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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:
key study
Study period:
August 2002
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Guideline compliant GLP study. Concentrations reported as nominal concentrations since no dose verification analysis was performed.
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
yes
Analytical monitoring:
no
Vehicle:
yes
Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: the test solutions were prepared with 100 µL acetone/L
- Controls: beside an untreated control, a solvent control was set up
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): acetone
- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s)): 100 µL/L in the final test solution
- Evidence of undissolved material (e.g. precipitate, surface film, etc): none
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Common name: Rainbow Trout
- Source: Thomas fish company, Anderson, California
- Length at study initiation (length definition, mean, range and SD): length of control fish at termination: 3.3 to 3.9 cm (mean 3.5 +/- 0.19 g)
- Weight at study initiation (mean and range, SD): wet weight of control fish at termination: 0.4718 to 0.8930 g (mean 0.6167 +/- 0.15 g)

ACCLIMATION
- Acclimation period: not reported
- Acclimation conditions (same as test or not): yes 13.1 to 14.1 °C during the last 11 days prior to test start
- Type and amount of food: salmon starter (Ziegler Brothers)
- Feeding frequency: not provided
- Health during acclimation (any mortality observed): good, no mortality during the last 7 days prior to test initiation
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
88 mg/L as CaCO3
Test temperature:
14.2 - 14.6°C
pH:
7.3 - 7.7
Dissolved oxygen:
6.9 - 10.9 mg/L
Nominal and measured concentrations:
Nominal: 0 (control), 0 (solvent control), 0.63, 1.25, 2.5, 5.0 and 10.0 mg CT-737-02/L corresponding to 0 (ccontrol), 0 (solvent control), 0.441, 0.875, 1.75, 3.5, and 7 mg a.i./L
Details on test conditions:
TEST SYSTEM
- Test vessel: 10L glass tanks
- Material, size, headspace, fill volume: fill volume 9 L
- Aeration: not reported
- No. of organisms per vessel: 7 fish per replicate
- No. of vessels per concentration (replicates): 2 replicates
- No. of vessels per control (replicates):2 replicates
- No. of vessels per vehicle control (replicates): 2 replicates
- Biomass loading rate: 0.5 g/L


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: US EPA moderately hard reconsituted
- Alkalinity: 36 mg/L as CaCO3
- Conductivity: 415 µS
- Intervals of water quality measurement: temperature, dissolved oxygen, pH, conductivity were measured initially and daily thereafter. Alkalinity and hardness of dilution water were measured at test initiation.


OTHER TEST CONDITIONS
- Photoperiod: 16 hr/8 hr light/dark cycle
- Light intensity: 7.0 to 9.3 micromolesper square meter per second.


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
mortality, behaviour and appearance initially, and daily thereafter

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2
- Justification for using less concentrations than requested by guideline: NA
- Range finding study: 5 fish per replicate exposed for 48 hours.
- Test concentrations: 0 (control), 0 (solvent control), 0.01, 0.1, 1, 10, and 100 mg CT-737-02/L
- Results used to determine the conditions for the definitive study: Mortality after 96 hours: 0/2, 0/2, 0/2, 0/2, 0/2, 2/2, and 2/2 dead fish at 0 (control), 0 (solvent control), 0.01, 0.1, 1, 10, and 100 mg CT-737-02/L, i.e., 0% mortality at control, solvent control, and up to 1 mg CT-737-02/L and 100% mortality at 10 and 100 mg CT-737-02/L
Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
1.96 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality
Remarks on result:
other: C.I.: 1.61 - 2.31 mg/L
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
2.8 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: C.I.: 2.3 - 3.3 mg/L
Details on results:
- Observations on body length and weight: NA
- Other biological observations: all of the fish exposed to 50 and 100 mg CT -737-02/L were dead within one hour. These fish demonstrated extreme stress immediately upon exposure.
- Mortality of control: none

- Behavioural abnormalities: at 2.5 mg CT-737-02/L one fish was dark and four fish were at the surface after 24 hours
- Observations on body length and weight: NA
- Other biological observations: NA
- Mortality of control: none
- Other adverse effects control: none
- Abnormal responses: none
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: At 0.63 mg CT-737-02/L a film was observed on the surface of the testing water.
- Effect concentrations exceeding solubility of substance in test medium:

Table 1 Number of dead fish and % mortality at the individual observation intervals

Nominal concentration

[mg CT-737 -02/L]

Number exposed

in two replicates

Cumulative Mortality

% mortality at 96 hours

24 hours

48 hours

72 hours

96 hours

0 (Control)

14

0

0

0

0

0

0.63

14

0

0

0

1

7

1.25

14

0

0

0

0

0

2.5

14

1

5

5

5

36

5.0

14

14

14

14

14

100

10.0

14

14

14

14

14

100

 

 

Validity criteria fulfilled:
yes
Conclusions:
96-hour LC50= 1.96 mg/L
Executive summary:

The acute toxicity of CT-737-02 - which contains about 70 % a.i. - to rainbow trout, Oncorhynchus mykiss, was determined in a static test. The test was performed according to OECD 203 without deviations to the guideline. The test was performed with a control, solvent control (100 µL acetone/L] and nominal 0.63, 1.25, 2.5, 5.0 and 10.0 mg CT-737 -02/L corresponding to 0.441, 0.875, 1.75, 3.5, and 7.0 mg a.i./L. For each test group, 2 replicates with 7 fish were set up. Dose verification analysis was not performed. During the study, the temperature of the test solutions ranged within 14.2 to 14.6 °C. After 96 hours of exposure, 0, 0, 0, 1, 0, 5, 14, and 14 out of 14 fish had died in the control, solvent control, 0.63, 1.25, 2.5, 5.0 and 10 mg CT-737 -02/L treatment groups. The 96 h LC50 was determined to be 2.8 mg CT-737 -02/L, corresponding to 1.96 mg a.i./L. The concentrations were based on nominal concentrations.

The results of this study are considered to be reliable with restrictions for the risk assessment.

Description of key information

LC50 for freshwater fish (rainbow trout) = 1.96 mg a.i./L

Key value for chemical safety assessment

LC50 for freshwater fish:
1.96 mg/L

Additional information

For the data endpoint “Short-term toxicity to fish” one study is available.

 

The GLP study from Cytec (Glover 2002) was classified as Klimisch 2 key study. The acute toxicity of CT-737 -02 - which contains about 70 % a.i. - to rainbow trout, Oncorhynchus mykiss, was determined in a static test. The test was performed according to OECD 203 without deviations to the guideline. The test was performed with a control, solvent control (100 µL acetone/L] and nominal 0.63, 1.25, 2.5, 5.0 and 10.0 mg CT-737 -02/L corresponding to 0.441, 0.875, 1.75, 3.5, and 7.0 mg a.i./L. For each test group, 2 replicates with 7 fish were set up. Dose verification analysis was not performed. During the study, the temperature of the test solutions ranged within 14.2 to 14.6 °C. After 96 hours of exposure, 0, 0, 0, 1, 0, 5, 14, and 14 out of 14 fish had died in the control, solvent control, 0.63, 1.25, 2.5, 5.0 and 10 mg CT-737 -02/L treatment groups. The 96 h LC50 was determined to be 2.8 mg CT-737 -02/L, corresponding to 1.96 mg a.i. /L. The concentrations were based on nominal concentrations.

The results of this study are considered to be reliable with restrictions for the risk assessment. Therefore, the acute LC50 of 1.96 mg a.i./L from the key study will be used for the further risk assessment.