Reaction mass of 1,1,2,2,3,3,3-heptafluoro-N-(heptafluoropropyl)-N-(pentafluoroethyl)propan-1-amine and 1,1,2,2,3,3,3-heptafluoro-N-(heptafluoropropyl)-N-(trifluoromethyl)propan-1-amine and 1,1,2,2,3,3,3-heptafluoro-N,N-bis(heptafluoropropyl)propan-1-amine

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 to 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

Test material information

Constituent 1

Reference substance name:

Reaction mass of 1,1,2,2,3,3,3-heptafluoro-N-(heptafluoropropyl)-N-(pentafluoroethyl)propan-1-amine and 1,1,2,2,3,3,3-heptafluoro-N-(heptafluoropropyl)-N-(trifluoromethyl)propan-1-amine and 1,1,2,2,3,3,3-heptafluoro-N,N-bis(heptafluoropropyl)propan-1-amine

EC Number:

920-778-3

Cas Number:

2176446-38-9

Molecular formula:

constituents: CnF(2n+3)N with n= 7-9

IUPAC Name:

Reaction mass of 1,1,2,2,3,3,3-heptafluoro-N-(heptafluoropropyl)-N-(pentafluoroethyl)propan-1-amine and 1,1,2,2,3,3,3-heptafluoro-N-(heptafluoropropyl)-N-(trifluoromethyl)propan-1-amine and 1,1,2,2,3,3,3-heptafluoro-N,N-bis(heptafluoropropyl)propan-1-amine

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): MTDID 50908
- Physical state: Colourless liquid
- Storage condition of test material: At room temperature

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 0002712253
- Physical state: colorless 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 50908 (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 undissolved 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 acyclical 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 in the medium

Test temperature:

20°C

pH:

7.8 - 8.0

Dissolved oxygen:

8.0 - 9.4 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 and septum
- Type: closed
- Material, size, headspace, fill volume: glass vials, 42.5 mL volume, no headspace
- Aeration: no
- No. of organisms per vessel: five (4 instead of 5 daphnids were introduced into one replicate of the 100 mg/L loading rate)
- 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)
- Ca/Mg ratio: 4:1
- Culture medium different from test medium: Yes, culture was in M7 (ISO medium with addition of trace elements, micronutrients, and vitamins).
OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 hours light; 8 hours dark
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:

Remarks:

The 48h-EC50 exceeded a loading rate of 100 mg/L, i.e. exceeded the maximum soluble concentration of MTDID 50908 in test medium.

Details on results:

- Mobility: no immobilization of test organisms was observed
- 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, undissolved test substance observed throughout the test.

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 approximately one month before the testing of MTDID 50908.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Remarks:

The validity criteria of OECD TG 202 were fulfilled. 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 of MTDID 50908 to Daphnia magna exceeded a loading rate of 100 mg/L which exceeded the maximum soluble concentration in the test medium (OECD TG 202).

Executive summary:

The 48-hour EC50 of MTDID 50908 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, which exceeded the maximum soluble concentration of MTDID 50908 in the test medium. No analytical monitoring was presented, but the loading rate was well above the solubility limit of the test material in water, and visible undissolved test substance was observed throughout the test. At the 100 mg/L loading level, no immobilization of the daphnids was observed by 48 hours (i.e. 48-hour EC50 is > 100 mg/L). The test was conducted according to an internationally accepted test guideline and was GLP compliant. It is reliable without restriction and suitable for Risk Assessment, Classification and Labeling, and PBT Analysis.