Registration Dossier

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2015-12-04 to 2015-12-16
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
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)
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No. of test material: I15FB2768
- Expiration date of the lot/batch: 01 July 2017 (retest date)
- Purity: 100% (based on base titration assay)

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature
- Stability under test conditions: no data
Analytical monitoring:
yes
Details on sampling:
- Sampling method: samples for possible analysis were taken from all test concentrations and the control at t=0 and t=48h. 2.0 mL of volume was taken from the approximate centre of the test vessels. At the end of the exposure period, the replicates were pooled at each concentration before sampling
- Sample storage conditions before analysis: the samples were stored in a freezer. Addionally, reserve samples of 2.0 mL were taken for possible analysis
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: preparation of test solutions started with a loading rate of 100 mg/L applying 2 days of magnetic stirring in the dark at room temperature , mostly in the dark. The obtained mixture was filtered through a 0.45 µm membrane (RC55, Whatman) to remove the undissolved fraction. The filter was preconditioned with a small volume of test solution that was discarded. The obtained SS was used as the highest test concentration. Lower test concentrations were prepared by subsequent dilutions of the SS in test medium.
- Evidence of undissolved material (e.g. precipitate, surface film, etc): All aqueous solutions were clear and colourless with exception of the highest concentration which was slightly yellowish.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Water-flea
- Source: in-house laboratory culture with a known history
- Age at study initiation (mean and range, SD): <24h (from parental daphnids of more than 2 weeks old)
- Method of breeding: 250 newborn daphnids (i.e. less than 3 days old) are placed into 5 litres of medium in an all-glass culture vessel. Medium is M7. After 7 days of cultivation half of the medium is renewed twice a week.
- Feeding during test: no
- Feeding during cultivation: fresh water algae, daily

ACCLIMATION
- Acclimation period: not relevant
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Hardness:
180 mg/L as CaCO3
Test temperature:
20-21°C
pH:
At t= 0h: 7.7 - 7.9
At t= 48h: 8.0
Dissolved oxygen:
At t= 0h: 9.1-9.5
At t= 48h: 9.0
Salinity:
not relevant
Nominal and measured concentrations:
Final test
Nominal concentrations (mg/L): 1.0, 10 and 100
Nominal concentration tested (mg/L): 100
Measured concentrations (mg/L) at t=0h: 0.0306
Measured concentrations (mg/L) at t=48h: 0.0320
Details on test conditions:
TEST SYSTEM
- Test vessel: beaker
- Material, size, headspace, fill volume: 100 mL, glass beaker filled with 80mL
- Aeration: not during the test
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): not reported
- No. of vessels per control (replicates): not reported

OTHER TEST CONDITIONS
- Photoperiod: 16h light daily

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Immobility was defined as those organisms which are not able to swim within 15 seconds after gentle agitation of the test container and was monitored after 24 and 48 hours of continuous treatment with the test substance.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: x10
- Range finding study: combined limit/range finding study was performed
- Test concentrations: 1.0, 10 and 100% of a SS prepared at a loading rate of 100 mg/L
- Results used to determine the conditions for the definitive study: yes
Reference substance (positive control):
yes
Remarks:
Potassium dichromate
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
- Mortality of control: none
- Other adverse effects control: no
- Abnormal responses: none
Results with reference substance (positive control):
- Results with reference substance valid? yes (should lie between 0.3 and 1.0 mg/L)
- Mortality:
- EC50/LC50: 48h-EC50 = 0.38 mg/L with a 95% confidence interval between 0.33 and 0.43 mg/L. The sensitivity of the daphnia was within the range determined with the historical data collected at WIL Research Europe.
Reported statistics and error estimates:
The 24 and 48h-EC50 could not be determined because no effect was observed at any of the tested concentrations.
Validity criteria fulfilled:
yes
Conclusions:
The acute toxicity of T001325 to Daphnia magna was determined in a 48-hour static test according to the OECD guideline 202.
The 48h-EC50 exceeded 31 µg/L, being the measured concentration in a saturated solution prepared at a loading rate of 100 mg/L. This concentration was considered the maximum soluble concentration in test medium.
In conclusion, the test item T001325 clearly had no toxic effect to Daphnia magna up to the maximum solubility in medium obtained with a loading rate of 100 mg/L.

Description of key information

The study of Migchielsen (2016) investigating the acute toxicity of T001325 in Daphnia magna according to OECD guideline 202, was considered as the key study for endpoint coverage. T001325 clearly had no toxic effect to Daphnia magna up to the maximum solubility in medium obtained with a loading rate of 100 mg/L under the conditions of the 48-hour static test.

Key value for chemical safety assessment

EC50/LC50 for freshwater invertebrates:
100 mg/L

Additional information