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:
2012-11-26 to 2012-11-29 (experimental phase)
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study with analytical monitoring

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solid
Details on test material:
- Batch Number: 0005473663
- Purity: > 98 %
- Appearance/colour: solid/white
- Expiry date: 01 February 2013
- Storage: At ambient temperature

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
Method: Analytical verification of application of the suspension was performed before filtration. A separate weighing of 10 mg/100 mL was prepared and stirred for 24 hours. After the stirring period the complete suspension was extracted. The analysis of samples from the separate, unfiltrated suspension of the test item was performed in order to demonstrate correct application of the test item. It was not the intention to quantify the water-soluble fraction of the test item since the water solubility lies below the LOQ of 1.0 mg/L.

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: 50 mg of the test substance was weighed on a weighing scoop and transferred to a 500 mL volumetric flask. Test medium was added up to the bench mark. The solution was stirred for 24 hours, afterwards insoluble particles of the test item were separated from the liquid phase by filtration through a filter with 0.45 μm mean pore size (according to OECD SERIES ON TESTING AND ASSESSMENT No. 23). The resulting filtrate was used as limit test concentration.

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Water flea
- Strain: Clone V
- Source: Federal Environmental Agency in Berlin/Germany
- Age at study initiation: 6 - 24 hours
- Feeding during test: none

Study design

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

Test conditions

Hardness:
13°dH (232 mg/L CaCO3)
Test temperature:
19.5 – 21.0 °C
pH:
7.44 – 8.47
Dissolved oxygen:
83 - 99 % of air saturation
Nominal and measured concentrations:
Nominal concentrations: 100 mg/L (loading rate)
Measured concentrations: 103 % of the application rate of the test item was analytically recovered from the unfiltered suspension (100 mg/L loading rate), thus confirming correct dosage of the insoluble test item. The toxicological endpoints were evaluated using nominal concentrations.
Details on test conditions:
TEST SYSTEM
- Test vessel: four 100 mL glass beakers per concentration
- Fill volume: 50 mL per test vessel
- Aeration: none
- No. of organisms per vessel: 5
- No. of vessels per concentration: 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: According to guideline
- Intervals of water quality measurement: daily

OTHER TEST CONDITIONS
- Photoperiod: 16 hours of illumination and 8 hours of darkness

EFFECT PARAMETERS MEASURED: Mobility
Reference substance (positive control):
yes
Remarks:
Potassium dichromate

Results and discussion

Effect concentrationsopen allclose all
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: loading rate
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: loading rate
Details on results:
- Mortality of control: none
Results with reference substance (positive control):
The EC50 (48 h) was determined to be between 1.0 and 2.0 mg/L

Applicant's summary and conclusion

Validity criteria fulfilled:
yes