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Short-term toxicity to fish

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Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
29 April - 3 May 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reason / purpose:
reference to other study
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
(1992)
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.1 (Acute Toxicity for Fish)
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:
ISO 7346-1 (Determination of the Acute Lethal Toxicity of Substances to a Freshwater Fish [Brachydanio rerio Hamilton-Buchanan (Teleostei, Cyprinidae)] - Part 1: Static Method)
Version / remarks:
(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, t=24h and t=96 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:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Preparation of test solutions started with a nominal concentration of 100 mg/L applying an 18-minute treatment period with ultrasonic waves followed by a 42-minute period of magnetic stirring. This was followed by a second treatment period (11 minutes) with ultrasonic waves to accelerate the dissolving of the test substance in the test medium. The pH of the resulting solution was adjusted from 3.5 to 6.5 using NaOH.
- Control: Test medium without test substance or other additives
- Evidence of undissolved material (e.g. precipitate, surface film, etc): The final test solution was clear and colourless
Test organisms (species):
Cyprinus carpio
Details on test organisms:
TEST ORGANISM
- Common name: Carp
- Source: Zodiac, proefacc, "De Haar Vissen", Wageningen University and Research Centre, the Netherlands
- Length at study initiation (mean and SD): 2.6±0.1 cm
- Weight at study initiation (mean and SD): 0.46±0.10 g
- Feeding during test: None

ACCLIMATION
- Acclimation period: At least 12 days after delivery
- Acclimation conditions (same as test or not): Yes
- Feeding frequency and type of food: Daily with pelleted fish food
- Health during acclimation (any mortality observed): In the batch of fish used for the test, mortality during the seven days prior to the start of the test was less than 5%.
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
180 mg CaCO3 per litre
Test temperature:
20.9 - 22.1 °C
pH:
Blank control: 7.4 - 7.8
100 mg/L: 6.5 - 7.3
Dissolved oxygen:
Blank control: 6.5 - 9.5 mg O2/L
100 mg/L: 5.7 - 8.9 mg O2/L
Nominal and measured concentrations:
- Nominal: 0 (blank control) and 100 mg/L
- Measured
0 h: not detected (blank control) and 96.5 mg/L
24 h: not detected (blank control) and 97.5 mg/L
96 h: not detected (blank control) and 90.3 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: 10 litres, all-glass, containing 9 litres of test solution
- Aeration: Aeration was introduced after 72 hours of exposure and was maintained until the end of the test.
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.36 g fish per litre

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: tap-water purified by reverse osmosis
- Culture medium different from test medium: No (adjusted ISO medium)
- Intervals of water quality measurement (dissolved oxygen content, pH and temperature): Daily in all vessels, beginning at the start of the test (day 0)

OTHER TEST CONDITIONS
- Adjustment of pH: yes (using NaOH)
- Photoperiod: 16 h light: 8 h dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Mortality and other effects were assessed at 2, 22, 48, 72 and 96 h following the start of exposure. In addition, every afternoon from day 0 and every morning from day 1 to observe for any dead or severely distressed fish.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: Limit test (100 mg/L)
- Range finding study: Not performed
Reference substance (positive control):
yes
Remarks:
Pentachlorophenol
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- Measured concentrations: Analysis of the samples taken from the limit concentration showed that the actual test concentration was in agreement with nominal at the start of the test (96% of nominal) and remained stable during the test period (94% of initial at the end of the test). Therefore, the effect parameters were expressed in terms of the analytically confirmed nominal concentration.

- Biological results: No mortality or other clinical effects were observed in both the control and the limit concentration during the test period.
At the start of the test fishes were not acclimated to the pH of the limit concentration, because the difference between the pH of the culture medium and the test solution was >0.5 unit. Nonetheless, no effects were observed on the fish exposed to the limit concentration and therefore it is concluded that the test was not influenced by this difference in pH.

- Acceptability of the test:
1. No mortality was observed in the control at the end of the test.
2. Test conditions were maintained constant throughout the test.
3. The dissolved oxygen concentration has been at least 60% of the air saturation value throughout the test (>5 mg/L at 22°C).
4. The concentration of the substance tested has been at least 80% of the nominal concentration throughout the test.
Results with reference substance (positive control):
Pentachlorophenol: 96h-LC50 for carp was 0.17 mg/L (95% confidence interval between 0.15 and 0.27 mg/L). Test was performed in January 2013.
Validity criteria fulfilled:
yes
Conclusions:
FDCA induced no visible effects in carp at 100 mg/L. Hence, the 96h-LC50 was >100 mg/L.
Executive summary:

In a 96-h acute toxicity study conducted according to OECD guideline 203, carp (Cyprinus carpio) were exposed to FDCA under static conditions at the following nominal concentrations (limit test): 0 (blank control) and 100 mg/L. Test substance induced no visible or lethal effects in carp at a nominal exposure concentration of 100 mg/L. The 96h-LC50 was >100 mg/L based on analytically confirmed nominal 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 96-h acute toxicity study conducted according to OECD guideline 203, carp (Cyprinus carpio) were exposed to FDCA. Test substance induced no visible or lethal effects in carp at a nominal exposure concentration of 100 mg/L. The 96h-LC50 was >100 mg/L based on analytically confirmed nominal concentrations. The study is considered to be reliable without restrictions.

Key value for chemical safety assessment

LC50 for freshwater fish:
100 mg/L

Additional information

In a 96-h acute toxicity study conducted according to OECD guideline 203, carp (Cyprinus carpio) were exposed to FDCA under static conditions at the following nominal concentrations (limit test): 0 (blank control) and 100 mg/L. Test substance induced no visible or lethal effects in carp at a nominal exposure concentration of 100 mg/L. The 96h-LC50 was >100 mg/L based on analytically confirmed nominal 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.