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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:
February 22-25, 2005.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
According to EU Method C.1, with GLP.
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
no
GLP compliance:
yes
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: 0.5004 g test substance was dispersed in 5000 mL dilution water. The test substance was added in drops to approximately 1000 mL dilution water, stirred by using magnetic stir plates and bars. Then the required amount of dilution water was added. The preparation was stirred for approximately half an hour to obtain a preparation for testing in which the test substance is completely hydrolysed.
- Controls: Yes (water)
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebrafish
- Strain: Brachydanio rerio
- Source: Fa. Amazonas Aquarium, A-2840 Grimmenstein
- Length at study initiation (length definition, mean, range and SD): 2.5 1: 0.1 (mean of control group at the end of study)
- Weight at study initiation (mean and range, SD): 0.3 :t 0.08 (mean of control group at the end of study)
- Feeding during test: No feeding (last feeding about 24 hours before start of the exposure).

ACCLIMATION
- Acclimation period: Approx. 10 weeks.
- Observations: Once daily for behaviour and mortality.
- Type and amount of food: Feed: TetraMin; Tetra Werke, Dr.rer.nat. Ulrich Baensch GmbH, D-49304 Meile.
- Feeding frequency: daily
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
No.
Hardness:
250 mg CaCO3/L
Test temperature:
20 ºC throughout the test period.
pH:
Test substance medium: 7.8-8.0
Control medium: 7.6-8.1
Dissolved oxygen:
Test substance medium: 90-97%.
Control medium: 88-95%..
Nominal and measured concentrations:
Nominal concentrations: 0 (control) and 100 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: Full glass vessel
- Type (delete if not applicable): covered with a transparent plastic lid.
- Material, size, headspace, fill volume:
Holding: full glass vessel (47 cm x 29 cm x 31 cm), filled with ca. 40 L.
Exposure: full glass vessels (29 cm x 20 cm x 24 cm), filled with 5 L of control and test medium
- Aeration:
Holding: continuous aeration by compressed air (water and oil filtered) and additional aeration by water recirculation using an EHEIM filter pump (maintenance of more than 80% of the air saturation value).
Exposure: no aeration.
- No. of organisms per vessel: 7 fish per vessel
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: Maximum loading of 1.0 9 fish/litre.

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Water was purified by recirculation (power filter pump EHEIM) through filter wool.

OTHER TEST CONDITIONS
- Photoperiod: Artificial light from 4 a.m. to 8 p.m.

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): All animals were observed for alterations and behavioural changes at setting-in of the fish and 2, 4, 24, 48, 72 and 96 hours afterwards.
Visual observations were made at the same time as the animal observation. Any change (like change in colour or precipitation) was recorded. The determinations of temperature, dissolved oxygen concentration and pH of the control and test medium were performed before introduction of the fish and then approximately 24, 48, 72 and 96 hours after the start of the test. Total hardness of the water was checked in the control vessel before beginning of the test.

TEST CONCENTRATIONS
- Range finding study: In a preliminary test with 3 fish no toxicity was noted at 100 mg/L
- Test concentrations: 100 mg/L
Reference substance (positive control):
no
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
other: test substance equivalents (variety of degradation products)
Basis for effect:
mortality (fish)
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
other: test substance equivalents (variety of degradation products)
Basis for effect:
mortality (fish)
Duration:
72 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
other: test substance equivalents (variety of degradation products)
Basis for effect:
mortality (fish)
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
other: test substance equivalents (variety of degradation products)
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
other: test substance equivalents (variety of degradation products)
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
other: test substance equivalents (variety of degradation products)
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
other: test substance equivalents (variety of degradation products)
Basis for effect:
mortality (fish)
Details on results:
All animals survived until the end of the test.
All animals of the test substance groups and of the negative control group were inconspicuous in behaviour and appearance until the end of the test.
The test media were clear and colourless during the whole exposure time.
Sublethal observations / clinical signs:

Mortality

Number of fish at the start of exposure: 7 in each group. The nominal concentration of test substance equivalents is displayed.

Group

Concentration

(mg/L)

Total number of dead fish at hours after start of exposure

0

24

48

72

96

Control

0

0

0

0

0

0

Test substance

100

0

0

0

0

0

Validity criteria fulfilled:
yes
Remarks:
(Constant conditions were maintained (temperature, pH), no mortality occurred in the negative contral group, the dissolved oxygen concentration was higher than 60% of the air saturation value throughout the test)
Conclusions:
The 96-hours LC50 value of the test substance Wasox-MMAC2 was > 100 mg/L (based on mortality).
Executive summary:

The acute toxicity of the test substance to the Zebrafish (Brachydanio rerio) was determined in a 96 hour static test (According to EU Method C.1). A total of 7 fish were treated with a single dose of 100 mg/L (limit test). A negative control group was included. All animals were observed for alterations and behavioural changes at setting-in of the fish and 2, 4, 24, 48, 72 and 96 hours afterwards. pH, temperature and dissolved oxygen concentration in control and test medium was controlled at the start and after approximately 14, 48, 72 and 96 hours. Test validity criteria were fulfilled. The 96-hours LC50 value of the test substance Wasox-MMAC2, based on mortality, was > 100 mg/L. The No Observed Effect Concentration (NOEC) was ≥100 mg/L.

Description of key information

Key study: EU Method C.1 and GLP. The 96-hours LC50 value of the test substance Wasox-MMAC2 was > 100 mg/L (based on mortality).

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
100 mg/L

Additional information

Key study: The acute toxicity of the test substance Wasox-MMAC2 to the Zebrafish (Brachydanio rerio) was determined in a 96 hour static test (According to EU Method C.1 and GLP). The 96-hours LC50 value of the test substance Wasox-MMAC2, based on mortality, was > 100 mg/L.