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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
Study period:
12 Apr - 20 Apr 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
1992
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Version / remarks:
1992
Qualifier:
according to guideline
Guideline:
EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test)
Version / remarks:
Public draft, 1996
Qualifier:
according to guideline
Guideline:
EPA OPP 72-1 (Fish Acute Toxicity Test)
Version / remarks:
1982/1985
GLP compliance:
yes (incl. QA statement)
Remarks:
Ministerium für Arbeit, Gesundheit und Soziales des Landes Nordrhein-Westfalen
Analytical monitoring:
yes
Details on sampling:
- Concentrations: All replicate test concentrations were analyzed at test start, after 2 days, and after 4 days.
- Sample storage conditions before analysis: Samples were immediately analyzed.
Vehicle:
no
Details on test solutions:
The test media with the test concentration was prepared after weighing of adequate amount of the test item and mixed as homogeneously as possible into glasses with test water using an ultra turrax. Afterwards the solution was transferred into the test vessels and filled up to 40 L test water.
Test organisms (species):
Cyprinus carpio
Details on test organisms:
TEST ORGANISM
- Common name: Common carp
- Source: Osage Catfisheries, Osage Beach, Missouri 65065, U.S.A.
- Length at study initiation (length definition, mean, range and SD): 4.8 ± 0.3 cm
- Weight at study initiation (mean and range, SD): 1.5 ± 0.3 g
- Feeding during test: Not fed 48h before and during the study.

ACCLIMATION
- Acclimation period: At least 14 days
- Acclimation conditions (same as test or not): Same as test
- Type and amount of food: Daily with commercial trout food (Brutfutter Ecostart 17, BioMar, Denmark).
- Health during acclimation (any mortality observed): Less than 5 % mortality was noted prior to the test initiation.
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
40 - 60 mg CaCO3/L
Test temperature:
20.3°C - 22.6°C
pH:
6.8 - 7.3
Dissolved oxygen:
85 - 100 %
Nominal and measured concentrations:
nominal (measured): 100 mg/L (77.3 - 108 mg/L)
Details on test conditions:
TEST SYSTEM
- Test vessel: 40 L fish tanks
- Material, size, fill volume: glass, 38 x 32 x 36 cm, fill volume 40 L

- No. of organisms per vessel: 15
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2
- Biomass loading rate: 0.56 g fish / L test medium

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted water according to ASTM Standard E 729-1988a, Standard Guide for Conducting Acute Toxicity
Tests with fishes, Macroinvertebrates, and Amphibians. Philadelphia, PA
- Total organic carbon: < 2 mg/L
- Total suspended solids: < 5 mg/L
- Metals (mg/L): metals were shown to be below detection limit
- Pesticides: all pesticides analyzed were below detection limit
- Chloride: 0.783 mmole/L
- Conductivity: < 0.2 mS/cm
- Culture medium different from test medium: no
- Intervals of water quality measurement: Dissolved oxygen, pH, and temperature once per day

OTHER TEST CONDITIONS
- Photoperiod: 16 hours light / 8 hours dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Observations for death, and for abnormal appearance and behavior were performed at 4, 24, 48, 72, and 96 hours (± 1 hour).

TEST CONCENTRATIONS
- Range finding study: Based on a range finder test (non-GLP), the definitive test concentration was set at 100 mg test item / L (limit test)
Reference substance (positive control):
yes
Remarks:
Copper(II)sulfate
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:
LC50
Effect conc.:
> 77.3 - 108 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Details on results:
All 30 fish showed no symptoms at this test concentration of 100 mg/L (nominal).
Results with reference substance (positive control):
The sensitivity of fish against the reference substance Copper(II)sulfate (CuSO4) was tested separately, resulting in a 96h-LC50 of 62.3 μg/L.
Sublethal observations / clinical signs:

Table 1: Number of dead test organisms

Contr (1)

Contr (2)

100 mg/L (1)

100 mg/L (2)

4h

0

0

0

0

Day 1

0

0

0

0

Day 2

0

0

0

0

Day 3

0

0

0

0

Day 4

0

0

0

0

Table 2: Recoveries based on nominal concentration

100 mg/L (1)

100 mg/L (2)

Day 0

79.4%

172%

Day 2

77.6%

75.7%

Day 4

74.8%

75%

Mean

Day 0-4

77.3%

108%

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15 Mar - 26 Apr 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
1992
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Version / remarks:
1992
Qualifier:
according to guideline
Guideline:
EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test)
Version / remarks:
Public draft, 1996
Qualifier:
according to guideline
Guideline:
EPA OPP 72-1 (Fish Acute Toxicity Test)
Version / remarks:
1982/1985
GLP compliance:
yes (incl. QA statement)
Remarks:
Ministerium für Arbeit, Gesundheit und Soziales des Landes Nordrhein-Westfalen
Analytical monitoring:
yes
Details on sampling:
- Concentrations: All replicate test concentrations were analyzed at test start, after 2 days, and after 4 days.
- Sample storage conditions before analysis: Samples were immediately analyzed.
Vehicle:
no
Details on test solutions:
The test media with the test concentration was prepared after weighing of adequate amount of the test item and mixed as homogeneously as possible into glasses with test water using an ultra turrax. Afterwards the solution was transferred into the test vessels and filled up to 40 L test water.
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Common name: Rainbow trout
- Source: Hatchery Forellenzucht Trostadt, 98646 Trostadt, Germany.
- Length at study initiation (length definition, mean, range and SD): 5.1 ± 1.0 cm
- Weight at study initiation (mean and range, SD): 1.6 ± 1.0 g
- Feeding during test: Not fed 48h before and during the study.

ACCLIMATION
- Acclimation period: At least 14 days
- Acclimation conditions (same as test or not): Same as test
- Type and amount of food: Daily with commercial trout food (Brutfutter Ecostart 17, BioMar, Denmark).
- Health during acclimation (any mortality observed): Less than 5 % mortality was noted prior to the test initiation and all unsuitable fish (e.g. injured, deformed, etc.) were eliminated from the test prior to the assignment of test groups.
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
40 - 60 mg CaCO3/L
Test temperature:
11.4°C – 12.3°C
pH:
6.7 - 7.3
Dissolved oxygen:
85 - 101 %
Nominal and measured concentrations:
nominal (measured): 100 mg/L (88.4 mg/L)
Details on test conditions:
TEST SYSTEM
- Test vessel: 40 L fish tanks
- Material, size, fill volume: glass, 38 x 32 x 36 cm, fill volume 40 L

- No. of organisms per vessel: 15
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2
- Biomass loading rate: 0.60 g fish / L test medium

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted water according to ASTM Standard E 729-1988a, Standard Guide for Conducting Acute Toxicity
Tests with fishes, Macroinvertebrates, and Amphibians. Philadelphia, PA
- Total organic carbon: < 2 mg/L
- Total suspended solids: < 5 mg/L
- Metals (mg/L): metals were shown to be below detection limit
- Pesticides: all pesticides analyzed were below detection limit
- Chloride: 0.783 mmole/L
- Conductivity: < 0.2 mS/cm
- Culture medium different from test medium: no
- Intervals of water quality measurement: Dissolved oxygen, pH, and temperature once per day

OTHER TEST CONDITIONS
- Photoperiod: 16 hours light / 8 hours dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Observations for death, and for abnormal appearance and behavior were performed at 4, 24, 48, 72, and 96 hours (± 1 hour).

TEST CONCENTRATIONS
- Range finding study: Based on a range finder test (non-GLP), the definitive test concentration was set at 100 mg test item / L (limit test)
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:
LC50
Effect conc.:
> 88.4 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Details on results:
The test concentration of 88.4 mg/L a.i. (nominal 100 mg/L) did not cause any mortality to Rainbow trout. So the 96h-LC50 is clearly above 88.4 mg a.s. / L.
Sublethal observations / clinical signs:

Table 1: Number of dead test organisms

Contr (1)

Contr (2)

100 (88.4) mg/L (1)

100 (88.4) mg/L (2)

4h

0

0

0

0

Day 1

0

0

0

0

Day 2

0

0

0

0

Day 3

0

0

0

0

Day 4

0

0

0

0

Table 2: Recoveries based on nominal concentration

100 mg/L (1)

100 mg/L (2)

Day 0

138%

106%

Day 2

79%

74%

Day 4

70%

64%

Mean

Day 0-4

96%

81%

Description of key information

Cyprinus carpio LC50 (96h) > 77.3 - 108 mg/L (mean measured)

Oncorhynchus mykiss LC50 (96h) > 88.4 mg/L (mean measured)

Key value for chemical safety assessment

Additional information

Two studies are available on the short-term toxicity of triafamone (CAS No. 874195-61-6) to fish (Buns, 2010; 2013). 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 77.3% - 108% and 81% - 96%, respectively. Different test species were used in the two studies. One study was conducted with the common carp (Cyprinus carpio) and the other study with the rainbow trout (Oncorhynchus mykiss) as test organism. Both fish species showed no mortality at the highest test item concentration of 100 mg/L (nominal). Based on the measured concentrations a LC50 (96h) > 77.3 - 108 mg/L triafamone is reported for Cyprinus carpio and a LC50 (96h) > 88.4 mg/L triafamone for Oncorhynchus mykiss.