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Diss Factsheets

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
- Concentrations:

0, 5, 10, 20, 40, 80 mg/l nominal.

- Sampling method:

The samples were filled into 2 mL glass vials.

- Sample storage conditions before analysis:

To each vial, 0.25 mL acetonitrile was added and samples were stored in the freezer at ≤ -18 °C. Of each sampled treatment, one of the analytical samples from 0 h, 24 h and 48 h was sent to the
analytical laboratory for chemical analysis using an insulated box with thermal packs. The remaining samples were stored as retain samples in the freezer (≤ -18 °C) until finalisation of the study.
Vehicle:
yes
Details on test solutions:
The test was performed with Elendt M4 medium according to OECD 202 (2004).
Test organisms (species):
Daphnia magna
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 1h 10 min - 23 h 40 min old at the start of the test.
Quality assurance takes place at regular intervals by testing the sensitivity of the test organisms to the reference item potassium dichromate (Honeywell Speciality Chemicals Seelze GmbH, Seelze, Germany; Lot no.: H1030). The recent quality testing was performed in November 2021 (GLP 1663) with EC50 (24h) = 2.02 mg/L which is in the declared range of 0.6 – 2.1 mg/L (24 h) according to OECD 202.
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Test temperature:
20.9-21.7
pH:
7.6-7.8 in control
7-7.6 in treatment
Dissolved oxygen:
7.8-8 mg/l in control
7.7-8.1 mg/l in treatment
Nominal and measured concentrations:
Nominal test item concentration [mg/L] : 0 (negative control), 5, 10, 20, 40, 80
The measured test item concentrations in the test item treatments were 89.5 – 105.0 % of the nominal loading rates
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
21.9 mg/L
95% CI:
>= 15.6 - <= 31.2
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC10
Effect conc.:
5 mg/L
95% CI:
>= 2 - <= 8
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
5 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
LOEC
Effect conc.:
10 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
75.4 mg/L
95% CI:
>= 51.4 - <= 166.6
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
EC10
Effect conc.:
19.3 mg/L
95% CI:
>= 8.9 - <= 28.1
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
NOEC
Effect conc.:
10 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
LOEC
Effect conc.:
20 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Validity criteria fulfilled:
yes
Remarks:
Immobilisation of the test organisms in the control at the end of the test was 0 (desired ≤ 10 %). Dissolved oxygen concentration in the control and the test item treatments at the end of the test ≥ 7.7 mg/L (Desired >=3 mg/l).
Conclusions:
A static acute immobilisation test with Daphnia magna according to OECD 202 (13 April 2004) was
conducted in order to investigate the effects of the test item on daphnids.

The substance is considered as difficult to test due to the surface activity (surface tension is 30.7
mN/m at 20 °C, EU method A.5) and adsorptive properties (according ECHA Decision on
Compliance Check).

According to OECD 202 and ECHA requirements with reference to OECD 23 for difficult to test
substances, evidence of stability of exposure concentrations must be provided.
The pre-test results (non-GLP) showed stable exposure concentrations throughout the test
duration within 80 -120% of the nominal concentrations in the substance-specific analysis and a
dose-response relationship was evident. For these reasons, no modification of the test method was
necessary for this test substance. To demonstrate the stability of the exposure concentration
during the test period, each test concentration was measured analytically at each measurement
time point. Thus, the ECHA requirements for difficult-to-test substances were fulfilled.

As the measured test item concentrations are within ± 20 % of the nominal concentrations,
according to OECD 202 (2004), all results are given in relation to the nominal test item
concentrations.

EC 50 (24h/48 h): 75.4/21.9 mg/l
LOEC (24h/48 h): 20/10 mg/l

Description of key information

A static acute immobilisation test with Daphnia magna according to OECD 202 (13 April 2004) was
conducted in order to investigate the effects of the test item on daphnids.


The substance is considered as difficult to test due to the surface activity (surface tension is 30.7
mN/m at 20 °C, EU method A.5) and adsorptive properties (according ECHA Decision on
Compliance Check).


According to OECD 202 and ECHA requirements with reference to OECD 23 for difficult to test
substances, evidence of stability of exposure concentrations must be provided.
The pre-test results (non-GLP) showed stable exposure concentrations throughout the test
duration within 80 -120% of the nominal concentrations in the substance-specific analysis and a
dose-response relationship was evident. For these reasons, no modification of the test method was
necessary for this test substance. To demonstrate the stability of the exposure concentration
during the test period, each test concentration was measured analytically at each measurement
time point. Thus, the ECHA requirements for difficult-to-test substances were fulfilled.


As the measured test item concentrations are within ± 20 % of the nominal concentrations,
according to OECD 202 (2004), all results are given in relation to the nominal test item
concentrations.


EC 50 (24h/48 h): 75.4/21.9 mg/l
LOEC (24h/48 h): 20/10 mg/l


This result is in excellent agreement with the QSAR (Model ECOSAR) prediction.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Dose descriptor:
EC50
Effect concentration:
21.9 mg/L

Additional information