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Short-term toxicity to fish

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Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2009
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Reference:
Composition 1
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
yes
Remarks:
chemical analyses were not conducted
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
yes
Remarks:
chemical analyses were not conducted
GLP compliance:
no
Test material information:
Composition 1
Specific details on test material used for the study:
-CAS no. 112-03-8
- Substance type: Monoalkyl quat
- Physical state: Solid
- Analytical purity: 91.6%
- Lot/batch No.: RCD/GU 2892
- Sample code: ECO 42
- Stability under test conditions: stable
- Storage condition of test material: at room temperature in the dark
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
1 g/L Stock solution was prepared by ultrasonic treatment in deionised water. A clear homogeneous solution was obtained.
Test concentrations were prepared by dilution of the stock solution in Dutch Standard Water: control (0), 0.056, 0.18, 0.32, 0.58 and 1.05 mg/L nominal.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
Test organisms:
- Common name: zebra fish
- Strain: Danio rerio
- Source: Imported from Singapore Batch 08-09-1992
- Length at study initiation: average 2-3 cm
- Feeding during test: No

Acclimation:
- No details but common practice was according to guidelines GLP lab
- Feeding frequency: 1-3 times a day six times a week
- Water: Dutch Standard Water
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
Dutch Standard Water: 11.7°dH
Test temperature:
Temperature controlled incubator: 22.4-22.8°C
pH:
7.7 - 8.1
Dissolved oxygen:
>8.2 mg/L
Salinity:
Dutch Standard Water: 100 mg/L NaHCO3; 20 mg/L KHCO3; 200 mg/L CaCl2.2H2O; 180 mg/L MgSO4.7H2O
Nominal and measured concentrations:
Nominal: 0, 0.056, 0.18, 0.32, 0.58 and 1.05 mg/L
Details on test conditions:
Semi-static with renewal after two days in glass aquaria covered with glass plates in an temperature controlled incubator. Light regime was 16h of ambient light per d provided by fluorecent tubes.
Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
0.064 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Remarks:
based on ca. 91.6% purity
Basis for effect:
mortality
Remarks on result:
other: 98% CL of 0.06 - 0.1 mg/L
Details on results:
No mortality was observed at 0.056 mg/L
100% mortality was observed at 0.1 mg/L after 69h.
No sublethal effects were observed in for those fish where no mortality was observed.
Reported statistics and error estimates:
LC50 was calculated using trimmed Spearman-Karber and Binomial test method (Stephan, 1977).

Table 1. Mortality

Mortality In the definitive test                      
Concentration Number of surviving animals
of test substance         Test duration (h)          
mg/L 0 3 5 21 24 29 45 48 53 69 72 77 94 96
control  7 7 7 7 7 7 7 7 7 7 7 7 7 7
0.056 7 7 7 7 7 7 7 7 7 7 7 7 7 7
0.100 7 7 7 7 7 7 5a 5a 4a 0
0.180 7 7 7a 0
0.320 7 7a 0
0.580 7 0
1.050 7 0                        
a = one fish almost dead
Validity criteria fulfilled:
yes
Conclusions:
Under the study conditions, the LC50 (96-hour) was calculated to be 0.07 mg/L (i.e., equivalent to 0.064 mg a.i./L), with 98% confidence limits of 0.06 and 0.1 mg/L (nominal concentrations).
Executive summary:

A study was conducted to determine the short-term toxicity to fish of the test substance according to OECD Guideline 203 and EU Method C.1, in compliance with GLP. Zebra fish (Brachydanio rerio) were exposed to the test substance (91.6% active ingredient) at nominal concentrations of 0, 0.056, 0.18, 0.32, 0.58 and 1.05 mg/L for 96 h under semi-static conditions. No analytical dose verification was conducted. Mortality and clinical signs were recorded. There was no mortality at 0.056 mg/L, whereas 100% mortality occurred at 0.18 mg/L. Under the study conditions, the 96 h LC50 was calculated to be 0.07 mg/L (equivalent to 0.064 mg a.i./L), with 98% confidence limits of 0.06 and 0.1 mg/L. The 96 h NOEC was 0.056 mg/L (Mark, 1992).

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
From February 13, 1989 to April 12, 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Reference:
Composition 1
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
GLP compliance:
yes
Test material information:
Composition 1
Specific details on test material used for the study:
- Molecular formula (if other than submission substance): C21H46NCl
- Physical state: Pellets
- Composition of test material, percentage of components: ca. 80% alkyltrimethyl ammonium chloride
- Lot/batch No.: 1061962182
Analytical monitoring:
no
Vehicle:
no
Details on test organisms:
Test organisms:
- Common name: Ide
- Source: Leine Zoo, Laatzen, Germany

Acclimation:
- Acclimation period: min. 12 days
- Feeding frequency: 3 times per week, fish received the equivalent of 4% of their bodyweight in feed
- Feed type: Kronen Fish Allround 2 (mm), Fa. Ssniff Spezialdiäten GmbH
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Test temperature:
20.8 - 23.1°C
pH:
7.48 - 7.66
Dissolved oxygen:
86 - 89%
Nominal and measured concentrations:
Nominal: 0, 0.1, 0.22, 0.48, 1.06 and 2.34 mg/L
Equivalent to: 0, 0.08, 0.18, 0.38, 0.85 and 1.87 mg a.i./L (based on ca. 80% a.i. in the test substance)
Details on test conditions:
Test system:
- Test vessel: 22L aquaria
- No. of organisms per vessel: 7

Test medium / water parameters
- Source/preparation of dilution water: Filtered tap water
- Photoperiod: 12h
Light intensity: ca. 10 µmol/m2.s

Effect parameters measured (with observation intervals if applicable): mortality and clinical signs at 24, 48, 72 and 96h
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
0.08 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
0.12 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
0.18 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality
Details on results:
Mortality occured at 0.22 mg/L and above. No clinical signs were observed in surviving fish at any dose.
Validity criteria fulfilled:
yes
Conclusions:
Under the study conditions, the 96-hour LC0 was 0.1 mg/L, the 96 -hour LC50 was 0.15 mg/L and the 96-hour LC 100 was 0.22 mg/L. This was equivalent to 0.08, 0.12 and 0.18 mg a.i./L, respectively (based on ca. 80% a.i. in the test substance).
Executive summary:

A study was conducted to determine the short-term toxicity to fish of the test substance according to OECD Guideline 203, in compliance with GLP. Seven Golden ide (Leuciscus idus) per group were exposed to the test substance under static conditions for 96 h at nominal concentrations of 0, 0.1, 0.22, 0.48, 1.06 and 2.34 mg/L, equivalent to 0, 0.08, 0.18, 0.38, 0.85 and 1.87 mg a.i./L (based on ca. 80% a.i. in the test substance). No analytical dose verification was conducted. Mortality and clinical signs were recorded. Mortality occurred at 0.2 mg/L and above. No clinical signs were observed in surviving fish at any concentration. Under the study conditions, the 96 h LC0 was 0.1 mg/L, the 96 h LC50 was 0.15 mg/L and the 96 h LC 100 was 0.22 mg/L, equivalent to 0.08, 0.12 and 0.18 mg a.i./L, respectively (Scheerbaum, 1997).

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
From February 13, 1989 to April 12, 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 1
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
no
GLP compliance:
yes
Test material information:
Composition 1
Specific details on test material used for the study:
- Physical state: Solid flakes
- Solubility: soluble in water
- Composition of test material, percentage of components: ca. 80% octadecyl trimethyl ammonium chloride, ca. 20% isopropyl alcohol
- Lot/batch No.: 06-FHFR 555
Analytical monitoring:
no
Details on sampling:
- Concentrations: 0.01 and 0.1 mg/L
- Sampling method: samples collected at test start, the at 48 and 96h with a glass flask from the center of the test vessel
Vehicle:
no
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
Test organism:
- Common name: Zebra fish
- Strain: Hamilton-Buchanan
- Source: West Aquarium, 3422 Bad Lauterberg, Germany
- Length at study initiation (length definition, mean, range and SD): 2.2 - 3.4 cm

Acclimation
- Acclimation period: min. 14 days
- Acclimation conditions (same as test or not): yes
- Feeding frequency: twice a day ad libitum
- Feed type: Tetra Min, Tetra Werke, Melle, Germany
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Test temperature:
21.0 - 22.3°C
pH:
7.6 - 8.3
Dissolved oxygen:
7.6 - 8.9 mg/L
Nominal and measured concentrations:
- Nominal: 0, 0.01, 0.1 and 1.0 mg/L
- Equivalent to: 0, 0.008, 0.08 and 0.8 mg/L
- Measured: At 0.1 mg/L, measured values were less than 80% of nominal values. The average of samples collected at 0 and 48h was equivalent to 0.05 mg/L. At 0.01 mg/L, the substance was not detectable. Results are reported based on nominal values.
Details on test conditions:
Test system:
- Test vessel: 10L glass vessels
- No. of organisms per vessel: 10

Test medium / Water parameters
- Source/preparation of dilution water: Reconstituted water according to ISO/DIS 7346/1

Other test conditions:
- Photoperiod: 12:12
- Light intensity: 700 Lux

Effect parameters measured (with observation intervals if applicable): mortality and clinical signs at 2, 4, 24, 48, 72 and 96h
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
0.008 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
>= 0.008 - <= 0.08 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
0.08 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality
Details on results:
- All fish in the 1 mg/L group died before test end.
- At 0.01 and 0.1 mg/L, effects on swimming behavioud and breathing, as well as changes in appearance and behaviour were noted.
- Dead fish were lighter coloured and showed reddened gills.
Validity criteria fulfilled:
yes
Conclusions:
Under the test conditions, the 96-hour LC0 was 0.01 mg/L, the 96-hour LC50 was 0.01 - 0.1 mg/L and the 96-hour LC 100 was 0.1 mg/L. This was equivalent to 0.008, 0.008- 0.08 and 0.08 mg/L, respectively, based on active ingredient.
Executive summary:

A study was conducted to determine the short-term toxicity to fish of the test substance according to OECD Guideline 203 and EU Method C.1, in compliance with GLP. Groups of ten Zebra fish (Brachydanio rerio) were exposed to the test substance (80% active ingredient) to the test substance for 96 h under static conditions at nominal concentrations of 0, 0.01, 0.1and 1.0 mg/L (i.e. 0, 0.008, 0.08 and 0.8 mg a.i./L). No analytical dose verification was conducted. Mortality and clinical signs were recorded. Symptoms were observed at all concentrations. Under the test conditions, the 96 h LC0 was 0.01 mg/L, the 96 h LC50 was 0.01 - 0.1 mg/L and the 96 h LC 100 was 0.1 mg/L, equivalent to 0.008, 0.008- 0.08 and 0.08 mg/L, respectively (Markert, 1989).

Description of key information

Key value for chemical safety assessment

LC50 for freshwater fish:
0.064 mg/L

Additional information

Study 1. A study was conducted to determine the short-term toxicity to fish of the test substance according to OECD Guideline 203 and EU Method C.1, in compliance with GLP. Zebra fish (Brachydanio rerio) were exposed to the test substance (91.6% active ingredient) at nominal concentrations of 0, 0.056, 0.18, 0.32, 0.58 and 1.05 mg/L for 96 h under semi-static conditions. No analytical dose verification was conducted. Mortality and clinical signs were recorded. There was no mortality at 0.056 mg/L, whereas 100% mortality occurred at 0.18 mg/L. Under the study conditions, the 96 h LC50 was calculated to be 0.07 mg/L (equivalent to 0.064 mg a.i./L), with 98% confidence limits of 0.06 and 0.1 mg/L. The 96 h NOEC was 0.056 mg/L (Mark, 1992).

 

Study 2. A study was conducted to determine the short-term toxicity to fish of the test substance according to OECD Guideline 203, in compliance with GLP. Seven Golden ide (Leuciscus idus) per group were exposed to the test substance under static conditions for 96 h at nominal concentrations of 0, 0.1, 0.22, 0.48, 1.06 and 2.34 mg/L, equivalent to 0, 0.08, 0.18, 0.38, 0.85 and 1.87 mg a.i./L (based on ca. 80% a.i. in the test substance). No analytical dose verification was conducted. Mortality and clinical signs were recorded. Mortality occurred at 0.2 mg/L and above. No clinical signs were observed in surviving fish at any concentration. Under the study conditions, the 96 h LC0 was 0.1 mg/L, the 96 h LC50 was 0.15 mg/L and the 96 h LC 100 was 0.22 mg/L, equivalent to 0.08, 0.12 and 0.18 mg a.i./L, respectively (Scheerbaum, 1997).

 

Study 3. A study was conducted to determine the short-term toxicity to fish of the test substance according to OECD Guideline 203 and EU Method C.1, in compliance with GLP. Groups of ten Zebra fish (Brachydanio rerio) were exposed to the test substance (80% active ingredient) to the test substance for 96 h under static conditions at nominal concentrations of 0, 0.01, 0.1and 1.0 mg/L (i.e. 0, 0.008, 0.08 and 0.8 mg a.i./L). No analytical dose verification was conducted. Mortality and clinical signs were recorded. Symptoms were observed at all concentrations. Under the test conditions, the 96 h LC0 was 0.01 mg/L, the 96 h LC50 was 0.01 - 0.1 mg/L and the 96 h LC 100 was 0.1 mg/L, equivalent to 0.008, 0.008- 0.08 and 0.08 mg/L, respectively (Markert, 1989).