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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:
2004-11-15 to 2004-11-19
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
This study was performed according to a Japanese Industrial Standard with GLP statement. Details of photoperiod, light intensity and validity of the test were not reported in the report. In addition, analytical monitoring was not performed.
Qualifier:
according to
Guideline:
other: Japanese Industrial Standard (JIS K 0102-1998-71.), "Testing methods for industrial waste water, Acute toxicity test with fish".
Deviations:
not specified
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes
Specific details on test material used for the study:
No additional information
Analytical monitoring:
no
Details on sampling:
Not applicable
Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Test sample and HCO-40 (10 times amount of test sample) were dissolved in N,N-dimethylformamide to prepare 10.0 g/L stock solution.
Test organisms (species):
Oryzias latipes
Details on test organisms:
TEST ORGANISM
- Common name: Rice fish
- Source: Kurume Laboratory Chemicals Evaluation and Research Institute, Japan.
- Length at study initiation: average 2.9 cm
- Weight at study initiation: average 0 .23 g

ACCLIMATION
- Conditions of acclimatization: After the external disinfection in an acclimatization tank, the fish were reared by ground water for 73 days in a flow-through system at the temperature of 25 ± 2 °C.
- External disinfection: The external disinfection was carried out in an acclimatization tank containing 20 mg/L ELBAZIU and 7 g/L sodium chloride for 24 h.
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
None
Hardness:
12 mg/L
Test temperature:
Temperature of test water
At initial exposure: 24.0 °C
Before renewal of test water: 24.7 °C
pH:
pH of test water
At initial exposure: 7.8 - 7.9
Before renewal of test water: 7.8 - 7.9
Dissolved oxygen:
Concentration of dissolved oxygen in test water
At initial exposure: 8.1 mg/L
Before renewal of test water: 7.0 - 7.6 mg/L
Salinity:
No data
Nominal and measured concentrations:
0.889, 1.33, 2.00 and 3.00 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: Glass gallon vessel
- Volume of test water: 3.85 L x 2/level
- Renewal rate of test solution (frequency/flow rate): Renewal of test water, at every 8 - 16 hours
- Number of fish: 10 fish/level

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Groundwater from the premises of Kurume Laboratory
- Water quality assessment: The dilution water for test was taken out on September 2, 2004 (however, for residual chlorine on September 8, 2004, for coliform bacteria count on September 21, 2004 ), and it was analyzed and measured.
- Total organic carbon: 0.1 mg/L
- Residual Chlorine: < 0.01 mg/L
- Alkalinity: 100 mg/L
- Conductance: 260 µs/cm

ESTIMATION OF 96-HOUR LC50 VALUE
The 96 h LC50 value was estimated by the Doudoroff method.
Reference substance (positive control):
yes
Remarks:
PCP-Na: pentachlorophenol sodium salt
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
1.09 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 95% CL = 0.889 - 1.33 mg/L
Details on results:
- 24 h observation: No mortality was observed at any of the concentrations tested.
- 48 h observation: No mortality was observed at 0, 0.889 and 1.33 mg/L. 100% mortality was observed at 2 and 3 mg/L.
- 72 h observation: No mortality was observed at 0 and 0.889 mg/L. 90, 100 and 100% mortality was observed at 1.33, 2 and 3 mg/L, respectively.
- 96 h observation: No mortality was observed at 0 and 0.889 mg/L. 100% mortality was observed at 1.33, 2 and 3 mg/L.
Results with reference substance (positive control):
The 48 h LC50 value of the reference substance (PCP-Na: pentachlorophenol sodium salt, Tokyo Kasei Kogyo) for the fish of the same lot (TFO-040815) was 0.704 mg/L.
Reported statistics and error estimates:
No data

None

Validity criteria fulfilled:
yes
Conclusions:
Under the test conditions, the 96 h LC50 for test item was 1.09 mg/L with 95% CL = 0.889 - 1.33 mg/L.
Executive summary:

The acute toxicity of the test item to Rice fish (Oryzias latipes) was conducted according to “Japanese Industrial Standard (JIS K 0102-1998-71), "Testing methods for industrial waste water, Acute toxicity test with fish" with GLP statement.

Test item was tested at concentrations of 0.889, 1.33, 2.00 and 3.00 mg/L under semi-static conditions for 96 h. 10 fish/level were used at the test concentrations and in the control.

 

At 24 h observation, no mortality was observed at any of the concentrations tested. During 48 h observation, no mortality was observed at 0, 0.889 and 1.33 mg/L. 100% mortality was observed at 2 and 3 mg/L. During 72 h observation, no mortality was observed at 0 and 0.889 mg/L. 90, 100 and 100% mortality was observed at 1.33, 2 and 3 mg/L, respectively. During 96 h observation, no mortality was observed at 0 and 0.889 mg/L. 100% mortality was observed at 1.33, 2 and 3 mg/L. The 96 h LC50 value was estimated by the Doudoroff method.

 

Under the test conditions, the 96 h LC50 for test item was 1.09 mg/L with 95% CL = 0.889 - 1.33 mg/L.

Description of key information

Japanese Industrial Standard (JIS K 0102-1998-71), GLP, key study, validity 2:

96h-LC50 (Oryzias latipes) = 1.09 mg/L (95% CL: 0.889 - 1.33 mg/L) based on nominal concentrations.

Key value for chemical safety assessment

LC50 for freshwater fish:
1.09 mg/L

Additional information

To assess the short-term toxicity of the registered substance to fish, one experimental study is available.

This study (Kurume, 2004) was assessed as the key study and was performed on the registered substance according to Japanese Industrial Standard (JIS K 0102-1998-71), "Testing methods for industrial waste water, Acute toxicity test with fish" with GLP statement. In this study, the test substance was exposed to Ricefish Oryzias latipes at concentrations of 0.889, 1.33, 2.00 and 3.00 mg/L under semi-static conditions for 96 hours, plus one control without test substance. No analytical monitoring was performed. After 96 hours of exposure, no mortality was observed at 0 and 0.889 mg/L and 100% mortality was observed at 1.33, 2.00 and 3.00 mg/L. Therefore, the 96h-LC50 was 1.09 mg/L with 95% CL = 0.889 - 1.33 mg/L, based on nominal concentrations.