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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Short-term toxicity to fish

Currently viewing:

Administrative data

Link to relevant study record(s)

Referenceopen allclose all

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
26 Jan - 30 Jan 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test)
Version / remarks:
1985
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: FIFRA 72-3 (a)
Deviations:
yes
Remarks:
12 fish were added to one control replicate.
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
- Concentrations: Samples were taken from all test chambers on Day 0 (prior to the introduction of the test organisms to the test chambers) and on Day 4 (test termination).
- Sampling method: Samples at each time point were taken at mid-depth.
- Sample storage conditions before analysis: Test solution samples were extracted on the same day they were collected.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test material was added directly to 18 L of artificially prepared saltwater at a nominal concentration of 100 mg/L for each replicate. Each replicate tank was stirred for 2 h and 12 min prior to use in the study.
- Eluate: no
- Differential loading: yes
- Controls: yes, test medium control
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): no
Test organisms (species):
Cyprinodon variegatus
Details on test organisms:
TEST ORGANISM
- Common name: sheepshead minnow
- Source: Aquatic Biosystems, Inc, Fort Collins, Colorado, USA on December 12, 2003 (Lot No. ABS122303)
- Age at study initiation: juvenile
- Length at study termination (length definition, mean, range and SD): 19.0 to 26.0 mm standard length (mean ± standard deviation = 21.3 ± 2.0 mm)
- Weight at study termination (mean and range, SD): 0.17 to 0.48 g wet weight (mean ± standard deviation = 0.26 ± 0.07 g)

ACCLIMATION
- Acclimation period: at least 14 days
- Acclimation conditions (same as test or not): same as test
- Type and amount of food during acclimation: newly hatched brine shrimp and/or a commercial fish food (Tetramin, Trout Chow)
- Feeding frequency during acclimation: daily; fish were not fed for greater than 48 hours prior to use in the study
- Health during acclimation (any mortality observed): no mortalities

FEEDING DURING TEST: none
Test type:
static
Water media type:
saltwater
Limit test:
yes
Total exposure duration:
96 h
Test temperature:
21.2 to 22.8 °C (mean of 22.3 °C)
pH:
7.6 to 8.1
Dissolved oxygen:
5.6 to 7.3 mg/L (71 to 92% saturation)
Salinity:
17 ppt (7.920 mg/L)
Nominal and measured concentrations:
control and 100 mg/L (nominal)
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume: 22 liter glass aquaria containing 18 liters of test solution with a water depth of 24.3 cm (aquarium dimensions 34.3 cm (L) x 21.6 cm (W) x 30.5 cm (H)); headspace: 4 liters
- Aeration: dilution water was aerated before use, but not during the test
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 3
- Biomass loading rate: 0.17 g fish tissue per liter of dilution water

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: spring water blended with reverse osmosis water to produce soft (40 to 60 mg/L) water. Artificial sea salts (HW Marinemix Professional from Hawaiian Marine Imports) were added to the dilution water to produce a salinity of approximately 15 ppt.
- Total organic carbon: 0.98 mg/L (spring water); 2.8 mg/L (reverse osmosis)
- Particulate matter: 4 mg/L of total suspended solids
- Metals: - Pesticides: - Chlorine: <3 μg/L (ppb)
- Ca/mg ratio: 10:1
- Intervals of water quality measurement: Weekly/monthly screens for total suspended solids, unionized ammonia, and residual chlorine and an annual water screen for all other parameters

OTHER TEST CONDITIONS
- Photoperiod: 16-hours light and 8-hours dark with a 30-minute transition period at initiation and termination of the light period
- Light intensity: 78 to 92 foot candles (mean = 915 lux)

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Observations for mortality and sublethal effects were performed daily until 96 hours.

TEST CONCENTRATIONS: based on preliminary data no toxicity was expected at 100 mg/L; thus, this was performed as a limit test with one treatment level and a control.
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LOEC
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Details on results:
- Behavioural abnormalities: no abnormalities were observed
- Mortality of control: none
- Other adverse effects control: none
- Abnormal responses: none
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no precipitates were observed
- Effect concentrations exceeding solubility of substance in test medium: no
Sublethal observations / clinical signs:

For details on chemical characteristics of dilution water, measured concentrations of the test substance and study observation data see attachment.

No toxic effects were observed in the dilution water control or the 100 mg a.i./L test level during the exposure period.

Table 1: Measured Test Concentrations During the 96-hour Exposure of the Sheepshead Minnow to Test Substance

Nominal Concentration

(mg/L)

Rep

Day 0 (New)

Day 4 (Old)

Meana

Standard Deviationa

Percent of Nominala

Control

A

ND

ND

-

-

-

Control

B

ND

ND

-

-

-

Control

C

ND

ND

-

-

-

100

A

97.5

101.4

99.5

-

-

100

B

99.7

124.7b

-

-

-

100

B

-

100.4

-

-

-

100

B

-

98.1

99.4

-

-

100

C

99.6

104.4

102.0

-

-

100 ppm Mean

 

 

 

100.2

2.3

100%

Lab Spike (101.1)

 

107.9

109.4

108.7

1.1

107%

ND = Not detected at or above the validated limit of quantitation (9.92 mg/L).

Conc. = Concentration.

Rep = Replicate

aCalculations for mean, standard deviation, and percent of nominal concentration are based on recoveries from Day 0 and Day 4.

bThis sample was rejected and reanalyzed in duplicate. The following two analysis were 100.4 and 98.1 mg a.i./L, respectively. The 124.7 mg a.i./L was not used in the mean recovery calculation.

Table 2: Validity criteria for OECD 203 (2019)

Criterion from the guideline

Outcome

Validity criterion fulfilled

The mortality in the control(s) should not exceed 10% (or one fish if less than ten are used) at the end of the test.

The mortality in the controls was 0% at the end of the test.

yes

The dissolved oxygen concentration must have been at least 60% of the air saturation value throughout the test.

The dissolved oxygen concentration ranged from 71 to 92% of the air saturation value throughout the test.

yes

There must be evidence that the concentration of the substance being tested has been satisfactorily maintained, and preferably it should be at least 80% of the nominal concentration throughout the test. If the deviation from the nominal concentration is greater than 20%, results should be based on the measured concentration.

The measured concentrations of the test substance was≥80% of the nominal concentration throughout the test (Overall Mean = 102%, Overall Std. Dev. = 2.3%).

yes

 

Validity criteria fulfilled:
yes
Remarks:
See Table 2 in "Any other information on results incl. tables".
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28 Oct 2002 - 01 Jan 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPP 72-1 (Fish Acute Toxicity Test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
- Concentrations: Samples were taken from all test chambers on Day 0 (prior to the introduction of the test organisms to the test chambers) and on Day 4 (test termination). The concentrations were a control and 100 mg/L (nominal), and - Sampling method: Samples at each time point were taken at mid-depth and did not include any extraneous materials.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test material was added directly to 35 liters of dilution water (i.e., blended well water) at a nominal concentration of 100 mg/L for each replicate. Each replicate tank was stirred for approximately one hour prior to use in the study.
- Eluate: no
- Differential loading: yes
- Controls: yes, test medium control
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): no
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Common name: Rainbow trout
- Source: Lot F-133, received from Pierce Associates, Inc., West Buxton, Maine on October 9, 2002.
- Age at study initiation: juvenile
- Length at study termination (length definition, mean, range and SD): 4.5 cm (mean) (SD = 0.29 cm; Range = 3.9 cm to 5.0 cm)
- Weight at study termination (mean and range, SD): 1.554 g (mean) (SD = 0.2513 g; Range = 1.151 g to 2.091 g)

ACCLIMATION
- Acclimation period: > 14 days
- Acclimation conditions (same as test or not): same as test
- Type and amount of food during acclimation: Rangen Salmon Starter (Lot #: SS19OCT01)
- Feeding frequency during acclimation: ad libitum; fish were not fed for greater than 48 hours prior to use in the study
- Health during acclimation (any mortality observed): One mortality occurred during the acclimation period for the population of 295 fish including the 48 hours prior to testing. The fish were therefore considered to be sufficiently healthy for testing.

FEEDING DURING TEST: none
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
176 mg/L as CaCO3
Test temperature:
12.3 to 13.3 °C (control)
12.4 to 13.6 °C (test item)
pH:
8.0 to 8.4
Dissolved oxygen:
67 to 106% saturation
Conductivity:
900 to 1200 μmhos/cm (μS/cm)
Nominal and measured concentrations:
control and 100 mg/L (nominal)
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): closed (glass sheets to prevent evaporation and entry of foreign materials)
- Material, size, headspace, fill volume: 37-Liter glass tanks (50-cm long, 30-cm high, 24.5-cm wide) containing approximately 35-Liters of test solution (test solution depth of approximately 28.6-cm)
- Aeration: none
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 3
- Biomass loading rate: 0.444 g/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: The dilution water used in this study was blended, filtered well water. The well water is blended with softened well water to lower the hardness. The water was filtered to remove iron, trace organics, and suspended particulates (including microbes). The water was analyzed for pesticides and heavy metal contaminants. There are no contaminants in the water believed to be at levels high enough to interfere with this study. Well water was monitored weekly for hardness, alkalinity, conductivity, pH, and dissolved oxygen.
- Total organic carbon: - Pesticides: - Chloride: 126 mg/L
- Alkalinity: 290 mg/L
- Intervals of water quality measurement: Discrete measurements of temperature, dissolved oxygen, pH, and conductivity were obtained at test initiation, 24, 48, 72, and 96 hours, or within one hour of the designated time.

OTHER TEST CONDITIONS
- Photoperiod: 16:8 light:dark (gradual intensity changes at dawn and dusk)
- Light intensity: 1500 lux (cool-white fluorescent tubes)

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Observations for death, and for abnormal appearance and behavior, were performed at 3, 6, 24, 48, 72, and 96 hours (± 1 hour).

TEST CONCENTRATIONS
- Range finding study: yes
- Test concentrations: control, 1.0, 10, and 100 mg/L
- Results used to determine the conditions for the definitive study: No mortality was observed in any treatment.
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
- Behavioural abnormalities: none
- Mortality of control: none
Sublethal observations / clinical signs:

For details on measured concentrations and study observation data of the test substance see attachment.

Biological results:

No mortality or sublethal effects observed.

Analysis of test solutions:

The method efficiency from dilution water fortified with the test item ranged from 93 to 99% with a mean percent recovery of 96% (SD= 3.36%).

The nominal concentration was 100 mg/L. The mean measured test item concentration was 96 mg/L over the course of the study. This represents 96% of the nominal concentrations. Test solutions at 0 and 96 hours ranged from 93 to 100% of nominal concentration. Analysis of the dilution water and control samples determined residues less than the limit of quantitation.

Table 1: Validity criteria for OECD 203 (2019)

Criterion from the guideline

Outcome

Validity criterion fulfilled

The mortality in the control(s) should not exceed 10% (or one fish if less than ten are used) at the end of the test.

The mortality in the controls was 0% at the end of the test.

yes

The dissolved oxygen concentration must have been at least 60% of the air saturation value throughout the test.

The dissolved oxygen concentration was≥67% of the air saturation value throughout the test.

yes

There must be evidence that the concentration of the substance being tested has been satisfactorily maintained, and preferably it should be at least 80% of the nominal concentration throughout the test. If the deviation from the nominal concentration is greater than 20%, results should be based on the measured concentration.

The measured concentrations of the test substance was≥80% of the nominal concentration throughout the test (Overall Mean = 96%, n=6, Overall Std. Dev. = 3.01%).

yes

 

Validity criteria fulfilled:
yes
Remarks:
See Table 1 in "Any other information on results incl. tables".
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
21 Apr - 25 Apr 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPP 72-1 (Fish Acute Toxicity Test)
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
- Concentrations: Samples were taken from all test chambers on Day 0 (prior to the introduction of the test organisms to the test chambers) and on Day 4 (test termination).
- Sampling method: Samples at each time point were taken at mid-depth and did not include any extraneous materials.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test material was added directly to 25 L of blended well water at a nominal concentration of 100 mg/L for each replicate. Each replicate tank was stirred for 2 h prior to use in the study and allowed to come to ambient temperature using a water bath..
- Eluate: no
- Differential loading: yes
- Controls: yes, test medium control
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): no
Test organisms (species):
Lepomis macrochirus
Details on test organisms:
TEST ORGANISM
- Common name: bluegill sunfish
- Source: Osage Catfisheries, Osage Beach, Missouri on April 01, 2003 (Lot: F-135)
- Age at study initiation: juvenile
- Length at study termination (length definition, mean, range and SD): 2.9 cm (mean) (SD = 0.18 cm; Range = 2.6 cm to 3.2 cm)
- Weight at study termination (mean and range, SD): 0.5176 g (mean) (SD = 0.1071 g; Range = 0.3386 g to 0.7268 g)

ACCLIMATION
- Acclimation period: at least 14 days
- Acclimation conditions (same as test or not): same
- Type and amount of food during acclimation: Rangen Salmon Starter (Lot #: SS19OCT01)
- Feeding frequency during acclimation: ad libitum; fish were not fed for greater than 48 hours prior to use in the study
- Health during acclimation (any mortality observed): no mortality

FEEDING DURING TEST: none
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
160 mg/L
Test temperature:
21.4 to 23.0 °C
pH:
8.1 to 8.6
Dissolved oxygen:
68 to 116%
Conductivity:
1000 to 1100 μmhos/cm (μS/cm)
Nominal and measured concentrations:
nominal: control, 100 mg/L
measured:
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): closed (covered with glass sheets to prevent evaporation)
- Material, size, headspace, fill volume: 37 liter glass tanks (50 cm long, 30 cm high, 24.5 cm wide)
- Aeration: no
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 3
- Biomass loading rate: 0.2070 g/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: well water blended with softened well water to lower the hardness and filtered to remove iron, trace organics, and suspended particulates (including microbes)
- Total organic carbon: 2.56 mg/L
- Particulate matter: - Metals: - Pesticides: - Alkalinity: 282 mg/L
- Ca/mg ratio: approximately 3.5
- Intervals of water quality measurement: Semi-annual

OTHER TEST CONDITIONS
- Photoperiod: 16:8 hour, light:dark photoperiod, with gradual intensity changes at dawn and dusk
- Light intensity: 1500 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): mortality, behavior and appearance were measured daily.

TEST CONCENTRATIONS
- Range finding study: None. The dose level was established from a definitive study with rainbow trout using the same test substance.
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LOEC
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
- Behavioural abnormalities: none
- Mortality of control: none
Sublethal observations / clinical signs:

No mortality or sub-lethal effects were observed in the control or concentration of 100 mg/L during the study.

Table 1: Measured test substance concentrations

 

Measured

Test Substance Concentrations in samples (mg/L)

Sample Name (mg/L)

21 APR. 03

25 APR. 03

Mean Recovery (mg/L)

Mean Percent Recovery (%)

Control-1

<LOQa

<LOQa

<LOQa

<LOQa

Control-2

<LOQa

<LOQa

<LOQa

<LOQa

Control-3

<LOQa

<LOQa

<LOQa

<LOQa

Dilution water-1

<LOQa

<LOQa

<LOQa

<LOQa

100-1

96.4710

97.6320

97.0515

97

100-2

97.7256

95.5164

96.6210

97

100-3

97.9311

94.0316

95.9814

96

Statistics

Overall Mean = 97%

n=6

Overall Std. Dev. = 1.54%

aLOQ = Limit of Quantitation (1.0 mg/L)

Table 2: Validity criteria for OECD 203 (2019)

Criterion from the guideline

Outcome

Validity criterion fulfilled

The mortality in the control(s) should not exceed 10% (or one fish if less than ten are used) at the end of the test.

The mortality in the controls was 0% at the end of the test.

yes

The dissolved oxygen concentration must have been at least 60% of the air saturation value throughout the test.

The dissolved oxygen concentration was≥68% of the air saturation value throughout the test.

yes

There must be evidence that the concentration of the substance being tested has been satisfactorily maintained, and preferably it should be at least 80% of the nominal concentration throughout the test. If the deviation from the nominal concentration is greater than 20%, results should be based on the measured concentration.

The measured concentrations of the test substance was≥80% of the nominal concentration throughout the test (Overall Mean = 97%, n=6, Overall Std. Dev. = 1.54%).

yes

 

Validity criteria fulfilled:
yes
Remarks:
See Table 2 in "Any other information on results incl. tables".

Description of key information

Freshwater:

LC50 (96 h) >100 mg test item/L (nominal, Oncorhynchus mykiss, OECD 203)

Marine water:

LC50 (96 h) >100 mg a.s./L (nominal, Cyprinodon variegatus, OECD 203)

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Dose descriptor:
LC50
Effect concentration:
> 100 mg/L

Marine water fish

Marine water fish
Dose descriptor:
LC50
Effect concentration:
> 100 mg/L

Additional information

Three studies are available on the short-term toxicity of the test item to fish (M-103513-02-2, M-076735-01-1, M-103514-02-2). The studies were performed according to OECD guideline 203 and GLP, with analytical monitoring of the test item concentration. The mean recovery rates ranged between 93 and 100 % of nominal, respectively. Different test species were used in the three studies, one with marine (Cyprinodon variegatus) and two with freshwater species (Oncorhynchus mykiss & Lepomis macrochirus).

The key study with rainbow trout, Oncorhynchus mykiss (M-103513-02-2) was assessed in a static system. Juvenile rainbow trout were exposed to 0 (control) and 100.0 mg/L of the test substance designed as a limit test for a 96 hour period. All treatments had 10 fish per test vessel. Each test chamber was sampled for analysis of the test item at 0 hour and after 96 hours. The mean measured concentration of the test item was 96 mg/L representing 96% of the nominal concentration. Test solutions at 0 hour ranged from 97 to 100% of nominal concentration, while at 96 hours ranged from 93 to 94% of nominal concentration therefore, all toxicity values were calculated based on the nominal concentrations of the test item. No mortality or sub-lethal effects were observed in the control or 100 mg/L treatments during the study. The 96-hour EC50 of the test item to Oncorhynchus mykiss could not be determined under the conditions of this study and is greater than 100 mg/L. The no observed effect concentration (NOEC) was 100 mg/L. The lowest observed effect concentration (LOEC) could not be determined under the conditions of this study.

The second study with a freshwater species (M-103514-02-2) was conducted with bluegill sunfish, Lepomis macrochirus and was assessed in a static system. Juvenile bluegill sunfish were exposed to nominal concentrations of 0 (control) and 100.0 mg/L of the test substance for a 96 hour period. All treatments had 10 fish per test vessel. Each test chamber was sampled for analysis of the test item at 0 hour (test start) and after 96 hours (test end). The mean measured concentration of the test item was 97 mg/L representing 97% of the nominal concentration. Test solutions at 0 hour ranged from 96 to 98% of nominal concentration, while at 96 hours ranged from 94 to 98% of nominal concentration therefore, all toxicity values were calculated based on the nominal concentrations of the test item during the study. No mortality or sub-lethal effects were observed in the control or 100 mg/L treatments during the study. The 96-hour EC50 of the test item to Lepomis macrochirus could not be determined under the conditions of this study and is greater than 100 mg/L. The no observed effect concentration (NOEC) was 100 mg/L. The lowest observed effect concentration (LOEC) could not be determined under the conditions of this study. The test item would be classified as practically non-toxic to Lepomis macrochirus.

The key study (M-076735-01-1) for the marine compartment was conducted with a saltwater species sheepshead minnow (Cyprinodon variegatus). Fish were exposed in a static system over a period of 96 h to 0 (control) and 100.0 mg a.i./L of the test substance designed as a limit test. All treatments had 10 fish per test vessel. The mean measured concentration of the test item was 100% of the nominal concentration, therefore, all toxicity values were calculated based on the nominal concentrations of the test item. No mortality was recorded. The NOEC and LOEC in the 96-hour exposure of the sheepshead minnow (Cyprinodon variegatus) to the test item were >= 100 mg a.i./L and >100 mg a.i./L, respectively. The LC50 (96 h) was derived to be > 100 mg a.i./L.