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
Remarks:
Daphnia magna
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2014-07-22 to 2014-07-29
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:
yes
Remarks:
Storage of test item and control substance instead of ≤ -20 °C), it was -14.9 °C.
Qualifier:
according to
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
GLP compliance:
yes (incl. certificate)
Remarks:
German GLP
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: SBL/027/LRB (India)
- Expiration date of the lot/batch: May 05, 2019

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: In the freezer (≤-20 °C), under dark and dry conditions
Analytical monitoring:
yes
Details on sampling:
Duplicate samples from the freshly prepared test medium of the only test concentration and the control were taken at the start of the test. For the determination of the stability of the test item under the test conditions and of the maintenance of the test item concentration during the test period, duplicate samples from the test medium of the only test concentration and the control were collected at the end of the test (after 48 h). One additional sample of the control were taken at test start and test end without any sample treatment. All samples were diluted by a factor of two with acetonitrile.
Vehicle:
no
Details on test solutions:
The test medium with the test item concentration of nominal 100 mg test item/L was prepared by dissolving 45.0 mg of the test item homogeneously in 450 mL test water by intense stirring for 10 minutes. The test medium was prepared just before introduction of the daphnids (= start of the test).
Test organisms (species):
Daphnia magna
Details on test organisms:
Species: Daphnia magna (Straus), clone 5
Age at Test Start: From 3.25 to 19.75 h old
Sex: Female
Origin: The daphnids introduced in the test were taken from our in house laboratory culture.
Breeding Conditions: The daphnids were bred in the laboratories of IBACON under similar temperature and light conditions as used in the test. The cultivation of the parental daphnids was performed in reconstituted water of a similar quality with regards to pH, the constituent salts and total hardness as the test water used in the test. The test organisms were not first brood progeny. The daphnids in the stock culture were fed at least on all working days with green algae (Desmodesmus subspicatus) freshly grown in the laboratories of IBACON.
Acclimatisation: Was not necessary, since the test was performed in the same medium as the culturing.
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Hardness:
Water Hardness: 2.5 mmol/L (= 250 mg/L) as CaCO3
Test temperature:
20 °C at test start; 20 °C at test end

pH:
8.0 to 8.1 at test start;
8.1 to 8.1 at test end; and thus the pH-value did not vary by more than 1.5 units

Dissolved oxygen:
8.0 to 8.1 at test start;
8.1 to 8.1 at test end; and thus the pH-value did not vary by more than 1.5 units

Nominal and measured concentrations:
100 mg test item/L and a control.
Details on test conditions:
Test Environment: Controlled environment room
Measurement of pH, Dissolved Oxygen and Water Temperature:
The water temperature, pH-values and dissolved oxygen concentrations were determined at test start and test end in each treatment group.
Water Temperature: 20 °C at test start; 20 °C at test end
pH-Values: 8.0 to 8.1 at test start; 8.1 to 8.1 at test end; and thus the pH-value did not vary by more than 1.5 units
Dissolved Oxygen Concentration: 8.8 to 9.1 mg/L at test start; 8.9 mg/L at test end
Light Regime: 16 h light : 8 h dark
Light Intensity:The light intensity was 590 to 940 lux (measured once during the test).

Reference substance (positive control):
yes
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: 95 % CI
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
LOEC
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
After 48 h of exposure no immobilisation of the test animals was observed in the control and in the only test concentration.
Results with reference substance (positive control):
Results of the most recent Test with the Reference Item Potassium dichromate performed in January 2014 (88291220)
Nominal Concentration % of immobilised daphnids after
[mg test item/L] 24 h 48 h
Control 0 0
0.09 0 0
0.21 0 0
0.45 0 5
1.0 45 95
2.2 100 100
EC50 [mg/L]: 0.862 0.491
95 % CI [mg/L]:n.d. 0.369 - 0.582
EC20 [mg/L]: 0.912 0.547
95 % CI [mg/L]:n.d. 0.432 - 0.642
EC10 [mg/L]: 1.02 0.671
95 % CI [mg/L]:n.d. 0.564 - 0.798
NOEC [mg/L]: 0.45 0.21
LOEC [mg/L]: 1.0 0.45
Values refer to nominal test concentrations; CI: Confidence interval; n.d.: not determinable; NOEC and LOEC were determined directly from the raw data.

In the most recent test with the reference item potassium dichromate performed in January 2014 (study code 88291220) the EC50 after 24 h was determined to be 0.862 mg test item/L indicating that the sensitivity of the Daphnia was consistent with the level proposed by the OECD 202 guideline (EC50-24 h between 0.6 and 2.1 mg potassium dichromate/L).

 Summary of Biological Results

 

Nominal Concentration

% of immobilised daphnids after

[mg test item/L]

24 h

48 h

Control

0

0

0.09

0

0

0.21

0

0

0.45

0

5

1.0

45

95

2.2

100

100

EC50 [mg/L]:

0.862

0.491

95 % CI [mg/L]:

n.d.

0.369 - 0.582

EC20 [mg/L]

0.912

0.547

95 % CI [mg/L]

n.d.

0.432 - 0.642

EC10 [mg/L]:

1.02

0.671

95 % CI [mg/L]:

n.d.

0.564 - 0.798

NOEC [mg/L]:

0.45

0.21

LOEC [mg/L]:

1.0

0.45

 

Values refer to nominal test concentrations; CI: Confidence interval; n.d.: not determinable; NOEC and LOEC were determined directly from the raw data.

 

In the most recent test with the reference item potassium dichromate performed in January 2014 (study code 88291220) the EC50 after 24 h was determined to be 0.862 mg test item/L indicating that the sensitivity of the Daphnia was consistent with the level proposed by the OECD 202 guideline (EC50-24 h between 0.6 and 2.1 mg potassium dichromate/L).

 

Analytical Results:

Mean Recovery in the Test Samples: Freshly prepared: 106 % (n = 2, RSD 1%).

Aged test media: 105 % (n = 2, RSD 1%).

Limit of Detection: 0.15 mg test item/L

Limit of Quantification: 10 mg test item/L 106% (n = 5, RSD 0%)

 

Summary of Analytical Results

 

sample description [mg test item/L]

% of RSD nominal1

RSD [%]

n

Control

n.a.

n.a.

4

100

105

1

4

 

1mean value of all measured samples per treatment group

RSD: relative standard deviation per treatment group

n: number of analysed samples

n.a.: not applicable

At the start of the test 106 % of the nominal test concentration was found. After 48 h test duration, 105 % of the nominal value was determined. During the test the daphnids were exposed to a mean of 105 % of nominal. Therefore, all reported results refer to nominal concentrations.

Validity criteria fulfilled:
yes
Conclusions:
The 48-h NOEC, LOEC and LC50 of FAT 40062/C to Daphnia magna was determined to be 100 mg, > 100 and > 100 mg test item/L respectively.
Executive summary:

The acute toxicity of FAT 40062/C to Daphnia magna in a static 48-h immobilization test was carried out according to OECD guideline No 202 and EU Method C.2. The purpose of this study was to evaluate the influence of the test item FAT 40062/C TE on the mobility of Daphnia magna. Young daphnids (< 24 h old) were exposed in astatic test for 48 h to test water containing the test item at the concentration of nominal 100 mg test item/L. This limit test was performed in compliance with the test guidelines to demonstrate that the test item has no toxic effect on daphnids up to at least this concentration. The purpose of the analytical part of this study was to verify the concentration of the test item in the test water. Test concentrations used I the study was 100 mg test item/L and a control. At the start of the test 106 % of the nominal test concentration was found. After 48 h test duration, 105 % of the nominal value was determined. During the test the daphnids were exposed to a mean of 105 % of nominal. Therefore, all reported results refer to nominal concentrations. The toxic effect of the test item FAT 40062/C TE to Daphnia magna was assessed in a static limit test. The 48-h NOEC was determined to be100 mg test item/L. The 48-h LOEC was determined to be > 100 mg test item/L and the 48-h EC50value was determined to be >100  mg test item/L. This study is classified acceptable and satisfies the guideline requirements for daphnia acute test studies.

Description of key information

The acute toxicity of FAT 40062/C to Daphnia magna in a static 48-h immobilization test was carried out according to OECD guideline No 202 and EU Method C.2. The purpose of this study was to evaluate the influence of the test item FAT 40062/C TE on the mobility of Daphnia magna. Young daphnids (< 24 h old) were exposed in astatic test for 48 h to test water containing the test item at the concentration of nominal 100 mg test item/L. This limit test was performed in compliance with the test guidelines to demonstrate that the test item has no toxic effect on daphnids up to at least this concentration. The purpose of the analytical part of this study was to verify the concentration of the test item in the test water. Test concentrations used I the study was 100 mg test item/L and a control. At the start of the test 106 % of the nominal test concentration was found. After 48 h test duration, 105 % of the nominal value was determined. During the test the daphnids were exposed to a mean of 105 % of nominal. Therefore, all reported results refer to nominal concentrations. The toxic effect of the test item FAT 40062/C TE to Daphnia magna was assessed in a static limit test. The 48-h NOEC was determined to be100 mg test item/L. The 48-h LOEC was determined to be >100 mg test item/L and the 48-h EC50value was determined to be >100 mg test item/L. This study is classified acceptable and satisfies the guideline requirements for daphnia acute test studies

Key value for chemical safety assessment

EC50/LC50 for freshwater invertebrates:
100 mg/L

Additional information