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:
15 Mar 2017 – 29 Mar 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

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
Test material form:
solid
Details on test material:
- Stabilisation: stable
- Safety precautions: The routine hygienic procedures were sufficient to assure personnel health and safety
- Colour: brownish red
- Storage conditions: room temperature

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
Analytical samples taken at 0 hours (initial value) and 24 hours from fresh and 48 h aged test solutions were analysed from control and all test item concentrations.

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
Daphnia magna Straus, Clone V, was used as the test organism. The animals are continuously bred in the laboratory and were originally purchased in a healthy condition from the Federal Environment Agency in Berlin/Germany.
Daphnia magna was bred as single culture (1 daphnid per 100 mL) in Elendt M4 medium. The pH- value of the aerated water was within a range of 6.0 – 9.0. The dissolved oxygen was above 60 % saturation and the total hardness 140 - 250 mg/L (as CaCO3), corresponding to 7.8 - 14°dH. The animals were fed with single cell green algae (Desmodesmus subspicatus, formerly Scenedesmus subspicatus) at least three times a week.
The daphnids were reared at a temperature of 20 ± 2 °C in a climatic chamber with 16 hours of illumination and 8 hours of darkness. The medium was changed three times per week. A pipette was used to separate the young daphnids from the adults.
Freshly hatched daphnids less than 24 hours old were used for the test.

Study design

Test type:
semi-static
Water media type:
freshwater
Total exposure duration:
48 h
Remarks on exposure duration:
Endpoints reported are the EC50 and the NOEC after 24 and 48 hours

Test conditions

Hardness:
The total hardness (as CaCO3) of the untreated control was determined to be 12°dH (214 mg/L CaCO3)
Test temperature:
19.7 – 21.0 °C
pH:
7.76 – 8.15
Dissolved oxygen:
The dissolved oxygen concentration at the end of the test should be 3 mg/L in all test units. In this test, the dissolved oxygen concentration at the end of the test was 8.6 mg/L.
Details on test conditions:
A stock solution (1300 mg/L, purity not considered), and a dilution (4 mg/L) was prepared in methanol. The stock solution was used for fortification of 13 mg/L recovery samples, the dilution was used for fortification of 0.07 mg/L recovery samples.

Results and discussion

Effect concentrationsopen allclose all
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
ca. 2.68 mg/L
Nominal / measured:
nominal
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
ca. 0.427 mg/L
Nominal / measured:
nominal
Details on results:
According to the results of the test, the EC50 (48 h) for immobilisation was determined to be
2.68 mg/L (nominal) corresponding to 1.93 mg/L (actual). The corresponding NOEC (48 h) was 0.427 mg/L (nominal) corresponding to 0.307 mg/L (actual).

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
According to the results of the test, the EC50 (48 h) was determined to be 2.68 mg/L (nominal) corresponding to 1.93 mg/L (actual). The corresponding NOEC (48 h) was 0.427 mg/L (nominal) corresponding to 0.307 mg/L (actual).