Registration Dossier

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

Link to relevant study record(s)

Referenceopen allclose all

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Biological part: 2016-07-27 to 2016-07-29 analytical part 2016-08-11 to 2016-08-26
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Version / remarks:
version adopted 2004-04-13
Qualifier:
equivalent or similar to
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
GLP compliance:
yes (incl. certificate)
Test material information:
Composition 1
Analytical monitoring:
yes
Details on sampling:
sampling at start of study (duplicate samples) and at end of study (48 hrs; duplicate samples after pooling the content of test beaker)
Vehicle:
no
Details on test solutions:
Reconstituted water according to ELENDT (1990):
Macro nutrients (mg/L):
CaCI2 x 7 H20 293.80
MgSO4 x 7 H20 123.30
KCI 5.80
NaHCO3 64.80
Na2SiO3 x 9H20 10.00
NaNO3 0.27
KH2PO4 0.14
K2HPO4 0.18

Trace elements (µg/L):
H3BO3 2860
MnCl2*4H20 361
LiCl 306
RbCl 71
SrCl2*6H20 152
NaBr 16
Na2MoO4 *2H2O 63
CuCl2*2H20 17
ZnCl2 13
CoCl2*6H20 10
KI 3.3
Na2SeO3 2.2
NH4VO3 0.6
Na2EDTA*2H20 2500
FeSO4*7H20 1000

Vitamins (µg/L):
Thiamine 75.00
B12 1.00
Biotin 0.75

Calculated water hardness 2.5mmol/L as caCO3
Calculated alkalinity: 0.9 mmol/L


Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna (Straus)
- Source: inhouse laboratory culture of study institute
- Age at study initiation (mean and range, SD): not older than 17.5 hours
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Hardness:
250 mg/L as CaCO3
Test temperature:
21°C
pH:
7.9 to 8.8 at test start
7.4 to 7.5 at test end
Dissolved oxygen:
6.8 to 9.0 mg/L at start
8.7 to 8.9 mg/L at end
Salinity:
alkalinity (calculated) = 0.9 mmol/L
Nominal and measured concentrations:
no concentration measured of test item as test item is insoluble. nominal concentration 100 mg/L

measured concentrations of ingredients

barium t=0 | barium t=48 h
_________________________
2.07 mg/L | 1.97 mg/l
_________________________
strontium t=0 | strontium t=48 h
29.9 mg/L | 29.32 mg/L
Details on test conditions:
TEST SYSTEM
20 daphnids per control and test concentration, 4 groups wih 5 individuals each. Each group is introduced in 60ml test medium

Dosage of test item: preparation of 100mg/L solution: 48.6 mg of test were mixed with 486 mL test water. The solution was ultrasonicated for 10 minutes and then stirred for 23.5 hours in the dark. Undissolved particles where separated by filtration. Resulting pH value of solution was 9.5 and readjusted to 8.8 with 2M Hcl.
Reference substance (positive control):
yes
Remarks:
potassium dichromate
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
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 2.02 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
other: Based on concentration of Barium (mean value of analytical concentartion at start and end of experiment)
Basis for effect:
mobility
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
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 29.61 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
other: based on concentration of strontium, mean value of measured concentration (mean value of analytical concentration at begin and end of test)
Basis for effect:
mobility
Results with reference substance (positive control):
In the most recent test (dated january 2016) EC50 after 24 hrs exposure of potassiumdichromate was measured as 1.58 mg test item /L (CI 95% 1.32-1.92) This is consistent with reference values given in OECD guideline 202 (EC50 (24 hrs) between 0.6 amd 2.1 mg test item/L
Reported statistics and error estimates:
as the test is a limit test with no effects, no statistical methods are required

Purpose

The purpose of this assay was to identify the aquatic toxicity potential of the test material in Daphnia magna straus to provide a rational basis for hazard estimation for the test item in aquatic environments.

 

Study design

For this purpose, juvenile Daphnia magna were exposed to an aqueous test material preparation over 48 hours, under defined conditions. The study comprised of four vessels per concentration containing five Daphnia magna, i.e. 20 Daphnia per concentration. The daphnia were observed for immobilization for up to 48 hours. The test was conducted as a limit test with a nominal concentrations of 100 mg/L for test substance. No higher concentration could be tested due to limit of solubility of test item The analytical check of the concentrations was performed at the start and at the end of the study using ICP-OES. The GLP study was performed according to OECD TG 202.

 

Results

The follwing results have been obtained after an exposure for 48 hours:

 

Nominal concentration Immobilization immobilized / exposed

[mg/L] 

24 hours 

48 hours 

100.0

0/20

0/20 

No daphnia magna exposed to an aqueous preparation of the nominal concentration of  100 mg/L were immobilized.

Consequently following endpoints after 24 hrs and 48 hrs exposure time were derived

24 h EC50 > 100 mg/L 

48 h EC50 > 100 mg/L 

NOEC ≥ 100 mg/L

LOEC >  100 mg/L

 

Conclusions

Under the given experimental conditions, the 48 hours EC50 to Daphnia magna is > 100 mg/L.

 

 

Validity criteria fulfilled:
yes
Conclusions:
Under the described experimental conditions, the EC50 of test substance in Daphnia magna is > 100 mg/L for 48 hrs exposure time.
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
For this endpoint information from a structural similar compound is available. This study for this similar compound was performed according to GLP and the methods applied are fully compliant with OECD TG 202. See chapter 13 report for a more detailed justification.
Reason / purpose:
read-across source
Related information:
Composition 1
Test material information:
Composition 1
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
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 2.02 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
element
Remarks:
Based on concentration of Barium (mean value of analytical concentartion at start and end of experiment)
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 29.61 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
element
Remarks:
based on concentration of strontium, mean value of measured concentration (mean value of analytical concentration at begin and end of test)
Basis for effect:
mobility
Validity criteria fulfilled:
yes

Description of key information

For a structural analogue substance the 48 h-EC50 value was determined to be greater than 100 mg/L (nominal).

Key value for chemical safety assessment

Additional information

A GLP study according to OECD 202 is available for a structural analogue substance. Juvenile Daphnia magna were exposed to an aqueous test material preparation over 48 hours under defined conditions in a limit test.

The analytical check of the concentrations of constituents with significant release was performed at the start and at the end of the study. Under the given experimental conditions, the EC50 to daphnia magna is > 100 mg/L (nominal).