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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Experimental test result performed according to the guideline.
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Principles of method if other than guideline:
Study was conducted to access the effect of test chemical on the mortality of fish Danio rerio. Test conducted according to OECD Guideline 203 (Fish, Acute Toxicity Test).
GLP compliance:
no
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
The test substance was soluble in water. Therefore, the test solution was prepared by dissolving 25 µl, 50 µl, 100 µl , 200 µl, 400 µl, 800 µl and 1600 µl of the test substance in 4 liters of potable water (passed through reverse osmosis system) with continuous stirring for achieving test concentrations of 6.25 mg/L, 12.5 mg/L, 25 mg/L, 50 mg/L, 100 mg/L, 200 mg/L and 400 mg/L, respectively.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name:Zebra Fish
- Source: Orange City Aquarium, India
- Length at study initiation (length definition, mean, range and SD): average 2.34 cm
- Weight at study initiation (mean and range, SD): average 0.35 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: 12 hours light and 12-hour darkness
-Diet : Standard brand feed, once daily
-Acclimatization: seven days
-feeding frequency: Once in a day
Test type:
static
Water media type:
freshwater
Total exposure duration:
96 h
Hardness:
32.5 mg of CaCO3
Test temperature:
22-25°C
pH:
7.9
Dissolved oxygen:
4.78-6.41 mg/L
Nominal and measured concentrations:
6.25 mg/L, 12.5 mg/L, 25 mg/L, 50 mg/L, 100 mg/L, 200 mg/L & 400 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: Plastic aquaria
- Material, size, headspace, fill volume: 5 liters of plastic aquaria filled with 4 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: 12 hours light and 12 hours darkness
Reference substance (positive control):
not specified
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
50 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: highest concentration at which no mortality was observed
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 50 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: lowest concentration at which 100% mortality was observed
Sublethal observations / clinical signs:

8.1. Mortality and symptoms

Nominal conc. (mg/l)

Number of fish

Mortality (cumulated) after

24h

48h

72h

96h

0 (control)

8

-

-

-

-

6.25

8

-

-

-

-

12.5

8

-

-

-

-

25

8

-

-

-

-

50

8

-

-

-

-

100

8

8

-

-

-

200

8

8

-

-

-

400

8

8

-

-

-

Nominal conc. (mg/l)

Number of fish

Symptoms after

24h

48h

72h

96h

0 (control)

8

NS

NS

NS

NS

6.25

8

M

M

M

M

12.5

8

M

M

M

M

25

8

M

M

M

M

50

8

M

M

M

M

100

8

-

-

-

-

200

8

-

-

-

-

400

8

-

-

-

-

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

8.2. pH and oxygen content:

Nominal conc. (mg/l)

pH readings after

24h

48h

72h

96h

0 (control)

5.13

5.29

2.35

5.15

6.25

5.22

5.31

5.48

5.2

12.5

5.30

5.38

5.51

5.40

25

5.3

5.38

5.51

5.40

50

5.35

5.40

5.51

5.40

Nominal conc. (mg/l)

Oxygen content (mg/l) after

24h

48h

72h

96h

0 (control)

5.55

6.12

6.41

6.36

6.25

4.84

5.83

5.84

5.61

12.5

4.78

5.49

5.62

5.66

25

5.14

5.71

5.93

5.66

50

5.12

5.48

5.71

4.83

8.3. Test temperature

Nominal conc. (mg/l)

Temperature (°C) after

24h

48h

72h

96h

0 (control)

24

25

22

23

6.25

24

25

22

23

12.5

24

25

22

23

25

24

25

22

23

50

24

25

22

23

Validity criteria fulfilled:
yes
Conclusions:
Based on nominal concentrations, experimental median lethal Concentrations [LC-50 (96 h)] for test material. on Zebra Fish Danio rerio was determine to be > 50 mg/L<100 mg/l.
Executive summary:

Study was conducted to assess the effect of test chemical on the mortality of fish Danio rerio. Test conducted according to OECD Guideline 203 (Fish, Acute Toxicity Test). The test substance was soluble in water. Therefore, the test solution was prepared by dissolving 25 µl, 50 µl, 100 µl , 200 µl, 400 µl, 800µl and 1600 µl of the test substance in 4 liters of potable water (passed through reverse osmosis system) with continuous stirring for achievingof the test substance in 4 liters of potable water (passed through reverse osmosis system) with continuous stirring for achieving test concentrations of 6.25 mg/L, 12.5 mg/L, 25 mg/L, 50 mg/L, 100 mg/L & 400 mg/L, respectively. Zebra Fish Danio rerio were exposed to these concentration for 96 hours. Bowl aquaria containing 4 liters of potable water (passed through reverse osmosis system) were loaded with 8 fishes. A static procedure was used for the study and it was conducted in compliance with the OECD guideline 203. After 96 hours of exposure to test item to various nominal test concentrations, LC50 was determine to be > 50 mg/L<100 mg/l . Based on the LC50, it can be consider that the chemical was and can be consider to be classified as aquatic chronic 3 as per the CLP classification criteria.

Description of key information

Short-term toxicity to fish:

Based on nominal concentrations, experimental median lethal Concentrations [LC-50 (96 h)] for test material. on Zebra Fish Danio rerio was determine to be > 50 mg/L<100 mg/l.  

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
50 mg/L

Additional information

Short-term toxicity to fish:

Following different studies includes experimental study for the target chemical and read-across analogues which is extracted by using mechanistic approach and functionally and structurally similar to the target chemical to observe the short- term toxicity of test chemical to fish.

First study was conducted to assess the effect of test chemical on the mortality of fish Danio rerio. Test conducted according to OECD Guideline 203 (Fish, Acute Toxicity Test). The test substance was soluble in water. Therefore, the test solution was prepared by dissolving 25 µl, 50 µl, 100 µl , 200 µl, 400 µl, 800µl and 1600 µl of the test substance in 4 liters of potable water (passed through reverse osmosis system) with continuous stirring for achieving of the test substance in 4 liters of potable water (passed through reverse osmosis system) with continuous stirring for achieving test concentrations of 6.25 mg/L, 12.5 mg/L, 25 mg/L, 50 mg/L, 100 mg/L & 400 mg/L, respectively. Zebra FishDanio reriowere exposed to these concentration for 96 hours. Bowl aquaria containing 4 liters of potable water (passed through reverse osmosis system) were loaded with 8 fishes. A static procedure was used for the study and it was conducted in compliance with the OECD guideline 203. After 96 hours of exposure to test item to various nominal test concentrations, LC50 was determine to be > 50 mg/L<100 mg/l . Based on the LC50, it can be consider that the chemical was and can be consider to be classified as aquatic chronic 3 as per the CLP classification criteria.

The above eperimental data was further supported by data summaried in authoritative database further explaining the toxicity of structurally similar read across substance

, Short term fish toxicity was conducted for 96 hrs for assessing the effect of test chemical. Study was performed using Menidia beryllina, saltwater fish of 40-100 mm in length. Test was conducted in static system for 96 h at 20°C and 7.6-7.9 pH. Test organisms were collected from Bayer AG Leverkusen. Test organisms became 14 d adapted to laboratory conditions.

Based on effect of test chemical on mortality of the test organism Menidia beryllina,the 96 hr LC50 was determined to be 15 mg/l.

On the basis of above determined LC50 value the test chemical was considered to be classified as category chronic-3 as per the CLP criteria and therefore toxic to fish.

In last study, short term fish toxicity was conducted for 96 hrs for assessing the effect of test chemical according to determination of the effect of water constituents Fish, DIN 38 412. Study was performed using Leuciscus idus , fresh-water fish in a static system. Test organisms were collected from BASF AG Ludwigshafen. Based on the effect , the 96 hr NOEC. LC0, LC50 and LC100  values was determined to be 22, 46, 46-100 and 100 mg/l respectively. On the basis of above determined LC50 value the test chemical was considered to be classified as category chronic -3 as per the CLP criteria and therefore considered to be toxic.

On the basis of above observations, test chemical was considered to be classified as category chronic -3 as per the CLP criteria and therefore considered to be toxic.

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