Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Ecotoxicological information

Short-term toxicity to fish

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
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
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 assess the effect of test chemical on the growth of fish Danio rerio. Test conducted according to OECD Guideline 203 (Fish, Acute Toxicity Test).
GLP compliance:
not specified
Analytical monitoring:
not required
Remarks:
As substance is stable
Vehicle:
not specified
Details on test solutions:
The test substance was soluble in water. Therefore, the test solution was prepared by dissolving 100 mg, 200 mg, 400 mg, 800 mg & 400 mg of the test substance in 4 liters of potable water (passed through reverse osmosis system) with continuous stirring for achieving test concentrations of 25 mg/L, 50 mg/L,100 mg/L, 200 mg/L & 400 mg/L, respectively.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebra Fish
- Strain: Danio rerio
- Source: Orange City Aquarium, Sitabuldi, Nagpur, MS (India)
- Age: 3-4 months
- Length at study initiation (length definition, mean, range and SD): average 2.5 cm
- Weight at study initiation (mean and range, SD): average 0.272 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 hours 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:
36.25 mg of CaCO3
Test temperature:
22°C
pH:
7.5
Dissolved oxygen:
7.5 mg/l
Nominal and measured concentrations:
The test concentrations selected for the study were 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 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: 12 hours light and 12-hour darkness

Reference substance (positive control):
not specified
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 400 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: LC0 were observed at 400 mg/l
Details on results:
LC50 was observed at > 400 mg/l.
Sublethal observations / clinical signs:

Table 1. Mortality and symptoms:

NominalConcentration

(mg/l)

Number of fish

Mortality (cumulated) after

24h

48h

72h

96h

0 (control)

8

-

-

-

-

25

8

-

2

-

-

50

8

-

-

-

-

100

8

-

-

-

-

200

8

-

-

-

-

400

8

-

-

-

-

Table 2: Visible Symptoms:

NominalConcentration(mg/l)

Number of fish

Symptoms after

24h

48h

72h

96h

0 (control)

8

NS8

NS8

NS8

NS8

25

8

NS8

NS6

NS6

NS6

50

8

NS8

NS8

NS8

NS8

100

8

NS8

NS8

NS8

NS8

200

8

NS8

NS8

NS8

NS8

400

8

NS8

NS8

NS8

NS8

Explanation of symptoms:

A: apathy

N: Narcotic-like state

C: Swimming near water surface

M: Slow movements compared to control

NS: No abnormal symptoms

S: Surfacing behaviour

L: Loss of equilibrium

SM: Shimming movement

H1: Hyperactivity

H2: Hypo activity

B: Bending behavior

F: Fin rot

IS: Invert Swimming

SB: Swimming behaviour

RF: Respiratory Function

P: Pigmentation

Table 3: pH and oxygen content:

NominalConcentration(mg/l)

pH readings after

24h

48h

72h

96h

0 (control)

7.8

7.6

7.6

7.6

25

7.8

7.5

7.5

7.5

50

7.7

7.7

7.7

7.6

100

7.7

7.6

7.6

7.5

200

7.6

7.6

7.6

7.4

400

7.6

7.6

7.4

7.4

NominalConcentration(mg/l)

Oxygen content (mg/l) after

24h

48h

72h

96h

0 (control)

6.5

6.5

6.2

6.1

25

6.5

6.5

6.2

6.1

50

6.5

6.5

6.3

6.2

100

6.6

6.6

6.2

6.1

200

6.6

6.6

6.3

6.2

400

6.7

6.6

6.2

6.1

Table 4: Test temperature

NominalConcentration(mg/l)

Temperature (°C) after

24h

48h

72h

96h

0 (control)

21

22

23

23

25

21

22

23

23

50

21

22

23

23

100

21

22

23

23

200

21

22

23

23

400

21

22

23

23

Validity criteria fulfilled:
yes
Conclusions:
Based on nominal concentrations, experimental median lethal Concentrations [LC-50 (96 h)] for test chemical on Zebra Fish Danio rerio was determine to be > 400 mg/l. No effect were observed at 400 mg/l.
Executive summary:

Study was conducted to access the effect of test chemical on the growth 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 100 mg, 200 mg, 400 mg, 800 mg & 400 mg of the test substance in 4 liters of potable water (passed through reverse osmosis system) with continuous stirring for achieving test concentrations of 25 mg/L, 50 mg/L,100 mg/L, 200 mg/L & 400 mg/L, respectively and Zebra Fish Danio rerio were exposed to these concentration for 96 hours. Bowl aquaria containing 2 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 > 400 mg/l . Based on the LC50, 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

Study was conducted to access the effect of test chemical on the growth 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 100 mg, 200 mg, 400 mg, 800 mg & 400 mg of the test substance in 4 liters of potable water (passed through reverse osmosis system) with continuous stirring for achieving test concentrations of 25 mg/L, 50 mg/L,100 mg/L, 200 mg/L & 400 mg/L, respectively and Zebra FishDanio reriowere exposed to these concentration for 96 hours. Bowl aquaria containing 2 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 > 400 mg/l . Based on the LC50, it can be consider that the chemical was nontoxic and can be consider to be not classified as per the CLP classification criteria.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
400 mg/L

Additional information

Study was conducted to access the effect of test chemical on the growth 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 100 mg, 200 mg, 400 mg, 800 mg & 400 mg of the test substance in 4 liters of potable water (passed through reverse osmosis system) with continuous stirring for achieving test concentrations of 25 mg/L, 50 mg/L,100 mg/L, 200 mg/L & 400 mg/L, respectively and Zebra FishDanio reriowere exposed to these concentration for 96 hours. Bowl aquaria containing 2 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 > 400 mg/l . Based on the LC50, it can be consider that the chemical was nontoxic and can be consider to be not classified as per the CLP classification criteria.