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Short-term toxicity to fish

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Endpoint:
short-term toxicity to fish
Type of information:
(Q)SAR
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
results derived from a (Q)SAR model, with limited documentation / justification, but validity of model and reliability of prediction considered adequate based on a generally acknowledged source
Justification for type of information:
Derived using calculation method software which has been validated for organic substances.
Qualifier:
no guideline followed
Principles of method if other than guideline:
Derived using calculation method software which has been validated for organic substances.
GLP compliance:
no
Test type:
not specified
Water media type:
not specified
Total exposure duration:
96 h
Hardness:
not available
Test temperature:
not available
pH:
not available
Dissolved oxygen:
not available
Salinity:
not available
Conductivity:
not available
Nominal and measured concentrations:
not available
Key result
Duration:
96 h
Dose descriptor:
LC50
Remarks:
freshwater
Effect conc.:
8.508 mg/L
Nominal / measured:
not specified
Conc. based on:
not specified
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC50
Remarks:
saltwater
Effect conc.:
10.808 mg/L
Nominal / measured:
not specified
Conc. based on:
not specified
Basis for effect:
mortality
Validity criteria fulfilled:
not applicable
Conclusions:
The estimated EC50 for freshwater fish was 8.508 mg/L.
Executive summary:

USA's EPA ECOSAR software is used to assess the toxicity on fish of the test item.

Measured values of the log Kow and the water solubility are used.

EC96h fish = 8.508 mg/ L

EC96h fish (saltwater) = 10.808 mg/ L

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Reason / purpose:
reference to same study
Qualifier:
according to
Guideline:
other: "Bioaccumulation test of chemical substances in fish and shellfish" described in "Kanpogyou, No.5", "Yakuhatsu, No.615" and "49 Kikyoku, No.392
GLP compliance:
yes
Analytical monitoring:
not specified
Details on sampling:
(1) Test water;
The test substance in the test water was analyzed twice every week, 16 times in total for both concentration 1 and 2 area during
exposure period using one sample each time.
(2) Test fish;
The test substance in the test fish was analyzed 2,4,6 and 8 week, 4 times in total, after the initiation of exposure for both
concentration 1 and 2, using two fish samples each time.
Vehicle:
yes
Test organisms (species):
Cyprinus carpio
Details on test organisms:
TEST FISH;
Common name: Common carp
Species: Carp (Cyprinus carpio)
Source: Kitamura fish farm (Yatsushiro-city, Kumamoto)
Lot. No.: TFC840717
Treatment: Sample fish were treated by placing them in a tetracycline hydrochloride solution (10 mg/L) under static water
conditions during 24-hours.
Acclimatization period: 14 days, 25oC.
Standard size of fish used in the study*:
Mean body weight; 22.4 g
Mean length; 9.7 cm
Mean content of lipid; 4.2%
* Measured value of representative sample from same acclimatization lot.
Test type:
flow-through
Water media type:
freshwater
Total exposure duration:
8 wk
Hardness:
No description
Test temperature:
Breeding temperature: 25 ± 2°C
pH:
No description
Dissolved oxygen:
Dissolved oxygen concentration in test aquarium:
Concentration 1 area; 5.7 – 7.3 mg/L
Concentration 2 area; 6.2 – 7.5 mg/L
Salinity:
No description
Nominal and measured concentrations:
The nominal test substance concentrations and the mean measured test substance concentrations of test water were shown in
Table.2.
Details on test conditions:
TEST SYSTEM;
(1) Equipment: Environmental control equipment with a flow-through water system
(2) Tank: 100 L glass aquarium
(3) Flow rate: 582 L/day
(stock solution : dilution water = 4 mL/minute : 400 mL/minute)
(4) Number of test fish used: 20 fish each breeding aquarium ( at the initiation of exposure)
(5) Exposure period: 8 weeks
(6) Exposure temperature: 25 ± 2°C
(7) Feeding: An amount of corresponding to about 2% of the test fish bodyweight was fed twice daily in halves.
RATIONAL OF THE TEST MATERIAL CONCENTRATION FOR DEFINITIVE TEST;
Based on the preliminary test result for 48-hr LC50, the test substance concentrations for definitive test were determined as
follows;
Concentration 1 area: 0.5 mg/L
Concentration 2 area: 0.05 mg/L
PRELIMINARY TEST;
(1) Test method: The preliminary test was performed according to the method of “Acute Toxicity Test in Fish” described in
Factory Effluent Test Method provided in JIS K 0102 using HCO-40 as dispersing agent.
(2) Species: Killifish (Oryzia latipes)
(3) During exposure: 48 hours
(4) Test result: 48-hr LC50 of test substance; 48.5 mg/L
(5) Dilution water: well water
Key result
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
ca. 48.5 mg/L
Nominal / measured:
not specified
Conc. based on:
not specified
Basis for effect:
mortality
Remarks on result:
other: Results determined in a preliminary test on Species: Killifish (Oryzia latipes), according to the method of “Acute Toxicity Test in Fish” described in Factory Effluent Test Method provided in JIS K 0102 using HCO-40 as dispersing agent.
Details on results:
no data
Results with reference substance (positive control):
no data
Conclusions:
The 48 hour LC50 was ca 48.5 mg/L.
Executive summary:

Information on the short term toxicity to fish was included in the "Bioaccumulation test of chemical substances in fish and shellfish" described in "Kanpogyou, No.5", "Yakuhatsu, No.615" and "49 Kikyoku, No.392.

Under the conditions of the study, the 48 hour LC50 was determined to be ca 48.5 mg/L to Cyprinus carpio.

Description of key information

"Bioaccumulation test of chemical substances in fish and shellfish" described in "Kanpogyou, No.5", "Yakuhatsu, No.615" and "49 Kikyoku, No.392

The 48 hour LC50 was ca 48.5 mg/L

Key value for chemical safety assessment

LC50 for freshwater fish:
48.5 mg/L

Additional information

The information that has been taken from a bioaccumulation study which was conducted with the substance on the freshwater fish Cyprinus carpio. The study was awarded a reliability score of 2 in accordance with the criteria set forth by Klimisch et al. (1997).

Under the conditions of the study the 48 hour LC50 was determined to be ca 48.5 mg/L

The experimental result is taken forward as the key data.