Registration Dossier

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19.03.2018 to 21.03.2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Experimental test result performed using standard test guideline
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Principles of method if other than guideline:
Short term toxicity of test chemical to aquatic invertebrates was performed according to the OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test) in a static system.
GLP compliance:
no
Analytical monitoring:
no
Vehicle:
yes
Remarks:
Acetone
Details on test solutions:
The stock solution 1 g/l was prepared by dissolving white powder in acetone. Test solutions of required concentrationas were prepared by mixing the stock solution of the test sample with reconstituted test water.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Water flea
- Strain: Straus
- Source: Own breeding at University of Chemistry and Technology, Prague
- Age at study initiation (mean and range, SD): The animals used for the test shall be less than 24 h old and should not be first brood progeny
- Feeding during test: No feeding

ACCLIMATION - No data available
- Acclimation period:
- Acclimation conditions (same as test or not):
- Type and amount of food:
- Feeding frequency:
- Health during acclimation (any mortality observed):
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
72 h
Remarks on exposure duration:
± 1 hr
Test temperature:
20±1°C
pH:
Concentration 0.0400 mg/l: pH 7.6 changed to 7.8 during test
Control: 7.8 changed to 8 during test
Acetone + control: 7.7 change to 7.8
Dissolved oxygen:
higher than 7.6 mg/L at the end of test
Nominal and measured concentrations:
0, 0, 0.0025, 0.0050, 0.0100, 0.0200, 0.0400 mg/l
Details on test conditions:
TEST SYSTEM
- Test vessel: 50 ml glass vessel
- fill volume: 25 ml
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:
Natural water (surface or ground water), reconstituted water or dechlorinated tap water are acceptable as culturing and dilution water if D. magna survives in it for the duration of the culturing, acclimation and testing without showing signs of stress. Waters in the range pH 6 to pH 9, with hardness between 140 mg/l and 275 mg/l (as CaCO3) are recommended.
As an example, the preparation of dilution water meeting the requirements is described below.
Dissolve known quantities of reagents in water. The dilution water prepared shall have a pH of 7.8 ± 0.5, a hardness of (225 ± 50) mg/l (expressed as CaCO3), a molar Ca + Mg ratio close to 4 + 1 and a dissolved oxygen concentration above 7 mg/l.

Prepare the solutions specified below:
- Calcium chloride solution: Dissolve 117.6 g of calcium chloride dihydrate (CaCl2.2H2O) in water (4.2) and make up to 1 l with water (4.2).
- Magnesium sulfate solution: Dissolve 49.3 g of magnesium sulfate heptahydrate (MgSO4.7H2O) in water (4.2) and make up to 1 l with water (4.2).
- Sodium bicarbonate solution: Dissolve 25.9 g of sodium bicarbonate (NaHCO3) in water (4.2) and make up to 1 l with water (4.2).
- Potassium chloride solution: Dissolve 2.3 g of potassium chloride (KCI) in water (4.2) and make up to 1 l with water (4.2).

Mixing
Mix 2.5 ml of each of the four solutions and make up to 1 l with water.
The dilution water shall be aerated until the dissolved oxygen concentration has reached saturation and the pH has stabilized. If necessary, adjust the pH to 7.8 ± 0.5 by adding sodium hydroxide (NaOH) solution or hydrochloric acid (HCI). The dilution water prepared in this way shall not be further aerated before use.

- Sodium hydroxide solution, e.g. [NaOH] : 1 mol/l.
- Hydrochloric acid, e.g. [HCl] : 1 mol/l.

Reference substance:
Dissolve 600 mg of potassium dichromate (K2Cr2O7) in water and make up to 1 l with water (4.2).

OTHER TEST CONDITIONS
- Adjustment of pH: no adjustment done
- Photoperiod: No - Darkness
- Light intensity:

CALCULATION:
EC50 was calculated using non linear regression by the software Prism 4.0
Reference substance (positive control):
yes
Remarks:
Potassium dichromate (K2Cr2O7)
Key result
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
0.005 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: 95 % CI was 0.0040 - 0.0077 mg/l
Results with reference substance (positive control):
- Results with reference substance valid
- EC50: 0.73 mg/L (24 hours)
Reported statistics and error estimates:
EC50 was calculated using non linear regression by the software Prism 4.0
Validity criteria fulfilled:
yes
Conclusions:
The median effective concentration (EC50) for the test substance, in Daphnia magna was determined to be 0.0055 mg/L on the basis of immobility of daphnia magna in a 48 hour study.
Executive summary:

Aim of this study was to assess the short term toxicity of test chemical to aquatic invertebrates daphnia magna. Study was performed according to the OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test) in a static system for the total exposure period of 48 hrs.

 

The stock solution 1 g/l was prepared by dissolving white powder in acetone. Test solutions of required concentrationas were prepared by mixing the stock solution of the test sample with reconstituted test water. 0, 0, 0.0025, 0.0050, 0.0100, 0.0200, 0.0400 mg/l concentrations were used in the study. Effects on immobilisation were observed for 48 hours. With the test substance one positive control Potassium dichromate (K2Cr2O7) was also run simultaneously. After the exposure of chemical, effect concentration EC50 was calculated using nonlinear regression by the software Prism 4.0.

 

The median effective concentration (EC50) for the test substance, in Daphnia magna was determined to be 0.0055 mg/L on the basis of immobility of daphnia magna in a 48 hour study. Based on the EC50 value, substance is likely to be hazardous to aquatic invertebrate and can be classified in aquatic acute 1 category as per the CLP classification criteria.

Description of key information

Aim of this first study was to assess the short term toxicity of test chemical to aquatic invertebrate daphnia magna. Study was performed according to the OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test) in a static system for the total exposure period of 48 hrs. The stock solution 1 g/l was prepared by dissolving white powder in acetone. Test solutions of required concentration as were prepared by mixing the stock solution of the test sample with reconstituted test water. 0, 0, 0.0025, 0.0050, 0.0100, 0.0200, 0.0400 mg/l concentrations were used in the study. Effects on immobilisation were observed for 48 hours. With the test substance one positive control Potassium dichromate (K2Cr2O7) was also run simultaneously. After the exposure of chemical, effect concentration EC50 was calculated using nonlinear regression by the software Prism 4.0. The median effective concentration (EC50) for the test substance, in Daphnia magna was determined to be 0.0055 mg/L on the basis of immobility of daphnia magna in a 48 hour study. Based on the EC50 value, substance is likely to be hazardous to aquatic invertebrate and can be classified in aquatic acute 1 category as per the CLP classification criteria.

Key value for chemical safety assessment

EC50/LC50 for freshwater invertebrates:
0.005 mg/L

Additional information

Summarized result for the evaluation of toxicity of test chemical on the mobility of aquatic invertebrate were studied and mention as below:

 

Aim of this first study was to assess the short term toxicity of test chemical to aquatic invertebrate daphnia magna. Study was performed according to the OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test) in a static system for the total exposure period of 48 hrs. The stock solution 1 g/l was prepared by dissolving white powder in acetone. Test solutions of required concentration as were prepared by mixing the stock solution of the test sample with reconstituted test water. 0, 0, 0.0025, 0.0050, 0.0100, 0.0200, 0.0400 mg/l concentrations were used in the study. Effects on immobilisation were observed for 48 hours. With the test substance one positive control Potassium dichromate (K2Cr2O7) was also run simultaneously. After the exposure of chemical, effect concentration EC50 was calculated using nonlinear regression by the software Prism 4.0. The median effective concentration (EC50) for the test substance, in Daphnia magna was determined to be 0.0055 mg/L on the basis of immobility of daphnia magna in a 48 hour study. Based on the EC50 value, substance is likely to be hazardous to aquatic invertebrate and can be classified in aquatic acute 1 category as per the CLP classification criteria.

 

Similar acute toxicity of test chemical on Daphnia magna were studied for 48 hrs. Test conducted under the static system. 3 months old daphnia magna were used. The effective concentration (EC50) value of test chemical on (Daphnia Magna) in a 48 hr study based on mortality was estimated to be 0.01 mg/L. Thus based on the EC50 value, chemical consider to be toxic and classified as aquatic acute 1 as per the CLP classification criteria.

 

Study was conducted to determine the effect of test chemical on the developmental changes on embryos of the hard clam Mercenaria mercenaria for 48 hrs. Test conducted under the static system. The EC50 value of test chemical on clam Mercenaria mercenaria in a 48 hr study based on developmental changes was observed to be 0.032 mg/L. Thus on the basis of EC50 value, chemical consider to be toxic and classified as aquatic acute 1 as per the CLP classification criteria.

 

Above studies was supported by this study from authoritative database. Aim of this study was to evaluate the effect of test chemical on the mobility of Ceriodaphnia dubia. Test conducted under the static system on less than 24 hrs old Ceriodaphnia dubia for 48 hrs. The effective concentration (EC50) value of test chemical on Ceriodaphnia dubia in a 48 hr study based on Intoxication was determine to be 0.0031 mg/L. Thus chemical consider to be toxic and classified as aquatic acute category 1 category as per the CLP classification criteria.

 

Short term toxicity of test chemical on Crustaceans were studied. The LC50 value of chemical on (Daphnia Magna) in a 48 hr study based on mortality was observed to be 0.011 mg/L.

 

In the sixth study toxicity of test chemical on invertebrate. After the exposure period of 48 hrs of chemical with daphnia magna, mortality were observed and calculated. The LC50 value of test chemical on Daphnia Magna in a 48 hr study based on mortality was determine to be 0.0077mg/L.

 

Thus based on the overall studies from experimental study, peer reviewed journal. Authoritative database and secondary source, it was concluded that the chemical was toxic and classified as aquatic acute category 1 as per the CLP classification.