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:
Not yet reported
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
no
GLP compliance:
yes
Analytical monitoring:
yes
Vehicle:
no
Test organisms (species):
Daphnia magna
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
>= 3.2 - <= 5.6 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
loading rate WAF
Basis for effect:
mobility
Details on results:
- No biologically relevant immobility (i.e. >10%) was observed in the control and at the three lowest test concentrations throughout the test.
- At the end of the test, 85 and 100% immobility was observed at the WAFs prepared at loading rates of 5.6 and 10 mg/L, respectively.
- It should be noted that 10 % immobility is allowed in the control and therefore, effects ≤ 10 % are considered to be biologically not relevant.

NUMBER OF INTRODUCED DAPHNIDS AND INCIDENCE OF IMMOBILITY IN THE FINAL TEST

Time (hours)

Replicate

Control

(mg/L)

Test item 1.0 mg/L loading rate WAF

Test item 1.8 mg/L loading rate WAF

Test item 3.2 mg/L loading rate WAF

Test item 5.6 mg/L loading rate WAF

Test item 10 mg/L loading rate WAF

0

A

5

5

5

5

5

5

0

B

5

5

5

5

5

5

0

C

5

5

5

5

5

5

0

D

5

5

5

5

5

5

0

Total

20

20

20

20

20

20

24

A

0

0

0

0

2

4

24

B

0

0

0

0

3*

3

24

C

0

0

1

0

2

2

24

D

0

0

0

0

3

3

24

Total immobilised

0

0

1

0

10

12

24

Effect %

0

0

5

0

50

60

48

A

0

0

0

0

4

5

48

B

0

0

1

0

5

5

48

C

0

0

1

0

3

5

48

D

0

0

0

0

5

5

48

Total immobilised

0

0

2

0

17

20

48

Effect %

0

0

10

0

85

100

*Microscopic observation revealed that no test item was attached to the daphnids.

ANALYTICAL RESULTS

Sampling time (hours)

Date of sampling

Date of analysis

Loading rate (mg/L)

Concentration analysed (mg/L)

Relative to initial (%)

Note

0

14 May 2018

23 May 2018

0

0.00065

Not applicable

1

0

14 May 2018

23 May 2018

1.0

0.014

Not applicable

1

0

14 May 2018

23 May 2018

1.8

0.112

Not applicable

-

0

14 May 2018

23 May 2018

3.2

0.0969

Not applicable

-

0

14 May 2018

23 May 2018

5.6

0.209

Not applicable

-

0

14 May 2018

23 May 2018

10

0.266

Not applicable

-

48

16 May 2018

23 May 2018

0

< 0.000091

< 14

2

48

16 May 2018

23 May 2018

1.0

< 0.000091

< 0.65

2

48

16 May 2018

23 May 2018

1.8

0.00086

0.76

1

48

16 May 2018

23 May 2018

3.2

0.00063

0.65

1

48

16 May 2018

23 May 2018

5.6

0.0015

0.71

1

48

16 May 2018

23 May 2018

10

0.0021

0.78

1

1 = Estimated value, calculated by extrapolation of the calibration curve.

2 = Not detected. The limit of detection of the method was determined to be 0.0912 µg/L taking a dilution factor of 2 into account.

Validity criteria fulfilled:
yes
Conclusions:
The 48-hour EC50 value is expressed in terms of loading rate and is considered to lie between 3.2 and 5.6 mg/L loading rate WAF. 
Executive summary:

GUIDELINE

A study was performed to assess the acute toxicity of the test item toDaphnia magna.The method followed was designed to be compatible with the OECD Guidelines for Testing of Chemicals (April 2004) No 202,"Daphniasp., Acute Immobilisation Test" referenced as Method C.2 of Commission Regulation (EC) No. 440/2008.

 

METHODS

For the final test, Water Accommodated Fractions (WAFs) were individually prepared at loading rates of 1.0, 1.8, 3.2, 5.6 and 10 mg/L. One hour of gentle magnetic stirring was applied to accelerate dissolution of test item in test medium. The obtained mixtures were allowed to settle for a period of approximately two hours. Thereafter, the WAFs were collected by means of siphoning over glass wool and used as test concentrations. At the end of the preparation procedure, all test solutions were clear and colourless.

RESULTS

No biologically relevant immobility (i.e. >10%) was observed in the control and at the three lowest test concentrations throughout the test. At the end of the test, 85 and 100% immobility was observed at the WAFs prepared at loading rates of 5.6 and 10 mg/L, respectively. It should be noted that 10 % immobility is allowed in the control and therefore, effects ≤ 10 % are considered to be biologically not relevant.

CONCLUSION

The 48-hour EC50 value is expressed in terms of loading rate and is considered to lie between 3.2 and 5.6 mg/L loading rate WAF. 

Description of key information

The 48-hour EC50 value is expressed in terms of loading rate and is considered to lie between 3.2 and 5.6 mg/L loading rate WAF. 

Key value for chemical safety assessment

EC50/LC50 for freshwater invertebrates:
3.2 mg/L

Additional information

GUIDELINE

A study was performed to assess the acute toxicity of the test item toDaphnia magna.The method followed was designed to be compatible with the OECD Guidelines for Testing of Chemicals (April 2004) No 202,"Daphniasp., Acute Immobilisation Test" referenced as Method C.2 of Commission Regulation (EC) No. 440/2008.

 

METHODS

For the final test, Water Accommodated Fractions (WAFs) were individually prepared at loading rates of 1.0, 1.8, 3.2, 5.6 and 10 mg/L. One hour of gentle magnetic stirring was applied to accelerate dissolution of test item in test medium. The obtained mixtures were allowed to settle for a period of approximately two hours. Thereafter, the WAFs were collected by means of siphoning over glass wool and used as test concentrations. At the end of the preparation procedure, all test solutions were clear and colourless.

RESULTS

No biologically relevant immobility (i.e. >10%) was observed in the control and at the three lowest test concentrations throughout the test. At the end of the test, 85 and 100% immobility was observed at the WAFs prepared at loading rates of 5.6 and 10 mg/L, respectively. It should be noted that 10 % immobility is allowed in the control and therefore, effects ≤ 10 % are considered to be biologically not relevant.

CONCLUSION

The 48-hour EC50 value is expressed in terms of loading rate and is considered to lie between 3.2 and 5.6 mg/L loading rate WAF.