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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:
22-25 February, 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:
0.5003 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 hydrolyzed.
The concentration is presented in units of mg test substance equivalents / L to indicate that not the test substance but a variety of degradation products was tested.




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, Grimmenstein.
- Feeding during test: no feeding (last feeding about 24 hours before start of the exposure).


ACCLIMATION
- Acclimation conditions (same as test or not): yes
- Type and amount of food: Feed: TetraMin; Tetra Werke, Dr.rer.nat. Ulrich Baensch GmbH, D-49304 Melle.
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
No.
Hardness:
Total hardness: 250 mg CaCO3/L
Test temperature:
20 ºC throughout the test period
pH:
Between 7.6 -8.1 in control medium, and between 7.8-8.0 in the test substance medium
Dissolved oxygen:
Test substance medium: 90-94%, and control medium: 90-97%.
Nominal and measured concentrations:
100 mg/L (nominal)
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: full glass vessel (47 cm x 29 cm x 31 cm), filled with ca. 40 L, covered with a transparent plastic lid.
- Aeration: continuous aeration by compressed air and additional aeration by water recirculation.
- No. of organisms per vessel: 7


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.
Reference substance (positive control):
no
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
dissolved
Basis for effect:
mortality (fish)
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
dissolved
Basis for effect:
mortality (fish)
Duration:
72 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
dissolved
Basis for effect:
mortality (fish)
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
dissolved
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
dissolved
Basis for effect:
mortality (fish)
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

Total number of dead fish
at hours after start of exposure

 

(mg/L)

0

24

48

72

96

Control

0

0

0

0

0

0

Test substance

100

0

0

0

0

0

There were no unforeseen events.

Validity criteria fulfilled:
yes
Conclusions:
The 96-hours LC50 value of the test substance, based on the nominal concentration of test substance equivalents at the start of the assay, was >100 mg/L. The No Observed Effect Concentration (NOEC) was ≥100 mg/L.
The concentrations are presented in units of mg test substance equivalents / L to indicate that not the test substance but a variety of degradation products was tested.
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. Test validity criteria were fulfilled.

The 96-hours LC50 value of the test substance, based on the nominal concentration at the start of the assay, was > 100 mg/L. The No Observed Effect Concentration (NOEC) was ≥100 mg/L.

Description of key information

The 96-hours LC50 value of the test substance, based on the nominal concentration at the start of the assay, was > 100 mg/L.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
100 mg/L

Additional information

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). The No Observed Effect Concentration (NOEC) was ≥100 mg/L.