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Ecotoxicological information

Short-term toxicity to fish

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short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22 April 2013 to 26 April 2013
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
according to guideline
OECD Guideline 203 (Fish, Acute Toxicity Test)
not specified
GLP compliance:
Specific details on test material used for the study:
Physical state/Appearance: Brown Liquid
Batch: 12D25
Purity: 94.0%
Analytical monitoring:
Details on sampling:
Based on the results of the range-finding test, the concentration for the definitive test was set as follows:
Control: n/a
Conc.1*: 110mg/L

*. Limit test at the corrected value by purity which is the maxImum concentration given in the Test Guideline.
Test organisms (species):
Oryzias latipes
Details on test organisms:
- Common name: Medaka
- Source: Breeding in the testing facility
- Age at study initiation: Two year or less after hatching
- Length at study initiation (length definition, mean, range and SD): Measurements: 2.30 cm (1.93 - 2.68 cm), n=10
(These values were measured and weighed for the fish of control at the end of exposure.)
- Weight at study initiation (mean and range, SD): Measurements: 0.101 g (0.054 - 0.153 g), n=10
(These values were measured and weighed for the fish of control at the end of exposure.)
- Feeding during test: None
- Food type:n/a
- Amount: n/a
- Frequency: n/a

- Acclimation period: 2 weeks

Test type:
Water media type:
Limit test:
Total exposure duration:
96 h
Post exposure observation period:
Test fish were observed at 3, 24, 48, 72 and 96 hours after the start of exposure.
The total hardness was 60 mg CaC03/L (within the appropriate range)
Test temperature:
7.8 (within the appropriate range)
Dissolved oxygen:
80% or more of the saturation (not aerated)
Nominal and measured concentrations:
Measured Concentrations of the Test Substance in Test Solutions

Test Group Nominal conc. Measured concentration (mg/L)
(mg/L) (Percent of Nominal, %)
0hr New 24 hr Old 72hr New 96 hr Old Mean

Control n/a <0.01 <0.01 <0.01 <0.01 n/a

Conc.1 110 107 121 117 122 117
(97) (110) (106) (111) (106)

New: New test solution freshly prepared
Old: Old test solution immediately prior to renewal or at the end of exposure
Mean: Time weighted mean

Details on test conditions:
- Test vessel: 5-L glass vessel (cover: clear polyvinyl chloride (PVC) plate)
- Number of vessels: 1 vessel/test group
- Type of flow-through (e.g. peristaltic or proportional diluter): Biomass loading: 1 g fish/L/day or less)
- Biomass loading rate: 10 fish/test group

- Source/preparation of dilution water: Dechlorinated water processed by treating Yokohama city tap water· with an activated charcoal filter and sodium thiosulfate. Water quality parameters of the dechlorinated water have been measured periodically (about every 6 months) by Mitsubishi Chemical Analytech Co., Ltd., and confirmed to be appropriate to use for dilution water (total hardness: 10-250 mg CaC03/L, pH: 6.7-8.5).
- Total organic carbon: 0.3mg/L

- Adjustment of pH: Not adjusted
- Photoperiod: 16-hour light / 8-hour dark
- Light intensity: 1000 lux or less

- Range finding study: 1.1, 11, 110 mg/L
- Test concentrations: 110mg/L
- Results used to determine the conditions for the definitive study: No mortality for 96 hours, No toxicological symptoms
Reference substance (positive control):
(CuS04(II)·5H2O, guaranteed reagent
96 h
Dose descriptor:
Effect conc.:
> 110 mg/L
Conc. based on:
test mat.
Remarks on result:
other: Effect concentration corrected with purity ( 94%). 95% confidence limits: not available.
Details on results:
- Behavioural abnormalities: 0
- Observations on body length and weight:
- Mortality of control: None
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values:
Sublethal observations / clinical signs:

Median Lethal Concentrations (LC50)

 Exposure period(hr)  LC50  95 -Percent confidence limits (mg/L)  Statistical method
 24  >117*[>110*]  -  -
 48  >117*[>110*]  -  -
72  >117*[>110*]  -  -
 96  >117*[>110*]  -

*: The LC50 (LL50) value was given as an estimated concentration range because this test

was a limit test.

[]: Corrected with purity

Validity criteria fulfilled:
Result based on the time-weighted mean of measured concentrations: 96-hour LC50: >117 mg/L
Result corrected by purity: 96-hour LC50: >110 mg/L

Description of key information

96-hour LC50 in Medaka >117 mg/L: Result based on the time-weighted mean of measured concentrations
96-hour LC50 in Medaka >110 mg/L: Result corrected by purity
No mortality at 110 mg/L (Nominal concentration).

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
117 mg/L

Additional information