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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
2003-09-03 to 2003-12-04
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)
Version / remarks:
adopted July 31st 1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Version / remarks:
adopted April 4th 1984
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
Samples were taken at the start and end of the experiment.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
A stock solution containing 1000 mg/L in dilution water was prepared. The stock solution then was used to prepare four concentrations in a geometric series, spaced by the factor 10.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: water flea
- Strain/clone: Straus
- Age at study initiation: between 0 and 24 hours
- Source: Umweltbundesamt Berlin
- Feeding during test: no

ACCLIMATION
Test animals were bred under similar (or the same) conditions as that used during the exposure period (holding water, temperature, background colour etc.), therefore additional acclimatization before the test was not necessary.
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Hardness:
250 mg/L
Test temperature:
20 +/- 2 °C (with one exception: +1 °C)
pH:
7.8 ± 0.2
Dissolved oxygen:
> 95 %
Salinity:
not applicable
Conductivity:
251 µS/cm
Nominal and measured concentrations:
Nominal conc.: 1000 mg/L
Measured concentration: recovery of more than 100 % of nominal
Details on test conditions:
TEST SYSTEM
- Test vessel: glass beaker (50 mL)
- Aeration: No.
- No. of organisms per vessel: 5
- No. of vessels per concentration: 4
- No. of vessels per control: 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: drinking water withe enriching minerals
- Culture medium different from test medium: no

OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 hours light and 8 hours darkness

EFFECT PARAMETERS MEASURED: immobilisation at 24 and 48 h

RANGE-FINDING STUDY
- Test concentrations: 1000, 100, 10 and 1 mg/L
- Results used to determine the conditions for the definitive study: yes
Reference substance (positive control):
yes
Remarks:
potassium dichromate
Duration:
48 h
Dose descriptor:
EC100
Effect conc.:
> 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
- Behavioural abnormalities: no test item related effects observed.
- Observations on body length and weight: no
- Other biological observations: no
- Mortality of control: no mortality was detected in the control.
- Other adverse effects control: no
- Abnormal responses: no
- Any observations that might cause a difference between measured and nominal values: none
- Effect concentrations exceeding solubility of substance in test medium: no
Results with reference substance (positive control):
- Results with reference substance valid? Yes
- Relevant effect levels: 24 h EC50i = 1.5 mg/L
- Limit test: no
- Dose-response test: yes
- EC50i: 1.5 mg/L

VALIDITY


 - The 24 h EC50 EC of K2Cr2O7 should lie between 0.6 and 2.4 mg/L. The 24 h EC50i of K2Cr2O7 was determined as 1.5 mg/L.


 - Immobilization in the blanks may not exceed 10 %. Immobilization in the blanks was 0 %.


 - The concentration of dissolved oxygen at the end of the test must be at least 60 % of the saturation value. The lowest concentration of dissolved oxygen at the end of the test was 7.5 mg/L. 100 % saturation equals 9.05 mg/L at 20 °C, giving 83 % oxygen saturation for the value measured.


 


ANALYTICAL DETERMINATIONS


The analytical determination of the test item in the test solution showed a very good recovery after 48 hours. The recovery of more than 100 % was probably caused by evaporation effects. The test item can be considered as stable under the test conditions.







































Nom. Conc.


in mg/L



Area resp. Conc. in mg/L



% recovery after 48 h



0 h



48 h



 



Area



Conc.



Area



Conc:



 



0



0



0



0



0





1000



2.301



1031.38



2.434



1090.99



105.78



 


RESULTS




































Parameter



Value



95 % confidence interval



NOEL 24 h



1000 mg/L



n.d.



24 h EC50i



> 1000 mg/L



n.d.



24 h EC100i



> 1000 mq/L



n.d.



NOEL 48 h



1000 mg/L



n.d.



48 h EC50i



> 1000 mg/L



n.d.



 

Validity criteria fulfilled:
yes
Conclusions:
Under the given experimental conditions, the 48 hours EC50 to Daphnia magna was determined to be > 1000 mg/L and the NOEC was determined to be 1000 mg/L.
Executive summary:

The aquatic toxicity of the test item was assessed using Daphnia magna in a 48 h Acute Immobilisation Test according to OECD TG 202 and under GLP conditions. For this purpose, young Daphnia were exposed to aqueous test media containing the test item for 48 hours. Based on results obtained in a non-GLP preliminary experiment Daphnia were exposed to a single concentration of 1000 mg/L (limit concentration). Potassium dichromate served as the reference control. A static test was performed as the test item was previously shown to be stable in the test medium. The purpose of the analytical part of this study was to verify the concentration of the test item in the test medium. The actual concentration of the test item in the treatment was determined before and after the test. The test item was determined to be stable under the test conditions. Therefore the nominal concentration was used to estimate the results. Healthy, young daphnids with known origin, history and acclimatization conditions were used. The test item and the control were tested using 20 daphnids (divided into 4 concurrent subgroups) each. Each test vessel contained approximately 40 mL test medium. The immobilisation of the test animals was recorded 24 and 48 h after treatment. Environmental conditions were recorded. All measured values remained within acceptable ranges. All validity criteria were met and therefore the study was considered as valid. The 48 h NOEC was determined to be 1000 mg/L and the EC50 value were determined to be > 1000 mg/L.

Description of key information

Under the given experimental conditions, the 48 hours EC50 to Daphnia magna was determined to be > 1000 mg/L and the NOEC was determined to be 1000 mg/L (reference 6.1.3-1).

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
1 000 mg/L

Additional information

The aquatic toxicity of the test item was assessed using Daphnia magna in a 48 h Acute Immobilisation Test according to OECD TG 202 and under GLP conditions. For this purpose, young Daphnia were exposed to aqueous test media containing the test item for 48 hours. Based on results obtained in a non-GLP preliminary experiment Daphnia were exposed to a single concentration of 1000 mg/L (limit concentration). Potassium dichromate served as the reference control. A static test was performed as the test item was previously shown to be stable in the test medium. The purpose of the analytical part of this study was to verify the concentration of the test item in the test medium. The actual concentration of the test item in the treatment was determined before and after the test. The test item was determined to be stable under the test conditions. Therefore the nominal concentration was used to estimate the results. Healthy, young daphnids with known origin, history and acclimatization conditions were used. The test item and the control were tested using 20 daphnids (divided into 4 concurrent subgroups) each. Each test vessel contained approximately 40 mL test medium. The immobilisation of the test animals was recorded 24 and 48 h after treatment. Environmental conditions were recorded. All measured values remained within acceptable ranges. All validity criteria were met and therefore the study was considered as valid. The 48 h NOEC was determined to be 1000 mg/L and the EC50 value were determined to be > 1000 mg/L.