Registration Dossier

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22 - 24 Nov 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Version / remarks:
2004
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Staatliches Gewerbeaufsichtsamt Hildesheim

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Sampling and analysis

Analytical monitoring:
yes
Remarks:
TOC
Details on sampling:
- Concentrations: all test item concentrations and the control were analytical verified- Sampling method: according to DIN EN 1484 in fresh media at the start of the exposure and at renewal (0 and 24 h) and in 24-h old media at renewal and at the end of the test (24 and 48 h)

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)- Method: 20 g test solution per replicate were weighed out into each test vessel. This corresponds to 20 mL per test vessel. Test solution was renewed after 24 h. Daphnids were transferred by pipette into freshly prepared test solutions.

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM - Common name: water flea - Strain/clone: Daphnia magna STRAUS (Clone 5) - Source: Niedersachsischer Landesbetrieb für Wasserwirtschaft, Kosten- und Naturschutz, Ander Scharlake 39, 31135 Hildesheim, Germany - Feeding during test: no - Food type: for culture daphnids with a mix of unicellular green algae with a cell density of >10 E+06 cells/mL. - Frequency: at least 5 times per week ACCLIMATION: Acclimatization was not necessary, because the dilution water was equivalent to the culture medium. METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES: Less than 24 h old daphnids from a healthy stock were used for the study. Juvenile daphnids were removed from the culture vessels at the latest 24 h before the start of the exposure and discarded. The juveniles born within the following period of max. 24 h preceding the exposure were used for the test. No first brood progeny was used for the test.

Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h

Test conditions

Hardness:
171 - 180 mg CaCO3/L
Test temperature:
18 - 19 °C
pH:
7.51 - 8.05 (Control)7.43 - 8.15 (test item concentrations)
Dissolved oxygen:
8.75 - 8.87 mg/L (control)8.72 - 8.93 mg/L (test item concentration)
Conductivity:
441 - 472 µS/cm
Nominal and measured concentrations:
Control, 6.25, 12.5, 25.0, 50.0 and 100 mg/L (nominal)
Details on test conditions:
TEST SYSTEM Test vessel: - Type: open (loosely covered with watch glasses) - Material, size, headspace, fill volume: Glass beakers (4 (ID) x 7 (H) cm), 50 mL capacity, Test volume: 20 mL - Aeration: None - Renewal rate of test solution: every 24 h - No. of organisms per vessel: 5 - No. of vessels per concentration (replicates): 4 - No. of vessels per control (replicates): 4 TEST MEDIUM / WATER PARAMETERS - Source/preparation of dilution water: Composition of the Culture Medium Elendt M4 according to OECD 202, Annex 3 (2004). Modifications: to a total hardness of approximately 160 to 180 mg CaC03/L - Culture medium different from test medium: Same as culture medium - Intervals of water quality measurement: Prior to the start of the exposure (0 h) and the water renewal (24 h), the water quality parameters (i.e. pH-value, dissolved oxygen concentration, temperature, conductivity and total hardness) of the dilution water were measured OTHER TEST CONDITIONS - Photoperiod: 16/8 h light/dark cycle - Light intensity: Diffuse light, light intensity of max. 1500 Iux EFFECT PARAMETERS MEASURED: Mobility RANGE-FINDING STUDY: non-GLP - Test concentrations: Control, 1, 10 and 100 mg/L - Results used to determine the conditions for the definitive study: Based on the results of the non-GLP range-finding the main test was performed.
Reference substance (positive control):
yes
Remarks:
Potassium dichromate

Results and discussion

Effect concentrations
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
29.9 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: 95% confidence limits: 25.1 - 45.5 mg/L
Details on results:
- Mortality of control: no immobility in the control - Others: Biological and analytical results are summarized with the Tables 1-2 in the section "Any other information on results incl. tables"
Results with reference substance (positive control):
- EC50: 0.802 mg/L

Any other information on results incl. tables

Table 1: Immobilization Rates after 24 and 48 hours of Exposure during the Definitive Test

Nominal test item concentration [mg/L]

IMMOBILIZATION [%]

24 hours

 

48 hours

Replicates

 

Replicates

1

2

3

4

Mean

1

2

3

4

Mean

100

100

100

100

100

100

100% mortality after 24 hours

50.0

100

100

100

100

100

100% mortality after 24 hours

25.0

0

0

0

0

0

0

20

0

0

5

12.5

0

0

0

0

0

20

0

0

0

5

6.25

0

0

0

0

0

0

0

0

0

0

Control

0

0

0

0

0

0

0

0

0

0

 

Table 2: Measured TOC Concentrations during the Definitive Test

Sampling date

2016-11-22 Start of the exposure interval 0 hours

2016-11-23 End of the exposure interval 24 hours

2016-11-23 Start of the exposure interval 24 hours

2016-11-24 End of the exposure interval 48 hours

Start of analysis

2016-11-22

2016-11-23

2016-11-23

2016-11-24

Nominal test item concentration [mg/L]

Total Organic Carbon (TOC)

Measured concentration 1) [mg/L]

Measured concentration 1) [mg/L]

Measured concentration 1) [mg/L]

Measured concentration 1) [mg/L]

100

52.6

53.1

Not determined, due to 100% mortality after 24 hours

50.0

27.1

27.6

25.0

14.9

14.9

15.5

17.3

12.5

8.34

8.16

9.21

9.30

6.25

5.43

5.34

6.25

6.51

Control

2.49

2.35

2.21

2.12

1) = measured TOC concentration, mean value of 2 injections The limit of quantification of the analytical method is set to 2.00 mg/L.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes