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Ecotoxicological information

Short-term toxicity to aquatic invertebrates

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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:
20 September to 12 October 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Kyoeisha; Bx 7080101
- Expiration date of the lot/batch: 01 Aug 2019
- Purity test date: 01 aug 2017

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Stability under test conditions: Stable
- Solubility and stability of the test substance in the solvent/vehicle:
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: none
- Preliminary purification step (if any):
- Final dilution of a dissolved solid, stock liquid or gel:
- Final preparation of a solid:

Analytical monitoring:
yes
Details on sampling:
- Concentrations:
- Sampling method: 50 mL test samples from each replicate were withdrawn and mixed together for each group at 0 and 48 h. The samples were divided into two equal portions. One portion (100 mL) was sent for test concentration analysis and the second portion (100 mL) was stored at -20 ± 5 ºC until study completion. Active ingredient concentration in water was determined using a validated analytical method
- Sample storage conditions before analysis:
Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method:
- Eluate:
- Differential loading: 1.81
- Controls: Yes
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): none
- Concentration of vehicle in test medium (stock solution and final test solution(s) or suspension(s) including control(s)):
- Evidence of undissolved material (e.g. precipitate, surface film, etc.):
- Other relevant information:
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: daphnia
- Strain/clone:
- Age at study initiation (mean and range, SD): less than 24h
- Stage and instar at study initiation: 2nd instar
- Method of breeding: no data
- Source:
- Age of parental stock (mean and range, SD): < 24h
- Feeding during test No
- Food type:
- Amount:
- Frequency:

ACCLIMATION
- Acclimation period: 48h
- Acclimation conditions (same as test or not):
- Type and amount of food: live algal cells
- Feeding frequency:
- Health during acclimation (any mortality observed):

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
no data
Test temperature:
20 ± 1 °C
pH:
no data
Dissolved oxygen:
no data
Salinity:
N/A
Conductivity:
no dats
Nominal and measured concentrations:
0.9, 1.7, 3.1 and 5.5 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: Glass beaker 600mL
- Type (delete if not applicable): open / closed no data
- Material, size, headspace, fill volume:
- Volume of solution: 100mL
- Aeration: none
- Type of flow-through (e.g. peristaltic or proportional diluter):
- Renewal rate of test solution (frequency/flow rate):
- No. of organisms per vessel: 20
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- No. of vessels per vehicle control (replicates): 4
- Biomass loading rate:

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: in-house
- Total organic carbon:
- Particulate matter:
- Metals:
- Pesticides:
- Chlorine:
- Alkalinity:
- Ca/mg ratio:
- Conductivity:
- Salinity:
- Culture medium different from test medium:
- Intervals of water quality measurement:

OTHER TEST CONDITIONS
- Adjustment of pH:
- Photoperiod: 16h light: 8h dark.
- Light intensity: 1320 to 1340 Lux.

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :

VEHICLE CONTROL PERFORMED: yes/no

RANGE-FINDING STUDY
- Test concentrations:
- Results used to determine the conditions for the definitive study:
Reference substance (positive control):
yes
Remarks:
Potassium dichromate
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
0.523 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
LOEC
Effect conc.:
0.235 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
LOEC
Effect conc.:
0.235 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
- Behavioural abnormalities:
- Observations on body length and weight: not applicable
- Other biological observations: none
- Mortality of control: none
- Other adverse effects control: none
- Immobilisation of control: Immobilisation of the control was 0%
- Abnormal responses:
- 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:
Results with reference substance (positive control):
- Results with reference substance valid? Yes
- Relevant effect levels:
- Limit test: no
- Dose-response test:
- ECx: EC50 0.43 mg/l
- Other:
Validity criteria fulfilled:
yes
Conclusions:
The EC50 was found to be 0.523 mg/L.

Description of key information

The EC50 was found to be 0.523 mg/L.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
0.523 mg/L

Additional information