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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:
2004-09-30 to 2004-10-30
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
Principles of method if other than guideline:
Solubiliser have been used to achieve exposure above the water solubiliy limit
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
0; 96 h
Vehicle:
yes
Details on test solutions:
SPAN 60 (Sorbitan Monolaureate)
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
Weight: 0.35 g
Length: 3.4 cm
Lot: 40816
Acclimatisation: Aug 16 - Sep 09, 2004
Delivery: 17 April 2003
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
no
Hardness:
250 mg/L
Test temperature:
25.1 +/- 1.0 °C
pH:
According to guideline
Dissolved oxygen:
According to guideline
Salinity:
According to guideline
Nominal and measured concentrations:
nominal 98.01 mg/L
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.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
- Effect concentrations exceeding solubility of substance in test medium: 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.
Results with reference substance (positive control):
- Mortality of control:
0 % after 96 hours
0.5 mg/L: 0% (24h), 70% (48h), 90% (72h), 100%(96 h)
0.05 mg/L: no mortality observed during the study
Validity criteria fulfilled:
yes
Conclusions:
The LC50 of the test material with solubilizer is between 0.08 and 0.3 mg/L, which is clearly above the limit of water solubility.
Executive summary:

The acute toxicity of the test material was studied in a pretest for a bioaccumulation study (OECD 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 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. The following concentrations have been applied: 0.05 and 0.5 mg/L

The test material does not possess acute toxic potential to fish up to the limit of solubility in water (< 0.058 mg/L). Using SPAN 60 as solubiliser, toxicity was observed at higher concentrations. The 96 hours LC50 is above the water solubility limit of the pure substance. With solubilizer the LC50 exceeds 100 mg/L (nominal).

The LC50 of the test material with solubilizer exceeds 100 mg/L (nominal), which is clearly above the limit of water solubility.

Description of key information

The test material does not possess acute toxic potential to fish up to the limit of solubility in water (< 0.058 mg/L). Using SPAN 60 as solubiliser, toxicity was observed at higher concentrations. The 96 hours LC50 is above the water solubility limit of the pure substance. With solubilizer the LC50 exceeds 100 mg/L (nominal).

Key value for chemical safety assessment

Additional information