Registration Dossier

Diss Factsheets

Ecotoxicological information

Short-term toxicity to fish

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
27 to 31 December 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Test guideline compliant study, good documentation, no dose verification performed
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
not specified
GLP compliance:
not specified
Analytical monitoring:
no
Vehicle:
no
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Common name: Rainbow trout
- Source: Aquatic Research Organisms, Hampton, NH, USA
- Age at study initiation (mean and range, SD): 74 days
- Length at study initiation (length definition, mean, range and SD): less than or equal to 50 mm total length, uniform size
- Feeding during test: none
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
US EPA moderately hard, reconstituted water. Alkalinity and water hardness were 80 and 90 mg/l CaCO3, respectively.
Test temperature:
15 ± 2 ° C
pH:
pH was measured initially and daily thereafter.
pH ranged between 7.0-7.7 units
Dissolved oxygen:
Dissolved oxygen was measured initially and daily thereafter.
Dissolved oxygen ranged between 8.8-9.6 mg/l.
Nominal and measured concentrations:
The test concentrations were 0(control), 250, 500, 1000, 2000, and 4000 mg test material/L, corresponding to 200, 400, 800, 1600 and 3200 mg Sodium di(1.3-dimethylbutyl) sulfosuccinate /L
Details on test conditions:
TEST SYSTEM
- Test vessel: 4L polypropylene vessels containing 3 L water.
- Aeration: Oil-free air was supplied at less than or equal to 100 bubbles per minute to maintain equal to or greater than 60% saturation.

- No. of organisms per vessel: 5 per tank
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2
- Biomass loading rate: less than or equal to 1.0g/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: US EPA moderately hard, reconstituted water
- Conductivity: 190 to 200 µmohs in the controls; Conductivity increased in a dose-dependent manner, with control values at approximately 200 µmohs and 4000 ppm values at 550 µmohs.
- Culture medium different from test medium: no data
- Intervals of water quality measurement: measured initially and daily thereafter

OTHER TEST CONDITIONS
- Photoperiod: 16hr/8hr light/dark cycle


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
LC0
LC50
LC100

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2
- Range finding study: An initial 48-h range finding test was performed, with concentrations ranging from 1 to 1000 mg CT 444 90 L/L and 5 fish per group. in the control and up to 100 mg CT 444 90 L/L no mortality was observed. At 1000 mg CT 444 90 L/L all fish died within 48 hours.
Reference substance (positive control):
not specified
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
1 550 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
1 240 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
1 200 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
960 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Duration:
72 h
Dose descriptor:
LC50
Effect conc.:
1 200 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
72 h
Dose descriptor:
LC50
Effect conc.:
960 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
400 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
500 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
960 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
1 200 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
1 600 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
2 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
- Behavioural abnormalities: not reported
- Mortality of control: none
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: none reporetd
Reported statistics and error estimates:
Data were analyzed according to the Spearman-Karber method, Probit analysis, or graphical interpolation (where applicable).
Sublethal observations / clinical signs:

None of the fish exposed to 0 (control), 250 or 500 ppm died by 96 hours. The corresponding mortalities at 96 hours for fish exposed to 1000, 2000, and 4000 ppm were 10, 100, and 100%, respectively. Most of the deaths that occurred at these concentrations occurred within 24 hours.

Validity criteria fulfilled:
yes
Conclusions:
The LC50 is 960 mg Sodium di(1.3-dimethylbutyl) sulfosuccinate /L.
Executive summary:

The acute toxicity of the test material containing 80% Sodium di(1.3-dimethylbutyl) sulfosuccinate, 15% water and 5% ethyl alcohol to rainbow trout, Oncorhynchus mykiss, was determined in a static test. The test was performed according to OECD 203. Deviations to the guideline were not reported. The test was performed with a control and nominal 250, 500, 1000, 2000 and 4000 mg test material /L corresponding to 200, 400, 800, 1600 and 3200 mg Sodium di(1.3-dimethylbutyl) sulfosuccinate/L. For each test group, 2 replicates with 5 fish were set up. Dose verification analysis was not performed. During the study, the temperature of the test solutions ranged within 15 +/- 2°C. After 96 hours of exposure, 0, 0, 0, 1, 10 and 10 out of 10 fish had died in the control, 200, 400, 800, 1600 and 3200 mg Sodium di(1.3-dimethylbutyl) sulfosuccinate/L treatment groups. The 96 h LC50 was determined to be 960 mg Sodium di(1.3-dimethylbutyl) sulfosuccinate/L. The concentrations were based on nominal concentrations.

The results of this study are considered to be reliable with restrictions for the risk assessment.

Description of key information

LC50 for freshwater fish (rainbow trout) = 960 mg/L

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
960 mg/L

Additional information

For the data endpoint “Short-term toxicity to fish” in total 2 studies on freshwater fish are available: one Klimisch 2 key study and one disregarded study with Klimisch 3 score.

 

The non-GLP study from Cytec (Cooke 1990) was classified as Klimisch 2 key study. The study was conducted according to the appropriate guidelines, without major deviations in the in-life phase but without dose verification analysis. In this study the acute toxicity of a formulation containing 80 % Sodium di(1.3-dimethylbutyl) sulfosuccinate to rainbow trout, Oncorhynchus mykiss was determined in a static test. The non-GLP test was performed according to OECD 203. The acute toxicity of the test material containing 80% Sodium di(1.3-dimethylbutyl) sulfosuccinate, 15% water and 5% ethyl alcohol to rainbow trout, Oncorhynchus mykiss, was determined in a static test. The test was performed with a control and nominal 250, 500, 1000, 2000 and 4000 mg test material /L corresponding to 200, 400, 800, 1600 and 3200 mg Sodium di(1.3-dimethylbutyl) sulfosuccinate/L. For each test group, 2 replicates with 5 fish were set up. During the study, the temperature of the test solutions ranged within 15 +/- 2°C. After 96 hours of exposure, 0, 0, 0, 1, 10 and 10 out of 10 fish had died in the control, 200, 400, 800, 1600 and 3200 mg Sodium di(1.3-dimethylbutyl) sulfosuccinate/L treatment groups. The 96 h LC50 was determined to be 960 mg Sodium di(1.3-dimethylbutyl) sulfosuccinate/L. The concentrations were based on nominal concentrations. Since this study represents the technically and scientifically best study, it is considered reliable and relevant for the risk assessment of Sodium di(1.3-dimethylbutyl) sulfosuccinate.

 

Beside the key study, one disregarded Klimisch 3 study is available for this endpoint. This study is considered not to be relevant for the risk assessment but added for informational purposes here since no dose verification was performed and major deviations to the guidelines were observed, i.e., the oxygen concentration declined to 2.0 mg/L at the highest treatment level.

 

The Cytec study from Bowman (1987) was classified as Klimisch 3 study. In this study the acute toxicity of the test material containing 80% Sodium di(1.3-dimethylbutyl) sulfosuccinate, 15% water and 5% ethyl alcohol to bluegill sunfish, Lepomis macrochirus, was determined in a static test. The test was performed according to OECD 203. Deviations to the guideline other than the time and dose dependent decline of the dissolved oxygen concentration to 2 mg /L in the highest treatment level were not reported. The test was performed with a control and nominal 100, 180, 320, 560 and 1000 mg test material /L corresponding to 80, 144, 256, 448 and 800 mg Sodium di(1.3-dimethylbutyl) sulfosuccinate/L. For each test group, 1 replicate with 10 fish was set up. Fish weighed on average 0.30 g and had a mean length of 24 mm. Dose verification analysis was not performed. During the study, the temperature of the test solutions ranged within 22 +/- 1°C. After 96 hours of exposure, 0, 0, 0, 0, 0 and 1 out of 10 fish had died in the control, 80, 144, 256, 448 and 800 mg Sodium di(1.3-dimethylbutyl) sulfosuccinate/L treatment groups. A dose- and time -dependent decrease in dissolved O2 was noted: it ranged from 6.4 (control) to 3.1 mg/L (448 and 800 mg Sodium di(1.3-dimethylbutyl) sulfosuccinate/L) at 48 hours and 5.9 (control) to 2.0 mg/L (800 mg Sodium di(1.3-dimethylbutyl) sulfosuccinate/L) at 96 hours.The 96 h NOEC was determined to be 448 mg Sodium di(1.3-dimethylbutyl) sulfosuccinate/L. The 96 h LC50 was determined to be > 800 mg Sodium di(1.3-dimethylbutyl) sulfosuccinate/L. The concentrations were based on nominal concentrations.

The results of this study are considered to be reliable. However, the dose dependent decline of the oxygen concentration may have confounded the test material based mortality in the test solutions. Hence, this study has strong restrictions for the risk assessment.

Both studies demonstrate that the test material and hence Sodium di(1.3-dimethylbutyl) sulfosuccinate has only a low toxicity to fish. Hence, the study with the best test design and scientifically most sound results was selected as key study. Therefore, the acute LC50 of 960 mg Sodium di(1.3-dimethylbutyl) sulfosuccinate/L from the key study will be used for the further risk assessment.