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Long-term toxicity to aquatic invertebrates

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Reference
Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Oct 2019 - Feb 2020
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 211 (Daphnia magna Reproduction Test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 0.63, 1.3, 2.5, 5.0 and 10 mg/L.
- Sampling method: Test solution samples were collected from one replicate test chamber of each treatment and control group two and one days prior to the start of exposure to confirm concentrations after conditioning the diluter system for three and four days, respectively. Samples of the stock solutions being delivered to the test system were collected for analysis on Day -2. Test solution samples also were collected from one replicate test chamber in each treatment and control group at the beginning of the test, approximately weekly during the test, and at the end of the test to measure concentrations of the test substance. Samples (8.00 mL) were collected from mid-depth, placed in glass vials containing 2.00 mL of acetonitrile and processed immediately for analysis.

Vehicle:
no
Test organisms (species):
Daphnia magna
Details on test organisms:
Name: Cladoceran (Daphnia magna)
Source: Eurofins - Easton cultures
Easton, Maryland 21601
Age: Neonates (< 24 hours old at initiation)
Test type:
flow-through
Water media type:
freshwater
Limit test:
no
Total exposure duration:
21 d
Hardness:
128-140 (mg/L as CaCO3)
Test temperature:
19.1 – 19.9°C
pH:
7.8 – 8.2
Dissolved oxygen:
≥90%; no aeration
Conductivity:
308-337 (μS/cm)
Nominal and measured concentrations:
Nominal Mean Measured
Negative Control < LOQ
0.63 mg a.i./L 0.60 mg a.i./L
1.3 mg a.i./L 1.1 mg a.i./L
2.5 mg a.i./L 2.1 mg a.i./L
5.0 mg a.i./L 4.7 mg a.i./L
10 mg a.i./L 10 mg a.i./L
Details on test conditions:
TEST SYSTEM
- Test vessel:continuous-flow diluter used to deliver each concentration of the test substance and a negative control (dilution water) to test vessels.
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: Test chambers were 7-L glass aquaria filled with approximately 6.5 L of test water. Test compartments were 300 mL glass beakers, approximately 6.5 cm in diameter and 12 cm in height. Nylon mesh screens covered two holes on opposite sides of each test compartment to permit test solution to flow in and out of the compartment. The depth of the test water in a representative compartment was 8.8 cm, while the depth of water in a representative test chamber was 15.2 cm.
- Aeration: no
- Type of flow-through (e.g. peristaltic or proportional diluter): proportional diluter
- Renewal rate of test solution (frequency/flow rate):The appropriate amount of the 100 mg a.i./L stock was injected into the diluter mixing chambers
assigned to treatment groups at target rates of 1.13, 2.34, 4.5, 9.0 and 18 mL/minute where they were mixed with dilution water delivered at rates of 199, 197, 195, 190 and 162 mL/minute to achieve the desired test concentrations. The negative control received dilution water only at a rate of 200 mL/min.
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- No. of vessels per vehicle control (replicates): no
- Biomass loading rate: NA

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:The water used for culturing and testing was freshwater obtained from a well approximately 40 meters deep located on the Eurofins-Easton site. The well water was passed through a sand filter to remove particles greater than approximately 25 m and pumped into a 37,800-L storage tank where the water was aerated with spray nozzles. Prior to use, the water was filtered to 0.45 micron to remove fine
particles and was passed through an ultraviolet (UV) sterilizer. The well water is characterized as moderately-hard water.
- Total organic carbon:<2 (mg C/L)
- Particulate matter:
- Metals: Appendix 5 in the report
- Pesticides: Appendix 5 in the report
- Chlorine: 3.9 mg/L
- Alkalinity:170 mg/L as CaCO3
- Ca/mg ratio: 125 (mg/L as CaCO3)
- Conductivity: 310 (μS/cm)
- Culture medium different from test medium:
- Intervals of water quality measurement: 4-Week Period

OTHER TEST CONDITIONS
- Adjustment of pH: No, the pH of the well water is 8
- Photoperiod:16 hours of light and 8 hours of darkness. A 30-minute transition period of low light intensity was provided when lights went on and off to avoid sudden changes in lighting.
- Light intensity: 872 lux at the surface of the water

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :

TEST CONCENTRATIONS
- Spacing factor for test concentrations: x2
- Justification for using less concentrations than requested by guideline: no
- Range finding study
- Test concentrations: 0.63, 1.3, 2.5, 5.0 and 10 mg a.i./L.
- Results used to determine the conditions for the definitive study:
Nominal Day 14 Mean Number of
Concentration Adult Survival (%) Young Produced Per
(mg a.i./L) (Observations) Reproductive Day

Negative Control 100 (10 AN) 13.3
0.16 100 (10 AN) 12.4
0.63 100 (10 AN) 11.6
2.5 100 (10 AN) 13.9
10 100 (10 AN) 12.8

Reference substance (positive control):
no
Key result
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
10 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Key result
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
10 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
reproduction
Key result
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
10 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality: Total number living offspring produced at the end of the test per parent daphnia at the start of the test excluding from the analysis parental accidental and/or inadvertent mortality {TG 211}
Key result
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
10 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
growth
Details on results:
- Behavioural abnormalities:
- Observations on body length and weight:
Mean Measured Concentration(mg a.i./L) Mean Total Length ± Std. Dev.(mm) Mean Dry Weight ± Std. Dev.(mg)
Negative Control 4.65 ± 0.059 1.26 ± 0.144
0.60 4.61 ± 0.028 1.17 ± 0.045
1.1 4.60 ± 0.103 1.10 ± 0.067
2.1 4.60 ± 0.016 1.15 ± 0.026
4.7 4.62 ± 0.032 1.09 ± 0.030
10 4.58 ± 0.045 1.03 ± 0.036
- Other biological observations:
- Mortality of control: survival in the negative control 95%
- Other adverse effects control: no
- Immobilisation of control:
- Abnormal responses:
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values:
- Effect concentrations exceeding solubility of substance in test medium:
Validity criteria fulfilled:
yes
Conclusions:
The cladoceran, Daphnia magna, was exposed to FR-513 at mean measured concentrations ranging from 0.60 to 10 mg/L under flow-through conditions for 21 days. There were no statistically significant treatment-related effects on survival, reproduction or growth at concentrations ≤ 10 mg/L in comparison the negative control. Consequently, the NOEC was determined to be 10 mg/L, and the LOEC was determined to be > 10 mg/L.
Executive summary:

The cladoceran, Daphnia magna, was exposed to FR-513 at mean measured concentrations ranging from 0.60 to 10 mg/L under flow-through conditions for 21 days. There were no statistically significant treatment-related effects on survival, reproduction or growth at concentrations ≤ 10 mg/L in comparison the negative control. Consequently, the NOEC was determined to be 10 mg/L, and the LOEC was determined to be > 10 mg/L.

Description of key information

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
10 mg/L

Additional information