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Diss Factsheets

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2018-03-02 to 2018-05-01
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guidelineopen allclose all
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
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
(2S,3S)-3-(ethoxycarbonyl)bicyclo[2.2.2]octan-2-aminium chloride
Cas Number:
1626394-43-1
Molecular formula:
C11H19NO2.HCl
IUPAC Name:
(2S,3S)-3-(ethoxycarbonyl)bicyclo[2.2.2]octan-2-aminium chloride
Test material form:
solid: particulate/powder
Details on test material:
- Physical state: powder
- Appearance: white powder
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:M16HD2757
- Expiration date of the lot/batch: 2018-07-04 (retest date)
- Purity test date: 2016-12-21 (certificate of analysis release date)

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: 62-140 g/L in water

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Sampling method: Samples for possible analysis were taken from all test concentrations and the control at t=0 and t=48h. 4.0 mL of volume was taken from the approximate centre of the test vessels. 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 4.0 mL were taken for possible analysis.

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Preparation of test solutions started with the highest test concentration of 100 mg/L. No other treatment than vigorous shaking was needed to completely dissolve the test item in medium. The lower test concentrations were prepared by subsequent dilutions of the highest test concentration in test medium.
- Evidence of undissolved material (e.g. precipitate, surface film, etc): All final test solutions were clear and colourless

Test organisms

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): < 24 h (from parental daphnids of more than 2 weeks old, maximum age 4 weeks)
- Method of breeding: 250 newborn daphnids (i.e. less than 3 days old) are placed into 5 liters 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 cultivation: fresh water algae, daily
- Feeding during test: no

Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h

Test conditions

Hardness:
180 mg/L as CaCO3
Test temperature:
20-21°C
pH:
At t=0h: 7.8
At t=48h: 8.4 - 8.7
Dissolved oxygen:
At t=0h: 8.9 - 9.0
At t=48h: 8.4 - 8.7
Salinity:
not relevant
Nominal and measured concentrations:
Combined limit/range-finding test:
Nominal concentrations (mg/L): 0, 0.1, 1, 10, 100
Final test (full test):
Nominal concentrations (mg/L): 0, 10, 18, 32, 56, 100
Measured concentrations (mg/L) at t=0h: 0.00068, 12.0, 21.1, 38.4, 67.7, 117
Measured concentrations (mg/L) at t=48h: 0.00069, 11.0, 20.1, 34.0, 61.8., 119
Details on test conditions:
TEST SYSTEM
- Test vessel: vessel
- Material, size, headspace, fill volume: 60 mL, all-glass filled with 50 mL
- Aeration: not during the test
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- Test medium: adjusted ISO medium

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 vessel and was monitored after 24 and 48 hours of continuous treatment with the test substance.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: x1.8
- Range finding study
- Test concentrations: 0 and 100mg/L
- Results used to determine the conditions for the definitive study: yes
Reference substance (positive control):
yes
Remarks:
Potassium dichromate

Results and discussion

Effect concentrations
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
60 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: 95% C.I.: 51-71 mg/L
Details on results:
- Mortality of control: none
- Other adverse effects control: no
- Abnormal responses: none
Results with reference substance (positive control):
- Results with reference substance valid? yes
- Mortality: no
- EC50/LC50: 48-h EC50 = 0.33 mg/L (95% CI: 0.71-0.90 mg/L). The sensitivity of the daphnids was within the range determined with the historical data collected at Charles River Den Bosch.
Reported statistics and error estimates:
- The 48h-EC50 was calculated from the probits of the percentages of affected daphnids and the logarithms of the corresponding test item concentrations (analytically confirmed nominal concentration) using the maximum likelihood estimation method.
- No 24h-EC50 could be calculated since the observed effects were below 50% after 24 hours of exposure.
- The calculations were performed with ToxRat Professional v. 3.2.1. (ToxRat Solutions® GmbH, Germany).

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The acute toxicity of T003680 to Daphnia magna was determined in a 48 hour static test according to OECD guideline 202 (GLP conditions). Based on analytically confirmed nominal concentrations, the 48-h EC50 was 60 mg/L (95% confidence interval between 51 and 71 mg/L). The results of the test can be considered reliable without restriction.