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:
06.08.2018 - 06.09.2018
Reliability:
1 (reliable without restriction)

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Version / remarks:
13 April 2004
GLP compliance:
yes (incl. QA statement)

Test material

Test material form:
solid: particulate/powder

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
Photometric analysis of the test item concentration in the test solutions was performed to
determine exposure concentration and stability of the test item during the test. One analytic sample
of ca. 10 mL was taken from each of the two additional vessels without daphndis of treatment A, C,
E and NC at the start of the experiment and after 24 h and 48 h. The samples were filled into 15
mL falcons and stored in the fridge (5°C ± 3°C) until measurement.
One analytic sample of the treatments A, C, E and NC from 0, 24 and 48 h was analyzed within ≤ 7
d after sampling. The storage stability of the analytical samples was verified over a period of 7 d
(Validation Study No. 1363, Hydrotox GmbH). The remaining samples were stored as retain
samples in the fridge (5 °C ± 3 °C) until finalization of the study.

Test solutions

Vehicle:
yes
Details on test solutions:
five nominal test item concentrations of 25 – 400 mg/L active substance were used.

Test organisms

Test organisms (species):
other: Daphnia magna Strauss
Details on test organisms:
The test organism Daphnia magna Straus originates from the clone breeding of the Federal
Environment Agency, department IV 2.4, Berlin, and has been cultivated at Hydrotox GmbH since
October 2012. The daphnids are cultured at 20 ± 2 °C with 16 h light : 8 h dark and placed into
fresh Elendt M4 medium twice a week. They are kept at approx. 10 animals / 200 mL and fed on
workdays with Desmodesmus subspicatus algae corresponding to 0.1 mg C × daphnid-1 × day-1.
The test organisms used were 0.5 – 24 h old at the start of the test.

Study design

Test type:
static
Limit test:
no
Total exposure duration:
48 h
Remarks on exposure duration:
The swimming capability of the daphnids was assessed after 24 h and 48 h exposure.

Test conditions

Test temperature:
20.4 – 21.1 °C
pH:
8.7
Dissolved oxygen:
7.8 mg/L
Conductivity:
678 μS/cm
Details on test conditions:
• The pH was 7.2 – 8.2 in the control and 7.4 – 8.2 in the test item treatments (recommended: 6 –
9; Table 3).
• The dissolved oxygen concentration was 8.4 – 8.4 mg/L in the control and 8.3 – 8.5 mg/L in the
test item treatment (required: ≥ 3 mg/L; Table 3).
• The temperature during the exposure was 20.4 – 21.1 °C (required: 18 – 22 °C, constant within
± 1 °C).

Results and discussion

Effect concentrationsopen allclose all
Key result
Duration:
24 h
Dose descriptor:
LOEC
Effect conc.:
> 400 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
LOEC
Effect conc.:
> 400 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mobility
Key result
Duration:
24 h
Dose descriptor:
NOEC
Effect conc.:
>= 400 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
>= 400 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mobility

Any other information on results incl. tables

Overview Immobility

Tab. 4: Overview Immobility: Overview over the effects on immobility in Daphnia magna at 48 h

Treatm.[mg/L]       Total Introduced       Mobile       Immobile       % Immobility

Control                         20                     20              0                     0,0

25,00                             20                     20              0                     0,0

50,00                              20                     20              0                     0,0

100,00                            20                     20              0                     0,0

200,00                            20                     20              0                     0,0

400,00                            20                     19              1                     5,0

 

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
Immobility
LOEC >400,00
NOEC >=400,00