test media samples without food, the measured concentrations as % nominal were between 83 and 104%. Therefore, the biological results were based on nominal concentrations.
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 test item concentrations
[mg/L]

 

0.1375

0.275

0.55

1.1

2.2

Mortality [%] after 21 days of exposure

0

0

0

0

10

60

Mean reproduction rate (living offspring per adult)

124.6

145.6

126.9

131.7

127.0

98.6

Mean reproduction rate in % of control

100.0

116.9

101.8

105.7

101.9

79.1

Mean body length of the adults [mm]

4.12

4.12

4.05

4.10

4.17

4.19

Mean body length of the adults in % of control

100.0

100.0

98.4

99.6

101.2

101.7

 

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

Parameter

Inhibition of reproduction rate

Immobility

Inhibition of growth

(21 days)

(21 days)

 

EC10  [mg/L]

1.6

1.1

n.d.

95% confidence interval

0.38 - 1.86

0.27 – 1.49

n.d.

 

n.d.: could not be determined, due to lack of inhibitory effects

 

):

Validity criteria fulfilled:
yes
Conclusions:
21-day EC10: 1.1 mg/L
Executive summary:

In the Klimisch 1 GLP study from Eckenstein (2015) the chronic toxicity of Sulfosuccinic (FA C12-18)E, 2Na on Daphnia magna was determined in an 21 day semi-static test according to OECD 211. The test was performed with concentrations of 0.1375, 0.275, 0.55, 1.1, and 2.2 mg Sulfosuccinic (FA C12-18)E, 2Na /L and a blank control. Ten replicates with 1 Daphnia each were set up. After 21 days 0, 0, 0, 0, 10, 60 and 100% mortality was observed in the control and at nominal test concentrations of 0.1375, 0.275, 0.55, 1.1, and 2.2 mg Sulfosuccinic (FA C12-18)E, 2Na /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

 

In the biologically relevant dose groups, the measured test item concentrations in the freshly prepared test media of the nominal concentrations of 0.55 to 2.2 mg/L were between 89 and 112% of the nominal values at the start of the test medium renewal periods. In the aged test media samples without food, the measured concentrations as % nominal were between 83 and 104%. Therefore, the biological results were based on nominal concentrations.

 

The EC10 for mortality is 1.1 mg/L, the EC10 for reproduction is 1.6 mg/L. Length was not affected. For the risk assessment, the more conservative EC10, i.e., the EC10 for mortality was used.

 

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

Description of key information

21-day EC10: 1.1 mg/L

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Dose descriptor:
EC10
Effect concentration:
1.1 mg/L

Additional information

In the Klimisch 1 GLP study from Eckenstein (2015) the chronic toxicity of Sulfosuccinic (FA C12-18)E, 2Na on Daphnia magna was determined in an 21 day semi-static test according to OECD 211. The test was performed with concentrations of 0.1375, 0.275, 0.55, 1.1, and 2.2 mg Sulfosuccinic (FA C12-18)E, 2Na /L and a blank control. Ten replicates with 1 Daphnia each were set up. After 21 days 0, 0, 0, 0, 10, 60 and 100% mortality was observed in the control and at nominal test concentrations of 0.1375, 0.275, 0.55, 1.1, and 2.2 mg Sulfosuccinic (FA C12-18)E, 2Na /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

 

In the biologically relevant dose groups, the measured test item concentrations in the freshly prepared test media of the nominal concentrations of 0.55 to 2.2 mg/L were between 89 and 112% of the nominal values at the start of the test medium renewal periods. In the aged test media samples without food, the measured concentrations as % nominal were between 83 and 104%. Therefore, the biological results were based on nominal concentrations.

 

The EC10 for mortality is 1.1 mg/L, the EC10 for reproduction is 1.6 mg/L. Length was not affected. For the risk assessment, the more conservative EC10, i.e., the EC10 for mortality was used.

 

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