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Short-term toxicity to aquatic invertebrates

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Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
read-across from supporting substance (structural analogue or surrogate)
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
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
WoE report is based on two short term toxicity to aquatic invertebrate studies as-
WoE 2. and WoE 3.
GLP compliance:
not specified
Analytical monitoring:
yes
Remarks:
WoE 2: yes and WoE 3: not specified
Vehicle:
no
Remarks:
WoE 2: no and WoE 3: not specified
Details on test solutions:
WoE 2: The test solution was prepared by dissolving 50 mg of the test chemical in 100 ml of ADaM’s media achieving a final test concentrations of 500 mg/l. Test chemical concentrations used for the study were 0, 7.5, 15, 30, 60, 120 mg/l, respectively.

WoE 3: no data available
Test organisms (species):
Daphnia magna
Details on test organisms:
WoE 2:
TEST ORGANISM
- Common name: Water flea
- Strain/clone: Eggs of Daphnia magna were obtained from MicroBio tests Kleimoer 15B-9030 MARIAKERKE (GENT) BELGIUM
- Feeding during test: no
- Other: A population of parthenogenetic females of synchronized age structure has been maintained for more than 2 years in the test facility under constant temperature conditions (18 to 22°C) at a 16 : 8 hour light-dark photoperiod (illumination: < 1000 lux). The culture media (Adams medium') was partly renewed once a week. During the maintenance of test organism, test daphnids were fed with unicellular green algae (Selenestrum capricornutum).

WoE 3:
TEST ORGANISM
- Common name: Water flea
Test type:
static
Water media type:
freshwater
Total exposure duration:
48 h
Hardness:
WoE 2: 140 mg of CaCO3
WoE 3: no data available
Test temperature:
WoE 2: 18-22°C
WoE 3: no data available
Nominal and measured concentrations:
WoE 2: Nominal concentrations: 0, 7.5, 15, 30, 60, 120 mg/l
WoE 3: no data available
Details on test conditions:
WoE 2:
TEST SYSTEM
- Test vessel: Glass beaker
- Aeration: No aeration during experiment
- Material, size, headspace, fill volume: 25 ml of glass beaker filled with 20 ml media having headspace of 5 ml
- No. of organisms per vessel: 10 daphnids

OTHER TEST CONDITIONS
- Photoperiod:16 hours light and 8 hours dark
- Light intensity: 1000 – 1500 Lux

WoE 3: no data available
Reference substance (positive control):
yes
Remarks:
WoE 2: potassium dichromate was used as a reference substance for the study and WoE 3: no data available
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 120 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: WoE 2
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 50 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: WoE 3
Results with reference substance (positive control):
WoE 2: The 48 hr EC50 value of reference substance potassium dichromate was determined to be 0.831 mg/l.
WoE 3: no data available

WoE 2:

Table: Assessment of test concentrations

Sr. no.

Concentrations (mg/l)

Wavelength (nm)

Absorbance

Temperature (°C)

1

blank

612

0.00

25

2

5.00

612

0.07

25

3

10.00

612

0.14

25

4

20.00

612

0.29

25

5

30.00

612

0.43

25

6

40.00

612

0.57

25

7

50.00

612

0.71

25

8

60.00

612

0.84

25

9

70.00

612

1.03

25

10

80.00

612

1.17

25

11

90.00

612

1.29

25

12

100.00

612

1.43

25

13

110.00

612

1.53

25

14

120.00

612

1.64

25

 

The absorbance and concentrations were recorded at 202 nm.

Table: Concentration after analytical Determination

Sr. No

Concentrations (mg/L)

Absorbance

(mean) (0 hour)

Analytical

Concentrations (0 hour)

Absorbance

(mean) (48 hour)

Analytical

Concentrations (48 hour)

1

blank

0.00

0.00

0.00

0.00

2

7.5

0.10

7.74

0.12

9.00

3

15

0.22

16.26

0.25

17.70

4

30

0.44

31.72

0.47

33.90

5

60

0.87

61.94

0.93

65.87

6

120

1.56

110.63

1.61

114.60

 

Table: pH, DO AND TEMPERATURE

Test

Concentration (mg/L)

pH

Dissolved oxygen

Temperature °C

0 Hour

24 Hour

48 Hour

0 Hour

24 Hour

48 Hour

0 Hour

24 Hour

48 Hour

Control

7.9

7.9

7.6

7.8

6.9

5.2

20.0

19

20

7.5

7.9

7.5

7.7

7.5

6.8

5.0

20.0

19

20

15

7.8

7.5

7.4

7.5

6.6

5.1

20.0

19

20

30

7.9

7.4

7.4

7.5

6.8

4.9

20.0

19

20

60

7.9

7.8

7.3

7.6

6.5

5.0

20.0

19

20

120

7.8

7.5

7.2

7.5

6.6

4..8

20.0

19

20

 

 

Table: IMMOBILIZATION AND INHIBITION

Sr. No

Test

Concentrations (mg/L)

0 Hour

24 Hour

48 Hour

Cumulative

Immobilization

Percent

Inhibition

1

Control

-

-

-

-

-

2

7.5

-

-

-

-

-

3

15

-

-

-

-

-

4

30

-

-

-

-

-

5

60

-

-

-

-

-

6

120

-

-

-

-

-

 

 

No

abnormality

observed

All

daphnids

are alive

No immobility observed

 

 

 

WoE 3: no data available

Validity criteria fulfilled:
not specified
Conclusions:
On the basis of the experimental studies of the read across chemical and applying the weight of evidence approach and by evaluating the effect of test chemical on test organism Daphnia magna, the 48hr EC50 value can be expected to be > 50 mg/l. Since the test chemical is readily biodegradable in nature, test chemical was considered as non-toxic and hence, considered to be not classified as per CLP classification criteria.
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”. The test solution was prepared by dissolving 50 mg of the test chemical in 100 ml of ADaM’s media achieving a final test concentrations of 500 mg/l. Test chemical concentrations used for the study were 0, 7.5, 15, 30, 60, 120 mg/l, respectively. Test concentrations were verified analytically by UV-Vis Spectrophotometer. Study was performed using 10 daphnids in a static system. Total 10 Daphnids/conc. were exposed to test chemical in 25 ml beakers in a volume of 20 ml of liquid solution containing both the chemical and media. The beakers were placed in a room at a temperature of 18 -22°C, hardness of water 140 mg of CaCO3 and under a photoperiod of 16:8 hr light: dark conditions with light intensity 1000 – 1500 Lux, respectively. One control vessel was also run simultaneously during the study. The animals were exposed to medium (i.e.a beaker containing only medium) and the test chemical concentrations for a period of 48 hour. Potassium dichromate was used as a reference substance for the study. The 48 hr EC50 value of reference substance was determined to be 0.831 mg/l. No Immobility were found in the control test animals and the dissolved oxygen concentration at the end of the test in the control and test vessel was ≥ 3 mg/l, thus validity criterion of the study has been fulfilled. As the concentration of the test chemical being tested has been satisfactorily maintained within ± 20 % of the nominal concentration throughout the test. Therefore, the analysis of the results was based on nominal concentration. On the basis of effect of test chemical on mobility of the test organism, the median effect concentration (EC50 (48 h)) value was determined to be > 120 mg/L. Thus, based on the EC50 value, chemical was considered as non-toxic to aquatic invertebrates and hence, considered to be 'not classified' as per CLP classification criteria.

Another short term toxicity to aq. Invertebrate study was conducted for 48 hrs for assessing the effect of test chemical. The study was performed in accordance to OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test) in a static system. Daphnia magna was used as a test organism for the study.On the basis of effect on the mobility of the test organism Daphnia magna, the 48 hr EC50 value was determined to be > 50 mg/l. Since the test chemical is readily biodegradable in water, chemical was considered as non-toxic to aquatic invertebrates and hence, considered to be not classified as per the CLP classification criteria.

On the basis of the experimental studies of the read across chemical and applying the weight of evidence approach and by evaluating the effect of test chemical on test organism Daphnia magna, the 48hr EC50 value can be expected to be > 50 mg/l. Since the test chemical is readily biodegradable in nature, test chemical was considered as non-toxic and hence, considered to be not classified as per CLP classification criteria.

Description of key information

On the basis of the experimental studies of the read across chemical and applying the weight of evidence approach and by evaluating the effect of test chemical on test organism Daphnia magna, the 48hr EC50 value can be expected to be > 50 mg/l. Since the test chemical is readily biodegradable in nature, test chemical was considered as non-toxic and hence, considered to be not classified as per CLP classification criteria.

Key value for chemical safety assessment

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”. The test solution was prepared by dissolving 50 mg of the test chemical in 100 ml of ADaM’s media achieving a final test concentrations of 500 mg/l. Test chemical concentrations used for the study were 0, 7.5, 15, 30, 60, 120 mg/l, respectively. Test concentrations were verified analytically by UV-Vis Spectrophotometer. Study was performed using 10 daphnids in a static system. Total 10 Daphnids/conc. were exposed to test chemical in 25 ml beakers in a volume of 20 ml of liquid solution containing both the chemical and media. The beakers were placed in a room at a temperature of 18 -22°C, hardness of water 140 mg of CaCO3 and under a photoperiod of 16:8 hr light: dark conditions with light intensity 1000 – 1500 Lux, respectively. One control vessel was also run simultaneously during the study. The animals were exposed to medium (i.e.a beaker containing only medium) and the test chemical concentrations for a period of 48 hour. Potassium dichromate was used as a reference substance for the study. The 48 hr EC50 value of reference substance was determined to be 0.831 mg/l. No Immobility were found in the control test animals and the dissolved oxygen concentration at the end of the test in the control and test vessel was ≥ 3 mg/l, thus validity criterion of the study has been fulfilled. As the concentration of the test chemical being tested has been satisfactorily maintained within ± 20 % of the nominal concentration throughout the test. Therefore, the analysis of the results was based on nominal concentration. On the basis of effect of test chemical on mobility of the test organism, the median effect concentration (EC50 (48 h)) value was determined to be > 120 mg/L. Thus, based on the EC50 value, chemical was considered as non-toxic to aquatic invertebrates and hence, considered to be 'not classified' as per CLP classification criteria.

 

Another short term toxicity to aq. Invertebrate study was conducted for 48 hrs for assessing the effect of test chemical. The study was performed in accordance to OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test) in a static system. Daphnia magna was used as a test organism for the study.On the basis of effect on the mobility of the test organism Daphnia magna, the 48 hr EC50 value was determined to be > 50 mg/l. Since the test chemical is readily biodegradable in water, chemical was considered as non-toxic to aquatic invertebrates and hence, considered to be not classified as per the CLP classification criteria.

 

On the basis of the experimental studies of the read across chemical and applying the weight of evidence approach and by evaluating the effect of test chemical on test organism Daphnia magna, the 48hr EC50 value can be expected to be > 50 mg/l. Since the test chemical is readily biodegradable in nature, test chemical was considered as non-toxic and hence, considered to be not classified as per CLP classification criteria.