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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:
21 September 2017 - 01 March 2018
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:
not specified
Qualifier:
according to guideline
Guideline:
EU Method C.20 (Daphnia magna Reproduction Test)
Deviations:
not specified
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
Batch: 280PE310516
Purity: UVCB (treat as 100%)
Storage Conditions: Room temperature in the dark
Analytical monitoring:
yes
Details on sampling:
- Concentrations:
range-finding test: 1.0, 10 and 100 mg/L.
Definitive test: 0.056, 0.10, 0.18, 0.32 and 0.56 mg/L

- Sampling method: A sample of each test concentration was taken for chemical analysis on Days 0 and 3 in order to determine the stability of the test item under test conditions
- Sample storage: All samples were stored frozen prior to analysis.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Due to the low aqueous solubility and complex nature of the test item, for the purposes of the study the test medium was prepared as a Water Accommodated Fraction (WAF) of the test item.
- Controls: identical conditions but not exposed to the test item
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: daphnia magna
- Strain/clone: 1st instar
- Justification for species other than prescribed by test guideline: Daphnia magna is a freshwater invertebrate representative of a wide variety of natural habitats, and can therefore be considered as an important non-target organism in freshwater ecosystems.
- Source: in house cultures
- Age of parental stock (mean and range, SD): 24 hours
- Food type: fed daily with a mixture of algal suspension (Desmodesmus subspicatus) and Tetramin® flake food suspension

ACCLIMATION
- Acclimation period: 24 hours
- Acclimation conditions (same as test or not): same


Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
21 d
Remarks on exposure duration:
not specified
Post exposure observation period:
not specified
Hardness:
248 to 290 mg/L as CaCO3
Test temperature:
19°C - 21°C
pH:
7.7 - 8.0
Dissolved oxygen:
≥7.7 mg O2/L
Salinity:
not specified
Conductivity:
not specified
Nominal and measured concentrations:
nominal
Details on test conditions:
TEST SYSTEM
- Test vessel: 150 mL glass vessels
- Type (delete if not applicable): closed
- Aeration: not aerated
- Renewal rate of test solution (frequency/flow rate): three times per week on Days 0, 2, 5, 7, 9, 12, 14, 16 and 19
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): For each test and control group 10 replicate test vessels

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted Water – Elendt M7 Medium
- Culture medium different from test medium: same
- Intervals of water quality measurement: Measurements were made on one replicate for each test concentration, once per week

OTHER TEST CONDITIONS
- Photoperiod: 16 hours light and 8 hours darkness with 20 minute dawn and dusk transition periods for 21 days
- Light intensity: not exceeding 1500 Lux

TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 1.0, 10 and 100 mg/L., 0.010, 0.10 and 1.0 mg/L.
- Results used to determine the conditions for the definitive study: yes
Reference substance (positive control):
no
Key result
Duration:
21 d
Dose descriptor:
NOELR
Effect conc.:
ca. 0.1 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Key result
Duration:
21 d
Dose descriptor:
LOELR
Effect conc.:
ca. 0.18 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Key result
Duration:
21 d
Dose descriptor:
EL50
Effect conc.:
ca. 0.11 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
immobilisation
Key result
Duration:
21 d
Dose descriptor:
EL50
Effect conc.:
ca. 0.13 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Details on results:
- Behavioural abnormalities:
- Observations on body length and weight: length, no differences statistically
- Mortality of control: 0%
- Effect concentrations exceeding solubility of substance in test medium: no
Results with reference substance (positive control):
not specified
Reported statistics and error estimates:
95% confidence limits
Validity criteria fulfilled:
yes
Conclusions:
Exposure of Daphnia magna to the test item resulted in significant mortalities at the loading rates of 0.18, 0.32 and 0.56 mg/L resulting in 90%, 100% and 100% mortalities by Day 4.
The 21-Day EL50 (immobilization) value, based on nominal loading rates, for the parental daphnia generation (P1) was calculated to be 0.11 mg/L with 95% confidence limits of 0.080 – 0.15 mg/L.
The 21-Day EL50 (reproduction) based on nominal loading rates was 0.13 mg/L with 95% confidence limits of 0.096 – 0.15 mg/L.
The Lowest Observed Effect Loading Rate and the No Observed Effect Loading Rate based on nominal loading rates were 0.18 and 0.10 mg/L respectively.

Description of key information

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
0.1 mg/L

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