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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:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Experimental test result performed using standard OECD test guideline
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
GLP compliance:
no
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
The test chemical solution was prepared by dissolving 2 mg of the test chemical in 20 ml of ADaM’s media achieving test concentrations of 100 mg/L.
Test organisms (species):
Daphnia magna
Details on test organisms:
- Common name: Water flea
- Food: No feeding after hatching
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Hardness:
150.5 mg of CaCO3
Test temperature:
20±2°C
pH:
7.1
Nominal and measured concentrations:
Nominal concentrations: 100 mg/l
Details on test conditions:
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

Reference substance (positive control):
yes
Remarks:
potassium dichromate was used as a reference substance for the study.
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
Results with reference substance (positive control):
The 48 hr EC50 value of reference substance potassium dichromate was determined to be 0.831 mg/l.

Immobility

Nominal

Concentration

(mg/l)

Number of

Daphnids

                                                     Immobility

0 h

24h

48h

Control

10

-

-

-

100

10

-

-

-


Oxygen content:

Nominal

Concentration

(mg/l)

Number of

Daphnids

                      DO(mg/L)

 

0 h

48h

 

Control

10

7.0

6.8

100

10

7.0

6.8

Test temperature:

Nominal

Concentration

(mg/l)

Number of

Daphnids

                     Temparature

 

0 h

48h

 

Control

10

21.2

21.5

100

10

21.2

21.5

 

Validity criteria fulfilled:
yes
Remarks:
1. In the control, including the control containing the solubilising agent, not more that 10 percent of the daphnids should have been immobilized. 2. The dissolved oxygen concentration at the end of the test should be 3 mg/l in control and test vessels
Conclusions:
Based on nominal concentrations, experimental median effective concentrations [EC50 (48 h)] for test chemical on Daphnia magna was determined to be > 100 mg/L.
Executive summary:

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 chemical solution was prepared by dissolving 2 mg of the test chemical in 20 ml of ADaM’s media achieving test concentrations of 100 mg/L. Limit test was performed using 100 mg/l of test chemical concentration. 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 20±2°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. 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 > 100 mg/L. Thus, based on the EC50 value, test chemical was considered as non-toxic to aquatic invertebrates and hence, considered to be 'not classified' as per CLP classification criteria.

Description of key information

An acute immobilisation test was conducted for 48 hrs for assessing the effect of test chemical on Daphnia magna (Experimental study report, 2019). The test was performed in accordance to OECD guideline No. 202“Daphnia sp.,Acute Immobilization Test”. The test chemical solution was prepared by dissolving 2 mg of the test chemical in 20 ml of ADaM’s media achieving test concentrations of 100 mg/L. Limit test was performed using 100 mg/l of test chemical concentration. 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 20±2°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. 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 > 100 mg/L. Thus, based on the EC50 value, test chemical was considered as non-toxic to aquatic invertebrates and hence, considered to be 'not classified' as per CLP classification criteria.

Key value for chemical safety assessment

EC50/LC50 for freshwater invertebrates:
100 mg/L

Additional information

Experimental study of the test chemical and supporting weight of evidence study for its functionally similar read across chemical were reviewed for short term toxicity to aquatic invertebrate end point which are summarized as below:

 

In an experimental study from study report (2019), 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 chemical solution was prepared by dissolving 2 mg of the test chemical in 20 ml of ADaM’s media achieving test concentrations of 100 mg/L. Limit test was performed using 100 mg/l of test chemical concentration. 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 20±2°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. 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 > 100 mg/L.

 

For the test chemical, short term toxicity to aquatic invertebrate study was conducted for 48 hrs for assessing the effect of test chemical (Experimental study report, 2016). The test was performed in accordance to OECD guideline No. 202 “Daphnia sp.,Acute Immobilization Test”. Daphnia magna was used as a test organism for the study. The stock solution 200 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 concentrations used for the study were 0, 10, 20, 40, 80 and 100 mg/l, respectively. Study was performed using total 5 organisms per vessel/replicates in a static 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. Control solution vessel containing reconstituted water without the test chemical was also setup during the study. 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. EC50 was calculated using non linear regression by the software Prism 4. In the control vessel containing reconstituted water without the test chemical, no daphnids were immobilized at the end of the test. On the basis of the mobility of the test organism Daphnia magna due to the exposure of test chemical, the 48hr median effect concentration (EC50) value was determined to be 202.6 mg/l (95 % C. I. - 146.1 to 280.9 mg/l ).

 

On the basis of the above results, it can be concluded that the test chemical was considered as non-toxic to aquatic invertebrates and hence, considered to be ‘not classified’ as per the CLP classification criteria.