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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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Administrative data

Link to relevant study record(s)

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 chemical
Justification for type of information:
Experimental data of test chemical from 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 for the determination of effect of test chemical on fish.
GLP compliance:
no
Analytical monitoring:
yes
Vehicle:
no
Test organisms (species):
other: 1: Danio rerio (previous name: Brachydanio rerio), 2: Pimephales promelas
Details on test organisms:
1: Details on test organisms
TEST ORGANISM
- Common name: zebra fish

2: Details on test organisms
TEST ORGANISM
- Common name: Fathead Minnow
- Age at study initiation (mean and range, SD): 30 days old
- Length at study initiation (length definition, mean, range and SD): 17.6 mm
- Weight at study initiation (mean and range, SD): 0.079 g

Test type:
other: 1: static, 2: flow-through
Water media type:
freshwater
Total exposure duration:
96 h
Post exposure observation period:
2: Every 24 hrs.
Hardness:
2: 44.5 mg CaCO3/l
Test temperature:
2: 24.4 ° C
pH:
2: 7.7
Dissolved oxygen:
2: 6.8 mg/L
Nominal and measured concentrations:
2: 0, nominal 5 concentrations in the range of 4.39 to 24.6 mg/l tested
Details on test conditions:
2: Details on test conditions:
Alkalinity: 44.5 mg CaCO3/l
Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
17.6 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 1st study
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
18.9 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 2nd study
Details on results:
1: Slow and inactive swimming behaviour and loss of equilibrium (uncontrolled movements) were also observed.
2: Details on result
- Behavioural abnormalities: Affected fish lost schooling behavior, were hypoactive and underreactive to external stimuli. They had increased respiration were darkly colored and lost equilibrium prior to death.

Reported statistics and error estimates:
1: Probit analysis
Sublethal observations / clinical signs:

1:

Fig: Effect concentration on the growth of fish.

Hours

Mortality rate of fish

0

0 %

24

80 %

48

90 %

72

90 %

96

90 %

 

Validity criteria fulfilled:
not specified
Conclusions:
1: Based on the mortality of freshwater fish Brachydanio rerio by the chemical exposure for 96 hrs, the LC50 was determine to be 17.6 mg/l and the LC0 and LC100 was 11.3 mg/l and 26.2 mg/l.
2: Based on the mortality of fishes Pimephales promelas after the exposure of chemical for 96 hrs, the LC50 was determine to be 18.9 mg/l.
Thus based on the above both studies, chemical consider to be toxic and classified as aquatic chronic 3 as per the CLP classification criteria.
Executive summary:

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

 

Aim of this study was to determine the nature of chemical on the mortality of freshwater fish Brachydanio rerio for total exposure of 96 hrs. Chemical was analytically monetarized by GC. Test conducted under static system. After incubation period of 96 hrs, slow and inactive swimming behaviour and loss of equilibrium (uncontrolled movements) were also observed. Based on the mortality of freshwater fish Brachydanio rerio by the chemical exposure for 96 hrs, the LC50 was determine to be 17.6 mg/l and the LC0 and LC100 was 11.3 mg/l and 26.2 mg/l. Based on the LC50, chemical was consider as toxic and classified in aquatic chronic 3 category as per the CLP classification criteria.

 

Similar study was also conducted on other fish. Aim of this study was to determine the nature of chemical on the mortality of fish Pimephales promelas for total exposure of 96 hrs. Study was conducted comparable to standard method and in accordance with general accepted scientific standards. Nominal 5 concentrations in the range of 4.39 to 24.6 mg/l were used and the sample was analytically monetarized by GC method. 0.079 g 30 days old Pimephales promelas (Fathead Minnow) were used. Test conducted under the flow- through system. Observations of fish behaviour and body morphology at regular intervals. Affected fish lost schooling behavior, were hypoactive and underreactive to external stimuli. They had increased respiration were darkly colored and lost equilibrium prior to death. Based on the mortality of fishes Pimephales promelas after the exposure of chemical for 96 hrs, the LC50 was determine to be 18.9 mg/l. based on the LC50, chemical was consider as toxic and classified as aquatic chronic 3 category as per the CLP classification criteria.

Thus based on the above both studies, chemical consider to be toxic and classified as aquatic chronic 3 as per the CLP classification criteria.

Description of key information

1: Based on the mortality of freshwater fish Brachydanio rerio by the chemical exposure for 96 hrs, the LC50 was determine to be 17.6 mg/l and the LC0 and LC100 was 11.3 mg/l and 26.2 mg/l.

2: Based on the mortality of fishes Pimephales promelas after the exposure of chemical for 96 hrs, the LC50 was determine to be 18.9 mg/l.

Thus based on the above both studies, chemical consider to be toxic and classified as aquatic chronic 3 as per the CLP classification criteria.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Dose descriptor:
LC50
Effect concentration:
17.6 mg/L

Additional information

Data available for the test chemical, structually and functionally similar read across chemicals has been reviewed to determine its effect on the mortality of fishes. The studies are as mentioned below:

 

Aim of this study was to determine the nature of chemical on the mortality of freshwater fish Brachydanio rerio for total exposure of 96 hrs. Chemical was analytically monetarized by GC. Test conducted under static system. After incubation period of 96 hrs, slow and inactive swimming behaviour and loss of equilibrium (uncontrolled movements) were also observed. Based on the mortality of freshwater fish Brachydanio rerio by the chemical exposure for 96 hrs, the LC50 was determine to be 17.6 mg/l and the LC0 and LC100 was 11.3 mg/l and 26.2 mg/l. Based on the LC50, chemical was consider as toxic and can be consider to to be classfied as aquatic chronic 3 category as per the CLP classification criteria.

 

Similar study was also conducted on other fish. Study was to determine the nature of chemical on the mortality of fish Pimephales promelas for total exposure of 96 hrs. Study was conducted comparable to standard method and in accordance with general accepted scientific standards. Nominal 5 concentrations in the range of 4.39 to 24.6 mg/l were used and the sample was analytically monetarized by GC method. 0.079 g 30 days old Pimephales promelas (Fathead Minnow) were used. Test conducted under the flow- through system. Observations of fish behaviour and body morphology at regular intervals. Affected fish lost schooling behavior, were hypoactive and underreactive to external stimuli. They had increased respiration were darkly colored and lost equilibrium prior to death. Based on the mortality of fishes Pimephales promelas after the exposure of chemical for 96 hrs, the LC50 was determine to be 18.9 mg/l. based on the LC50, chemical was consider as toxic and can be consider to not classified as aquatic chronic 3 category as per the CLP classification criteria.

Thus based on the above both studies, chemical consider to be toxic and classified as aquatic chronic 3 as per the CLP classification criteria.