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 fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16-Oct-2017 to 27-Oct-2017

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

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 203 (Fish, Acute Toxicity Test)

Version / remarks:

1992

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, 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, extremely volatile

Sampling and analysis

Analytical monitoring:

no

Remarks:

Limit test conducted at 10 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, 3.3L screw-top glass flasks were completely filled with medium and closed with a septum-sealed screw cap and parafilm. MTDID 50908 (18.6 μL) was then injected through the septum with gas-tight syringe. Flasks were rotated slowly for five days, and then allowed to settle for two days. MTDID 50908 was loaded at only 10 mg/L, because higher loading levels may lead to formation of microdroplets of MTDID 50908 which would remain in suspension.
- Controls: Blank only
- Evidence of undissolved material: Test solutions were clear and colorless, with a small amount of visible test substance droplets at the bottom of the flasks at the beginning of the test.

Test organisms

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebra-fish
- Source: Zodiac, proeffac, De Haar Vissen, Wageningen University and Research Centre, The Netherlands
- Length at study initiation: 1.9 ± 0.3 cm
- Weight at study initiation: 0.07 ± 0.02 g
- Feeding during test: no
ACCLIMATION
- Acclimation period: at least 12 days after delivery
- Acclimation conditions (same as test or not): Adjusted ISO medium, formulated using RO-water (tapwater purified by reverse osmosis; GEON Waterbehandeling, Berkel-Enschot, The Netherlands) with the following composition:
CaCl2.2H2O 211.5 mg/L
MgSO4.7H2O 88.8 mg/L
NaHCO3 46.7 mg/L
KCl 4.2 mg/L
- Type of food during acclimation: pelleted fish food (Cyprico Crumble Excellent (300-500 um), Coppens International bv, Helmond, The Netherlands)
- Feeding frequency during acclimation: daily until 24 hours prior to the start of the test
- Health during acclimation (any mortality observed): no more than 5% mortality in the seven days prior to the test

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test conditions

Hardness:

180 mg CaCO3/L

Test temperature:

21.1 - 21.9 °C

pH:

7.6 - 7.9

Dissolved oxygen:

7.1 - 9.2 mg/L

Nominal and measured concentrations:

Nominal: 10 mg/L
Measured: not evaluated

Details on test conditions:

TEST SYSTEM
- Test vessel: 3.3 liter glass flasks
- Type: closed
- Fill volume: 3.3 liters
- Aeration: no
- No. of organisms per vessel: 3
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 3
- Biomass loading rate: 0.06 g fish/liter
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: ISO medium prepared using reverse-osmosis purified water (GEON Waterbehandeling, Berkel-Enschot, The Netherlands)
OTHER TEST CONDITIONS
- Adjustment of pH: None
- Photoperiod:16 hours light; 8 hours dark
EFFECT PARAMETERS MEASURED: Mortality and/or severely distressed fish at 3, 24, 48, 72, and 96 hours.
TEST CONCENTRATIONS
- Test concentrations: 10 mg/L

Reference substance (positive control):

yes

Remarks:

pentachlorophenol (PCP)

Results and discussion

Effect concentrations

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 10 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other:

Remarks:

There was no mortality or clinical effects at the only concentration tested.

Details on results:

Details on results
- Behavioural abnormalities: None
- Mortality of control: None
- Other adverse effects control: None
- Effect concentrations exceeding solubility of substance in test medium: Yes

Results with reference substance (positive control):

- Results with reference substance valid? yes
- Mortality: yes
- LC50: 0.15 mg/L (95% CI, 0.10 mg/L to 0.22 mg/L)
- Other: The sensitivity of zebra-fish originating from the present batch for PCP falls within the expected range of sensitivities generally observed for a similar species (carp) during the past years. Sensitivity trend data for zebra-fish are still being collected. The reference test was done 5 months prior to the limit test with MTDID 50908.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Remarks:

There was no control mortality, DOC > 60% of saturation, tests conducted in closed vessels to maintain concentration of test substance.

Conclusions:

96-hour LC50 of MTDID 50908 to zebra-fish (Danio rerio) > 10 mg/L (nominal) in a limit test per OECD TG 203. No toxicity was observed. The loading rate exceeded the maximum soluble concentration for MTDID 50908 in test medium.

Executive summary:

The 96-hour LC50 of MTDID 50908 to zebra-fish (Danio rerio) was examined in a static, limit test conducted according to OECD TG 203. Test solutions were prepared as the control (0 mg/L) and at 10 mg/L, a level in excess of the water solubility of MTDID 50908. Test bottles were entirely filled (no headspace) and closed to avoid loss of test substance. No mortality or other clinical effects were observed at the 10 mg/L loading rate or in controls. The study was well-documented, followed an international standard method, and was GLP compliant.

Because MTDID 50908 is a multi-constituent substance with varying constituent solubilities, and testing was conducted at a loading level of 10 mg/L, without analytical measurement, the study is deemed reliable with restrictions. The results from this study are considered suitable for Risk Assessment, Classification and Labeling, and PBT Analysis.