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Ecotoxicological information

Long-term toxicity to aquatic invertebrates

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Link to relevant study record(s)

Reference
Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 211 (Daphnia magna Reproduction Test)
Deviations:
not specified
GLP compliance:
no
Remarks:
Published study not conducted to GLP
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: not reported
- Stability under test conditions: stable (within 20 % of initial concentration after 3 days)
- Solubility and stability of the test substance in the solvent/vehicle: n/a
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: n/a

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: powder dissolved in ultrapure water at a rate of 15 mg/L.
- Preliminary purification step (if any): n/a
- Final dilution of a dissolved solid, stock liquid or gel: 15 mg/L
- Final preparation of a solid: n/a

FORM AS APPLIED IN THE TEST (if different from that of starting material): Applied as a dissolved liquid

OTHER SPECIFICS: n/a
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 0.11, 0.23, 0.45, 0.90 and 1.8 mg/L
- Sampling method: Test solution replaced 3 times per week- analysis conducted on initial and expired solutions. Details not reported.
- Sample storage conditions before analysis: Not reported
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Treatment solution prepared from an initial 15 mg/L stock solution.
- Eluate: Not reported
- Differential loading: 1 daphnid per 50 mL treatment solution
- Controls: dilution water
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): n/a
- Concentration of vehicle in test medium (stock solution and final test solution(s) or suspension(s) including control(s)): n/a
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): not reported
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Water flea
- Strain/clone: Daphnia magna Straus 1820 (Clone A)
- Justification for species other than prescribed by test guideline: n/a
- Source: ECT Oekotoxikologie, Flörsheim, Germany.
- Age of parental stock (mean and range, SD): not reported
- Feeding during test: yes
- Food type: D. subspicatus
- Amount: 0.15 mg C/female
- Frequency: daily

ACCLIMATION
- Acclimation period: not reported
- Acclimation conditions (same as test or not): 20 daphnids housed per 3 L aquaria containing 2.5 L Elendt M4 media, at 21 ± 1 ºC in a 16 h: 8 h light:dark photoperiod.
- Type and amount of food: D. subspicatus (0.13 mg/C daphnid) 4 times per week, Tetramin (20 mg blended in deionised water per aquarium) twice per week, dry yeast (5 µg blended in deionised water per aquarium).
- Health during acclimation (any mortality observed): not reported

QUARANTINE (wild caught)
- Duration: n/a
- Health/mortality: n/a

METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES: not reported
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
21 d
Hardness:
not reported
Test temperature:
Measured at solution change-overs
pH:
Measured at solution change-overs
Dissolved oxygen:
Measured at solution change-overs
Salinity:
not required
Conductivity:
not reported
Nominal and measured concentrations:
Nominal
Details on test conditions:
TEST SYSTEM
- Test vessel: 100 mL beaker
- Type (delete if not applicable): not reported
- Material, size, headspace, fill volume: Glass
- Aeration: No
- Type of flow-through (e.g. peristaltic or proportional diluter): N/A
- Renewal rate of test solution (frequency/flow rate): Changed 3 times per week
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10
- No. of vessels per vehicle control (replicates): n/a
- Biomass loading rate: 1 daphnid per vessel (50 mL)

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: in accordance with ISO 10706
- Total organic carbon: not reported
- Particulate matter: not reported
- Metals: not reported
- Pesticides: not reported
- Chlorine: not reported
- Alkalinity:not reported
- Ca/mg ratio: not reported
- Conductivity: not reported
- Culture medium different from test medium: not reported
- Intervals of water quality measurement: 3 times per week

OTHER TEST CONDITIONS
- Adjustment of pH: not reported
- Photoperiod: not reported
- Light intensity: not reported

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : immobility

TEST CONCENTRATIONS
- Spacing factor for test concentrations: n/a
- Justification for using less concentrations than requested by guideline: n/a
- Range finding study: no
- Test concentrations: n/a
- Results used to determine the conditions for the definitive study: n/a
Reference substance (positive control):
no
Key result
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
0.9 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Key result
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
0.23 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Key result
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
0.23 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
morphology
Remarks:
Body length
Key result
Duration:
21 d
Dose descriptor:
LOEC
Effect conc.:
1.8 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Key result
Duration:
21 d
Dose descriptor:
LOEC
Effect conc.:
0.45 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Key result
Duration:
21 d
Dose descriptor:
LOEC
Effect conc.:
0.45 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
morphology
Remarks:
Body length
Details on results:
- Behavioural abnormalities:
- Observations on body length and weight: Adverse effects observed. NOEC for body length was 0.23 mg/L.
- Other biological observations: not reported
- Mortality of control: not reported
- Other adverse effects control: not reported
- Abnormal responses: not reported
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no
- Effect concentrations exceeding solubility of substance in test medium: no
Results with reference substance (positive control):
n/a
Reported statistics and error estimates:
Values were calculated by non-linear regression model using GraphPad Prism (version 6.0). Results were analysed by one-way analysis of variance followed by Dunnett's test. p < 0.05 was considered as a statistically significant difference.
Validity criteria fulfilled:
not specified
Conclusions:
The 21 day No Observed Effect Concentration and Lowest Observed Effect Concentration for mortality were 0.90 and 1.80 mg/L, respectively.
The 21 day No Observed Effect Concentration and Lowest Observed Effect Concentration for reproduction, based on number of offspring, brood size, days to first brood and number of broods per female were 0.23 and 0.45 mg/L, respectively.
Executive summary:

The 21-day-chronic toxicity of Bisphenol AF to Daphnia magna was studied under semi-static conditions.  Daphnids were exposed to a control, and test chemical at nominal concentrations of 0.11, 0.23, 0.45, 0.90 and 1.8 mg/L.  The 21-day NOEC based on mortality was 0.90 mg/L.  The 21-day NOEC based on reproductivity was 0.23 mg/L.  Production of offsprings in the treated groups indicated that Bisphenol AF had an effect on the reproduction at concentrations greater than 0.23 mg/L.  The most sensitive end point was reproductivity (NOEC = 0.23 mg/L).


 


Results Synopsis


 


Test Organism Age: < 24 h old


Test Type: Semi-static


NOEC (mortality): 0.90 mg/L


NOEC (reproduction): 0.23 mg/L


 


Applicant's interpretation:


For the husbandry water fleas were kept in 3-L aquariums covered with glass plates (20 daphnids in 2.5 L of Elendt M4 medium) at 21 ± 1 °C in a 16 h light/8 h dark photoperiod. Water fleas were fed daily as follows: four times with green algae D. subspicatus (0.13 mg of C/daphnid), twice per week with Tetramin (20 mg blended in deionized water/aquarium) and once a week with dry yeast (5 mg blended in deionized water/aquarium).  Ten replicate vessels (50 mL medium/ medium-test-item) containing 1 daphnid each (Straus 1820 (Clone A)) was used at each concentration and the dilution water control.  During testing Daphnia were fed 0.15 mg of C/daphnid. Media was changed three times a week on Monday, Wednesday and Friday. The concentrations tested were 0.11, 0.23, 0.45, 0.90, 1.8 mg/L. The endpoints of 21 d chronic toxicity tests were survival of females, reproduction, i.e., cumulative number of living offspring per surviving female, the average brood size per female, the number of broods per female, days to first brood and body length.


During the test they assessed the stability of BPAF in the Daphnia medium (Elendt M4 medium) and showed it to be stable over 3 days.  After dosing, BPAF stayed at 90 % of nominal concentrations, therefore the use of nominal concentrations can be used in line with the guideline. This showed that dosing technique was appropriate as well as the stability of the test item in the test system.  Water quality parameters were meausred but not reported. Validity criterion for number of neonates per parent animal in the controls (> 60 per parent require) was met, however whether there was mortality in the controls or not was not reported. Despite this omision the study is well conducted and expected to be reliable.


 

Description of key information

NOEC (reproduction) = 0.23 mg/L, ISO 10706 (2000), Tišler et al., 2016

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Dose descriptor:
NOEC
Effect concentration:
0.23 mg/L

Additional information

In a single key study by Tisler et al., 2016, a suite of aquatic ecotoxicity tests were conducted to identify hazards to the aquatic environment and conduct a risk assessment using measured concentration of BPAF from the environment to determine a risk characterisation ratio (i.e. predicted exposure concentration (PEC)/predicted no effect concentration (PNEC). Firstly, a suite of low tier aquatic toxicity tests were conducted on V. fischeri (bacteria), Desmodesmus subspicatus (green algae), Daphnia magna (invertebrate) and Danio rerio (fish; common name zebrafish).  Based on there results they found daphnids to be the most sensitive trophic level and as such conducted a long-term test using Daphnia magna.

For the husbandry water fleas were kept in 3-L aquariums covered with glass plates (20 daphnids in 2.5 L of Elendt M4 medium) at 21 ± 1 °C in a 16 h light/8 h dark photoperiod. Water fleas were fed daily as follows: four times with green algae D. subspicatus (0.13 mg of C/daphnid), twice per week with Tetramin (20 mg blended in deionized water/aquarium) and once a week with dry yeast (5 mg blended in deionized water/aquarium).  Ten replicate vessels (50 mL medium/ medium-test-item) containing 1 daphnid each (Straus 1820 (Clone A)) was used at each concentration and the dilution water control.  During testing Daphnia were fed 0.15 mg of C/daphnid. Media was changed three times a week on Monday, Wednesday and Friday. The concentrations tested were 0.11, 0.23, 0.45, 0.90, 1.8 mg/L. The endpoints of 21 d chronic toxicity tests were survival of females, reproduction, i.e., cumulative number of living offspring per surviving female, the average brood size per female, the number of broods per female, days to first brood and body length.

During the test they assessed the stability of BPAF in the Daphnia medium (Elendt M4 medium) and showed it to be stable over 3 days.  After dosing, BPAF stayed at 90 % of nominal concentrations, therefore the use of nominal concentrations can be used in line with the guideline. This showed that dosing technique was appropriate as well as the stability of the test item in the test system.  Water quality parameters were meausred but not reported. Validity criterion for number of neonates per parent animal in the controls (> 60 per parent require) was me, however whether there was mortality in the controls or not was not. Despite this omision the study is well conducted and expected to be reliable.

The lowest NOEC for reproduction will be used in the chemical safety assessment. The NOEC was 0.23 mg/L.