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Ecotoxicological information

Short-term toxicity to fish

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Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
equivalent or similar to
Guideline:
other:
Version / remarks:
Based on EPA 540/9-85-006
Principles of method if other than guideline:
Based on EPA 540/9-85-006
GLP compliance:
yes
Specific details on test material used for the study:
Proxel Press Paste
Batch number: SRC/ASG/NBY2668/35
Purity 76.1%
Analytical monitoring:
yes
Details on sampling:
Test system solutions were collected at 0 time, 48 and 96 hours and analyzed for the test substance. No delay in analysis was reported.
Vehicle:
no
Details on test solutions:
Nominal
mg/l
Control
3.2
5.6
10
18
32
Test organisms (species):
Cyprinodon variegatus
Details on test organisms:
Criteria Details
Species/strain Sheepshead minnow (Cyprinodon variegates)
Source Sea Plantations Inc. Salem, Massachusetts, USA
Wild caught No
Age/size Age not reported. Data for control fish at termination of study, weight range 0.33 to 0.79 g, mean 0.057 g, length 23 to 30 mm, mean 27 mm.
Kind of food Promin® (batch FF196/1)
Amount of food Not Reported
Feeding frequency Not Reported (Not fed during conduct of the study or the 48 hours prior)
Pretreatment Fish were held in the dilution water for 10 days prior to study. Temperature 22±1°C. No medication given to fish.
Feeding of animals during test No (fasted for 48 hours prior to study initiation)
Test type:
static
Water media type:
saltwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
Not Reported
Test temperature:
22°C
pH:
8.1
Dissolved oxygen:
7.0 mg/l (control at Day 0)
Salinity:
35.1%
Nominal and measured concentrations:
Nominal
0 Hour 48 Hour 96 Hour
Control <0.0099 <0.01 <0.01
3.2 1.0 3.3 3.5
5.6 1.9 5.9 5.5
10 2.9 11 10
18 4.7 19 19
32 8.4 33 TD
Details on test conditions:
Using the in house protocol BA124 and USEPA-540/9-85-006, ten sheepshead minnow per test concentration were placed into individual containers treated between 3.2 and 32 mg/l test substance. A control container was also used. The dilution solution consisted of seawater diluted with deionized water to achieve the desired salinity. The test substance did not fully dissolve during the initial time interval, but reached equilibrium and was consistent with the nominal concentration by 48 hours. The test system was maintained at 25 ± 1°C with a defined photoperiod. The test system was observed at 24, 48, 72 and 96 hours. Mortality was the observed endpoint. There were no unusual events reported. A clear dose response curve was obtained
Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
ca. 16.7 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
act. ingr.
Basis for effect:
mortality
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
ca. 22 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Reported statistics and error estimates:
No statistical analysis was performed other than calculation of means.
Validity criteria fulfilled:
yes
Conclusions:
Results and discussion
Solubility of the test substance was an issue, however, analysis at 48 and 96 hours indicated that equilibrium was met and corresponded well with the nominal or weighed concentration. Low dissolved oxygen was noted at 48 hours, but was overcome with aeration post 48 hours.
LC0 5.7 mg/l at 96 hours (4.3 mg/l BIT)
LC50 22 mg/l at 96 hours (16.7 mg/l BIT)
LC100 33 mg/l at 48 hours (25.1 mg/l BIT)

Conclusion
The validity criteria can be considered as fulfilled. The dose-response relationship appears to be logical responding as expected with increasing time and total dose. While the dissolved oxygen dropped in the first 48 hours, addition of aeration of the test containers corrected the lack so that at 72 and 96 hours the levels had returned to normal.
Executive summary:

A study was conducted to determine the acute toxicity of the substance to Cyprinodon variegates according to EPA Guideline 540/9 -85 -006. Glass vessels with a working volume of 15 L were used to hold the test fish. Fish were exposed to nominal test substance concentrations of 0, 3.2, 5.6, 10, 18 and 32 mg/L. No replicates were kept for the test concentrations. Samples of the test solution were collected for analysis at 0, 48 and 96 h for analysis of concentrations, pH, temperature and dissolved oxygen. Under the study conditions, the 96 h LC50 of the substance was determined to be 22 mg/L (equivalent to 16.7 mg a.i./L) (Roberts, 1993).

Description of key information

Key value for chemical safety assessment

LC50 for freshwater fish:
2.15 mg/L

Additional information

A study was conducted to determine the acute toxicity of the substance to Oncorynchus mykiss according to OECD Guideline 203. Glass vessels with a working volume of 15 L were used to hold the test fish. Fish were exposed to nominal test substance concentrations of 0, 0, 0.5, 1, 2, 4 and 8 mg/L under static conditions. Samples of the test solution were collected for analysis at 0 and 96 h for analysis of concentrations in the test medium. Under the study conditions, the nominal 96 h LC50 of the substance was determined to be 2.18 mg/L (equivalent to 2.15 mg a.i./L) (Jenkins, 1995).

A study was conducted to determine the acute toxicity of the substance to Cyprinodon variegates according to EPA Guideline 540/9 -85 -006. Glass vessels with a working volume of 15 L were used to hold the test fish. Fish were exposed to nominal test substance concentrations of 0, 3.2, 5.6, 10, 18 and 32 mg/L. No replicates were kept for the test concentrations. Samples of the test solution were collected for analysis at 0, 48 and 96 h for analysis of concentrations, pH, temperature and dissolved oxygen. Under the study conditions, the 96 h LC50 of the substance was determined to be 22 mg/L (equivalent to 16.7 mg a.i./L) (Roberts, 1993).