Registration Dossier

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:
1 - 3 August 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reason / purpose:
reference to other study
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Version / remarks:
(2004)
Deviations:
yes
Remarks:
The test was only performed with pH adjustment of test medium, which is a deviation from the OECD guideline. However, the ECHA guidance (R.7b) recommends a pH adjustment if it does not lie within the specified range for the test.
Qualifier:
according to
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Version / remarks:
(2008)
Deviations:
yes
Remarks:
The test was only performed with pH adjustment of test medium, which is a deviation from the OECD guideline. However, the ECHA guidance (R.7b) recommends a pH adjustment if it does not lie within the specified range for the test.
Qualifier:
according to
Guideline:
other: ISO International Standard 6341: "Water quality - Determination of the inhibition of the mobility of Daphnia magna Straus - Acute toxicity test, Third edition (1996)
Deviations:
yes
Remarks:
The test was only performed with pH adjustment of test medium, which is a deviation from the OECD guideline. However, the ECHA guidance (R.7b) recommends a pH adjustment if it does not lie within the specified range for the test.
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 0 (blank control) and 100 mg/L were analyzed.
- Frequency: at t=0 h and t=48 h
- Volume: 4.5 ml from the approximate centre of the test vessels
- Storage: Samples were stored in a freezer until analysis. In the analytical report it was confirmed that samples were stable when stored in the freezer (see IUCLID Chapter 8 for all details).
Vehicle:
no
Details on test solutions:
- Method: Preparation of test solutions started with a nominal concentration of 100 mg/L applying a 6-minute treatment period with ultrasonic waves to accelerate the dissolving of the test substance in the test medium. The pH of this concentration was adjusted from 3.7 to 6.5 using 1N NaOH. The lower test concentrations were prepared by subsequent dilutions of the 100 mg/L concentration in test medium. FDCA was completely soluble in test medium at the concentrations tested.
- Controls: Test medium without test substance or other additives
- Evidence of undissolved material (e.g. precipitate, surface film, etc): The final test solutions were all clear and colourless.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISMS
- Common name: Water flea
- Source: In-house laboratory culture with a known history.
- Age at study initiation: <24 h
- Feeding during test: None

BREEDING
- Method: Daphnids used were at least third generation, obtained by acyclical parthenogenesis under specified breeding conditions. Each batch started with newborn daphnids (i.e. less than 3 days old) and the maximum age of the cultures was 4 weeks.
- Medium: M7 (Elendt, B.-P., 1990: Selenium deficiency in Crustacea. An ultrastructural approach to antennal damage in Daphnia magna Straus. Protoplasma 154, 25-33).
- Conditions (same as the test or not): yes
- Feeding: Daily with a suspension of fresh water algae.
- Health during acclimation (any mortality observed): Daphnids originated from a healthy stock, 2nd to 5th brood, showing no signs of stress such as mortality >20%, presence of males, ephippia or discoloured animals and there was no delay in the production of the first brood.
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
Approximately 180 mg CaCO3/L
Test temperature:
Start of the test: 20.4°C.
During the test: 20.0 - 20.8°C
pH:
Blank control: 8.0
0.1 mg/L: 8.0
1.0 mg/L: 8.0
10 mg/L: 7.8 - 8.0
100 mg/L: 6.5 - 7.6
Dissolved oxygen:
9.0 - 9.6 mg/L
Nominal and measured concentrations:
Nominal concentrations (combined limit/range-finding test): 0 (blank control), 0.1, 1.0, 10 and 100 mg/L
Measured concentrations
0 h: 0* (blank control) and 99 mg/L (100 mg/L)
48 h: 0* (blank control) and 100 mg/L (100 mg/L)

*) In the chromatograms, a small peak was observed at the retention time of FDCA. This response was due to carry-over
from a previous injection. FDCA was therefore not considered to be present in the nominal 0 mg/L samples.
Details on test conditions:
TEST SYSTEM
- Test vessel: all glass with 100 mL capacity containing 80 mL of test solution.
- Aeration: None
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4 for the highest test concentration and 2 for the lower test concentrations
- No. of vessels per control (replicates): 4
- Loading: 5 daphnids per 80 mL of test solution

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: tap water purified by reverse osmosis
- Culture medium used during the breeding period different from test medium: Yes (M7 medium prepared from adjusted ISO medium)
- Test medium: adjusted ISO medium
- Intervals of water quality measurement: pH was measured at the beginning and at the end of the test for the control and all test concentrations. Dissolved oxygen was measured at the beginning and at the end of the test for the highest test concentration and the control. Temperature was measured continuously in a temperature control vessel.

OTHER TEST CONDITIONS
- Adjustment of pH: Yes (pH of the highest test concentration was adjusted from 3.7 to 6.5 using 1N NaOH)
- Photoperiod: 16 h light : 8 h dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Immobility (including mortality) at 24 and 48 h.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: x10
Reference substance (positive control):
yes
Remarks:
Potassium dichromate
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
Details on results:
- Measured concentrations: Analysis of the samples taken from the highest test concentration showed that the actual concentration was in agreement with nominal at the start of the test (99%) and remained stable during the test period (100% of nominal at the end of the test). Given these results, effect parameters were based on nominal concentrations.
- Biological results: After 48 hours of exposure no immobilisation of daphnids was observed at any of the test concentration and the control.

- Acceptability of the test:
1. In the control, no daphnids became immobilised;
2. The oxygen concentration at the end of the test was ≥ 3 mg/L in control and test vessels.
Results with reference substance (positive control):
- Potassium dichromat: 48h-EC50 was 0.41 mg/L (95% confidence interval between 0.36 and 0.46 mg/L). Test was performed in September 2011.
Validity criteria fulfilled:
yes
Conclusions:
FDCA did not induce acute immobilisation of Daphnia magna at 100 mg/L after 48 hours of exposure. Hence, the 48h-EC50 was >100 mg/L.
Executive summary:

In a 48-h acute toxicity study conducted according to OECD guideline 202, water fleas (Daphia magna) were exposed to FDCA under static conditions at the following nominal concentrations: 0 (blank control), 0.1, 1.0, 10, and 100 mg/L. The test substance did not induce significant acute immobilisation of Daphnia magna. The 48h-EC50 was >100 mg/L based on analytically confirmed nominal exposure concentrations. The test was only performed with pH adjustment of test medium, which is a deviation from the OECD guideline. However, the ECHA guidance (R.7b) recommends a pH adjustment if it does not lie within the specified range for the test and it is assumed that the pH adjustment does not lead to removal of the substance. Therefore, it is concluded that the pH adjustment does not influence the reliability of the study.

Description of key information

In a 48-h acute toxicity study conducted according to OECD guideline 202, water fleas (Daphia magna) were exposed to FDCA. The test substance did not induce significant acute immobilisation of Daphnia magna. The 48h-EC50 was >100 mg/L based on analytically confirmed nominal exposure concentrations. The study is considered to be reliable without restrictions.

Key value for chemical safety assessment

EC50/LC50 for freshwater invertebrates:
100 mg/L

Additional information

In a 48-h acute toxicity study conducted according to OECD guideline 202, water fleas (Daphia magna) were exposed to FDCA under static conditions at the following nominal concentrations: 0 (blank control), 0.1, 1.0, 10, and 100 mg/L. The test substance did not induce significant acute immobilisation of Daphnia magna. The 48h-EC50 was >100 mg/L based on analytically confirmed nominal exposure concentrations. The test was only performed with pH adjustment of test medium, which is a deviation from the OECD guideline. However, the ECHA guidance (R.7b) recommends a pH adjustment if it does not lie within the specified range for the test and it is assumed that the pH adjustment does not lead to removal of the substance. Therefore, it is concluded that the pH adjustment does not influence the reliability of the study.