Registration Dossier
Registration Dossier
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EC number: 200-198-0 | CAS number: 54-21-7
Short-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Experimental test result using OECD guideline.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- GLP compliance:
- no
- Analytical monitoring:
- no
- Vehicle:
- no
- Details on test solutions:
- 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 continuous one hour stirring for achieving test concentrations of 100 mg/L.
- Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name:Zebra Fish
- Strain:Danio rerio
- Source: Unique Aqua Fish Corner
- Length at study initiation (length definition, mean, range and SD): average2.04 cm
- Weight at study initiation (mean and range, SD): average 0.084 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 - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Hardness:
- 185 mg of CaCO3
- Test temperature:
- 23°C
- pH:
- 7.1
- Dissolved oxygen:
- 7.4
- Nominal and measured concentrations:
- 100 mg/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel: Plastic aquaria
- Material, size, headspace, fill volume: 5 liters of plastic aquaria filled with 2 liter of water
- 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):
- not specified
- 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 (fish)
- Remarks on result:
- other: not toxic
- Sublethal observations / clinical signs:
Mortality and symptoms
Nominal
Concentration
Number of
fish
Mortality (cumulated) after
3 h
6 h
24h
48h
72h
96h
(mg/l)
V1
V2
V1
V2
V1
V2
V1
V2
V1
V2
V1
V2
Control
4
4
-
-
-
-
-
-
-
-
-
-
-
-
100
4
4
-
-
-
-
-
-
-
-
-
-
-
-
Nominal
Concentration
Number of
fish
Mortality (cumulated) after
3 h
6 h
24h
48h
72h
96h
(mg/l)
V1
V2
V1
V2
V1
V2
V1
V2
V1
V2
V1
V2
Control
4
4
NS4
NS4
NS4
NS4
NS4
NS4
NS4
NS4
NS4
NS4
NS4
NS4
100
4
4
NS4
NS4
NS4
NS4
NS4
NS4
NS4
NS4
NS4
NS4
NS4
NS4
Explanation of symptoms:
A: apathy
N: narcotic-like state
C: swimming near water surface
D: swimming at the bottom of bowl
M: Slow movements compared to control
NS: No abnormal symptoms
Number behind symbol for symptom= number of affected fish
pH and oxygen content:
Nominal
Concentration
Number of
fish
pH reading after
24h
48h
72h
96h
(mg/l)
V1
V2
V1
V2
V1
V2
V1
V2
Control
4
4
7.4
7.4
7.5
7.5
7.6
7.6
7.7
7.7
100
4
4
7.7
7.7
7.8
7.8
7.9
7.9
8.0
8.0
Nominal
Concentration
Number of
fish
Oxygen content (mg/l) after
24h
48h
72h
96h
(mg/l)
V1
V2
V1
V2
V1
V2
V1
V2
Control
4
4
6.7
6.7
6.6
6.6
6.5
6.5
6.4
6.4
100
4
4
6.5
6.5
6.4
6.4
6.3
6.3
6.2
6.2
Temperature
Nominal
Concentration
Number of
fish
Temperature (°C) after
24h
48h
72h
96h
(mg/l)
V1
V2
V1
V2
V1
V2
V1
V2
Control
4
4
23.9
23.9
23.8
23.8
24.1
24.1
23.8
23.8
100
4
4
23.9
23.9
23.8
23.8
24.1
24.1
23.8
23.8
- Validity criteria fulfilled:
- yes
- Conclusions:
- Based on nominal concentration, the median lethal concentration LC50 (96 h) for test chemical on Danio rerio was observed to be >100 mg/L.
- Executive summary:
Study was conducted to access the effect of test chemical on the growth of zebra fish Danio rerio. The experiment was performed according to OECD Guideline 203 (Fish, Acute Toxicity Test). 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 continuous stirring.
Bowl aquaria containing 2 liters of potable water (passed through reverse osmosis system) were loaded with 8 fish. A static procedure was used to determine the lethal concentration of test chemical for fish. The zebra fish were exposed to the concentration of 100mg/ L, and test was conducted for the period of 96 hrs. the exposed fish were observed for any visual behavioural abnormality and mortality.
After the 96 hours of exposure to test chemical at nominal test concentrations, LC50 was determine to be >100 mg/l . Based on the LC50, it can be consider that the chemical was not toxic and can be consider to be not classified as per the CLP classification criteria.
Reference
Description of key information
Study was conducted to access the effect of test chemical on the growth of zebra fishDanio rerio. The experiment was performed according to OECD Guideline 203 (Fish, Acute Toxicity Test). 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 continuous stirring.
Bowl aquaria containing 2 liters of potable water (passed through reverse osmosis system) were loaded with 8 fish. A static procedure was used to determine the lethal concentration of test chemical for fish. The zebra fish were exposed to the concentration of 100mg/ L, and test was conducted for the period of 96 hrs. the exposed fish were observed for any visual behavioural abnormality and mortality.
After the 96 hours of exposure to test chemical at nominal test concentrations, LC50 was determine to be >100 mg/l . Based on the LC50, it can be consider that the chemical was not toxic and can be consider to be not classified as per the CLP classification criteria.
Key value for chemical safety assessment
Additional information
Following experimental studies for the test chemical was summarized to conclude the extent of toxicity of test substance in fishes is as follows:
Study was conducted to access the effect of test chemical on the growth of zebra fishDanio rerio. The experiment was performed according to OECD Guideline 203 (Fish, Acute Toxicity Test). 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 continuous stirring.
Bowl aquaria containing 2 liters of potable water (passed through reverse osmosis system) were loaded with 8 fish. A static procedure was used to determine the lethal concentration of test chemical for fish. The zebra fish were exposed to the concentration of 100mg/ L, and test was conducted for the period of 96 hrs. the exposed fish were observed for any visual behavioural abnormality and mortality.
After the 96 hours of exposure to test chemical at nominal test concentrations, LC50 was determine to be >100 mg/l . Based on the LC50, it can be consider that the chemical was not toxic and can be consider to be not classified as per the CLP classification criteria.
Key study was supported by publication from the peer reviewed journal, Acute Toxic studies of the test chemical was studied on the fresh water fish Pimephales promelas. The test was performed for the period of 96 hrs, based on the mortality of the fishes, the median lethal concentration was determined. Stocks were prepared in 18.9 L stainless steel carbonation vessels, by mixing test substance in the Lake Superior water. The median lethal concentration of test chemical (LC50) was determined to be 1370 mg/L. Most of the effected fishes at concentration greater than 1370 have lost their schooling behaviour and were swimming at the surface.
Key study was supported by publication from peer reviewed journal, Test chemical was evaluated for the determination of median lethal concentration (LC50) using fish as a animal model, for the tenure of 96 h. Test chemical was exposed to the nominal concentrations, ranging from 0 to 3080 with the geometric mean of 1.53. The experiment was conducted in the flow through condition.
The basis for the determination of the LC50 concentration was mortality. Most of the fishes lost their schooling behaviour, equilibrium and were hyperactive prior to their death. The median lethal concentration of the fish was determined as 2160 mg/L.
Based on the overall availale study report and publication data, the test chemical cannot be classified.
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