Registration Dossier

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:
20 - 22 July 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

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
Chemical structure
Reference substance name:
-
EC Number:
459-520-5
EC Name:
-
Cas Number:
132182-92-4
Molecular formula:
Hill formula: C7H3F13O CAS formula: C7H3F13O
IUPAC Name:
1,1,1,2,2,3,4,5,5,5-decafluoro-3-methoxy-4-(trifluoromethyl)pentane
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sumitomo 3M Ltd, lot #1
- Purity: 99.96%
- Synonyms: T-7869
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Concentrations: negative control and test substance solutions, taken at start of test, before renewal, after renewal, and at end of test.
- Sampling method: Samples of new or renewal solution were taken from the middle of the flask used to prepare the exposure solution. For old test solutions, equal volumes were taken from the middle of the test vessels and combined.
- Sample storage conditions before analysis: No

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Test substance (50 µL/L) was added to dilution water in a 1-L Erlenmeyer flasks, which was closed with a stopper to exclude headspace. The flask was stirred 24 h at 20 ± 1 °C. The middle layer of the settled solution was then transferred to test vessels, which were immediately closed with a glass plate with exclusion of any headspace.
- Controls: Dilution water. A test using potassium dichromate as reference substance was done about the time of the present test to verify reproducibility of the system.
- Chemical name of vehicle: no vehicle
- Evidence of undissolved material: Test solutions were clear and colorless throughout the test.

CONCENTRATION OF TEST SUBSTANCE IN TEST MEDIUM:
To establish range of expected test substance concentrations in this study, triplicate 500 mL flasks were set up as above and stirred for 24 and 48 hours at the test temperature (20 ± 1 °C). After settling for one hour, triplicate samples were taken from the middle of the flasks, and then pretreated and analyzed as described in the section on analytical method. The overall mean after 24 hours was 0.356 mg/L, and after 48 hours was 0.369 mg/L.

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Water flea
- Strain/clone: Clone A
- Source: Kurume internal stock originally obtained from University of Sheffield, United Kingdom
- Age of parental stock: 21 days, fed daily with algae (Chlorella vulgaris) at 0.1 - 0.2 mgC/day.
- Age of organisms used in the test: <24 hrs
- Feeding during test: No

Study design

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

Test conditions

Hardness:
42.7 mg CaCO3/L
Test temperature:
19.8 - 20.0 °C
pH:
7.5 - 7.7
Dissolved oxygen:
8.5 - 8.7 mg/L
Conductivity:
17.3 mS/m
Nominal and measured concentrations:
Loading rate was 50 µL/L (corresponds to ca. 80 mg/L)
Mean measured concentration was 0.368 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: glass Petri plate, 8 cm diamter x 5 cm depth, fill volume ca. 250 mL, no headspace
- Type: closed
- Aeration: No
- Renewal rate of test solution: once per 24 h
- No. of organisms per vessel: five
- No. of vessels per concentration: four
- No. of vessels per control: four

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: dechlorinated tap water
- Total organic carbon: 0.4 mg/L
- Particulate matter: <1 mg/L
- Metals: - Pesticides: - Chlorine: <0.01 mg/L
- Alkalinity: 33 mg/L
- Ca/mg ratio: 4.0
- Intervals of water quality measurement: Most recent dilution water quality assay 12 days before start of test

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16h:8h light:dark
- Light intensity: room lighting
- Temperature control: Test flasks were kept in a thermostatted water bath to maintain temperature.

EFFECT PARAMETERS MEASURED: Immobility at 24-hour intervals.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: none
- Justification for using less concentrations than requested by guideline: limit test
- Range finding study : yes
- Test concentrations: test at ca 80 mg/L loading rate and 31.6% dilution thereof
- Results used to determine the conditions for the definitive study: no toxicity, loss of concentration
over time, loss not mediated by presence/absence of organisms
Reference substance (positive control):
no

Results and discussion

Effect concentrations
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 0.368 mg/L
Nominal / measured:
meas. (TWA)
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: No immobilization observed in saturated solutions.
Details on results:
Individual concentrations are presented in the Illustration. Concentration of new or renewal solutions were generally consistent with the value derived from preliminary testing on attainable medium concentration (0.369 mg/L), but are somewhat higher than the pure-water solubility limit of 0.233 mg/L. Pooled concentrations after 24 hours exposure were similarly consistent with starting concentrations. Nevertheless, a time-weighted average concentration was calculated.
Results with reference substance (positive control):
A 48-hour acute toxicity test of potassium dichromate was done as part of regular quality checks around the time of this test. The LC50 was 0.283 mg/L. This was within the control range 0.231 ± 0.121 mg/L, where range is twice the standard deviation.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Remarks:
Control mortality <10 % (none); dissolved oxygen >3 mg/L (8.5 mg/L)
Conclusions:
HFE s-601 is not toxic at the limit of water solubility (OECD 202)
Executive summary:

The toxicity of HFE s-601 to invertebrates was assessed in a semi-static, limit test according to OECD TG 202. Water soluble fractions were prepared every 24 hours at a loading rate of ca. 80 mg/L. Test vessels were entirely closed with no exposure to air.  Measured test substance concentrations were generally consistent between the beginning and ending of the 24-hour periods prior to solution renewal.  Overall test substance concentration was reported as a time-weighted average. No mortalities were seen among test organisms or controls. The EC50 of HFE s-601 to Daphnia magna was >0.368 mg/L (saturated solution).

The test was conducted under GLP in accord with internationally accepted test guidelines, with analytical confirmation of test substance concentration. Therefore, this test is considered reliable with restrictions and is suitable for Risk Assessment, Classification & Labeling, and PBT Analysis.

Categories Display