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Ecotoxicological information

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:
2009-04-30 to 2009-09-30
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
yes
Specific details on test material used for the study:
Batch No.: 20090226
Purity: 99.38%
Analytical monitoring:
yes
Details on sampling:
Water samples were taken from the controls and each exposure level at the start (0 h), before and after renewing of test solution (48 h) and at the end (96 h) of the test for analysis.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION;
704 mg of test substance was added to 7 L dilution water to prepare 100 mg/L of nominal test concentration of test solution. This solution was homogenized with ultra-homogenizer for 30 minutes and stirred for about 48 hours to ensure that the limit of solubility was reached.
Test organisms (species):
Oryzias latipes
Details on test organisms:
TEST ORGANISM
- Common name: Ricefish
- Source: In house
- Age at study initiation: Approx. 1 month
- Length at study initiation (mean ± SD): 2.57 cm ± 0.1 cm
- Weight at study initiation (mean ± SD): 0.14 g ± 0.01 g

ACCLIMATION
- Acclimation period: 7 d
- Acclimation conditions: Same as test
- Type and amount of food: brine shrimp nauplii AM, tetramin flake PM
- Feeding frequency: Daily, except during final 24 hr period
- Health during acclimation: No mortality observed
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
< 0.01 mg/L CaCO3
Test temperature:
23.5 °C ± 0.1 °C
pH:
7.49 - 8.13
Dissolved oxygen:
5.6 mg/L - 8.6 mg/L
Nominal and measured concentrations:
100 mg/L (nominal)
0.05 mg/L (mean measured)
Details on test conditions:
TEST SYSTEM
- Test vessel: Vessel containing 7 L of test solution.
- Renewal rate of test solution (frequency/flow rate): 48 hours renewal
- No. of organisms per vessel: 7


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Tap water
- Chlorine: < 0.01 mg/L


OTHER TEST CONDITIONS
- Photoperiod: 16 hours light/8 hours dark.
- Light intensity: 1576 to 1584 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Fish were examined daily for intoxication and mortality. The criteria of death employed in the study were (i) absence of respiratory movement and (ii) absence of response to external stimulation.

TEST CONCENTRATIONS
- Range finding study
- Test concentrations: The range finding test was conducted as the nominal concentrations of 100 mg/L under static conditions.
- Results used to determine the conditions for the definitive study: Based on the results of the range finding test 0% mortality and no adverse effects were observed at the nominal concentration of 100 mg/L. Therefore the definitive test was conducted at a nominal test concentration of 100 mg/L.
Reference substance (positive control):
no
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
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 0.05 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
There were no mortalities or adverse effects observed in any of the fish exposed to test solution.
Reported statistics and error estimates:
No need for statistics and error estimates because no adverse effect was detected at the limit concentration.
Validity criteria fulfilled:
not applicable
Remarks:
No validity criteria
Conclusions:
The 96 h LC50 value expressed in terms of the nominal concentration (based on loading rate) and measured concentration were determined > 100 mg/L and > 0.05 mg/L respectively. The 96 h NOEC was expressed as ≥ 100 mg/L (≥0.05 mg/L).

Description of key information

96 h LC50 > 100 mg/L  (nominal), > 0.05 mg/L (mean measured) (OECD 203).

Key value for chemical safety assessment

Additional information

In study No. EG09013, no toxicity was observed in a solution at the limit of water solubility. The nominal concentration of 100 mg/L produced a mean measured concentration of 0.05 mg/L, which is consistent with the experimentally determined water solubility limit of 0.047 mg/L. Acute toxicity to fish is therefore not of concern.

In another supporting study, the 96h-NOEC and 96h-LC0 of the test substance to zebra fish were determined to be the loading rate of 100 mg/L (mean measured concentration 0.35 mg/L). The 96h-LOEC, 96h-LC50 and 96h-LC100 were clearly higher than the loading rate of 100 mg/L (mean measured concentration 0.35 mg/L).