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Ecotoxicological information

Short-term toxicity to aquatic invertebrates

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Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 10, 2015 - March 13, 2015
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)
Version / remarks:
13 April 2004
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Version / remarks:
2008
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
no
Remarks:
The test item concentration in the reconstituted water was not quantified at the start and the end of this study. Because of the low water solubility (< 1 mg/L), the compound cannot be detected with standard analytical methods.
Vehicle:
yes
Remarks:
reconstituted water
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- The test medium (reconstituted water and test item) was prepared freshly. Therefore, the calibrated tlask with test medium was treated in an ultrasonic device for 1 hour. Subsequently, the preparation was stirred with a magnetic stirrer for further 23 hours. Afterwards, the forrnulation was passed through a membrane filter with a pore size of 0.2 μm. The filtrate was used for the study.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Water flea
- Strain/clone: Daphnia magna Straus
- Source: IBACON GmbH (Roßdorf, Germany)
- Age of parental stock (mean and range, SD): Parental animals were used until they were about 6 weeks old.
- Feeding during test: no

ACCLIMATION
- Acclimation period:To avoid an acclimation phase before start of the study, reconstituted water was used during culture as weil as during the study.
- Acclimation conditions (same as test or not): same as test
- Type and amount of food: ad libitum with unicellular green algae Desmodesmus subspicatus
- Feeding frequency: three times per week

METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES:
Before start of the experimental phase, the young daphnids were separated from their different parent animals and put into a collective test vessel containing reconstituted water. The daphnids were visually inspected for motility. If daphnids did not make any swimming movements within 15 seconds after their test vessels have been gently agitated, they were considered to be immobile and were not used for the study. At the start of the experimental phase the daphnids were cautiously removed using a pipette, separated from the reconstituted water using a finemesh sieve, and placed into the test vessels containing test media (test item group) or reconstituted water (control group).
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Hardness:
about 250 mg/L CaCO3
Test temperature:
21.1 - 21.8°C
pH:
7.70 - 7.73
Dissolved oxygen:
8.07 - 8.16 O2 mg/L
Salinity:
NA
Nominal and measured concentrations:
100 mg/L (nominal)
Details on test conditions:
TEST SYSTEM
- Test vessel: glass vessels
- Type: open
- Material, size, headspace, fill volume: glass, fill volume: 20 mL
- Aeration: no
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per vehicle control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
According to ELENDT M4 medium. After preparation the reconstituted water was aerated for 24 hours. Hardness: about 2.5 mmol/L (about 250 mg/L CaC03), pH: 7.9 ± 0.3, after an aeration of 24 hours.

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours light and 8 hours dark
- Light intensity: 667 - 668 Lux

EFFECT PARAMETERS MEASURED: mobility after 24 and 48 hours

VEHICLE CONTROL PERFORMED: yes

Reference substance (positive control):
no
Remarks:
No positive control used in this study. The accuracy and reliability of the test method is demonstrated periodically as recommended by guidelines with potassium dichromate.
Key result
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other:
Remarks:
EC50 > maximum solubility
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other:
Remarks:
EC50 > maximum solubility
Details on results:
- Mortality of control: no
- Other adverse effects control: no
Validity criteria fulfilled:
yes
Conclusions:
Under the conditions of the present study, an aqueous solution of nominal 100 mg/L of revealed no aquatic toxicity in the test system. The 48h EC50 exceeded the maximum solubility (nominal > 100 mg/L) and, thus, could not be determined in this study.
Executive summary:

The objective of this study was to evaluate the influence of the test item on the immobilization of Daphnia magna.

For this purpose, juvenile daphnids were exposed to a nominal test item concentration of 100 mg/L (limit test) over 48 hours, in an open static system. The daphnids were observed for immobilization 24 and 48 hours after placing in the aqueous test item solution. The study comprised of one test item group with four test vessels containing five daphnids each, i.e. 20 daphnids in total. Additionally, one control group (20 daphnids) was used.

The test item concentration in the reconstituted water was not quantified at the start and the end of this study. Because of the low water solubility (< 1 mg/L), the compound cannot be detected with standard analytical methods and the development of an analytical method with a sufficiently low detection and quantification limit is not justified.

Due to the absence of any adverse effects at the saturation concentration, the study was performed without analytical concentration verification.

Daphnids exposed to an aqueous preparation of a nominal concentration of 100 mg/L of the test item were not affected.

The following EC50 values for daphnids were determined:

24h EC50: > maximum solubility (nominal> 100 mg/L)

48h EC50: > maximum solubility (nominal > 100 mg/L)

The 48h EC50 exceeded the maximum solubility (nominal > 100 mg/L) and, thus, could not be determined in this study.

Description of key information

Under the conditions of the present study, an aqueous solution of nominal 100 mg/L of revealed no aquatic toxicity in the test system. The 48h EC50 exceeded the maximum solubility (nominal > 100 mg/L) and, thus, could not be determined in this study.

Key value for chemical safety assessment

Additional information

The objective of this study was to evaluate the influence of the test item on the immobilization of Daphnia magna.

For this purpose, juvenile daphnids were exposed to a nominal test item concentration of 100 mg/L (limit test) over 48 hours, in an open static system. The daphnids were observed for immobilization 24 and 48 hours after placing in the aqueous test item solution. The study comprised of one test item group with four test vessels containing five daphnids each, i.e. 20 daphnids in total. Additionally, one control group (20 daphnids) was used.

The test item concentration in the reconstituted water was not quantified at the start and the end of this study. Because of the low water solubility (< 1 mg/L), the compound cannot be detected with standard analytical methods and the development of an analytical method with a sufficiently low detection and quantification limit is not justified.

Due to the absence of any adverse effects at the saturation concentration, the study was performed without analytical concentration verification.

Daphnids exposed to an aqueous preparation of a nominal concentration of 100 mg/L of the test item were not affected.

The following EC50 values for daphnids were determined:

24h EC50: > maximum solubility (nominal> 100 mg/L)

48h EC50: > maximum solubility (nominal > 100 mg/L)

The 48h EC50 exceeded the maximum solubility (nominal > 100 mg/L) and, thus, could not be determined in this study.