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Ecotoxicological information

Short-term toxicity to aquatic invertebrates

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Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
experimental data of read across substances
Justification for type of information:
Data for the target chemical is summarized based on the structurally similar read across chemicals
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Principles of method if other than guideline:
WoE report is based on three toxicity to aquatic invertebrate studies as-
WoE 2, WoE 3 and WoE 4.
GLP compliance:
not specified
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
WoE 2: The stock solution 100 mg/L was prepared in reconstituted water. Test solutions of required concentrations were prepared by mixing the stock solution of the test substance in reconstituted test water.
WoE 3 and WoE 4: The stock solution 100.0 g/l was prepared in acetone. Test solutions of required concentrations were prepared by mixing the stock solution of the test substance in reconstituted 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
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Remarks on exposure duration:
± 1 hr
Test temperature:
20±2°C
pH:
WoE 2:
Test at 16 mg/l: 7.8 (changed to 7.7 during test)
Control: 7.8 (changed to pH 7.7 during test)

WoE 3:
.sample at concentration 8.0 mg/l: pH = 7.9 did not change during the test,
control: = 7.9 changed to pH = 7.8 during the test
control + acetone: 7.9 changed to pH = 7.8 during the test

WoE 4:
sample at concentration 100 mg/l: pH = 8.1 changed to pH 7.8 during the test
control: = 8.0 changed to pH = 7.9 during the test
control + acetone: 8.1 changed to pH 7.9 during the test
Dissolved oxygen:
WoE 2 and WoE 3: > 8 mg/L at the end of test
WoE 4: > 7.4 mg/L at the end of test both in the control and the sample
Nominal and measured concentrations:
WoE 2: 0, 0.5, 1, 2, 4, 8 and 16 mg/L respectively
WoE 3: Nominal test chemical conc. used for the were 0, 0, 0.5, 1.0, 2.0, 4.0 and 8.0 mg/L, respectively.
WoE 4: Nominal concentrations: 0, 0, 6.0, 12.0, 25, 50 and 100 mg/L, respectively
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:
48 h
Dose descriptor:
EC50
Effect conc.:
> 6.4 - < 28 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Results with reference substance (positive control):
WoE 2:
- Results with reference substance valid
- EC50: 0.76 mg/L (24 hours)

WoE 3:
- Results with reference substance valid
- EC50: 0.79 mg/L (24 hours)
Validity criteria fulfilled:
yes
Remarks:
In the control, no daphnids have been immobilised and the dissolved oxygen conc. at the end of the test was observed to be d be > 3 mg/l in both control and test vessels.
Conclusions:
On the basis of the experimental studies of the structurally and functionally similar read across chemical and applying the weight of evidence approach and by evaluating the effect of test chemical
on test daphnids, the 48 hr EC50/LC50 value can be expected to be in the range 6.4 to 28 mg/l, respectively.
Executive summary:

Data available of the structurally and functionally similar read across chemicals has been reviewed to determine the effect of the test chemical on aquatic invertebrates. The studies are as mentioned below:

An acute immobilisation test was conducted for 48 hrs for assessing the effect of test chemical on Daphnia magna. The test was performed in accordance to OECD guideline No. 202 “Daphnia sp.,Acute Immobilization Test”. Own breeding stock at University of Chemistry and Technology, Prague of Daphnia magna was used as a test organism for the study.The stock solution 100 mg/l was prepared by dissolving test chemical in reconstituted water. Test solutions of required concentrations were prepared by mixing the stock solution of the test sample in reconstituted water.Nominal test chemical conc. used for the study were0, 0, 0.6, 1.0, 1.7, 2.9, 4.9 and 8.3 mg/L, respectively. Study was performed using total 5 organisms per vessel/replicates in a static fresh water system. Daphnids were exposed to test chemical in 50 ml glass vessel in a volume of 25 ml of liquid solution containing both the chemical and media. The beakers were placed in a room at a temperature of 20±1°C. 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. On the basis of the effect of test chemical on the mobility of the test organism Daphnia magna, the 48 hr EC50 value was determined to be 7 mg/l with a 95% confidence interval value ranging from 5.5 to 8.8 mg/l, respectively. Thus, based on the EC50 value, test chemical can considered as toxic to aquatic invertebrates. Since, the test chemical is readily biodegradable in water, chemical can be considered as non-toxic to aquatic invertebrate and thus can be considered to be not classified as per the CLP classification criteria.

Another acute immobilisation test was conducted for 48 hrs for assessing the effect of test chemical on Daphnia magna. The test was performed following the OECD guideline No. 202 “Daphnia sp.,Acute Immobilization Test”. Own breeding stock at University of Chemistry and Technology, Prague of Daphnia magna was used as a test organism for the study.The stock solution 10.0 g/l was prepared in acetone. Test solutions of required concentrations were prepared by mixing the stock solution of the test sample in reconstituted water. Nominal test chemical concentrations used for the study were 0, 0, 0.5, 1.0, 2.0, 4.0 and 8.0 mg/L, respectively. Study was performed using total 5 organisms per vessel/replicates in a static fresh water system. Daphnids were exposed to test chemical in 50 ml glass vessel in a volume of 25 ml of liquid solution containing both the chemical and media. The beakers were placed in a room at a temperature of 20±1°C. 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. On the basis of the effect of test chemical on the mobility of the test organism Daphnia magna, the 48 hr EC50 value was determined to be 6.4 mg/l. Thus, based on the EC50 value, test chemical can considered as toxic to aquatic invertebrates. Since, the test chemical is readily biodegradable in water, chemical can be considered as non-toxic to aquatic invertebrate and thus can be considered to be not classified as per the CLP classification criteria.

For the test chemical, short term toxicity to aquatic invertebrate study was conducted for 48 hrs for assessing the effect of test chemical onDaphnia magna. The test was performed in accordance with the OECD guideline No. 202 “Daphnia sp.,Acute Immobilization Test”. Own breeding stock at University of Chemistry and Technology, Prague ofDaphnia magna was used as a test organism for the study.The stock solution 100.0 g/l was prepared in acetone. Test solutions of required concentrations were prepared by mixing the stock solution of the test sample in reconstituted water. Nominal test chemical concentrations used for the study were 0, 0, 6.0, 12.0, 25, 50 and 100 mg/L, respectively. Study was performed using 5 organisms per vessel/replicates in a static fresh water system. Daphnids were exposed to test chemical in 50 ml glass vessel in a volume of 25 ml of liquid solution containing both the chemical and media. The beakers were placed in a room at a temperature of 20±1°C. 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. On the basis of the effect of test chemical on the mobility of the test organism Daphnia magna, the 48 hr EC50 value was determined to be 28 mg/l (95 % CI 19.9 - 39.2 mg/l). Thus, based on the EC50 value, test chemical can considered as toxic to aquatic invertebrates. Since, the test chemical is readily biodegradable in water, chemical can be considered as non-toxic to aquatic invertebrate and thus can be considered to be not classified as per the CLP classification criteria.

On the basis of the experimental studies of the structurally and functionally similar read across chemical and applying the weight of evidence approach and by evaluating the effect of test chemical on test daphnids, the 48 hr EC50/LC50 value can be expected to be in the range 6.4 to 28 mg/l, respectively. Thus, based on the EC50 value, test chemical can considered as toxic to aquatic invertebrates. Since, the test chemical is readily biodegradable in water, chemical can be considered as non-toxic to aquatic invertebrate and thus can be considered to be not classified as per the CLP classification criteria.

Description of key information

On the basis of the experimental studies of the structurally and functionally similar read across chemical and applying the weight of evidence approach and by evaluating the effect of test chemical on test daphnids, the 48 hr EC50/LC50 value can be expected to be in the range 6.4 to 28 mg/l, respectively.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
6.4 mg/L

Additional information

Data available of the structurally and functionally similar read across chemicals has been reviewed to determine the effect of the test chemical on aquatic invertebrates. The studies are as mentioned below:

An acute immobilisation test was conducted for 48 hrs for assessing the effect of test chemical on Daphnia magna. The test was performed in accordance to OECD guideline No. 202 “Daphnia sp.,Acute Immobilization Test”. Own breeding stock at University of Chemistry and Technology, Prague of Daphnia magna was used as a test organism for the study.The stock solution 100 mg/l was prepared by dissolving test chemical in reconstituted water. Test solutions of required concentrations were prepared by mixing the stock solution of the test sample in reconstituted water.Nominal test chemical conc. used for the study were0, 0, 0.6, 1.0, 1.7, 2.9, 4.9 and 8.3 mg/L, respectively. Study was performed using total 5 organisms per vessel/replicates in a static fresh water system. Daphnids were exposed to test chemical in 50 ml glass vessel in a volume of 25 ml of liquid solution containing both the chemical and media. The beakers were placed in a room at a temperature of 20±1°C. 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. On the basis of the effect of test chemical on the mobility of the test organism Daphnia magna, the 48 hr EC50 value was determined to be 7 mg/l with a 95% confidence interval value ranging from 5.5 to 8.8 mg/l, respectively. Thus, based on the EC50 value, test chemical can considered as toxic to aquatic invertebrates. Since, the test chemical is readily biodegradable in water, chemical can be considered as non-toxic to aquatic invertebrate and thus can be considered to be not classified as per the CLP classification criteria.

Another acute immobilisation test was conducted for 48 hrs for assessing the effect of test chemical on Daphnia magna. The test was performed following the OECD guideline No. 202 “Daphnia sp.,Acute Immobilization Test”. Own breeding stock at University of Chemistry and Technology, Prague of Daphnia magna was used as a test organism for the study.The stock solution 10.0 g/l was prepared in acetone. Test solutions of required concentrations were prepared by mixing the stock solution of the test sample in reconstituted water. Nominal test chemical concentrations used for the study were 0, 0, 0.5, 1.0, 2.0, 4.0 and 8.0 mg/L, respectively. Study was performed using total 5 organisms per vessel/replicates in a static fresh water system. Daphnids were exposed to test chemical in 50 ml glass vessel in a volume of 25 ml of liquid solution containing both the chemical and media. The beakers were placed in a room at a temperature of 20±1°C. 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. On the basis of the effect of test chemical on the mobility of the test organism Daphnia magna, the 48 hr EC50 value was determined to be 6.4 mg/l. Thus, based on the EC50 value, test chemical can considered as toxic to aquatic invertebrates. Since, the test chemical is readily biodegradable in water, chemical can be considered as non-toxic to aquatic invertebrate and thus can be considered to be not classified as per the CLP classification criteria.

For the test chemical, short term toxicity to aquatic invertebrate study was conducted for 48 hrs for assessing the effect of test chemical onDaphnia magna. The test was performed in accordance with the OECD guideline No. 202 “Daphnia sp.,Acute Immobilization Test”. Own breeding stock at University of Chemistry and Technology, Prague ofDaphnia magna was used as a test organism for the study.The stock solution 100.0 g/l was prepared in acetone. Test solutions of required concentrations were prepared by mixing the stock solution of the test sample in reconstituted water. Nominal test chemical concentrations used for the study were 0, 0, 6.0, 12.0, 25, 50 and 100 mg/L, respectively. Study was performed using 5 organisms per vessel/replicates in a static fresh water system. Daphnids were exposed to test chemical in 50 ml glass vessel in a volume of 25 ml of liquid solution containing both the chemical and media. The beakers were placed in a room at a temperature of 20±1°C. 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. On the basis of the effect of test chemical on the mobility of the test organismDaphnia magna, the 48 hr EC50 value was determined to be 28 mg/l (95 % CI 19.9 - 39.2 mg/l). Thus, based on the EC50 value, test chemical can considered as toxic to aquatic invertebrates. Since, the test chemical is readily biodegradable in water, chemical can be considered as non-toxic to aquatic invertebrate and thus can be considered to be not classified as per the CLP classification criteria.

On the basis of the experimental studies of the structurally and functionally similar read across chemical and applying the weight of evidence approach and by evaluating the effect of test chemical on test daphnids, the 48 hr EC50/LC50 value can be expected to be in the range 6.4 to 28 mg/l, respectively. Thus, based on the EC50 value, test chemical can considered as toxic to aquatic invertebrates. Since, the test chemical is readily biodegradable in water, chemical can be considered as non-toxic to aquatic invertebrate and thus can be considered to be not classified as per the CLP classification criteria.