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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
From Dec. 12, 2000 to Jan. 18, 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
no
GLP compliance:
yes
Analytical monitoring:
no
Remarks:
Considering the low aqueous solubility of the test substance (<1 mg/L), the test item concentration in medium was not verified analytically.
Details on sampling:
Considering the low aqueous solubility of the test substance (<1 mg/L), the test item concentration in medium was not verified analytically.
Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: To produce the limit test concentration of 1.1 mg/L of the test substance was added to 1 L of dilution water, then treated with an ultrasonic bath for 1 h and afterwards stirred for 24 h on a magnetic stirrer. Finally, undissolved particles of the test substance were removed by filtration.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Water flea
- Strain: Daphnia magna STRAUS, parthenogenetic females
- Source: Strain of Bundesgesundheitsamt Berlin
- The neonates are separated from their parent Daphnia by filtration prior to the acute test.

ACCLIMATION
- Acclimation period: Yes
- Acclimation conditions (same as test or not): Same
- Type and amount of food: unicellular green algae, ad libitum
- Health during acclimation (any mortality observed): No
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Post exposure observation period:
None
Hardness:
14.5 °dH (= 258.8 mg/L CaCO3).

Test temperature:
20 °C
pH:
7.7
Dissolved oxygen:
8.4 mg/L (Oxygen saturation, % - 94.8)
Salinity:
No data
Nominal and measured concentrations:
0, and 1 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: 50 mL glass beakers holding 10 neonates in 20 mL of test medium
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: Beaker, 50 mL, fill volume: 20 mL
- Aeration: None
- Renewal rate of test solution: No
- No. of organisms per vessel: 10 neonates/vessel
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2

TEST MEDIUM/WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted water (M4 medium)
- Culture medium different from test medium: No

OTHER TEST CONDITIONS
- Adjustment of pH: Yes
- Photoperiod: 16 h light/8 h dark
- Light intensity: illumination < 1000 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Test substance-induced alteration of the normal mobility behaviour and the loss of locomotory actions of the neonates, observed at 24 and 48 h.

TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 0, and 1 mg/L
Reference substance (positive control):
no
Duration:
48 h
Dose descriptor:
EC0
Effect conc.:
> 1 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
EC0
Effect conc.:
> 1 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
- Behavioural abnormalities: No changes
Considering the low aqueous solubility of the test substance (< 1 mg/L) no specific analysis was established.
Results with reference substance (positive control):
Not applicable
Reported statistics and error estimates:
No data

Table 1. Results

Immobilisation for Daphnia magna

(initial population: 20)

24 h

48 h

Absolute

0

0

Cumulative

0

0

Cumulative %

0

0

Validity criteria fulfilled:
yes
Conclusions:
Considering the low aqueous solubility of the test substance (<1 mg/L) no specific analysis was established. The 48 h EC0 value of the test substance was determined to be >1 mg/L.
Executive summary:

A study was performed to assess the acute toxicity of test substance to Daphnia magna Straus under static conditions. The study was conducted in accordance with EU method C.2 and OECD guideline 202 in compliance with GLP.

The Daphnia were exposed to a limit test substance concentration of nominally 1 mg/L.

The test was conducted using dissolved test material at maximum water solubility. Auxiliaries used to prepare the test media, i.e. for maximisation of the dissolved fraction, and removal of undissolved material, were an ultrasonic bath, a magnetic stirrer and folded filter.

Observations were made on the swimming ability and the immobilisation rate, respectively, after 24 and 48 h of exposure. The EC0 value at time intervals from 24-48 h was 1 mg/L.

The test result is expressed in terms of nominal concentration. Considering the low aqueous solubility of the test substance (< 1 mg/L) no specific analysis was established.

The hardness of the dilution water used was 14.5 °dH (= 258.8 mg/I CaCO3). Under the employed test conditions, the EC0 value at any time from 24 to 48 h was ≥1 mg/L. No immmobility and no sublethal effects were observed in any test daphnids at any point in time. Therefore, an EC50 cannot be established.

Description of key information

The EC0 value at any time from 24 to 48 h was ≥ 1 mg/L. No immobility and no sublethal effects were observed in any test daphnids at any point in time. Therefore, no EC50 can be established.

Key value for chemical safety assessment

Additional information

A study was performed to assess the acute toxicity of test substance to Daphnia magna Straus under static conditions. The study was conducted in accordance with EU method C.2 and OECD guideline 202 in compliance with GLP.

The Daphnia were exposed to a limit test substance concentration of nominally 1 mg/L.

The test was conducted using dissolved test material at maximum water solubility. Auxiliaries used to prepare the test media, i.e. for maximisation of the dissolved fraction, and removal of undissolved material, were an ultrasonic bath, a magnetic stirrer and folded filter.

Observations were made on the swimming ability and the immobilisation rate, respectively, after 24 and 48 h of exposure. The EC0 value at time intervals from 24-48 h was 1 mg/L.

The test result is expressed in terms of nominal concentration. Considering the low aqueous solubility of the test substance (< 1 mg/L) no specific analysis was established.

The hardness of the dilution water used was 14.5 °dH (= 258.8 mg/I CaCO3). Under the employed test conditions, the EC0 value at any time from 24 to 48 h was ≥1 mg/L. No immobility and no sublethal effects were observed in any test daphnids at any point in time. Therefore, an EC50 cannot be established.