Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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:
18 January 2017 - 28 January 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
yes
Remarks:
temperature range in excess of ± 1 ºC This was considered to have had no adverse effect on the integrity of the test, no adverse effects to exposure were observed in any of the control or test vessel.
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
1-bromoheptadecafluorooctane
EC Number:
207-028-4
EC Name:
1-bromoheptadecafluorooctane
Cas Number:
423-55-2
Molecular formula:
C8BrF17
IUPAC Name:
1-bromoheptadecafluorooctane
Test material form:
liquid
Specific details on test material used for the study:
Physical state/Appearance: Clear colorless liquidBatch: PFOBV42001Purity: 99.8%Expiry Date: 01 January 2018Storage Conditions: Room temperature in the dark

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
Samples were taken from the solvent control and the 0.020 mg/L test group from the bulk test preparation at 0 hours and from the pooled replicates at 48 hours for quantitative analysis.

Test solutions

Vehicle:
yes
Remarks:
dimethylformamide
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)- Method: A nominal amount of test item (20 mg) was dissolved in a final volume of 10 mL of dimethylformamide to give a 20 mg/10 mL solvent stock solution from which a dilution was made to give a further solvent stock solution of 2.0 mg/10 mL. An aliquot (100 μL) of the 2.0 mg/10 mL solvent stock solution was dispersed in 1 liter of test media with the aid of magnetic stirring for approximately 10 minutes to give the required test concentration of 0.020 mg/L and a final solvent concentration of 100 μL/L. The control consisted of test medium only and the solvent control consisted of test medium and dimethylformamide at a final solvent concentration of 100 μL/L.- Controls: control (Elendt M7) and solvent control- Chemical name of vehicle (organic solvent, emulsifier or dispersant):dimethylformamide- Concentration of vehicle in test medium (stock solution and final test solution(s) or suspension(s) including control(s)):100 μL/L

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM - Source: in-house laboratory cultures - Feeding during test: none ACCLIMATIONCultures maintained under test conditions, free from disease METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES:Gravid adults were isolated the day before initiation of the test, such that the young daphnids produced overnight were less than 24 hours old. These young were removed from the cultures and used for testing.

Study design

Test type:
static
Water media type:
other: Elendt M7 Medium
Limit test:
yes
Total exposure duration:
48 h

Test conditions

Test temperature:
18-20 deg C
pH:
7.6 - 8.0
Dissolved oxygen:
7.6 -9.7 mg/L
Nominal and measured concentrations:
Nominal 0.020 mg/L; measured 0 hours 0.013 mg/L; 48 hours 0.0096 mg/L. Geometric mean measured = 0.011 mg/L.solvent control at 0 and 48 hours
Details on test conditions:
TEST SYSTEM - Test vessel: Conical flasks - Type (delete if not applicable): closed, sealed with a ground glass stopper - Material, size, headspace, fill volume: glass, 100 mL completely filled - Aeration: none - Type of flow-through (e.g. peristaltic or proportional diluter): static - No. of organisms per vessel: 5 - No. of vessels per concentration (replicates): 4 - No. of vessels per control (replicates): 4 - No. of vessels per vehicle control (replicates): 4 TEST MEDIUM / WATER PARAMETERS - Source/preparation of dilution water: Elendt M7 medium prepared as described in the OECD Test guideline OTHER TEST CONDITIONS - Adjustment of pH: none - Photoperiod:16 hours light and 8 hours dark with 20 minute transition periods. - Light intensity: 200 - 1200 Lux EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Any immobilization or adverse reactions to exposure were recorded at 24 and 48 hours after the start of exposure. The criterion of effect used was that daphnia were considered to be immobilized if they were unable to swim within 15 seconds after gentle agitation. VEHICLE CONTROL PERFORMED: yes
Reference substance (positive control):
yes

Results and discussion

Effect concentrationsopen allclose all
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
> 0.011 mg/L
Nominal / measured:
meas. (geom. mean)
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 0.011 mg/L
Nominal / measured:
meas. (geom. mean)
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
0.011 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat. (dissolved fraction)
Basis for effect:
mobility
Details on results:
- Behavioural abnormalities: - Observations on body length and weight: none - Other biological observations: A single immobilized daphnid was observed to be immobilized in the 0.011 mg/L test preparation after 48 hours exposure. This was considered to be due to natural causes rather than a true toxic effect given that only 5% immobilization occurred. - Mortality of control: No immobilization was observed in the control and solvent control vessels - Other adverse effects control: No sub-lethal effects of exposure were observed throughout the test.
Results with reference substance (positive control):
- Results with reference substance valid: yes- Relevant effect levels: immobilisation 24 hour EC50- Dose-response test: 0.32, 0.56, 1.0, 1.8 and 3.2 mg/L- ECx: 24 hour EC50 = 1.2 mg/L within the normal range for this reference item (The results of the inter laboratory tests and a Technical Corrigendum to ISO 6341 give an EC50-24 hour for potassium dichromate within the range 0.6 mg/L to 2.1 mg/L.)
Reported statistics and error estimates:
An estimate of the EC50 values was given by inspection of the immobilization data.The No Observed Effect Concentration (NOEC) was determined by inspection of the immobilization data, with less than 10% immobilization being considered insignificant.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The acute toxicity of the test item to the freshwater invertebrate Daphnia magna has been investigated and, based on the geometric mean measured test concentration gave a 48-Hour EC50 value of greater than 0.011 mg/L. The No Observed Effect Concentration was 0.011 mg/L.This study showed that there were no toxic effects at the limit of solubility.