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Ecotoxicological information

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 test chemicals
Justification for type of information:
Data is from collection of data
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
WoE report was prepared based on two short term toxicity study on fish for the test chemical.
GLP compliance:
no
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
WoE 2: The stock solution was prepared by dissolving 1 g of the test substance in 1 liters of potable water (passed through reverse osmosis system) with continuous one hour stirring for achieving test concentrations of 6.25 mg/L,12.5 mg/L,25 mg/L,50 mg/L,100 mg/L,respectively. Potable water (passed through reverse osmosis system) was used.

WoE 3: The test solution was prepared by dissolving 400 mg of the test substance in 4 liters of potable water (passed through reverse osmosis system) with 1 hr continuous stirring for achieving test concentrations of 100mg/L, respectively
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
WoE 2
TEST ORGANISM
- Common name: Zebra Fish
- Strain: Danio rerio
- Length at study initiation (length definition, mean, range and SD): average 2.04 cm
- Weight at study initiation (mean and range, SD): average 0.085 g
-Housing:The fishes were kept in a static tank in tap water passed through reverse osmosis system, under natural conditions along with proper feed and aeration.
-Duration of housing: 15 days
-Photoperiod: 16 hours light and 8 hours dark
-Diet : Standard brand feed, once daily
-Acclimatization: seven days
-feeding frequency: Once in a day

WoE 3
TEST ORGANISM
- Common name: ZEBRA FISH
- Length at study initiation (length definition, mean, range and SD):average 1.63 cm
- Weight at study initiation (mean and range, SD):0.1899g (average)

ACCLIMATION
- Acclimation period:7 days
- Type and amount of food during acclimation:Standard brand feed
- Feeding frequency during acclimation:Daily once
- Health during acclimation (any mortality observed):During last 48 hours = 0

FEEDING DURING TEST
- Food type:Standard brand feed
- Frequency:Withdrawal of food 1 day before and during exposure
Test type:
static
Water media type:
freshwater
Total exposure duration:
96 h
Post exposure observation period:
24, 48, 72 and 96 hrs
Hardness:
WoE 2: 181.5 mg of CaCO3
WoE 3: 148.5 mg of CaCO3
Test temperature:
23°C to 23.5 °C
pH:
7.2 to 7.15
Dissolved oxygen:
7.0 mg/l to 7.9 mg/l
Nominal and measured concentrations:
WoE 2: Nominal concentration 6.25 mg/L,12.5 mg/L,25 mg/L,50 mg/L, and 100 mg/L, respectively
WoE 3: 100 mg/l
Details on test conditions:
WoE 2 and 3:
TEST SYSTEM
- Test vessel: Aquaria
- Material, size, headspace, fill volume: 5 liter filled with 2 liters of solution
- Aeration: Aeration in test vessels was provided 1 day before the start of experiment
- No. of organisms per vessel: 8 fishes

OTHER TEST CONDITIONS
- Photoperiod: 16 hours light and 8 hours dark

Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: WoE 2
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: WoE 3
Details on results:
After the exposure period of test chemical for 96 hrs with the test animal zebra fish, no effect were observed at 100 mg/l.
Validity criteria fulfilled:
not specified
Conclusions:
Based on nominal concentrations, experimental median lethal Concentrations [LC-50 (96 h)] for test chemical on Zebra fish (Danio rerio) was consider to be > 100 mg/L as no effects were observed on the test concentration of 100 mg/l. Thus, on the basis of LC50 value, it can be concluded that the chemical was non toxic and can be consider to be not classified as per the CLP classification criteria.
Executive summary:

Data available for the test chemicals have been reviewed to determine the short term toxicity of the test chemical on fish.The studies are as mentioned below:

An acute study was carried out to assessing the effect of test chemical on freshwsater fishes. Test conducted according to OECD Guideline 203 (Fish, Acute Toxicity Test). Zebra fish (Danio rerio) was used a test organism. The stock solution was prepared by dissolving 1 g of the test substance in 1 liters of potable water (passed through reverse osmosis system) with continuous one hour stirring for achieving test concentrations of 6.25 mg/L,12.5 mg/L,25 mg/L,50 mg/L,100 mg/L, respectively. Potable water (passed through reverse osmosis system) was used. Test conducted under the static system for 96 hours. Fishes were exposed to these concentrations for 96 hours. The Stability of Test substance was determined as per the Spectrophotometric method and found to be stable for 4 days at 25°C. Aquaria used in the study having the water capacity of 5 liters filled with 2 liters of water and were loaded with 8 fishes. Test consider to be valid as it fulfills all necessary criteria. The mortality in the control was found to be 0 percent at the end of the test. Constant conditions were maintained as far as possible throughout the test and, static procedures used. The dissolved oxygen concentration was found to be 79.76 per cent of the air saturation value throughout the test. After 96 hours of exposure to test chemical with fishes, no effects were observed upto the higher test concentration of 100 mg/l, thus LC50 value consider to be > 100 mg/l. Thus based on the LC50 value, it was concluded that the test chemical was nontoxic and not classified as per the CLP classification criteria.

Above study further supported by the second study from experimental source. In an experimental study, an acute test was conducted for 96 hours for assessing the effect of test chemical on the fishes.This study was conducted by following the OECD Guideline 203 (Fish, Acute Toxicity Test). Zebra Fish Danio rerio was used a test organism. The test solution was prepared by dissolving 400 mg of the test substance in 4 liters of potable water (passed through reverse osmosis system) with 1 hr continuous stirring for achieving test concentrations of 100 mg/L respectively. Study conducted under the static system. Mortality were used a test parameter on which the effects were calculated after the exposure period of 96 hours. After 96 hours of exposure periods, effects were calculated. No effects (NOEC) was observed at the limit test concentration of 100 mg/l, thus on the basis of NOEC value, LC50 was consider to be > 100 mg/l and chemical consider th be nontoxic and not classified as per the CLP classification criteria.

Based on the LC50 value, it can be consider that the chemical was nontoxic and can be consider to be not classified as per the CLP classification criteria.

Description of key information

Based on nominal concentrations, experimental median lethal Concentrations [LC-50 (96 h)] for test chemical on Zebra fish (Danio rerio) was consider to be > 100 mg/L as no effects were observed on the test concentration of 100 mg/l. Thus, on the basis of LC50 value, it can be concluded  that the chemical was non toxic and can be consider to be not classified as per the CLP classification criteria.

Key value for chemical safety assessment

Additional information

Data available for the test chemicals and structually and functionally similar read across chemicals have been reviewed to determine the short term toxicity of the test chemical on fish.The studies are as mentioned below:

An acute study was carried out to assessing the effect of test chemical on freshwsater fishes. Test conducted according to OECD Guideline 203 (Fish, Acute Toxicity Test). Zebra fish (Danio rerio) was used a test organism. The stock solution was prepared by dissolving 1 g of the test substance in 1 liters of potable water (passed through reverse osmosis system) with continuous one hour stirring for achieving test concentrations of 6.25 mg/L,12.5 mg/L,25 mg/L,50 mg/L,100 mg/L, respectively. Potable water (passed through reverse osmosis system) was used. Test conducted under the static system for 96 hours. Fishes were exposed to these concentrations for 96 hours. The Stability of Test substance was determined as per the Spectrophotometric method and found to be stable for 4 days at 25°C. Aquaria used in the study having the water capacity of 5 liters filled with 2 liters of water and were loaded with 8 fishes. Test consider to be valid as it fulfills all necessary criteria. The mortality in the control was found to be 0 percent at the end of the test. Constant conditions were maintained as far as possible throughout the test and, static procedures used. The dissolved oxygen concentration was found to be 79.76 per cent of the air saturation value throughout the test. After 96 hours of exposure to test chemical with fishes, no effects were observed upto the higher test concentration of 100 mg/l, thus LC50 value consider to be > 100 mg/l. Thus based on the LC50 value, it was concluded that the test chemical was nontoxic and not classified as per the CLP classification criteria.

Above study further supported by the second study from experimental source. In an experimental study, an acute test was conducted for 96 hours for assessing the effect of test chemical on the fishes.This study was conducted by following the OECD Guideline 203 (Fish, Acute Toxicity Test). Zebra Fish Danio rerio was used a test organism. The test solution was prepared by dissolving 400 mg of the test substance in 4 liters of potable water (passed through reverse osmosis system) with 1 hr continuous stirring for achieving test concentrations of 100 mg/L respectively. Study conducted under the static system. Mortality were used a test parameter on which the effects were calculated after the exposure period of 96 hours. After 96 hours of exposure periods, effects were calculated. No effects (NOEC) was observed at the limit test concentration of 100 mg/l, thus on the basis of NOEC value, LC50 was consider to be > 100 mg/l and chemical consider th be nontoxic and not classified as per the CLP classification criteria.

Based on the LC50 value, it can be consider that the chemical was nontoxic and can be consider to be not classified as per the CLP classification criteria.