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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:
2014-06-04 to 2014-06-06
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well performed OECD study with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Analytical purity: 99.0 % (w/w)
- Purity test date: 2012-02-29

Sampling and analysis

Analytical monitoring:
no

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna
- Strain: Clone 5
- Source:
Origin: Institut für Wasser-, Boden- und Lufthygiene (WaBoLu)
Breeder: DR.U.NOACK-LABORATORIEN, Käthe-Paulus-Str. 1, 31157 Sarstedt, Germany
- Age at study initiation (mean and range, SD): 2 to 24 h old daphnids from a healthy stock were used for the study
- Method of breeding:
Culture: In glass vessels (2 - 3 L capacity) with approximately 1.8 L culture medium, at 20 +- 2°C, in an incubator, 16 h illumination; light intensity
of max. 20 µE x m-2 x s-1
Culture medium: Elendt M4, according to ELENDT (1990), modified to a total hardness of 160 to 180 mg CaCO3/L
Cultur feeding: At least 5 times per week ad libitum with a mix of unicellular green algae, e.g. Pseudokirchneriella subcapitata and
Desmodesmus subspicatus, with an algae cell density of > 106 cells/mL
- Feeding during test: No feeding

ACCLIMATION
- Acclimation period: At least 2 h in dilution water.
- Acclimation conditions (same as test or not): Same as test conditions.
- Health during acclimation (any mortality observed): No mortality observed.

Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h

Test conditions

Hardness:
258 mgCaCO3/L
Test temperature:
18 - 22°C, constant within ± 1°C
pH:
pH at the Start of the Exposure (0 h)
(measured in one additional replicate of the saturated solution and the control)

Nominal loading
of the test item
[mg/L] pH-value
1.00 (Saturated solution) 7.68
Control 7.84



pH at the End of the Exposure (48 h)
(measured in all replicates of the saturated solution and the control)

Nominal loading
of the test item
[mg/L] pH-values
Replicates
1 2 3 4
1.00 (Saturated solution) 7.29 7.29 7.31 7.39
Control 7.43 7.39 7.43 7.45
Dissolved oxygen:
O2-concentration at the Start of the Exposure (0 h)
(measured in one additional replicate of the saturated solution and the control)

Nominal loading
of the test item
[mg/L] DissolvedO2-concentration[mg/L]
1.00 (Saturated solution) 5.30
Control 8.12


O2-concentration at the End of the Exposure (48 h)
(measured in all replicates of the saturated solution and the control)

Nominal loading
of the test item
[mg/L] DissolvedO2-concentration[mg/L]
Replicates
1 2 3 4
1.00 (Saturated solution) 8.46 8.42 8.28 8.35
Control 8.47 8.37 8.37 8.34
Nominal and measured concentrations:
Limit concentration: saturated solution (nominal loading level 1.00 mg/L)
Details on test conditions:
TEST SYSTEM
- Test vessel: Glass beakers (4 cm ID x 7 cm H), 50 mL capacity, loosely covered with watch glasses
- Aeration: None
- 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: ISO Test water, according to OECD 202, Annex 3
Component Concentration [mg/L]
KCl 5.76
NaHCO3 64.8
CaCl2 x 2 H2O 294
MgSO4 x 7 H2O 123

- Water Quality Parameters of the Dilution Water prior to the Start of the Exposure (0 h):
pH-value DissolvedO2-concentration[mg/L] Temperature[°C] Conductivity[µS/cm] Total hardness [mg CaCO3/L]
7.84 8.12 22.0 654 258

- Culture medium different from test medium: Elendt M4, according to ELENDT (1990), modified to a total hardness of 160 to 180 mg CaCO3/L
- Intervals of water quality measurement: test start (0h) and test end (48h)

OTHER TEST CONDITIONS
- Photoperiod: 16/8 h light/dark cycle
- Light intensity: Diffuse light, light intensity of max. 20 µE x m-2 x s-1

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Immobilisation, 24 h interval

TEST CONCENTRATIONS
- Test concentration: limit concentration (saturated solution, nominal loading 1.00 mg/L)
Reference substance (positive control):
yes
Remarks:
Potassium dichromate

Results and discussion

Effect concentrationsopen allclose all
Duration:
48 h
Dose descriptor:
NOELR
Effect conc.:
1 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: immobilisation
Duration:
48 h
Dose descriptor:
LOELR
Effect conc.:
> 1 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: immobilisation
Duration:
48 h
Dose descriptor:
EL100
Effect conc.:
> 1 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: immobilisation
Duration:
48 h
Dose descriptor:
EL50
Effect conc.:
> 1 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: immobilisation
Duration:
48 h
Dose descriptor:
EL10
Effect conc.:
> 1 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: immobilisation
Details on results:
See below
Results with reference substance (positive control):
The percentage immobility for the reference item was determined after 24 h. The EC50-value with 95 % confidence interval (CI) was calculated by sigmoidal dose-response regression. The EC50-value for the most recent of the monthly performed reference tests was:
EC50: 1.53 mg/L (CI 1.35 - 1.72 mg/L).
The EC50-value of the reference item potassium dichromate after 24 h is within the prescribed concentration range of 0.6 - 2.4 mg/L of quality criteria according to AQS P 9/2 (02/2000) for daphnids clone 5 cultured in Elendt M4 medium. The EC50-value of the reference item is also within therecommended range of 0.6 - 2.1 mg/L according to OECD-Guideline 202.

Any other information on results incl. tables

The percentage immobility, determined in the saturated solution with a nominal loading of 1.00 mg/L of the test item Hostasol Red GG and the control after 24 and 48 h under static conditions, is presented in the table below. There was no effect observed at the saturated solution and the control.

 

Immobilisation Rates of the definitive Test after 24 and 48 hours of Exposure

(n = 20, divided into 4 replicates with 5 daphnids each)

Hostasol Red GG

Nominal loading

of the test item

 

[mg/L]

IMMOBILISATION [%]

24 h

48 h

Replicates

Replicates

1

2

3

4

MV

1

2

3

4

MV

1.00

(Saturated solution)

0

0

0

0

0

0

0

0

0

0

Control

0

0

0

0

0

0

0

0

0

0

MV   = mean value

All replicates of the saturated solution of the test item and the control were colourless and clear throughout the exposure period.

 

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
At the saturated solution with a nominal loading of 1.00 mg/L of the test item Hostasol Red GG, no effects were observed on Daphnia magna.
Executive summary:

In the acute immobilisation test with Daphnia magna (STRAUS), the effects of the saturated solution* with a nominal loading of 1.00 mg/L of the test item were determined according to OECD 202 (2004). The limit test was conducted under static conditions over a period of 48 hours.

The test item is a red powder and sparingly soluble in water (< 0.02 mg/L at 20 °C). Therefore, a saturated solution was prepared by stirring with approximately 1100 rpm for 48 h at room temperature followed by filtration (membrane filter: 0.45 µm, RC, Macherey-Nagel) to achieve the saturated solution.Twenty daphnids were exposed to the saturated solution and the control.

No analytical monitoring was performed during the test period because the test item has a very low solubility in water and organic solvents. Therefore, an analytical standard method with a sufficient sensitivity could not be established.Exposures are expressed in terms of the original concentration of the test item in water at the start of the mixing period (loading rate). The EL-values are presented in the table below.

Water quality parameters (i.e. pH-value and dissolved oxygen concentration), measured at the start (0 h) and at the end of the exposure (48 h), were within the acceptable limits. The validity criteria of the test guidelines were fulfilled.

 

At the saturated solution* with a nominal loading of1.00 mg/L of the test item, no effects were observed on Daphnia magna.

 

  EL10-, EL50-EL100-Values, NOEL and LOEL

   (based on the nominal loading levels of the test item)

Endpoints

Test

duration

[h]

Test item

Nominal loading level of the test item

[mg/L]

EL10

24

> 1.00

48

> 1.00

EL50

24

> 1.00

48

> 1.00

EL100

24

> 1.00

48

> 1.00

NOEL

48

  1.00

LOEL

48

> 1.00

  

*)  Saturated solution: The maximum dissolved concentration of the test item that can be achieved under the test conditions in the test medium,

acc. to OECD Series, No. 23 (2000).