Registration Dossier

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:
9 Oct 2017 - 18 Oct 2017
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 guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Reaction mass of perfluoro(dimethyl - N - Butylamine ) and perfluoro (methyl - di - N - propylamine) and perfluoro (dimethyl - N - propylamine and 2,2,3,3,5,5,6,6, octafluoro-4-(trifluoromethyl)morpholine and perfluoro-N-pentane
EC Number:
908-205-5
Cas Number:
2187449-42-7
IUPAC Name:
Reaction mass of perfluoro(dimethyl - N - Butylamine ) and perfluoro (methyl - di - N - propylamine) and perfluoro (dimethyl - N - propylamine and 2,2,3,3,5,5,6,6, octafluoro-4-(trifluoromethyl)morpholine and perfluoro-N-pentane
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 002602456
- Physical state: colorless, clear liquid
- Expiration date of the lot/batch: 07 June 2020

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
- Stability under test conditions: test substance stable in water, but extremely volatile

Sampling and analysis

Analytical monitoring:
no
Remarks:
Limit test conducted at 100 mg/L (nominal) loading level, which is above the water solubility of the test material

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test substance is extremely volatile. Therefore, 42.5 mL air-tight vials were completely filled with medium and closed with a septum-sealed screw cap and parafilm. MTDID 22327 (2.4 μL) was then injected through the septum with gas-tight syringe. Vials were rotated slowly for seven days, and then centrifuged at 500 g for 90 minutes to pull dissolved test substance into a single drop at the bottom of the vial.
- Controls: Blank only
- Evidence of undissolved material: Test solutions were clear and colorless, with a visible small droplet of undissolved test substance at the bottom.

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Water flea
- Strain/clone: Daphnia magna (Straus, 1820), at least third generation, obtained by a cyclical parthenogenesis under specified breeding conditions.
- Source: In-house laboratory culture with a known history.
- Age of parental stock: > 2 weeks
- Age at study initiation: < 24 hrs
- Feeding during test: No
- Culturing: Adult daphnids were cultured in M7 medium (ISO medium plus trace elements, micronutrients, and vitamins). Adult daphnids in the cultures were held for at least 14 days, and were not more than 4 weeks old prior to collection of the juveniles for testing. During the period preceding the test, water temperatures were 18 - 22°C. Daphnids in the cultures were fed daily a suspension of freshwater algae. The adults were fed prior to test initiation, but neonates were not fed during the test.
- Health: Daphnids originated from a healthy stock, 2nd to 5th brood, showing no signs of stress such as mortality >20%, presence of males, ephippia or discoloured animals and there was no delay in the production of the first brood.

Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h

Test conditions

Hardness:
180 mg CaCO3
Test temperature:
20 °C
pH:
7.7 - 8.0
Dissolved oxygen:
8.8 - 9.0 mg/L
Nominal and measured concentrations:
Nominal: 100 mg/L
Measured: not evaluated
Details on test conditions:
TEST SYSTEM
- Test vessel: vials with screw cap, septum, and parafilm
- Type: closed
- Material, size, headspace, fill volume: glass vials, 42.5 mL volume, no headspace
- Aeration: no
- No. of organisms per vessel: five
- No. of vessels per concentration (replicates): four
- No. of vessels per control (replicates): four

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: ISO medium prepared using reverse-osmosis purified water (GEON Waterbehandeling, Berkel-Enschot, The Netherlands)
- Culture medium different from test medium: Yes, culture medium was M7 (ISO medium with addition of trace elements, micronutrients, and vitamins).

OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 hours daily

EFFECT PARAMETERS MEASURED: immobilization (including mortality) observed at 24 and 48 hours
Reference substance (positive control):
yes
Remarks:
Potassium dichromate (K2CrO7)

Results and discussion

Effect concentrations
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat. (total fraction)
Basis for effect:
mobility
Remarks on result:
other: The 48h-EC50 exceeded a loading rate of 100 mg/L and as such exceeded the maximum soluble concentration of MTDID 22327 in test medium.
Details on results:
- Mobility: one test organism was immobilized in the limit concentration during the test
- Mobility of control: no immobilization observed
- Other adverse effects control: no other signs of disease or stress
- Effect concentrations exceeding solubility of substance in test medium: yes
Results with reference substance (positive control):
- Results with reference substance valid? Yes
- Dose-response test: Yes
- ECx: 48-hr EC50 = 0.41 mg/L (95% CI, 0.34 mg/L to 0.46 mg/L)
- Other: The sensitivity of Daphnia magna originating from the batch used in this test, for potassium dichromate fell within the expected range of sensitivity observed during previous years (n > 60; 48-hr EC50 between 0.3 and 1.0 mg/L.) The reference substance test was conducted within one month of the testing of MTDID 22327.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Remarks:
Control immobilization was < 10% at the end of the test. The dissolved oxygen concentration was ≥ 3 mg/L in the control and test vessels at the end of the test.
Conclusions:
The 48-hour EC50 (immobilization) of MTDID 22327 to Daphnia magna exceeded a loading rate of 100 mg/L which exceeded the maximum soluble concentration for MTDID 22327 in test medium.
Executive summary:

The 48-hour EC50 of MTDID 22327 to Daphnia magna was examined in a static test conducted according to OECD TG 202. Test solutions were prepared as the control (0 mg/L) and at 100 mg/L. A visible droplet of undissolved test material was present in the vessel throughout the test. At the 100 mg/L loading level, one daphnid of the twenty in test solution was immobilized during the 48-hour period (i.e. 48-hour EC50 > 100 mg/L), with no immobilization in controls. No analytical monitoring was presented, but the loading rate was well above the solubility limit of the test material in water. The test substance showed essentially no effect at this loading rate. The test was conducted according to internationally accepted test guidelines and was GLP compliant. It is reliable without restriction and suitable for Risk Assessment, Classification and Labeling, and PBT Analysis.