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Short-term toxicity to fish

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Reference
Endpoint:
short-term toxicity to fish
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
Experimental data of read across chemicals
Justification for type of information:
Data is from handbook or collection of data
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
other: Refer below principle
Principles of method if other than guideline:
WoE was prepared to determine the short term toxicity of test chemical, based on the mortality of fish. The studies are as mentioned below:
GLP compliance:
no
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
The test solution was prepared by dissolving 500 mg of the test substance in 500 ml of potable water (passed through reverse osmosis system) with continuous 1 hr stirring. After stirring stock was analytically detected and the solubility was found 672.34 mg/L, on the basis of this value following test concentration was prepared 0.1562mg/L,0.3125mg/L,0.625mg/L,1.25mg/L,2.5mg/L ,respectively.

WoE 3:
Details on test solutions
The test solution was prepared by dissolving 1g of the test substance in 1 liters of potable water (passed through reverse osmosis system) with 1 hour continuous stirring. After that analytically detect stock, solubility found 981.56 mg/L and calculations done accordingly. Concentrations decided as follows 0.625mg/L,1.25mg/L,2.5mg/L,5mg/L,10mg/L,respectively.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebra fish(Danio rerio)
- Source: Anytime Pet, Jariphataka, Nagpur
- Length at study initiation (length definition, mean, range and SD): average 1.29 cm
- Weight at study initiation (mean and range, SD): 0.049g (average)


ACCLIMATION
- Acclimation period: 7 days
- Acclimation conditions (same as test or not): Same as test
- Feeding frequency during acclimation: Daily once
- Health during acclimation (any mortality observed): No mortality were observed

Other conditions during acclimation:
- Photoperiod 16 hours light and 8 hours dark
- Temperature range: 24.1 °C
- pH range 7.1
- DO range 7.0 mg/l
- Aeration Continous

WoE - 3:
TEST ORGANISM
- Common name:Zebra Fish
- Strain:Danio rerio
- Source:Koyal aquarium, Nagpur
- Age at study initiation (mean and range, SD): -
- Length at study initiation (length definition, mean, range and SD):average 1.79 cm
- Weight at study initiation (mean and range, SD):0.1204g (average)
- Food type:Standard brand feed,
- Frequency: once daily
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
24, 48, 72, 96 hrs
Hardness:
155.5 (mg of CaCO3)
Test temperature:
23 °C
pH:
7.2 to 7.03
Dissolved oxygen:
6.41 mg/L to 7 mg/l
Nominal and measured concentrations:
WoE 2: 0.1562mg/L, 0.3125mg/L, 0.625mg/L, 1.25mg/L and 2.5mg/L
WoE 3: 0.625mg/L,1.25mg/L,2.5mg/L,5mg/L,10mg/L
Details on test conditions:
TEST SYSTEM: WoE 2:
- Test vessel: Aquaria
- Material, size, headspace, fill volume: Aquaria having the water capacity of 5 liters filled with 2 liters of water with 3 liter of headspace.
- Aeration: Aeration in test vessels was provided 1 day before the start of experiment
- No. of organisms per vessel: 8
- No. of vessels per concentration (replicates): 2


OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 hours light and 8 hours dark


EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Observations of (mortality, visible symptoms, pH, Temperature, dissolved oxygen content) were recorded after 24 hours, 48 hours, 72 hours and 96 hours of the start of the experiment.

WoE 3:
Details on test conditions
Photoperiod: 16 hours light and 8 hours dark
Volume of water: 2 liters
No. of animals per vessel: 8 fishes
Test temperature: 23 °C
Adaptation: Test conditions corresponded to housing conditions
Withdrawal of food: 1 day before and during exposure
Aeration: Aeration in test vessels was provided 1 day before the start of experiment

Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
< 0.156 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: WoE 2
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
0.156 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
0.625 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: WoE - 3
Validity criteria fulfilled:
yes
Conclusions:
WoE 2: Based on nominal concentrations, experimental median lethal Concentrations [LC-50 (96 h)] of test chemical on Zebra fish (Danio rerio) was determined to be < 0.1562 mg/L by observing the mortality. Thus based on LC50, it can be concluded that the chemical was toxic.
WoE 3: Based on nominal concentrations, experimental median lethal Concentrations [LC-50 (96 h)] of test chemical on Zebra fish(Danio rerio) was observed to be 0.625 mg/L.
Under the test condition it is observed that the toxicity ranges from 0.625 to <0.1562 mg/l.
Executive summary:

Data available for the test chemical has been reviewed to determine the toxicity of test chemical on the mortality of fishes. The studies are as mentioned below:

 

The study was designed to assess the toxic effects of the test chemical on the fishes. Test conducted in accordance with OECD Guideline 203 (Fish, Acute Toxicity Test). Zebra fish (Danio rerio) was used as a test organism. 0.1562mg/L, 0.3125mg/L, 0.625mg/L, 1.25mg/L, 2.5mg/L concentrations were prepared from the stock solution. 8 fishes exposed to the test concentration. 8 fishes was added per concentration. Test conducted under the static system for 96 hours. The effect of test chemical was calculated on the basis of mortality of test fish’s Zebra fish (Danio rerio). Observations including (mortality, pH, Temperature, dissolved oxygen content) were recorded in the interval of 24, 48 and 96 hours. Based on nominal concentrations, experimental median lethal Concentrations [LC-50 (96 h)] of test chemical on Zebra fish (Danio rerio) was determined to be < 0.1562 mg/L by observing the mortality. Thus based on LC50 it can be concluded that the chemical was toxic and classified as aquatic acute 1/ chronic 1 as per the CLP criteria.                                                                                                                                                                                                              

 

Above study further supported by the second from experimental source. Principle of this study was to determine the toxic effects of the test chemical on the fishes. Test conducted in accordance with OECD Guideline 203 (Fish, Acute Toxicity Test). Zebra fish (Danio rerio) was used as a test organism. The nominal concentration selected for the experiment was 0.625mg/L, 1.25mg/L, 2.5mg/L, 5mg/L, 10mg/L and test fish were exposed to these concentration for 96 hours. 8 fishes was added per concentration. . Test conducted under the static system for 96 hours. The effect of test chemical was calculated on the basis of mortality of test fish’s Zebra fish (Danio rerio). Observations including (mortality, pH, Temperature, dissolved oxygen content) were recorded in the interval of 24, 48 and 96 hours. Based on nominal concentrations, experimental median lethal Concentrations [LC-50 (96 h)] of test chemical on Zebra fish (Danio rerio) was observed to be 0.625 mg/L. Thus based on the LC50 value, chemical consider to be toxic and classified as aquatic acute 1/chronic 1 as per the CLP classification criteria.           

 

Thus based on the above studies, it is observed that the chemical is toxic and can be consider to be classified in aquatic acute 1/ chronic 1 category as per the CLP classification criteria.

Description of key information

WoE 2: Based on nominal concentrations, experimental median lethal Concentrations [LC-50 (96 h)] of test chemical on Zebra fish (Danio rerio) was determined to be < 0.1562 mg/L by observing the mortality. Thus based on LC50, it can be concluded that the chemical was toxic.

WoE 3: Based on nominal concentrations, experimental median lethal Concentrations [LC-50 (96 h)] of test chemical on Zebra fish(Danio rerio) was observed to be 0.625 mg/L.

Under the test condition it is observed that the toxicity ranges from 0.625 to <0.1562 mg/l.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
0.625 mg/L

Additional information

Data available for the test chemical and structurally and functionally similar read across chemicals extracted using mechanistic approach has been reviewed to determine the toxicity of test chemical on the mortality of fishes. The studies are as mentioned below:

 

The study was designed to assess the toxic effects of the test chemical on the fishes. Test conducted in accordance with OECD Guideline 203 (Fish, Acute Toxicity Test).Zebra fish (Danio rerio) was used as a test organism. 0.1562mg/L, 0.3125mg/L, 0.625mg/L, 1.25mg/L, 2.5mg/L concentrations were prepared from the stock solution. 8 fishes exposed to the test concentration. 8 fishes was added per concentration. Test conducted under the static system for 96 hours. The effect of test chemical was calculated on the basis of mortality of test fish’s Zebra fish (Danio rerio). Observations including (mortality, pH, Temperature, dissolved oxygen content) were recorded in the interval of 24, 48 and 96 hours. Based on nominal concentrations, experimental median lethal Concentrations [LC-50 (96 h)] of test chemical on Zebra fish (Danio rerio) was determined to be < 0.1562 mg/L by observing the mortality. Thus based on LC50 it can be concluded that the chemical was toxic and classified as aquatic acute 1/ chronic 1 as per the CLP criteria.                                                                                                                                                                                                              

 

Above study further supported by the second from experimental source. Principle of this study was to determine the toxic effects of the test chemical on the fishes. Test conducted in accordance with OECD Guideline 203 (Fish, Acute Toxicity Test). Zebra fish (Danio rerio) was used as a test organism. The nominal concentration selected for the experiment was 0.625mg/L, 1.25mg/L, 2.5mg/L, 5mg/L, 10mg/L and test fish were exposed to these concentration for 96 hours. 8 fishes was added per concentration. . Test conducted under the static system for 96 hours. The effect of test chemical was calculated on the basis of mortality of test fish’s Zebra fish (Danio rerio). Observations including (mortality, pH, Temperature, dissolved oxygen content) were recorded in the interval of 24, 48 and 96 hours. Based on nominal concentrations, experimental median lethal Concentrations [LC-50 (96 h)] of test chemical on Zebra fish (Danio rerio) was observed to be 0.625 mg/L. Thus based on the LC50 value, chemical consider to be toxic and classified as aquatic acute 1/chronic 1 as per the CLP classification criteria.           

 

Thus based on the above studies, it is observed that the chemical is toxic and can be consider to be classified in aquatic acute 1/ chronic 1 category as per the CLP classification criteria.