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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:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
the specificity reference standard solution (100 mg/L), the serial dilutions were made by using acetonitrile, to prepare further concentrations such as 1, 5, 10, 15, 20 and 25 mg/L separately, These reference standard solutions were injected into HPLC and a linear curve was plotted for the concentration of reference standard versus observed peak area and the correlation coefficient was determined. The linearity of method was established by injecting six different concentrations of reference standard by HPLC and plotting the respective concentration (mg/L) against their respective peak area and the coefficient of correlation (r) was 0.999, the coefficient of determination (R2) was 0.997.
Vehicle:
no
Details on test solutions:
Aroud 25.4 mg of the test item in a 100 ml volumetric flask dissolved and made up to the mark using natural water and the resulting concentration is 254 mg/L, coded as stock. Test solutions of the selected concentrations were prepared by dilution of a stock solution.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Water Flea
- Age at study initiation (mean and range, SD): mean Aged less than 24 hours.
- Source: Test system was obtained from microworms, wihch further subcultured at ecotoxicity laboratory of CRO
- Feeding during test : no feed was given during test


ACCLIMATION
- Acclimation period: Sufficient number of healthy, brood Daphnia was collected from stock for at least two days before start of test and kept in separate container under test conditions with feed. The first progeny of daphnids collected on day 1 was discarded. Daphnids produced on day 2 (Aged less than 24 hours old) was used for testing.
- Acclimation conditions (same as test or not): same as test conditions
- Health during acclimation (any mortality observed): All the daphina were healthy



METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES, INCLUDING CULTURING CONDITIONS:
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Hardness:
170 mg/L, CaCO3
Test temperature:
20 - 21°C
pH:
6.8 - 7.5
Dissolved oxygen:
7.8 - 8.7
Conductivity:
0.221 mS/cm
Nominal and measured concentrations:
Nominal concentrations and measured concentrations: 100mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: 25ml glass beaker
- Type (delete if not applicable): loosly covered with glass lid to reduce loss of evopration and entry of dust
- Material, size, headspace, fill volume: glass beaker, 25 ml beaker, head soace of 5 ml and fill volume is 20 ml
- Volume of solution: 20 ml
- Aeration: no aerration was provided
- No. of organisms per vessel: 5 organism/ vessel
- No. of vessels per concentration (replicates): 4 vessel/ conc
- No. of vessels per control (replicates): 4 vessels
- No. of vessels per vehicle control (replicates): no vehicle control


VEHICLE CONTROL PERFORMED: no

RANGE-FINDING STUDY
- Test concentrations: 6.25, 12.5, 25, 50 and 100 mg/L
- Results used to determine the conditions for the definitive study:There was no immobilization (percent) and any abnormal behaviour observed in exposed Daphnids in control group and in all the tested concentrations of 6.25, 12.5, 25, 50 and 100 mg/L for a period of 48 hours.
Reference substance (positive control):
yes
Remarks:
Potassium Dichromate
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
- Mortality of control: No mortaliity in control
- Immobilisation of control: no immobilisation in control
- Abnormal responses: no abnormal responses
Results with reference substance (positive control):
the immobilisation potential of daphnids with test item Potassium dichromate, a definitive test was conducted with 5 test concentrations of 0.2, 0.4, 0.8, 1.6 and 3.2 mg/L along with a control group without test item. The selected concentrations were in a geometric series with a sepration factor of 2.0. Each concentration contained four replicates and 5(five) Daphnids per replicate. The treated Daphnids were maintained in a test condition.
During the test period, all the beaker was incubated in the room under controlled temperature and light. The room temperature during the test period was between 18.4ºC and 20.1ºC, the average light intensity was between 1384 and 1417 Lux. The pH of the control at the beginning and at the termination of the experiment was between 7.1 and 7.0, respectively. The pH of the test concentrations was between 7.2 and 7.3 at the beginning of the test and 7.0 to 7.5 at test termination. The Dissolved oxygen of the control at the beginning and at the termination of the experiment was between 7.9 and 7.6 mg/L, respectively. The Dissolved oxygen of the test concentrations was between 8.2 and 8.6 mg/L at the beginning of the test and 7.7 to 7.9 mg/L at test termination.
No cumulative immobilization (percent) observed in control group and 0.2 mg/L whereas, 25% and 70% in the tested concentration of 0.4, and 0.8 mg/L for a period of 48 hours. The tested concentration of 1.6 and 3.2 mg/L, showed 100% immobilization. No Daphnids exhibited any abnormal behaviour in control group and in all the tested concentrations for a period of 48 hours.
Based on the results of this study, the EC50 value for 24 hours of Potassium Dichromate was found to be 0.690 mg/L with 95% confidence interval between 0.631 mg/L and 0.749 mg/L.


Mean Immobilization (%) data–Definitive test
Concentration
(mg/L) Immobilization (%) Cumulative Immobilization (%)
24 hours 48 hours 48 hours
Control 0 0 0
0.2 0 0 0
0.4 15 10 25
0.8 55 15 70
1.6 100 - 100
3.2 100 - 100

 TABLES

Table1: Percentage of DaphniaImmobilization

Concentration

(mg/L)

Daphnia Immobilization (%)

24 hours

48 hours

Cumulative

Immobilization(%)

Range finding test

Control

0.0

0.0

0.0

6.25

0.0

0.0

0.0

12.5

0.0

0.0

0.0

25

0.0

0.0

0.0

50

0.0

0.0

0.0

100

0.0

0.0

0.0

Limit test

Control

0.0

0.0

0.0

100

0.0

0.0

0.0

Table 2: LC50Valueof test item

Parameters

24 hours

48 hours

EC50

Greater than 100 mg/L

Greater than 100 mg/L

95% confidence interval- Lower Fiducial limit

NA

NA

95% confidence interval - Upper Fiducial limit

NA

NA

Note:EC50- Median Effective Concentration, Note: mg/L – milligram per liter, NA-Not applicable

Individual Daphnia Immobilization

Concentration

(mg/L)

Replication

Immobilization

(Numbers)

Cumulative

Immobilization

(Numbers)

 for period of

48 hours

24 hours

48 hours

Range finding test

Control

R1

0

0

0

R2

0

0

6.25

R1

0

0

0

R2

0

0

12.5

R1

0

0

0

R2

0

0

25

R1

0

0

0

R2

0

0

50

R1

0

0

0

R2

0

0

100

R1

0

0

0

R2

0

0

Limit test

Concentration

(mg/L)

Replication

Immobilization

(Numbers)

Cumulative

Immobilization

(Numbers)

 for period of 48 hours

24 hours

48 hours

Control

R1

0

0

0

R2

0

0

R3

0

0

R4

0

0

100

R1

0

0

0

R2

0

0

R3

0

0

R4

0

0

Daphnia Abnormal Behaviour

Concentration

(mg/L)

Replication

Abnormal Behaviour

24 hours

48 hours

Range finding test

Control

R1

N(5)

N(5)

R2

N(5)

N(5)

6.25

R1

N(5)

N(5)

R2

N(5)

N(5)

12.5

R1

N(5)

N(5)

R2

N(5)

N(5)

25

R1

N(5)

N(5)

R2

N(5)

N(5)

50

R1

N(5)

N(5)

R2

N(5)

N(5)

100

R1

N(5)

N(5)

R2

N(5)

N(5)

Limit test

Concentration

(mg/L)

Replication

Abnormal Behaviour

24 hours

48 hours

Control

R1

N(5)

N(5)

R2

N(5)

N(5)

R3

N(5)

N(5)

R4

N(5)

N(5)

100

R1

N(5)

N(5)

R2

N(5)

N(5)

R3

N(5)

N(5)

R4

N(5)

N(5)

Key: N – Normal

Physicochemical Parameters (pH, Temperature (oC) and DO (mg/L)

Concentration

(mg/L)

pH

Temperature (⁰C)

Dissolved oxygen (mg/L)

0 hour

48 hour

0 hour

48 hour

0 hour

48 hour

Range finding test

Control

6.8

6.9

20

20

8.0

7.8

6.25

6.9

7.2

20

20

8.5

8.3

12.5

7.0

7.3

21

20

8.5

8.4

25

7.0

7.4

20

20

8.8

8.6

50

7.1

7.5

20

21

8.7

8.5

100

7.1

7.5

20

21

8.7

8.5

Limit test

Control

6.8

6.8

20

21

8.2

5.2

100

6.9

7.0

20

21

8.1

4.9

Total hardness

170 mg/L, CaCO3


Validity criteria fulfilled:
yes
Remarks:
In the control, not more that 10 percent (0%) of the Daphnids should have been immobilised. The dissolved oxygen concentration at the end of the test was ≥ 3 mg/ L (4.9 to 8.2 mg/ L) in control and test vessels.
Conclusions:
Based on the results of the study, the test item, EC50 value at 48 hours was found to be greater than 100 mg/L.
Executive summary:

The objective of this study was conducted to evaluate the Acute toxicity of test chemical  to the Daphnia sp., (Daphnia magna). The study was performed in compliance with following regulatory guideline: OECD Guideline for Testing of chemicals OECD NO. 202, Adopted by the Council on 13 April 2004, Daphnia sp. Acute Immobilization Test.

Solubility of test item was performed by dissolving in the natural water (ground water) at 254 mg/L. Based on the solubility test, a vehicle was selected as a natural water for the test in the study.

Stability of the test item in natural water determined by analyzing the test concentrations of 1 and 100.0 mg/L at 0 hour, 24 hour and 48 hour showed that the test item concentration remained 80% to 120%(96.81 to 98.34 %) with respect to initial measured concentration and hence the dose verification for limit test was performed at the beginning and at the termination of the test.

The brood daphnids were acclimatized 48 hours prior to the test item exposure in dilution water. Less than 24 hours old daphnids were collected from the acclimatized gravid females and exposed to the test item. After exposure on day 0, daphnids were observed for Immobilization at 24 and 48 hours.

Range finding test was conducted with test concentration of 6.25, 12.5, 25, 50 and 100 mg/L along with a control group without test item by static method. Each concentration contained two replicates and 5(five) Daphnids per replicate. Test item was formulated in natural water. The treated Daphnids were maintained in a condition. No immobilization (percent) and any abnormal behaviour observed in control group and in all the tested concentrations of 6.25, 12.5, 25, 50 and 100 mg/L for a period of 48 hours.

Based on the results of range finding test, the limit test was conducted with a test concentration of 100 mg/L along with a control group without test item by static method. A limit test concentration contained four replicates and 5(five) Daphnids per replicate. Test item was formulated in natural water. The treated Daphnids were maintained in a test condition. No immobilization (percent) and any abnormal behaviour observed in control group and a limit tested concentration of 100 mg/L for a period of 48 hours.

During thelimit test period, all the beakers were incubated in the roomunder test condtion.The pH of the control at the start and at termination of the study was 6.8 and therefore did not vary more than 1.5 units during the study. The pH of the limit test concentrations was 6.9 at the beginning of the test and 7.0 at test termination. The room temperature was between 19.0°C and 20.9°C. The temperature of the control and a limit test concentrationat the beginning of the test and at test termination was 20°C and 21°C. The Dissolved oxygen of the control at the start and at termination of the study was 8.2 and 5.2 mg/L. The Dissolved oxygen of the limit test concentration was 8.1 at the beginning of the test and 4.9 mg/L at test termination. The mean intensity of light ranged from 1425 to 1443 Lux.

The test item available in the test medium (natural water) was determined by a validated HPLC system. The test item concentration of test chemical in the test medium at the initiation (0 hour) 97.12% and after 48 hours 96.40 % of the nominal test concentrations. As the measured concentration was within 80 to 120% of the nominal concentration during the exposure period.

Based on the results of this study, the EC50value for 48 hours of Sodium 1,1,3-trioxo-2,3-dihydro-1H-11ambda6, 2-benzothiazol-2-ide was found to be greater than 100 mg/L.The results observed in the present study meets all the validity criteria as per OECD 202 Test guideline. Based on the outcomes test chemcial cannot be classified

Description of key information

The objective of this study was conducted to evaluate the Acute toxicity of test chemical  to the Daphnia sp., (Daphnia magna). The study was performed in compliance with following regulatory guideline: OECD Guideline for Testing of chemicals OECD NO. 202, Adopted by the Council on 13 April 2004, Daphnia sp. Acute Immobilization Test.

Solubility of test item was performed by dissolving in the natural water (ground water) at 254 mg/L. Based on the solubility test, a vehicle was selected as a natural water for the test in the study.

Stability of the test item in natural water determined by analyzing the test concentrations of 1 and 100.0 mg/L at 0 hour, 24 hour and 48 hour showed that the test item concentration remained 80% to 120%(96.81 to 98.34 %) with respect to initial measured concentration and hence the dose verification for limit test was performed at the beginning and at the termination of the test.

The brood daphnids were acclimatized 48 hours prior to the test item exposure in dilution water. Less than 24 hours old daphnids were collected from the acclimatized gravid females and exposed to the test item. After exposure on day 0, daphnids were observed for Immobilization at 24 and 48 hours.

Range finding test was conducted with test concentration of 6.25, 12.5, 25, 50 and 100 mg/L along with a control group without test item by static method. Each concentration contained two replicates and 5(five) Daphnids per replicate. Test item was formulated in natural water. The treated Daphnids were maintained in a condition. No immobilization (percent) and any abnormal behaviour observed in control group and in all the tested concentrations of 6.25, 12.5, 25, 50 and 100 mg/L for a period of 48 hours.

Based on the results of range finding test, the limit test was conducted with a test concentration of 100 mg/L along with a control group without test item by static method. A limit test concentration contained four replicates and 5(five) Daphnids per replicate. Test item was formulated in natural water. The treated Daphnids were maintained in a test condition. No immobilization (percent) and any abnormal behaviour observed in control group and a limit tested concentration of 100 mg/L for a period of 48 hours.

During thelimit test period, all the beakers were incubated in the roomunder test condtion.The pH of the control at the start and at termination of the study was 6.8 and therefore did not vary more than 1.5 units during the study. The pH of the limit test concentrations was 6.9 at the beginning of the test and 7.0 at test termination. The room temperature was between 19.0°C and 20.9°C. The temperature of the control and a limit test concentrationat the beginning of the test and at test termination was 20°C and 21°C. The Dissolved oxygen of the control at the start and at termination of the study was 8.2 and 5.2 mg/L. The Dissolved oxygen of the limit test concentration was 8.1 at the beginning of the test and 4.9 mg/L at test termination. The mean intensity of light ranged from 1425 to 1443 Lux.

The test item available in the test medium (natural water) was determined by a validated HPLC system. The test item concentration of test chemical in the test medium at the initiation (0 hour) 97.12% and after 48 hours 96.40 % of the nominal test concentrations. As the measured concentration was within 80 to 120% of the nominal concentration during the exposure period.

Based on the results of this study, the EC50value for 48 hours of Sodium 1,1,3-trioxo-2,3-dihydro-1H-11ambda6, 2-benzothiazol-2-ide was found to be greater than 100 mg/L.The results observed in the present study meets all the validity criteria as per OECD 202 Test guideline. Based on the outcomes test chemcial cannot be classified

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
100 mg/L

Additional information

Various short term studies available for the test chemical were reviewed to determine the toxic nature of test chemical on the growth and mobility of aquatic invertebrates. The studies are as mentioned below:

The objective of this study was conducted to evaluate the Acute toxicity of test chemical  to the Daphnia sp., (Daphnia magna). The study was performed in compliance with following regulatory guideline: OECD Guideline for Testing of chemicals OECD NO. 202, Adopted by the Council on 13 April 2004, Daphnia sp. Acute Immobilization Test.

Solubility of test item was performed by dissolving in the natural water (ground water) at 254 mg/L. Based on the solubility test, a vehicle was selected as a natural water for the test in the study.

Stability of the test item in natural water determined by analyzing the test concentrations of 1 and 100.0 mg/L at 0 hour, 24 hour and 48 hour showed that the test item concentration remained 80% to 120%(96.81 to 98.34 %) with respect to initial measured concentration and hence the dose verification for limit test was performed at the beginning and at the termination of the test.

The brood daphnids were acclimatized 48 hours prior to the test item exposure in dilution water. Less than 24 hours old daphnids were collected from the acclimatized gravid females and exposed to the test item. After exposure on day 0, daphnids were observed for Immobilization at 24 and 48 hours.

Range finding test was conducted with test concentration of 6.25, 12.5, 25, 50 and 100 mg/L along with a control group without test item by static method. Each concentration contained two replicates and 5(five) Daphnids per replicate. Test item was formulated in natural water. The treated Daphnids were maintained in a condition. No immobilization (percent) and any abnormal behaviour observed in control group and in all the tested concentrations of 6.25, 12.5, 25, 50 and 100 mg/L for a period of 48 hours.

Based on the results of range finding test, the limit test was conducted with a test concentration of 100 mg/L along with a control group without test item by static method. A limit test concentration contained four replicates and 5(five) Daphnids per replicate. Test item was formulated in natural water. The treated Daphnids were maintained in a test condition. No immobilization (percent) and any abnormal behaviour observed in control group and a limit tested concentration of 100 mg/L for a period of 48 hours.

During thelimit test period, all the beakers were incubated in the roomunder test condtion.The pH of the control at the start and at termination of the study was 6.8 and therefore did not vary more than 1.5 units during the study. The pH of the limit test concentrations was 6.9 at the beginning of the test and 7.0 at test termination. The room temperature was between 19.0°C and 20.9°C. The temperature of the control and a limit test concentrationat the beginning of the test and at test termination was 20°C and 21°C. The Dissolved oxygen of the control at the start and at termination of the study was 8.2 and 5.2 mg/L. The Dissolved oxygen of the limit test concentration was 8.1 at the beginning of the test and 4.9 mg/L at test termination. The mean intensity of light ranged from 1425 to 1443 Lux.

The test item available in the test medium (natural water) was determined by a validated HPLC system. The test item concentration of test chemical in the test medium at the initiation (0 hour) 97.12% and after 48 hours 96.40 % of the nominal test concentrations. As the measured concentration was within 80 to 120% of the nominal concentration during the exposure period.

Based on the results of this study, the EC50value for 48 hours of Sodium 1,1,3-trioxo-2,3-dihydro-1H-11ambda6, 2-benzothiazol-2-ide was found to be greater than 100 mg/L.The results observed in the present study meets all the validity criteria as per OECD 202 Test guideline. Based on the outcomes test chemcial cannot be classified

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 solution of white crystalline powder 100 mg/l was prepared by dissolving the substance in reconstituted test water. 100 mg/l concentration 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 > 100 mg/L on the basis of mobility inhibition effects in a 48 hour study. After the exposure period of 48 hrs, only 8% inhibition were observed at 100 mg/l. Based on the EC50 value, substance is likely to be non-hazardous to aquatic invertebrate and cannot classified as per the CLP classification criteria.

 

Above study was supported by the second supporting study. Acute Immobilization Study of test chemical was performed on Daphnia magna in a Semi-Static System for 48 hrs. Test performed according to the OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test). The test substance was soluble in water. Therefore, the test solution was prepared by dissolving 100 mg of the test substance in 100 ml of ADaM’s media. Achieving test concentrations of 1 g/L, respectively. And test Daphnia magna were exposed to these concentration for 48 hours. Study consider to be valid as it performs according to the guideline. 1. In the control, including the control containing the solubilizing agent, not more that 10 percent of the daphnids should have been immobilized as per the guideline and the same results were obtain in the test. 2. The dissolved oxygen concentration at the end of the test should be 3 mg/l in control and test vessels. The median lethal concentration (EC50) for test chemical on Daphnia magna in a 48 hours study on the basis of immobilization effect was determine to be > 100 mg/l. Thus, on the basis of this EC50 value and according to CLP criteria for aquatic classification of the substance, it is concluded that the substance does not exhibit short term toxicity to Daphnia and thus not classified as per the CLP classification criteria.

Thus based on the above studies, chemical consider to be nontoxic and not classified as per the CLP classification criteria.