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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:
2014-07-06 to 2014-08-08
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
- Sampling method: For determination of the test item five replicate samples were taken from the test solution and the control at the start and at the end of the test.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: By mechanical dispersion. An amount of 0.3 g test item was dissolved in 3000 mL dilution water (ISO medium) using an overnight shaking in order to obtain the nominal concentration.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebrafish
- Source: Black Molly Bt.. 8200 Veszprém, Jutasi út 29
- Age at study initiation: Juveniles were used.
- Length at study initiation: Range of 2 ± 1 cm
- Method of breeding: Fish were held for at least 12 days before test initiation in the fish laboratory of TOXI-COOP ZRT. under the same conditions as used during the exposure period. Fish were held during the acclimatisation period and the study in reconstituted water (ISO medium according to OECD Guidelines).
- Feeding during test: The fish were not fed during the test.
- Food type: Commercial diet for fish at least three times per week until one day before the start test start.
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
none
Hardness:
249 mg/L (as CaCO3)
Test temperature:
22.2 - 23.2 °C
pH:
7.10 - 8.29
Dissolved oxygen:
72.4 - 99.1 %
Nominal and measured concentrations:
Nominal: 100 mg/L
Measured concentrations of the test item were 117.4 mg/L at the start and 118.7 mg/L at the end of the test.
Details on test conditions:
TEST SYSTEM
- Test vessel: Glass aquariums.
- Fill volume: 3 litres test liquid.
- No. of organisms per vessel: 10 (females and males)
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.69 g/L (control), 0.72 g/L (test item)

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: ISO medium, prepared according to recommendations of Annex 2 of the OECD 203 guideline. Seperate stock solutions of individual substances were first prepared in deionised water (prepared in TOXI-COOP ZRT. by MILLIPORE ELIX 3 water purification system.) The ISO medium was prepared by adding 50 mL from each of four stock solutions to one litre deionised water.

OTHER TEST CONDITIONS
- Photoperiod: 16 h light/ 8 h dark

EFFECT PARAMETERS MEASURED: Mortality of Zebrafish

TEST CONCENTRATIONS
- Range finding study: Toxic effects were not observed during the preliminary test therefore a limit test was carried out with one treatment group at a concentration of 100 mg/L

OBSERVATIONS
Fish were observed after 3, 6, 24, 48, 72 and 96 hours for signs of intoxication and mortality.
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 (fish)
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LOEC
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
- No mortalities observed
- The test item showed no toxic effects at the limit concentration of 100 mg/L.
Reported statistics and error estimates:
The mean of the measured concentrations of the test item were 117.4 mg/L at the start and 118.7 mg/L at the end of the test.
Validity criteria fulfilled:
yes
Conclusions:
Based on the results of this study, the test item had no toxic effect at the limit concentration of 100 mg/L on Zebrafish. Accordingly, the 96-h LC50 value was determined to be > 100 mg/L. The 96-h NOEC was determined to be 100 mg/L.
Executive summary:

The purpose of this study is to evaluate the acute toxicity of the test item on Zebrafish (Brachydanio rerio) according to OECD Guideline 203, Commission Regulation (EC) C.1 and OPPTS 850.1075. A limit test was performed in which the test animals were exposed to aqueous test media containing the test item for 96 hours at only one concentration (100 mg/L) plus a control in order to demonstrate that the test item has no toxic effects on fish up to at least this test concentration. Based on the results of the analytical method validation the concentration of the decomposition product Aldehyde M (2,2 -Dimethyl-3 -(N-morpholino)-propanal) of the test item was expected to remain within 80 -120 % of the nominal over the testing period therefore the experiment was carried out under static conditions. Significant toxic effect was not observed during the preliminary test, therefore only one test concentration (100 mg/L) and one control group was tested in a limit test. The measured test item concentration remained within ± 20 % of the nominal concentrations over the test period of 96 hours; therefore the biological results are based on the nominal concentration. Five replicate samples were taken from the test concentration and the control at the start and at the end of the experiment and analysed by a reverse phase HPLC method with UV detection. The mean of the measured concentrations of the test item were 117.4 mg/L at the start and 118.7 mg/L at the end of the test. Mortality and any sub-lethal effects were not observed during the 96-h exposure period either in the treated or in the control group. Accordingly, the 96-h NOEC was determined to be 100 mg/L and the LOEC and the LC50 values were determined to be higher than 100 mg/L.

Description of key information

Based on the results of an acute toxicity to fish study, the test item had no toxic effect at the limit concentration of 100 mg/L on Zebrafish. Accordingly, the 96-h LC50 value was determined to be > 100 mg/L. The 96-h NOEC was determined to be 100 mg/L.

Key value for chemical safety assessment

Additional information

The purpose of this study is to evaluate the acute toxicity of the test item on Zebrafish (Brachydanio rerio) according to OECD Guideline 203, Commission Regulation (EC) C.1 and OPPTS 850.1075. A limit test was performed in which the test animals were exposed to aqueous test media containing the test item for 96 hours at only one concentration (100 mg/L) plus a control in order to demonstrate that the test item has no toxic effects on fish up to at least this test concentration. Based on the results of the analytical method validation the concentration of the decomposition product Aldehyde M (2,2 -Dimethyl-3 -(N-morpholino)-propanal) of the test item was expected to remain within 80 -120 % of the nominal over the testing period therefore the experiment was carried out under static conditions. Significant toxic effect was not observed during the preliminary test, therefore only one test concentration (100 mg/L) and one control group was tested in a limit test. The measured test item concentration remained within ± 20 % of the nominal concentrations over the test period of 96 hours; therefore the biological results are based on the nominal concentration. Five replicate samples were taken from the test concentration and the control at the start and at the end of the experiment and analysed by a reverse phase HPLC method with UV detection. The mean of the measured concentrations of the test item were 117.4 mg/L at the start and 118.7 mg/L at the end of the test. Mortality and any sub-lethal effects were not observed during the 96-h exposure period either in the treated or in the control group. Accordingly, the 96-h NOEC was determined to be 100 mg/L and the LOEC and the LC50 values were determined to be higher than 100 mg/L.