Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
9 - 20 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)
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 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 (especially for difficult test substances)
- Method: The test substance is extremely volatile. Therefore, 3.3 L glass flasks were completely filled with medium and closed with screw caps with a septum and parafilm. MTDID 22327 (19.4 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 22327 was loaded at only 10 mg/L because higher loading levels may lead to formation of microdroplets of MTDID 22327 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: Zebrafish
- Source:Zodiac, proefacc, “De Haar Vissen”, Wageningen University and Research Centre, the Netherlands
- Length at study initiation: 1.9 ± 0.2 cm
- Weight at study initiation: 0.07 ± 0.02 g

ACCLIMATION
- Acclimation period: at least 12 days after delivery
- Acclimation conditions: Adjusted ISO medium, formulated using RO-water (tap-water 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 and amount of food during acclimation: fed daily with pelleted fish food (Cyprico Crumble Excellent (300-500 um), Coppens International bv, Helmond, The Netherlands)
- Health during acclimation (any mortality observed): In the batch of fish used for the test, mortality during the seven days prior to the start of the test was less than 5%.

FEEDING DURING TEST
- No feeding from 24 hours prior to the test and during the total test period.

Study design

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

Test conditions

Hardness:
180 mg/L CaCO3
Test temperature:
21.2 - 21.5 °C
pH:
7.8 - 8.0
Dissolved oxygen:
7.1 - 9.0
Nominal and measured concentrations:
Nominal: 10 mg/L
Measured: not evaluated
Details on test conditions:
TEST SYSTEM
- Test vessel: 3.29 L glass flasks
- Type: closed
- Fill volume: 3.29 L
- Aeration: no
- No. of organisms per vessel: 3
- No. of vessels per concentration: 3
- No. of vessels per control: 3
- Biomass loading rate: 0.06 g fish/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: ISO medium, formulated using RO-water (tap-water purified by reverse osmosis; GEON Waterbehandeling, Berkel-Enschot, The Netherlands)

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours light; 8 hours dark

EFFECT PARAMETERS MEASURED: mortality and other effects at 3.5, 24, 48, 72, and 96 hours following the start of exposure. In addition, every afternoon from day 0 to observe for any dead or severly distressed fish.

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: No mortality or clinical effects at only concentration tested.
Details on results:
- Behavioural abnormalities: no
- Mortality of control: no
- Other adverse effects control: no
- Abnormal responses: no
- 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% confidence interval between 0.10 and 0.22 mg/L)
- Other: Sensitivity trend data for this species are still being collected. 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. The reference substance test was conducted five months before the testing of MTDID 22327.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Remarks:
No control mortality, DOC > 60% of saturation
Conclusions:
96-hour LC50 of MTDID 22327 to zebra-fish (Brachydanio rerio) > 10 mg/L (nominal) in a limit test per OECD 203. No toxicity was observed. The loading rate exceeded the maximum soluble concentration for MTDID 22327 in test medium.
Executive summary:

The 96-hour LC50 of MTDID 22327 to zebra-fish (Brachydanio 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. 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 the loading level of 10 mg/L exceeded the water solubility of MTDID 22327 (< 5 ppm) potentially only by a factor of two, and because MTDID 22327 is a UVCB chemical, the study is deemed reliable with restrictions. The results from this study are considered suitable for Risk Assessment, Classification and Labeling, and PBT Analysis.