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:
30.05.2018-17.09.2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guidelineopen allclose all
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 (incl. certificate)
Remarks:
LAUS GmbH

Test material

Reference
Name:
Unnamed
Type:
Constituent

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
no

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna
- Strain/clone: Berlin
- Justification for species other than prescribed by test guideline:
- Source: Umweltbundesamt Berlin
- Age of parental stock (mean and range, SD):
- Feeding during test: No

Study design

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

Test conditions

Hardness:
2.502 mmol/L
Test temperature:
20+/-2 °C
pH:
6.2-7.9
Dissolved oxygen:
8.0-9.0 mg/L
Nominal and measured concentrations:
8.4 / 18 / 40 / 84 / 182 mg/L (nominal)
4.6+/-1 /10 / 22 / 46 / 100 mg/L (active ingeredient, without water content of 55%)
Details on test conditions:
TEST SYSTEM
- Test vessel: glass beakers, nominal volume 50 mL, tall shape
- Type: open
- Material, size, headspace, fill volume: 50mL
- Aeration:
- Type of flow-through (e.g. peristaltic or proportional diluter):
- Renewal rate of test solution (frequency/flow rate):
- No. of organisms per vessel:5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 5
- No. of vessels per vehicle control (replicates):4

TEST MEDIUM / WATER PARAMETERS
Medium M4-Medium (recipe of ELENDT)
Dilution water (Daphnia medium) with the following specification was used (stated in SOP 11800201)
Parameter Concentration in mg/L
CaCl2*2H2O 293.80
MgSO4*7H2O 123.30
NaHCO3 64.80
KCl 5.80
Resulting hardness in mmol/L: 2.502
Resulting hardness in mg CaCO3/L: 250


RANGE-FINDING STUDY
- Test concentrations:
- Results used to determine the conditions for the definitive study:
Reference substance (positive control):
yes
Remarks:
Potassium dichromate K2Cr2O7

Results and discussion

Effect concentrationsopen allclose all
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 161.51 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Remarks:
measured concentration based on measured Cr content in unfiltered solution
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 88.83 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
act. ingr.
Remarks:
measured concentration based on measured Cr content in unfiltered solution, corrected for water content
Basis for effect:
mobility
Details on results:
In filtered solution 8experiment 1 and 2) the concentrations were lower: Exp. 1 EC50 (48h) >10.68 mg/L test mat. and Exp. 2 EC50 (48h) >9.59 mg/L test mat.
Results with reference substance (positive control):
Potassium dichromate K2Cr2O7 was used as positive control in a current reference study. The 24h-EC50 value was determined as 1.9 mg/L, lying within the demanded range of 0.6 – 2.1 mg/L.
Reported statistics and error estimates:
Results was calculated with the help of validated software (Microsoft Excel®). The estimation of the biological data was accomplished using the software ToxRat® Professional, version 3.2.1.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The EC 50 (48 h) for Daphnia magna was >161.51 mg/L (>88.83 mg/L active ingredient).
Executive summary:

The toxicity of the test substance to Daphnia magna was investigated in a test conducted according to OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test; 2004), EU Method C.2 (Acute Toxicity for Daphnia; 2008). At a test substance concentration of 161.51 mg/L measured (= 88.83 mg/L active ingr.) 20% immobilisation to daphnids could be detected (48 h EC50> 161.51mg/L measured or 88.83 mg/L active ingr. 100 mg/L).