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Ecotoxicological information

Short-term toxicity to fish

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Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1 June to 19 June 1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
not specified
Principles of method if other than guideline:
Study is designed only as a screening study.
GLP compliance:
no
Specific details on test material used for the study:
No further details specifiedin the study report.
Analytical monitoring:
not specified
Details on sampling:
Not specified in the report.
Vehicle:
yes
Details on test solutions:
Preliminary solution in 1% v/v Tween 80-acetone.
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
Test Species: Rainbow trout (Oncorhynchus mykiss).
Length: 4.4 ± 0.3 cm.
Weight: 1. 19 ± 0. 30 g Loading: 0.60 g bodyweight/litre.
Supplier: Parkwood Trout Farm, Kent, U.K.
Screening study: 2 fish
Main study: 10 fish
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
No post exposure observation period specified in the study report.
Hardness:
Approximately 50 mg/l as CaC03
Test temperature:
14.0°C
pH:
Not specified
Dissolved oxygen:
Not specified
Salinity:
Not applicable
Conductivity:
Not specified
Nominal and measured concentrations:
Nominal concentrations:
Range finding study: 0.10, 1.0, 10 mg/l
Main study: 1.0 mg/l
Details on test conditions:
Method of Preparation: Preliminary solution in 1% v/v Tween 80-acetone.
Media Renewal: Daily.
Medication: None.
Test Water: Dechlorinated tap water (Sodium thiosulphate).
Test Vessels: 20 l.
Aeration: Yes.
Reference substance (positive control):
not specified
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 1 - < 10 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
2/2 deaths at 10 mg/l; 0/10 deaths at 1 mg/l. LC50 considered to lie between 1 and 10 mg/l.
Results with reference substance (positive control):
No reference substance utilised.
Sublethal observations / clinical signs:

Range Finding Study – Dates: 1 – 5 June 1992.

Concentration (mg/l)

Cumulative Mortality (initial population = 2)

24 Hours

48 Hours

72 Hours

96 Hours

Control

0

0

0

0

Solvent Control

0

0

0

0

0.10

0

0

0

0

1.0

0

0

0

0

10

2

2

2

2

 

Definitive Study – Dates: 15 – 19 June 1992

Concentration (mg/l)

Cumulative Mortality (initial population = 10)

24 Hours

48 Hours

72 Hours

96 Hours

Control

0

0

0

0

Solvent Control

0

0

0

0

1.0 R1

0

0

0

0

1.0 R2

0

0

0

0

R1– R2: Replicates R1– R2

Validity criteria fulfilled:
yes
Conclusions:
96h LC50 >1.0 mg/l, <10 mg/l.
Executive summary:

96h LC50 >1.0 mg/l, <10 mg/l.

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not specified
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods
Qualifier:
according to guideline
Guideline:
other: "Testing Method Concerning New Chemical Substances, etc.,”
Deviations:
not specified
Principles of method if other than guideline:
This study was performed in accordance with "Testing Method Concerning New Chemical Substances, etc.,” the Joint Notice of Director of Pharmaceutical and Food Safety Bureau, the Ministry of Health, Labour and Welfare, Director of Manufacturing Industries Bureau, the Ministry of Economy, Trade and Industry, and Director of Environmental Policy Bureau, the Ministry of the Environment (November 21, 2003, Yakushoku-hatsu No. 1121002, Heisei 15-11-13 Seikyoku No. 2, Kanpoki-hatsu No. 031121002, final revision partly on November 20, 2006).
GLP compliance:
yes
Specific details on test material used for the study:
No further details specified in the study report.
Analytical monitoring:
yes
Details on sampling:
Test concentration (nominal): control, 0.40, 0.63, 1.0, 1.6, 2.5, 4.0 mg/L
common ratio; 1.6
Vehicle:
not specified
Details on test solutions:
Not specified
Test organisms (species):
Oryzias latipes
Details on test organisms:
Test organism: killifish (Oryzias laptipes)
Number of test organism: 10 fish/test area
Lighting: room light, 16 hours light/8 hours dark
Feeding: no feeding
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
No post exposure observation period specified in the report.
Hardness:
Not specified.
Test temperature:
24±1°C
pH:
Not specified
Dissolved oxygen:
Not specified
Salinity:
Not applicable.
Nominal and measured concentrations:
Nominal concentrations
Details on test conditions:
Exposure method: semi-static water (all test solution was renewed at 48 hours.)
Exposure period: 96 hours
Volume of test solution: 5 L/vessel
Replicates: 1 vessel/test area
Aeration: none
pH: pH adjustment of the test solution was not performed.
Reference substance (positive control):
not specified
Key result
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
2.9 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Key result
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
2.7 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Key result
Duration:
72 h
Dose descriptor:
LC50
Effect conc.:
2.7 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
2.5 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
No further details on results specified in the report
Results with reference substance (positive control):
Reference substance not used in this study
Reported statistics and error estimates:
The variance of test substance concentration was considered to be decrease due to volatilization. Therefore, time-weighted average (the arithmetical mean of logarithmic means at the start of exposure and 48 hours before water renewal, and 48 hours after water renewal and at the end of exposure) was calculated for each effect concentration.
Validity criteria fulfilled:
yes
Conclusions:
50% lethal concentration
24-hour 50% lethal concentration (LC50): 2.9 mg/L (95% confidence limit: 2.3-3.8 mg/L), 48-hour 50% lethal concentration (LC50): 2.7 mg/L (95% confidence limit: 2.3-4.7 mg/L), 72-hour 50% lethal concentration (LC50): 2.7 mg/L (95% confidence limit: 2.0-4.0 mg/L), 96-hour 50% lethal concentration (LC50): 2.5 mg/L (95% confidence limit: 1.9-3.7 mg/L)
Executive summary:

This study was performed in accordance with "Testing Method Concerning New Chemical Substances, etc.,” the Joint Notice of Director of Pharmaceutical and Food Safety Bureau, the Ministry of Health, Labour and Welfare, Director of Manufacturing Industries Bureau, the Ministry of Economy, Trade and Industry, and Director of Environmental Policy Bureau, the Ministry of the Environment (November 21, 2003, Yakushoku-hatsu No. 1121002, Heisei 15-11-13 Seikyoku No. 2, Kanpoki-hatsu No. 031121002, final revision partly on November 20, 2006).

 

50% lethal concentration

24-hour 50% lethal concentration (LC50): 2.9 mg/L (95% confidence limit: 2.3-3.8 mg/L),

48-hour 50% lethal concentration (LC50): 2.7 mg/L (95% confidence limit: 2.3-4.7 mg/L),

72-hour 50% lethal concentration (LC50): 2.7 mg/L (95% confidence limit: 2.0-4.0 mg/L),

96-hour 50% lethal concentration (LC50): 2.5 mg/L (95% confidence limit: 1.9-3.7 mg/L)

 

On the basis of the results noted in the study, classification under the Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008 is as follows:

N; R51/53 Dangerous for the environment; Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.

Chronic aquatic toxicity, Category 2; H411: Toxic to aquatic life with long lasting effects.

Description of key information

Key value determined using Japaneses test guidelines.

Key value for chemical safety assessment

Fresh water fish

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

Additional information

Main study:


50% lethal concentration


24-hour 50% lethal concentration (LC50): 2.9 mg/L (95% confidence limit: 2.3-3.8 mg/L),


48-hour 50% lethal concentration (LC50): 2.7 mg/L (95% confidence limit: 2.3-4.7 mg/L),


72-hour 50% lethal concentration (LC50): 2.7 mg/L (95% confidence limit: 2.0-4.0 mg/L),


96-hour 50% lethal concentration (LC50): 2.5 mg/L (95% confidence limit: 1.9-3.7 mg/L)


 


 


Non-GLP Supporting study:


 


96h LC50 >1.0 mg/l, <10 mg/l.


 


On the basis of the results noted in the study, classification under the CLP Regulation (EC No 1272/2008 is as follows:


 


Chronic aquatic toxicity, Category 2; H411: Toxic to aquatic life with long lasting effects.