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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
Study period:
2001-12-05 to 2002-03-26
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
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
10 mL of the test solution was collected from the container of each test group at the starting of and 48 hr after exposure.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: 500 mg test chemical was dissolved in 500 mL dilution water to prepare 1000 mg/L of test stock solution. From this stock test solution, the test solutions were prepared by further diluting with water (c = 100 mg/L)
- Controls: 1 control
Test organisms (species):
Oryzias latipes
Details on test organisms:
TEST ORGANISM
- Common name: Killifish
- Strain: Lot No.: FJ01A4
- Source: in-house breeding
- Age at study initiation (mean and range, SD): Not described
- Length at study initiation (length definition, mean, range and SD): 2.2 cm (mean); 1.9 - 2.4 cm ; n = 10
- Weight at study initiation (mean and range, SD): 0.16 g (mean); 0.09 - 0.24 g; n = 10
- Method of breeding: flow-through system
- Feeding during test: no feeding

ACCLIMATION
- Acclimation period: 21-Dec-2001 to 21-Jan-2002
- Acclimation conditions (same as test or not): same
- Type and amount of food: Tetramine
- Feeding frequency: about 2% of fish weight/day, no feeding in 24 hours before starting of exposure
- Health during acclimation (any mortality observed): death rate was 5% or less in seven days before expsure and grssly healthy and normal fish was used

Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Test temperature:
23.9 - 24.0°C
pH:
7.3 - 7.8
Dissolved oxygen:
5.2 - 8.2 mg/L, maintaing 60% or more of the saturated dissolved oxygen concentration, was measured at the beginning and every 24 hours (saturated dissolved oxygen concentration at 24°C: 8.25 mg/L)
Nominal and measured concentrations:
100 mg/L (nominal concentration)
The concentration was measured by GC at the starting of and 48 hours after the test. the results were within +/-20% of the nominal concentration.
Details on test conditions:
TEST SYSTEM
- Material, size, headspace, fill volume: 3 L glass beaker
- Aeration: None
- Renewal rate of test solution (frequency/flow rate): once after 48 hours
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: dechlorinated water; tap water was dechlorinated and treated by activated carbon. Before using the dilution water, aeration was fully carried out.
Dilution water chemistry:
- pH: 7.7
- Total hardness (converted to CaCO3): 55.6 mg/L
- COD: 0.2 mg/L
- Metals: not detected: total mercury, copper, cadmium, zinc, lead, aluminium, nickel, total chromium, manganese, tin. 0.05 mg/L iron
- Pesticides: not detected
- Free chlorine: not detected
- Alkalinity: 37.5 mg/L
- Conductivity: 171 µs/cm
- Culture medium different from test medium: no
- Intervals of water quality measurement: Temperature, dissolved oxygen concentration and pH were measured at the starting of the test and after that, once daiy

OTHER TEST CONDITIONS
- Photoperiod: 16 - 8 hour light-dark photocycle
- Light intensity: room light
- Test temperature: 24 +- 1°C

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Signs of toxicity, dead, abnormal respiration, abnormal swimming, inability to swim were recorded at the starting, 24, 48, 72 and 96 hr after exposure

TEST CONCENTRATIONS
- Test concentrations: 100 mg/L of concetration and control were set
- Results used to determine the conditions for the definitive study: Based on the results of the preliminary test
Reference substance (positive control):
yes
Remarks:
confirmation of sensitivity: LC50 (96 hr) by reference substance (copper (II) sulfate pentahydrate, special grade chemical) was 0.40 mg/L (converted to anhydride).
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Basis for effect:
mortality (fish)
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Basis for effect:
mortality (fish)
Details on results:
The mortality of the control was 0% and it fullfilled the conditions of establishing the test. No mortality was observed at the highest concentration of 100 mg/L. No abnormal symptoms were observed in the control and highest concentration group during the exposure period.

Infrared absorption spectrum of the refrigerated test chemical was detected at the start and the end of the test, and both spectrums are not contradictory to each other.


Results with reference substance (positive control):
confirmation of sensitivity: LC50(96 hr) by reference substance (copper (II) sulfate pentahydrate, special grade chemical) was 0.40 mg/L (converted to anhydride). It has not been described whether the data are historical reference data of the laboratory.
Reported statistics and error estimates:
Statistical Method
a) Data Analysis: All of test organisms were lived at the end of the test period, therefore the LC50 is more than the highest concentration.
b) Method of Calculating Mean Measured Concentrations (i.e. arithmetic mean, geometric mean, etc.): Mean measured concentration was not calculated.
Sublethal observations / clinical signs:

- Measured Concentrations: The test concentrations were
measured at 0 h and 48 h.  For all of them, the deviations
from the nominal were less than +/-20%.
----------------------------------------------------------
Nominal  Measured Conc., mg/L     Percent of Nominal
Conc.     
----------------------------------------------------------
  

mg/L       0 Hour    48 Hours      0 Hour    48 Hours
----------------------------------------------------------
Control      < 2       < 2           ---      ---
100          95.9      103          95.9     103
----------------------------------------------------------



- Cumulative Mortality: None of test organisms were killed
during exposure period at control and 100 mg/L.
-----------------------------------------------------------
Nominal        Cumulative Number of Dead (Percent Mortality)
Conc.      
-----------------------------------------------------------
mg/L            24hr       48hr        72hr       96hr
-----------------------------------------------------------

Control        0 (0)      0 (0)       0 (0)      0 (0)
100            0 (0)      0 (0)       0 (0)      0 (0)
-----------------------------------------------------------



-Other Effect: Toxicological symptom was not observed at any
concentration.

-----------------------------------------------------------
Nominal                       Symptoms
Conc.             
-----------------------------------------------------------
mg/L                24hr    48hr    72hr    96hr
-----------------------------------------------------------
Control              n        n       n       n
100                  n        n       n       n
-----------------------------------------------------------
-n: No abnormalities are detected 



- Calculation of toxicity values: The calculation of
toxicity values was the nominal concentration. The reason is
that all of the deviations from the nominal concentration
were less than +/-20%.

Validity criteria fulfilled:
yes
Conclusions:
LC50 > 100 mg/L and NOEC 100 mg/L
Executive summary:

In a 96-h acute toxicity study, killifish (Oryzias latipes) were exposed to MMB at the nominal concentration of 100 mg./L under semistatic, unaerated conditions, observations were made during 0, 24, 48, 72 and 96 hours after the exposure.

The 96 -h LC50was > 100 mg./L.  The LC100 was > 100 mg/L. The NOEC was 100 mg/L.

This toxicity study is classified as acceptable and satisfies the OECD No.203 guideline requirement for acute toxicity test to Killifish (oryzias latipes).

 

Description of key information

96h-LC50 > 100 mg/L

96h-NOEC = 100 mg/L

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
100 mg/L

Additional information

In a 96-h acute toxicity study, killifish (Oryzias latipes) were exposed to MMB at the nominal concentration of 100 mg./L under semistatic, unaerated conditions, observations were made during 0, 24, 48, 72 and 96 hours after the exposure.

The 96 -h LC50was > 100 mg./L.  The LC100 was > 100 mg/L. The NOEC was 100 mg/L.

This toxicity study is classified as acceptable and satisfies the OECD No.203 guideline requirement for acute toxicity test to Killifish (oryzias latipes).