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Ecotoxicological information

Short-term toxicity to fish

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Administrative data

short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
21 December 2007 - 6 February 2008
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study has been performed according to OECD guidelines and according to GLP principles.

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guidelineopen allclose all
according to guideline
OECD Guideline 203 (Fish, Acute Toxicity Test)
according to guideline
other: Fish, Acute Toxicity Test stipulated in the "Testing Methods for New Chemical Substances" (November 21, 2003; No. 1121002, MHLW; November 13, 2003, No. 2, METI; No. 031121002, MOE, Japan)
GLP compliance:

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): S-500
- Substance type: yellow powder
- Physical state: solid
- Lot/batch No.: MF1456-2345
- Stability under test conditions: stable (confirmed by IR)
- Storage condition of test material: dark storage place at room temperature

Sampling and analysis

Analytical monitoring:
Details on sampling:
- Concentrations: control and 100 mg/l (nominal)
- Sampling method: Equal volume for analysis was taken out from the middle layer of the test solution for each vessel and mixed. This was done at the start of exposure, before and after the renewal and the end of exposure.
- Sample storage conditions before analysis: not applicable

Test solutions

Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: mixing and stirring by magnetic stirrer for 48 h.
- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s)): not applicable
- Evidence of undissolved material (e.g. precipitate, surface film, etc): suspension with floating material

Test organisms

Test organisms (species):
Oryzias latipes
Details on test organisms:
- Common name: Medaka
- Strain: not indicated
- Source: Kurume Laboratory, Fukuoka, Japan
- Age at study initiation (mean and range, SD): 4 months of age
- Length at study initiation (length definition, mean, range and SD): 2.3 +/- 1.2 cm
- Feeding during test: no

- Acclimation period: 35 days
- Acclimation conditions (same as test or not): same as test
- Type and amount of food: feed mixture for carp (2C)
- Health during acclimation (any mortality observed): no mortality during the 7 days before the start of the test

Study design

Test type:
Water media type:
Limit test:
Total exposure duration:
96 h
Post exposure observation period:

Test conditions

37 mg CaCO3/l
Test temperature:
23.7 - 24.2 °C
7.8 - 8.0
Dissolved oxygen:
8.0 - 8.2 mg O2/l
Nominal and measured concentrations:
Nominal 100 mg/l:
peak 1 not detected (< 0.000071 mg/l),
peak 2 not detected (<0.00031 mg/l),
peak 3 not detected at the start of the test and before/after renewal (<0.0024 mg/l), but 0.0034 mg/l at end of test
peak 4 not detected (<0.0045 mg/l)
Test item (i.e. sum of 4 peaks) not detected (<0.0073 mg/l).
Details on test conditions:
- Test vessel:
- Type (delete if not applicable): closed with lid
- Material, size, headspace, fill volume: 3 L glass tank (16 cm diameter, 17 cm depth). Fill volume: 2.5 L.
- Aeration: yes
- Renewal rate of test solution (frequency/flow rate): after 48 h
- No. of organisms per vessel: 4
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2

- Source/preparation of dilution water: dechlorinated tap water
- Total organic carbon: <0.1 mg/l
- Particulate matter: <1 mg/l
- Pesticides: <0.0001 mg/l each
- Chlorine: <0.02 mg/l
- Alkalinity: 29 mg/l
- Ca/mg ratio: 10.3 / 2.8
- Conductivity: 15.5 mS/m
- Culture medium different from test medium: no

- Adjustment of pH: no
- Photoperiod: 16 h light, 8 h dark
- Light intensity: artificial light of white fluorescent lamp

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : LC50 and LL50
Reference substance (positive control):
copper sulphate

Results and discussion

Effect concentrationsopen allclose all
96 h
Dose descriptor:
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: effect concentration > solubility of test item in dilution water
96 h
Dose descriptor:
Effect conc.:
> 100 mg/L
Nominal / measured:
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
- Behavioural abnormalities: none observed
- Observations on body length and weight: body length 2.6-2.8 cm and body weight 0.13 - 0.18 g.
- Mortality of control: no mortality
- Effect concentrations exceeding solubility of substance in test medium: no effects observed above the water solubility of the test substance.
Results with reference substance (positive control):
- Results with reference substance valid? Yes
- Mortality: yes
- LC50: 96-h LC50 0.54 mg/l

Applicant's summary and conclusion

Validity criteria fulfilled:
This study was conducted as a limit test in order to confirm the effect of the test item on the test organisms at around the solubility of the test item in dilution water. As a result, the concentration of the test item in the test solution during the exposure was below the determination limit (<0.0073 mg/L), therefore, results based on the quantified concentration of the test item could not be evaluated. it was concluded that the test item did not have an acute effect on the test organisms at around the solubility of the test item in dilution water because no adverse effect for test organisms was observed in above conditions. In addition, as the environmental conditions were also within the suitable range, it was evaluated that the study complied with the test guidelines.