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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:
supporting study
Study period:
From February 28, 1983 to March 04, 1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods
Remarks:
No analytical dose verification.
Qualifier:
according to guideline
Guideline:
ISO 7346-1 (Determination of the Acute Lethal Toxicity of Substances to a Freshwater Fish [Brachydanio rerio Hamilton-Buchanan (Teleostei, Cyprinidae)] - Part 2: Semi-static method)
Deviations:
yes
Remarks:
(Control data not reported)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
yes
Remarks:
(Control data not reported)
GLP compliance:
yes
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Chemical name of vehicle: Water
- Concentration of vehicle in test medium (stock solution): Stock suspension of 10 g/L was prepared from which appropriate aliquots were pipetted into the test vessels and filled up to final volume of 5 L with standard dilution water.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebra fish
- Feeding: Not during the test
- Mortality (prior to test): < 0.1 %
- Pretreatment: None
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
About 250 mg CaCO3/L
Test temperature:
22.0-23.5°C
pH:
7.4-7.8
Dissolved oxygen:
62-92%
Nominal and measured concentrations:
Nominal : 11, 16, 22, 32, 45 and 90 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type: 10 L fish basins containing 5 L test water
- Fill volume: 5 L
- No. of organisms per concentration: 10
- Renewal rate of test solution (frequency/flow rate): Daily


TEST MEDIUM: Standard dilution water


OTHER TEST CONDITIONS
- Photoperiod: About 16 h daily

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Mortalities were recorded at 0, 6, 24, 48, 72 and 96 h

Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
LC10
Effect conc.:
ca. 11 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
ca. 31 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Key result
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
ca. 90 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Details on results:
- Behavioural abnormalities: No
Sublethal observations / clinical signs:

Table 1: Mortality (%)

Conc.

(mg product/L)

Incubation time (h)

0

6

24

48

72

96

11

0

0

0

0

n.d.

0

16

0

0

20

20

n.d.

20

22

0

10

10

40

n.d.

40

32

0

0

40

10

n.d.

10

45

0

30

80

90

n.d.

90

90

0

100

100

100

n.d.

100

n.d.=not determined

Validity criteria fulfilled:
not specified
Remarks:
(Control data not reported)
Conclusions:
Under the study conditions, the 96 h LC0, LC50 and LC100 were 11, 31 and 90 mg/L, respectively.
Executive summary:

A study was conducted to assess the acute toxicity of the test substance, C12-18 and C18-unsatd. MEA, to Zebra fish (Danio rerio) according to OECD Guideline 203 and ISO Method 7346/2 under semi static conditions. The fish (10 per dose) were exposed to the test substance (directly dissolved in test medium) in a concentration range of 11-90 mg/L for 96 h and immobility was determined at 96 h. No analytical dose verification was conducted. Under the study conditions, the 96 h LC0, LC50 and LC100 were 11, 31 and 90 mg/L, respectively (Gode, 2001).

Endpoint:
short-term toxicity to fish
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
From February 23, 1996 to April 05, 1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
KL 2 due to RA and no analytical dose verification.
Justification for type of information:
Refer to the section 13 for details on the category justification.
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
no
Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Solvent control: 100 µL/L Tetrahydrofuran
- Chemical name of vehicle (organic solvent): Tetrahydrofuran
- Concentration of vehicle in test medium (stock solution): 30 mg/mL
- Preparation of test solution: Test material (300 mg) was dissolved in 10 mL (final volume) of tetrahydrofuran to give the solvent stock solution from which an aliquot (2.0 mL) was dispersed in 20 L (final volume) of dechlorinated tap water to give the test concentration of 3.0 mg/L.
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Common name: Rainbow trout
- Source: Donnington Fish Farm, Upper Swell, Gloucestershire, UK
- Age at study initiation (mean and range, SD): Juvenile
- Length at study initiation (length definition, mean, range and SD): 4.8 cm (SD = 0.2)
- Weight at study initiation (mean and range, SD): 1.56 g (SD = 0.15)
- Feeding during test: No


ACCLIMATION
- Acclimation period: 8 d
- Acclimation conditions (same as test or not): Maintained in a glass fiber tank with a single pass water renewal system
- Type and amount of food: Commercial trout pellets, discontinued 24 h prior to definitive study
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
100 mg/L as CaCO3
Test temperature:
14 ± 1°C
pH:
7.4-7.9
Dissolved oxygen:
≥ 9.1 mg O2/L
Nominal and measured concentrations:
Nominal concentrations:
- Range finding study: 0.30 and 3.0 mg/L
- Definitive study: 3.0 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): Closed
- Material, size, headspace, fill volume: 20 L glass exposure vessel
- Aeration: Aerated via narrow bore glass tubes
- Renewal rate of test solution (frequency/flow rate): Daily
- No. of organisms per vessel: Three in range finding study, ten in definitive study
- No. of vessels per concentration (replicates): Two
- No. of vessels per vehicle control (replicates): Two
- Biomass loading rate: 0.78 g bw/L


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Dechlorinated tap water


OTHER TEST CONDITIONS
- Photoperiod: 16 h light and 8 h darkness


TEST CONCENTRATIONS
- Justification for using less concentrations than requested by guideline: 3 mg/L was reported to be highest attainable test concentration based on the solubility of the test material under the test conditions
- Range finding study
- Test concentrations: 0.30 and 3.0 mg/L
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 3 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: -
Key result
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
ca. 3 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: -
Details on results:
- Behavioural abnormalities: No
- Mortality of control: No
- Abnormal responses: No
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: No
- Effect concentrations exceeding solubility of substance in test medium: No
Sublethal observations / clinical signs:

Table 1: Cumulative mortality data in the range-finding study

Nominal concentration (mg/L)

Cumulative Mortality (Initial Population: 3)

24 h

48 h

72 h

96 h

Control

0

0

0

0

Solvent Control

0

0

0

0

0.3

0

0

0

0

3

0

0

0

0

Table 2: Cumulative mortality data in the definitive study

Nominal concentration (mg/L)

Cumulative Mortality (Initial Population: 10)

% mortality

3 h

6 h

24 h

48 h

72 h

96 h

96 h

Control

0

0

0

0

0

0

0

Solvent control

0

0

0

0

0

0

0

3.0 R1

0

0

0

0

0

0

0

3.0 R2

0

0

0

0

0

0

0

* R1-R2 = Replicates 1 & 2

Validity criteria fulfilled:
yes
Conclusions:
Under the study conditions, the nominal 96 h LC50 and NOEC were >3 and 3 mg/L, respectively
Executive summary:

A study was conducted to determine the acute toxicity of the read across substance, C8-18 and C18-unsatd. MEA, to Rainbow trout (Oncorhynchus mykiss) according to OECD Guideline 203 and EU Method C.1, in compliance with GLP. Based on the results of a range-finding study, fish (10 per group) were exposed to an aqueous dispersion of the test substance at a concentration of 3 mg/L, the highest attainable concentration due to limited water solubility, for 96 h under semi-static conditions. The substance was previously dissolved in tetrahydrofuran and a solvent control was run in parallel with the negative control and the test substance groups. No analytical dose verification was conducted. Under the study conditions, the nominal 96 h LC50 and NOEC were >3 and 3 mg/L, respectively (Wetton, 1996).

Description of key information

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
3 mg/L

Additional information

A study was conducted to determine the acute toxicity of the read across substance, C8-18 and C18-unsatd. MEA, to Rainbow trout (Oncorhynchus mykiss) according to OECD Guideline 203 and EU Method C.1, in compliance with GLP. Based on the results of a range-finding study, fish (10 per group) were exposed to an aqueous dispersion of the test substance at a concentration of 3 mg/L, the highest attainable concentration due to limited water solubility, for 96 h under semi-static conditions. The substance was previously dissolved in tetrahydrofuran and a solvent control was run in parallel with the negative control and the test substance groups. No analytical dose verification was conducted. Under the study conditions, the nominal 96 h LC50 and NOEC were >3 and 3 mg/L, respectively (Wetton, 1996).

A study was conducted to assess the acute toxicity of the test substance, C12-18 and C18-unsatd. MEA, to Zebra fish (Danio rerio) according to OECD Guideline 203 and ISO Method 7346/2 under semi static conditions. The fish (10 per dose) were exposed to the test substance (directly dissolved in test medium) in a concentration range of 11-90 mg/L for 96 h and immobility was determined at 96 h. No analytical dose verification was conducted. Under the study conditions, the 96 h LC0, LC50 and LC100 were 11, 31 and 90 mg/L, respectively (Gode, 2001).