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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:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
yes
Analytical monitoring:
yes
Vehicle:
no
Details on test solutions:
Preparation of the test solutions: separately for each concentration 0.0465, 0.10, 0.2150, 0.4647, 1.00 and 2.15 g test substance were added to the test water using an ultra-turrax stirrer. From the beginning of preparing the test solutions until the terminatin of placing the fish into the aquaria 25 minutes were needed.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
- Animal breeder/supplier: Charles River Aquatics, Someren ; Netherlands
- Age of animals: about 7 months
- Weight: 0.18 (0 .12 -0 .26) g
- Length: 2.75 (2 .2 - 3 .1) cm
- Housing: The fish were kept in a flow-through tank in tap water, not chlorinated, passed through a charcoal filter and aerated with oil-free air.
- Duration of housing: about 1 month
- Photoperiod: 16 hours light and 8 hours dark
- Mortality: during the last 14 days 0%
- Medical treatement: none
- Diet: "TETRA MIN" standard feed for aquarium fish TETRA - WERKE, MELLE, FRG , ad libitum; and on workdays generally additionally live artemia
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Test temperature:
21-22 °C
Nominal and measured concentrations:
- Nominal concentrations of 0, 4.64, 10.0, 21.5, 46.4, 100 and 215 mg/L.
- The analytically detected concentrations were initially in the range of 96.0 - 107.8 % and after about 96 hours between 0 - 41.6 % of the nominal concentrations.
Details on test conditions:
- Groups of 10 fish were exposed to the test substance
- Test water: municipal water, not chlorinated and passed through a charcoal filter, aerated.
- Total hardness: about 2.5 mmol/L
- Acid capacity: about 5.5 mmol/L,
- Ca content: about 90 mg/L
- Mg content: about 10 mg/L
- pH: about 8.0 - 8.6
- Oxygen content > 60% of maximum saturation.
- Test vessels: all-glass aquaria, 30x22x24 cm, one aquarium for each test group.
- Mortality and Symptoms were checked at 0, 1, 4, 24, 48, 72 and 96 hours.
- Statistical method: Probit analysis (Finney, 1971)
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
5 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
16.07 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
58.9 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality

Based on nominal concentrations the following effect values were observed:
LC0
  (96h) = 4.64 mg/L
LC50
 (96h) = 21.7 mg/L (95% confidence limits: 14.38-32.79 mg/L)
LC100 (96h) = 100 mg/L
NOEC
       = 4.64 mg/LLC50  (1h) > 215 mg/l (1% significance level)
LC50
  (4h) > 215 mg/l (10% significance level)
LC50
 (24h)  46.4 - 100 mg/L (1% significance level)
LC50
 (48h)  approx. 21.5 mg/L
LC50
 (72h)  approx. 21.5 mg/L

Based on the mean value of the analytically detected concentrations the following effect values were determined:
LC5
 (96h) = 4.98 mg/L (95% confidence limits: 1.86-7.68 mg/L)
LC50 (96h)
 = 16.07 mg/L (95% confidence limits: 11,48-23,23 mg/L)
LC95 (96h)
 = 51.92 mg/L (95% confidence limits: 32.61-152.22 mg/L)
Mortality occurred first at the concentration 10.0 mg/L (nominal).
Other substance-related effects were apathy, narcotic-like state, tumbling and slight to very slight apathy

 

Validity criteria fulfilled:
yes
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2005-11-01 to 2006-01-17
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
No analytical monitoring was performed, no information given about purity of the test substance
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
1992
Deviations:
yes
Remarks:
No analytical monitoring was performed
Qualifier:
according to
Guideline:
other: OSPARCOM (1995), Protocol for a fish acute toxicity test.
Deviations:
no
GLP compliance:
yes
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test substance was prepared as water accommodated fractions (WAFs). The stocks were prepared and stirred in 2 litre beakers with 1.5 litres of treated seawater and the appropriate weight of test material added. 1 litre is then siphoned into clean beakers and added to the appropriate test tank.
Test organisms (species):
other: Scophthalmus maximus
Details on test organisms:
TEST ORGANISM
- Common name: Scophthalmus maximus
- Source: France Turbot
- Length at study initiation: 39.9 - 44.2 mm
- Weight at study initiation: 1.213 - 2.041 g
- Method of breeding: The fishes were held under semi-static conditions in 200 litre capacity polythene tanks, containing 1 µm filtered ultra-violet treated seawater and supplied with gentle aeration.

ACCLIMATION
- Acclimation period: 23 days

FEEDING DURING TEST
- Food type: Food in pellet
- Frequency: ad libitum at least twice daily
Test type:
semi-static
Water media type:
saltwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
none
Test temperature:
14.7 - 15.9 °C
pH:
7.86 - 8.93
Dissolved oxygen:
97-100 %
Salinity:
35-37 %
Conductivity:
35-36 mS/cm
Nominal and measured concentrations:
Nominal concentrations: 100, 180, 320, 560, 1000 mg/L
No measured concentrations
Details on test conditions:
TEST SYSTEM
- Test vessel: 14 L capacity moulded soda-lime glass tanks.
- Material, size, headspace, fill volume: Test vessels containing 10 or 13 litres of test media.
- Aeration: Gently aeration
- No. of organisms per vessel: 7
- No. of vessels per concentration: 1
- No. of vessels per control: 1
- Biomass loading rate: Maximum loading density was 1 g

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Natural local seawater is pumped to holding tanks from Scapa Flow, Orkney. The treatment process was:
Sand filtered to remove particulate, filtered to 1µm, heated to 16 °C, UV treated, degassed and held at a Quantity of 3000 to 5000 litres. The water is constantly pumped through the system and trickle replenished as the water is used.
- Intervals of water quality measurement: Water quality measurements and mortality observations were conducted daily and fed food in pellet form ad libitum at least twice daily.
- Renewal rate of test solution: Replacement of media after 48 h

OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: constant illumination

EFFECT PARAMETERS MEASURED: Mortalities were determined in each vessel every 24h period.

TEST CONCENTRATIONS
- Range finding study: Concentrations were determined based on results of the range finding test. Range finding tests were conducted under static conditions (no replacement of test medium) over 96h with five animals exposed per concentration (one replicate).
- Test concentrations: 100, 180, 320, 560, 1000 mg/L
Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
240.04 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- Any observations that might cause a difference between measured and nominal values: There were no interferences in this test
Results with reference substance (positive control):
No reference substance used
Validity criteria fulfilled:
yes

Description of key information

Freshwater: The short-term toxicity to fish in freshwater was tested in two OECD guideline studies.The LC50 was determined to be16.07 mg/L.

 

Saltwater: The short-term toxicity to fish in salt water was tested in an OECD guideline study.The LC50 was determined to be 240.04 mg/L.

Key value for chemical safety assessment

LC50 for freshwater fish:
16.07 mg/L
LC50 for marine water fish:
240.04 mg/L

Additional information

Freshwater

Key

The test substance was tested in an OECD guideline 203 study with Danio rerio. The test substance was added to the test water using an ultra-turrax stirrer. The nominal concentrations tested were 0, 4.64, 10.0, 21.5, 46.4, 100 and 215 mg/L. The analytically detected concentrations were initially in the range of 96.0 - 107.8 % and after about 96 hours between 0 - 41.6 % of the nominal concentrations. The test was conducted under static conditions with 10 fishes exposed to the test substance. The test substance exhibited a 96 h LC50 of 16.07 mg/L. All relevant validity criteria were met.

Supporting

The test substance was tested in an OECD guideline study with Danio rerio. A limit test with 100 mg/L was conducted. No mortality was observed. The LC50 was determined to be >100 mg/L.

Conclusion: Two OECD guideline studies were conducted. The key study showed a LC50 of 16.07 mg/L, the supporting study showed no adverse effects. As a worst case the LC50 value of 16.07 mg/L was chosen as key value.

Salt water

The test substance was tested in an OECD guideline study with Scophthalmus maximus. The test substance was added to the test system via water accommodated fractions. 5 nominal concentrations were tested: 100, 180, 320, 560 and 1000 mg/L. No analytical monitoring was performed. The test was conducted under semi-static conditions with replacement of media after 48 h over 96 h with seven fish exposed per concentration in the salt water system. The test substance exhibited a 96 h LC50 of 240.04 mg/L. All relevant validity criteria were met.