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Ecotoxicological information

Short-term toxicity to aquatic invertebrates

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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:
11 July 2006 to 21 July 2006
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:
2004
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
the Swiss GLP Monitoring Authorities (issued Nov 2005)
Specific details on test material used for the study:
- Solubility in water: 1100 mg/L, pH 3.88
- Storage: In the refrigerator at about 4 °C, under nitrogen
Analytical monitoring:
yes
Details on sampling:
- Sampling method: Just before the start of the test, duplicate samples (10 mL) were taken from each test concentration in medium (without daphnids), and the control (without daphnids). After 48 hours, duplicate samples were taken from each test concentration and from the control. For the 48-hour stability samples, the contents of the respective replicates were combined prior to sampling.
- Concentrations: Nominal concentrations of 10 to 100 mg/L from both sampling times (0 and 48 hours). The samples of the lowest test concentration of 4.6 mg/L were not analyzed since this concentration was below the 48-hour NOEC determined in this test. From the control only one of the duplicate samples was analyzed at each of the sampling times.
- Sample storage conditions before analysis: All samples were deep-frozen (at about -20 °C) and protected from light immediately after sampling. Based on pre-experiments for investigation of the storage stability (without GLP), the test item was found to be stable in the test water under these storage conditions.
Vehicle:
no
Details on test solutions:
The test medium of the highest nominal concentration of 100 mg/L was prepared by dissolving 50.1 mg of test item completely in 500 mL of test water using ultrasonic treatment for 15 minutes and intense stirring for 3 hours at room temperature in the dark. Adequate volumes of this test medium were diluted with test water to prepare the test media with the lower test item concentrations. The test media were prepared just before introduction of the daphnids (i.e., start of the test).

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Strain/clone: Daphnia magna STRAUS 'clone 5' (as defined by supplier)
- Source: Originally supplied by the University of Sheffield/UK in 1992. Since that time, the clone has been bred in the laboratories of RCC in reconstituted water of the quality identical to the water quality used in the tests (in respect to pH, main ions, and total hardness) and under temperature and light conditions identical to those of the tests (see below).
- Age: <24 hours (and not first brood progeny)
- Feeding during test: no
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
250 mg/L as CaCO3
Test temperature:
20 °C
pH:
- Start: 7.8
- End: 7.7 - 7.9
Dissolved oxygen:
- Start: 8.6 - 8.8 mg/L
- End: 8.5 - 8.7 mg/L
Nominal and measured concentrations:
- Nominal concentrations: 0 (control), 4.6, 10, 22, 46, and 100 mg/L
- Measured concentrations: n.a., 5.5, 15, 34, and 83 mg/L (mean measured test concentrations calculated as the geometric mean over all measurements per test concentration and corrected for % mean recovery of fortified QC samples).

- Test item recovery: The measured test item concentrations at the start of the test ranged from 75 to 90% of the nominal values (after correction for % mean recovery of fortified QC samples). At the end of the test (t=48h) 41 to 76% of the nominal values were found. The losses may be due to adsorption of the test item onto glass surfaces. The mean measured test concentrations varied in the range of 55 to 83% of the nominal values. The reported biological results are based on the mean measured test item concentrations.
Details on test conditions:
TEST SYSTEM
- Test vessel: 100 mL glass beakers filled with 50 mL of test solution and covered with glass plates.
- Aeration: The test water was aerated prior to the start of the study until oxygen saturation was reached. During the test period, the test water was not aerated.
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- Biomass loading rate: 1 da /10 mL of test solution.

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: According to guideline
- Water quality criteria: At the start and at the end of the test, the pH values, the dissolved oxygen concentrations, and the water temperature were determined in each test concentration and the control. The appearance of the test media was visually recorded at the start of the test and after 24 and 48 hours.

OTHER TEST CONDITIONS
- Adjustment of pH: not reported (assumed 'no')
- Photoperiod: 16-hour light to 8-hour dark
- Light intensity: between approximately 470 and 640 Lux

EFFECT PARAMETERS MEASURED
Immobility after 24 and 48 hours exposure.

RANGE-FINDING STUDY
- Test concentrations: not reported
- Results used to determine the conditions for the definitive study: yes
Reference substance (positive control):
yes
Remarks:
potassium dichromate (September 2005)
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
28 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: 95% CI: 23 - 34 mg/L
Details on results:
- Immobility: No immobility of the test organisms was observed up to and including the test item concentration of 5.5 mg/L (mean measured concentration). At the test concentration of 15 mg/L one test organism was found to be immobile at observations after 24 and 48 hours. This low immobilization rate was estimated as a significant toxic effect, because at the next higher test concentration of 34 mg/L, 65% and 70% of the daphnids were found to be immobile at the observations after 24 and 48 hours, respectively. At the highest test concentration of 83 mg/L, the immobility rate increased to 90% and 100% at the observations after 24 and 48 hours, respectively.
- Mortality of control: no
- Other adverse effects control: no
- Effect concentrations exceeding solubility of substance in test medium: No. The test media containing nominal concentrations of up to and including 46 mg/L were clear solutions throughout the entire test duration. At the highest concentration of 100 mg/L the test medium was very slightly turbid and colored during the whole test.
Results with reference substance (positive control):
- Results with reference substance valid? yes
- Relevant effect levels: 48-hour EC50: 0.81 mg/L
- Other: Results shows that the toxic performance was valid and within the historical range of the test laboratory (from 1996 to 2005: 48-hour EC50: 0.53-1.1 mg/L)).
Reported statistics and error estimates:
The 24-hour and 48-hour EC50 and the 95% confidence limits were calculated by Probit Analysis.

Table: Effect of test item on the mobility of Daphnia magna

Nominal test item concentration (mg/L)

Mean measured test item concentration (mg/L)

Immobilized daphnids after 24 hours (20 daphnids tested)

Immobilized daphnids after 48 hours (20 daphnids tested)

No.

%

No.

%

Control

-

0

0

0

0

4.6

n.a.

0

0

0

0

10

5.5

0

0

0

0

22

15

1

5

1

5

46

34

13

65

14

70

100

83

18

90

20

100

Validity criteria fulfilled:
yes
Remarks:
no immobility/mortalities in the control and O2 > 3 mg/L throughout the entired test period
Conclusions:
The 48-h EC50 is 28 mg/L in Daphnia magna.
Executive summary:

The acute toxicity of the test item to Daphnia magna was examined in a study according to OECD TG 202, and in compliance with GLP critera.

Groups of 20 daphnids (4 replicates of 5 animals) were exposed to nominal test substance concentrations of 0 (control), 4.6, 10, 22, 46, and 100 mg/L for 48 hours under static conditions. Test substance analysis was performed for the nominal concentrations of 10 to 100 mg/L at the start (t=0h) and at the end of exposure (t=48h). The lowest test concentration of 4.6 mg/L was not analyzed since this concentration was below the 48-hour NOEC determined in this test.

Mean measured concentrations, calculated as the geometric mean over all measurements per test concentration and corrected for % mean recovery of fortified QC samples (94%), were determined to be n.a. (in the control), 5.5, 15, 34, and 83 mg/L. As some of the measured test concentrations were found to be outside 80 -120% of nominal at test start and all of the measured concentrations at test end, results are expressed as mean measured concentrations.

No immobility of the test organisms was observed up to and including the test item concentration of 5.5 mg/L (mean measured concentration). At the mean measured test concentration of 15 mg/L one test organism was found to be immobile at observations after 24 and 48 hours. This low immobilization rate was estimated as a significant toxic effect, because at the next higher mean measured test concentration of 34 mg/L, 65% and 70% of the daphnids were found to be immobile at the observations after 24 and 48 hours, respectively. At the highest mean measured test concentration of 83 mg/L, the immobility rate increased to 90% and 100% at the observations after 24 and 48 hours, respectively.

Based on these findings, the 48 -h EC50 value was determined to be 28 mg/L (95% CI: 23 - 34 mg/L), based on mean measured concentrations.

Description of key information

The acute toxicity of the test item to Daphnia magna was examined in a study according to OECD TG 202, and in compliance with GLP critera.

Groups of 20 daphnids (4 replicates of 5 animals) were exposed to nominal test substance concentrations of 0 (control), 4.6, 10, 22, 46, and 100 mg/L for 48 hours under static conditions. Test substance analysis was performed for the nominal concentrations of 10 to 100 mg/L at the start (t=0h) and at the end of exposure (t=48h). The lowest test concentration of 4.6 mg/L was not analyzed since this concentration was below the 48-hour NOEC determined in this test.

Mean measured concentrations, calculated as the geometric mean over all measurements per test concentration and corrected for % mean recovery of fortified QC samples (94%), were determined to be n.a. (in the control), 5.5, 15, 34, and 83 mg/L. As some of the measured test concentrations were found to be outside 80 -120% of nominal at test start and all of the measured concentrations at test end, results are expressed as mean measured concentrations.

No immobility of the test organisms was observed up to and including the test item concentration of 5.5 mg/L (mean measured concentration). At the mean measured test concentration of 15 mg/L one test organism was found to be immobile at observations after 24 and 48 hours. This low immobilization rate was estimated as a significant toxic effect, because at the next higher mean measured test concentration of 34 mg/L, 65% and 70% of the daphnids were found to be immobile at the observations after 24 and 48 hours, respectively. At the highest mean measured test concentration of 83 mg/L, the immobility rate increased to 90% and 100% at the observations after 24 and 48 hours, respectively.

Based on these findings, the 48 -h EC50 value was determined to be 28 mg/L (95% CI: 23 - 34 mg/L), based on mean measured concentrations.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
28 mg/L

Additional information