Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
The stability of test concentration/s during exposure was checked by chemical analysis (DOC) at 0 and 48 hours according to the semi-static conditions.
Vehicle:
no
Details on test solutions:
Pre-treatment of test item and preparation of test item concentrations
To produce the only test concentration 105.5 mg/L (on 2010-06-07) and 105.2 mg/L (on 2010-06-08) of the test item were added each to 1 litre of dilution water and treated for 24 h on a magnetic stirrer. Finally undissolved particles of the test item were removed by filtration using aseptic filters of pore size 0.45 + 0.2 μm (sartobran 150 sterile capsule). The pH was measured to be pH 8.0 on 2010-06-08 and pH 7.9 on 2010-06-09.
19 mL of the solution were taken and diluted with 1 mL dilution water containing 10 daphnids resulting in a final nominal concentration of 100 mg/L. For each test item concentration and control 2 replicates were prepared.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISMS:
- Source: Strain of Bundesgesundheitsamt Berlin
- Maintenance and Acclimatisation:
A population of parthenogenetic females of synchronized age structure has been maintained for more than 15 years in the test facility under constant temperature conditions (20 +/- 1 °C) at a 16 : 8 hou r light-dark photoperiod (illumination: < 1000 lux). The culture water (so-called 'M4 medium') was partly renewed once a week. The Daphnia were exclusively fed with unicellular green algae (Desmodesmus subspicatus) 'ad libitum'. Mortalities of parent Daphnia during the culture period were recorded daily in a semiquantitative way. The neonates were separated from their parent Daphnia by filtration prior to the acute test.
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Hardness:
15.3 °dH (= 273.1 mg/L CaCO3)
Test temperature:
21.3 °C after 24 hrs
pH:
8.1 after 24 hrs
Dissolved oxygen:
9.4 Oxygen ([mg/l) after 24 hrs
Nominal and measured concentrations:
Effective concentrations (100 mg/l) were below the detection limit of the DOC determination (< 2 mg/L) at 0 and 24 hours according to the semi-static conditions
Details on test conditions:
RANGE FINDING TEST:
- direct weighing of the test substance
- 105.5 mg of test item were added to 1 l of dilution water
- treated for 24 h on a magnetic stirrer
- filtration of undissolved particles by using aseptic filters, pore size 0.45+0.2 µm (sartoban 150 sterile capsule)
- 19 mL of the solution diluted with 1 mL dilution water containing 10 daphnids resulting in a final nominal concentration of 100 mg/L
- test concentrations (nominal): 2 (10, 100 mg/l)
- pH: 8.0

PRETREATMENT:
- direct weighing of the test substance
- 105.2 mg of test item were added to 1 l of dilution water
- treated for 24 h on a magnetic stirrer
- filtration of undissolved particles by using aseptic filters, pore size 0.45+0.2 µm (sartoban 150 sterile capsule)
- 19 mL of the solution diluted with 1 mL dilution water containing 10 daphnids resulting in a final nominal concentration of 100 mg/L
- pH: 7.9

TEST SYSTEM:
- water for maintenance and dilution: M4 medium, originally described in Water Research 24 (9), Sept. 1990; 1157-1167
- temperature of incubation unit: 20-21 °C
- photoperiod: 16 hours light, 8 hours dark (ilumination < 1000 lux)
- test vessel: 50 ml glass beakers, 20 ml test medium
- number of daphnids per beaker: 10 daphnids (neonates)
- no feeding during the exposure period
- test parameter: item-induced alteration of the normal mobility behaviour and the loss of locomotory actions of the neonates
- test concentrations (nominal): 1 (100 mg/l) plus 1 control
- replicates: 2

Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
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:
No toxic effects against daphnia were observed at a limit test concentration of 100 mg/L. The results are expressed in terms of nominal concentrations at 24 h and 48 h. Effective concentrations were below the detection limit of the DOC determination (< 2 mg/L) at 0 and 24 hours according to the semi-static conditions, respectively.
Validity criteria fulfilled:
yes
Remarks:
The fluctuation of the temperature during the test was 1.1 °C and only slightly higher than the proposed range of ±1 °C. This is not regarded to be relevant to the results.
Conclusions:
In a semi-static test an EC50 of > 100 mg/l after 48 h was obtained for the test item against daphnia magna. The result is expressed in terms of nominal concentrations. No toxic effects against fish were observed at a limit test concentration of 100 mg/L under exposure conditions.
Executive summary:

The study was conducted in accordance with EEC Methods for Determination of Ecotoxicity Annex to Directive 92/69/EEC, Part C which is in most parts equivalent to the OECD Guideline No. 202. The Daphnia were exposed to a limit test concentration of nominally 100 mg/L dissolved in water. Observations were made on the swimming ability and the immobilisation rate, respectively, after 24 and 48 hours of exposure. No toxic effects on mortality against Daphnia were observed after 48 h. The results are expressed in terms of nominal concentrations. Effective concentrations were below the detection limit of the DOC determination (< 2 mg/L) at 0 and 24 hours according to the semi-static conditions, respectively.

Description of key information

In a semi-static test  an EC50 of > 100 mg/L after 48 h was obtained for the substance against daphnia magna. The result is expressed in terms of nominal concentrations. No toxic effects against fish were observed at a limit test concentration of 100 mg/L under exposure conditions. 

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
100 mg/L

Additional information

"Should read: > 100 mg/L"

Concerning the toxicity towards aquatic invertebrates, a study was conducted in accordance with EEC Methods for Determination of Ecotoxicity Annex to Directive 92/69/EEC, Part C which is in most parts equivalent to the OECD Guideline No. 202. The Daphnia were exposed to a limit test concentration of nominally 100 mg/L dissolved in water under semi-static conditions. Observations were made on the swimming ability and the immobilisation rate, respectively, after 24 and 48 hours of exposure. No toxic effects on mortality against Daphnia were observed after 48 h. The results are expressed in terms of nominal concentrations. Effective concentrations were below the detection limit of the DOC determination (< 2 mg/L) at 0 and 24 hours according to the semi-static conditions, respectively.

The test item is insoluble or only poorly soluble in water. A suitable selective and sensitive chromatographical method for the determination of the test item in aqueous solutions could not be established. Therefore an accompanying analysis by means of a chromatographical method could not be performed. The quantification of the test item was performed by DOC determination.