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Ecotoxicological information

Short-term toxicity to aquatic invertebrates

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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:
2016-09-30 to 2016-10-11
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
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: • Guidance document on aquatic toxicity testing of difficult items and mixtures, OECD series on testing and assessment number 23, December 14, 2000
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: I16AB0081
- Expiration date of the lot/batch: 2018-01-11 (retest date)
- Purity test date: 2016-02-18 (certificate of analysis release date)
- Purity: 99.3% (chromatographic purity by GC)

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
- Stability under test conditions: not indicated
- Solubility and stability of the test substance in the solvent/vehicle: <0.01 g/L in water
Analytical monitoring:
yes
Details on sampling:
- Sampling method: samples for possible analysis were taken form all test concentrations and the control at t=0 and t=48h. 2.0 mL of volume was taken. At the end of the exposure period, the replicates were pooled at each concentration before sampling
- Sample storage conditions before analysis: the samples were stored in a freezer. Additionally, reserve samples of 2.0 mL were taken for possible analysis
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Preparation of test solutions started with a loading rate of 100 mg/L applying a three-day period of magnetic stirring to ensure maximum dissolution of the test item in test medium. The resulting aqueous mixture was filtered through a 0.45 µm membrane filter (Whatman; RC55) to remove the undissolved fraction of the test item. The filter was pre-conditioned with a small volume of test solution that was discarded. The obtained Saturated Solution (SS) was used as the highest test concentration. The lower test concentrations were prepared by subsequent dilutions of the SS in test medium.
- Evidence of undissolved material (e.g. precipitate, surface film, etc): All final test solutions were clear and colourless
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Water-flea
- Source: in-house laboratory culture with a known history
- Age at study initiation (mean and range, SD): <24h (from parental daphnids of more than 2 weeks old)
- Method of breeding: 250 newborn daphnids (i.e. less than 3 days old) are placed into 5 litres of medium in an all-glass culture vessel. Medium is M7. After 7 days of cultivation half of the medium is renewed twice a week.
- Feeding during test: no

ACCLIMATION
- Acclimation period: max. 4 weeks
- Acclimation conditions (same as test or not): yes
- Type and amount of food: fresh water algae.
- Feeding frequency: daily
- Health during acclimation (any mortality observed): no
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Hardness:
180 mg/L as CaCO3
Test temperature:
20°C
pH:
At t= 0h: 8.0-8.2
At t= 48h: 8.2-8.3
Dissolved oxygen:
At t= 0h: 8.9-9.1
At t= 48h: 9.2
Salinity:
not relevant
Nominal and measured concentrations:
Combined limit/range-finding test
Nominal concentrations: Solutions containing 1.0, 10 and 100% of a SS prepared at 100 mg/L
Nominal concentration analysed: 0 and 100 % of saturated solution
Measured concentrations (mg/L) at t=0h: n.d., 0.822
Measured concentrations (mg/L) at t=48h: n.d., 0.793
The geometric mean measured concentration during the test in the 100% SS at a loading rate of 100 mg/L was 0.82 mg/L.
n.d. = not detected
Details on test conditions:
TEST SYSTEM
- Test vessel: beaker
- Material, size, headspace, fill volume: 100 mL, glass beaker filled with 80mL
- Aeration: not during the test
- Type of flow-through (e.g. peristaltic or proportional diluter): no flow-through
- Renewal rate of test solution (frequency/flow rate):no renewal, static system
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

OTHER TEST CONDITIONS
- Photoperiod: 16h light daily

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Immobility was defined as those organisms which are not able to swim within 15 seconds after gentle agitation of the test container and was monitored after 24 and 48 hours of continuous treatment with the test substance.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: x10
- Range finding study
- Test concentrations: 1.0 and 10 and 100% of a SS prepared at a loading rate of 100 mg/L
- Results used to determine the conditions for the definitive study: yes
Reference substance (positive control):
yes
Remarks:
Potassium Dichromate
Key result
Duration:
48 h
Dose descriptor:
EL50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: 100% v/v saturated solution, equivalent to a loading rate of 100 mg/L
Details on results:
- Mortality of control: none
- Other adverse effects control: no
- Abnormal responses: none
- No adverse effects were observed at the limit loading rate of 100 mg/L (apart from 2/20 daphnids immobilised after 48 h, which was not considered to be significantly different from the control).
- The geometric mean measured concentration during the test in the 100% saturated solution with loading rate of 100 mg/L was 0.82 mg/L.
Results with reference substance (positive control):
- Results with reference substance valid? yes
- EC50/LC50: 48h-EC50 = 0.39 mg/L. the sensitivity of the daphnia was within the range determined with the historical data collected at WIL Research Europe.
Reported statistics and error estimates:
The 24 and 48h-EC50 could not be calculated as the test item was not toxic at the concentrations tested (EC50 > maximum soluble concentration).
Validity criteria fulfilled:
yes
Conclusions:
The acute toxicity of T000625 to Daphnia magna was determined in a 48-hour static combined range finder-limit test according to the OECD guideline 202.
Under the conditions of the present study, the 48h-EC50 was beyond the maximal loading rate tested, i.e. the EL50 was > 100 mg/L. No significant adverse effects were observed at this limit loading rate. The geometric mean measured concentration at this loading rate was 0.82 mg/L (i.e. the maximum soluble fraction in a saturated solution prepared at a loading rate of 100 mg/L). The results of the test can be considered reliable without restriction.

Description of key information

The study of Migchielsen (2017), investigating the acute toxicity of T000625 in Daphnia magna in a combined range finder-limit test according to OECD guideline 202, was considered as the key study for endpoint coverage. Since no significant adverse effects were observed at the limit loading rate of 100 mg/L, the EL50 was > 100 mg/L.

The geometric mean measured concentration at this loading rate was 0.82 mg/L (i.e. the maximum soluble fraction in a saturated solution prepared at a loading rate of 100 mg/L). Based on the results it can be concluded that T000625 is not harmful to aquatic invertebrates.

Key value for chemical safety assessment

Additional information