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Ecotoxicological information

Short-term toxicity to fish

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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:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: FIFRA 72-3
Deviations:
no
Principles of method if other than guideline:
The afore mentioned guidelines were harmonized for various test parameters (i.e. temperature, light, etc.) to achieve optimal environmental conditions for the test organism. Scientific discretion was implemented where guideline parameters do not fully converge.
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Test solutions were prepared by adding the appropriate amount of stock solution (SCV120806)
to 30-L of dilution water. All test solutions with the exception of the control vessel, had a solvent load of 0.1 ml/L. This was achieved by adding additional solvent (acetone) to test solutions as needed.
- Controls: yes
- Chemical name of vehicle: Acetone
- Concentration of vehicle in test medium: 0.1 ml/L
Test organisms (species):
Cyprinodon variegatus
Details on test organisms:
TEST ORGANISM
- Common name: Sheepshead minnow
- Source: Aquatic Biosystems Inc., Fort Collins, CO
- Age at study initiation: Juvenile
- Length at study initiation: 24.9 ± 2.5 mm
- Weight at study initiation: 0.41 ± 0.15 g

ACCLIMATION
- Acclimation period: > 14 days
- Feeding Frequency: At least 3x each week. Not fed for 24 hours prior to testing.
- Food: Tetra min and brine shrimp
- Health: No mortalities during 48 hours prior to testing, no treatments for disease
- Photoperiod: 16 hours light, 8 hours dark
- Light/Dark Transition Period: 30 minutes
- Light Intensity: 50 to 100 footcandles
- Temperature: 22 ± 1.0 °C
- Salinity: 17±1‰

Test type:
static
Water media type:
saltwater
Limit test:
no
Total exposure duration:
96 h
Test temperature:
22 ± 1.0 °C (22.1 to 23.1 °C)
pH:
7.9 to 8.1
Dissolved oxygen:
5.0 to 7.7 mg/L (64 to 97% saturation)
Salinity:
17 ‰
Nominal and measured concentrations:
Nominal Test Concentrations: Control, solvent control, 0.09, 0.19, 0.38, 0.75 and 1.50 mg a.i./L
Mean Measured Test Concentrations: Control (
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: All glass aquaria, 38-L (49.5 x 25.4 x 30.5 cm) and fill volume of 30-L (49.5 x 25.4 x 23.8 cm),
- Aeration: Yes, aeration was added on study day 2 due to declining D.O. levels. The aeration was maintained until the study ended.:
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): 1


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: according to guideline (Water used for estuarine organism studies and culturing in the Bayer CropScience Aquatic Toxicology Laboratory consists of artificial sea salts (HW Marinemix Professional from Hawaiian Marine Imports) mixed with blended soft water to produce a salinity of approximately 17 parts per thousand (‰).


OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours light, 8 hours dark
- Light intensity: 629 to 720 lux (Cool white fluorescents)

EFFECT PARAMETERS MEASURED: Survival (mortality) and sublethal behavioral effects
Measurement Technique for Survival: Visual enumeration
Measurement Technique for Sublethals: Visual observations
Observation Interval: Approximately 4, 24, 48, 72 and 96 hours
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
0.96 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
0.43 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Sublethal observations / clinical signs:

Results:

Sublethal Observations

 

Frequency

Nominal Test Concentration (mg a.i./L)

(maximum observed during scheduled observation events)

Control

0

Solvent Control

0

0.10

0

0.21

0

0.43

0

0.77

1

1.56

3

 

Mortality

Nominal Test Concentration (mg a.i./L)

Percent Dead at 96-Hours

Control

0

Solvent Control

0

0.10

0

0.21

0

0.43

0

0.77

20

1.56

100

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: FIFRA 72-1
Deviations:
no
Principles of method if other than guideline:
The aforementioned guidelines were harmonized for various test parameters (i.e. temperature, light, etc.) to achieve optimal environmental conditions for the test organism. Scientific discretion was implemented where guideline parameters do not fully converge.
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Test solutions were prepared by adding the appropriate amount of stock solution (SOM102306)
to 45-L of soft processed water. All test solutions with the exception of the control vessel, had a
solvent load of 0.076 ml/L. This was achieved by adding additional solvent (Acetone) to test
solutions as needed.
- Controls: yes
- Chemical name of vehicle: Acetone
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Common name: Rainbow trout
- Source: Troutlodge, Inc., Sumner, WA
- Age at study initiation: Juvenile
- Length at study initiation: 51.6 ± 4.7 mm
- Weight at study initiation: 2.97 ± 0.67 g
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
50-58 mg/L CaCO2
Test temperature:
12.3 to 12.5 °C
pH:
7.4 to 8.0
Dissolved oxygen:
6.8-10.3 mg/L
Salinity:
-
Nominal and measured concentrations:
Nominal Test Concentrations: Control, solvent control, 0.09, 0.19, 0.38, 0.75, and 1.5 mg a.i./L
Mean Measured Test Concentrations: Control (<0.003), solvent control (<0.003), 0.10, 0.19, 0.42, 0.78 and 1.46 mg a.i./L
Details on test conditions:
TEST SYSTEM
- Test vessel:
Test Vessel Material: All Glass
Test Vessel Size: 48-L (52.1x 30.5 x 30.5 cm)
Testing Volume: 45-L (52.1x 30.5 x 28.3 cm)
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): 1
- Biomass loading rate: 0.66 g/L (grams of fish per liter test solution)

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: according to guideline


OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 hours light, 8 hours dark
- Light intensity: 770 to 919 lux (measured range)

EFFECT PARAMETERS MEASURED: Survival (mortality) and sublethal behavioral effects
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
0.572 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
0.42 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Sublethal observations / clinical signs:

Test results:

Sublethal Observations 

 

Frequency

Mean Measured Test Concentration (mg a.i./L)

(maximum observed during scheduled observation events)

Control

0

Solvent Control

0

0.10

0

0.19

0

0.42

0

0.78

0

1.46

6 Loss of Equilibrium

 

Mortality

Mean Measured Test Concentration (mg a.i./L)

Percent Dead at 96-Hours

Control

0

Solvent Control

10 % (one fish escaped from test aquarium. It appeared normal but was sacrificed since it was no longer in the test solution.)

0.10

0

0.19

0

0.42

0

0.78

100 %

1.46

100 %

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: FIFRA 72-1
Deviations:
no
Principles of method if other than guideline:
The afore mentioned guidelines were harmonized for various test parameters (i.e. temperature, light, etc.) to achieve optimal environmental conditions for the test organism. Scientific discretion was implemented where guideline parameters do not fully converge.
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Test solutions were prepared by adding the appropriate amount of stock solution (SPP010708A)
to 30-L of dilution water. All test solutions with the exception of the control vessel, had a
solvent load of 0.1 ml/L.
- Controls: yes
- Chemical name of vehicle: Dimethylformamide (DMF)
Test organisms (species):
Pimephales promelas
Details on test organisms:
TEST ORGANISM
- Common name: Fathead Minnow
- Source: Aquatic Bio Systems, Fort Collins, CO
- Age at study initiation: Juvenile
- Length at study initiation: 41.5 ± 2.6 mm
- Weight at study initiation: 0.62 ± 0.11 g

ACCLIMATION
- Acclimation period: > 14 days
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
50 to 54 mg/L CaCO2
Test temperature:
22.1 to 22.8 °C
pH:
7.6 to 8.1
Dissolved oxygen:
7.3 to 8.4 mg/L (D. O. Saturation Range (%): 84 to 96%)
Salinity:
-
Nominal and measured concentrations:
Nominal Test Concentrations: Control, Solvent Control, 0.13, 0.26, 0.52, 1.05 and 2.09 mg a.i./L
Mean Measured Test Concentrations: Control (<0.01), Solvent Control (<0.01), 0.15, 0.27, 0.55, 1.07 and 2.19 mg a.i./L
Details on test conditions:
TEST SYSTEM
- Test vessel:
Test Vessel Material: All Glass
Test Vessel Size: 38-L (49.5 x 25.4 x 30.5 cm)
Testing Volume: 30-L (49.5 x 25.4 x 23.8 cm)
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): 1
- Biomass loading rate: 0.21 g/L (grams of fish per liter test solution)

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: according to guideline
- Interval for Water Quality Measurements: Daily for pH and D.O.; Day 0 and Day 4 for alkalinity, hardness, and
conductivity


OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 hours light, 8 hours dark
- Light intensity: 718 to 1008 lux

EFFECT PARAMETERS MEASURED: Survival (mortality) and sublethal behavioral effects
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
0.77 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
0.27 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Sublethal observations / clinical signs:

Test results:

Sublethal Observations

 

Frequency

Mean Measured Test Concentration (mg a.i./L)

(maximum observed during scheduled observation events)

Control

0

Solvent Control

0

0.15

0

0.27

0

0.55

10

1.07

10

2.19

2

 

Mortality

Mean Measured Test Concentration (mg a.i./L)

Percent Dead at 96-Hours

Control

0

Solvent Control

0

0.15

0

0.27

0

0.55

0

1.07

100%

2.19

100%

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:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: EU 91/414/EEC
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: FIFRA 72-3
Deviations:
no
Principles of method if other than guideline:
The aforementioned guidelines were harmonized for various test parameters (i.e. temperature, light, etc.) to achieve optimal environmental conditions for the test organism. Scientific discretion was implemented where guideline parameters do not fully converge.
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Test solutions were prepared by adding the appropriate amount of stock solution (SLM111306)
to 34-L of dilution water. All test solutions with the exception of the control vessel, had a
solvent load of 0.1 ml/L. This was achieved by adding additional solvent (acetone) to test
solutions as needed.
- Controls: yes
- Chemical name of vehicle: Acetone
Test organisms (species):
Lepomis macrochirus
Details on test organisms:
TEST ORGANISM
- Common name: Bluegill
- Source: Osage Catfisheries, Osage Beach, MO, USA
- Age at study initiation: Juvenile
- Length at study initiation: 37.7 ± 2.6 mm
- Weight at study initiation: 1.32 ± 0.33 g


ACCLIMATION
- Acclimation period: > 14 days
- Acclimation conditions (same as test or not): same
- Type and amount of food: Tetramin and brine shrimp
- Feeding frequency: At least 3x each week. Not fed for 24 hours prior to testing
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
56 to 58 mg/L
Test temperature:
22.0 to 22.3 °C
pH:
8.0 to 8.1
Dissolved oxygen:
6.6 to 8.1 mg/L (75 to 93% saturation)
Salinity:
-
Nominal and measured concentrations:
Nominal Test Concentrations: Control, Solvent Control, 0.09, 0.19, 0.38, 0.75 and 1.50 mg a.i./L
Mean Measured Test Concentrations: Control (<0.006), solvent control (<0.003), 0.10, 0.21, 0.39, 0.75 and 1.54 mg a.i./L
Details on test conditions:
TEST SYSTEM
- Test vessel:
Test Vessel Size: 38-L (49.5 x 25.4 x 30.5 cm)
Test Vessel Material: All glass aquaria
Test Vessel Fill Volume: 34-L (49.5 x 25.4 x 27 cm)
- Aeration: yes
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): 1


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: according to guideline

OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 hours light, 8 hours dark
- Light intensity: 50 - 100 footcandles, 538 to 1076 lux (Cool white fluorescents)

EFFECT PARAMETERS MEASURED: Survival (mortality) and sublethal behavioral effects
Measurement Technique for Survival: Visual enumeration
Measurement Technique for Sublethals: Visual observations
Observation Interval: Approximately 4, 24, 48, 72 and 96 hours
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
0.32 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
0.21 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Sublethal observations / clinical signs:

Results:

Sublethal Observations

 

Frequency

Mean Measured Test Concentration (mg a.i./L)

(maximum observed during scheduled observation events)

Control

0

Solvent Control

0

0.10

0

0.21

0

0.39

2

0.75

0

1.54

9

Mortality

Mean Measured Test Concentration (mg a.i./L)

Percent Dead at 96-Hours

Control

0

Solvent Control

0

0.10

0

0.21

0

0.39

80

0.75

100

1.54

100

Description of key information

The substance is toxic to fish.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
0.32 mg/L

Marine water fish

Marine water fish
Effect concentration:
0.96 mg/L

Additional information

Four short term studies with fish were performed for the evaluation of short term effects to freshwater (cold and warm water) and saltwater fish. All studies referred to herein were conducted in accordance with the prevailing OECD testing guidelines (OECD 203) and GLP. Following the evaluation of the acute toxicity studies with fish, it has been concluded that the lowest LC50 for fish is 0.32 mg/L for Lepomis macrochirus.

All short term effects of the substance towards fish were found in the same range providing a LC50 (96h) of 0.57 mg/L for the cold water rainbow trout (Oncorhynchus mykiss) and an LC50 (96h) of 0.77 mg/L for the Fathead Minnow (Pimephales promelas). The saltwater test revealed in a LC50 of 0.96 mg/L for Sheepshead Minnow (Cyprinodon variegatus).

The substance is toxic to fish.