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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:
from 2004-04-28 to 2004-06-11
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Use of solvents to increase exposure; Pre test for bioaccumulation study. This study was performed according to GLP and the methods applied are fully compliant with OECD TG 203.
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Specific details on test material used for the study:
Batch: L538792
Analytical monitoring:
yes
Details on sampling:
0; 24, 48, 72, 96 h
Vehicle:
yes
Details on test solutions:
According to guideline
PREPARATION AND APPLICATION OF TEST SOLUTION
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): SPAN 60
- Concentration of vehicle in test medium (stock solution and final test solution(s) at different concentrations and in control(s)):

- Nominal values

Substance Concentration Solubilizer SPAN-60
pos. Control 0.5 mg/L 500 mg/L
Test item: 100 mg/L 500 mg/L
Test item: 50 mg/L 500 mg/L
Test item: 25 mg/L 500 mg/L
Test item: 12.5 mg/L 500 mg/L
Test item: 6.25 mg/L 500 mg/L

- Analytical values

Substance Concentration Solubilizer SPAN-60
pos. Control 0.5 mg/L 500 mg/L
Test item: 99.4 mg/L 500 mg/L
Test item: 46.9 mg/L 500 mg/L
Test item: 25.9 mg/L 500 mg/L
Test item: 12.6 mg/L 500 mg/L
Test item: 6.55 mg/L 500 mg/L
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
Weight: 0.21 +/- 0.01 g
Length: 2.9 +/- 0.1 cm
Lot: 40315
Date: 2004-03-15
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
no
Test temperature:
24.3 +/- 0.1 °C
Nominal and measured concentrations:
see "any other information on results"
Details on test conditions:
10 fish per 4 L
Reference substance (positive control):
not specified
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 99.4 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality

- Mortality of control: 0 % after 96 hours

Mortality in %

 Sample              Mortality / [%]
 Test Material  Concentration / [mg/L]  24 h  48 h  72 h 96 h
 Positive Control  0.5  0  20  40  90
 Positive Control  0.05  0  0  0  0
Test item  99.4

 0 

 0

 0

 0

Test item

 49.9

 0

 0

 0

 0

Test item

 25.9

 0

 0

 0

 0

Test item

 12.6

 0

 0

 0

 0

 Test item

 6.55

 0

 0

 0

 0

SPAN-60

 500

 0

 0

 0

 0

 Blank

 0

 0

 0

 0

 0

All concentrations tested were at or above the solubility limit of the pure test substance. To achive the exposure concentrations, solvent SPAN 60 was used.

Validity criteria fulfilled:
yes
Conclusions:
The LC50 of the test material exceeds 99.4 mg/L and is clearly above the limit of water solubility.
Executive summary:

Study Design

The acute toxicity of the test material was studied in a pretest for a bioaccumulation study (OECD TG 305) using solvents to increase exposure. The GLP test was performed according to the METI Guideline: Concentration Test on Chemical Substances in Fish.

To achive the exposure concentrations, solvent SPAN 60 (500 mg/L) was used. All concentrations tested were at or above the solubility limit of the pure test substance. For the test Brachydanio rerio (new name: Danio rerio) was used.

Results

At a test material concentration of 99.4 mg/L adjusted with SPAN 60 as solubilzer no mortality was observed after 24, 48, 72 and 96 hours, respectively.

The test material does not possess acute toxic potential to fish up to the limit of solubility in water. The 96 hours LC50 exceeds the water solubility limit of the pure substance.

Conclusion

The LC50 of the test material exceeds 99.4 mg/L and is clearly above the limit of water solubility.

Description of key information

The LC50 of the test material exceeds 99.4 mg/L (with solubilizer) and is clearly above the limit of water solubility.

NOEC = 99.4 mg/L (measured initial) with solubilizer

Key value for chemical safety assessment

Additional information