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Short-term toxicity to aquatic invertebrates

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Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
17 October 2012 - 05 October 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 850.1010 (Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 0 (dilution medium control), 6.25, 12.5, 25, 50, and 100 mg/L
At the start of the definitive test, specific analytical vessels were prepared in the same manner as the exposure vessels (100 mL media in a 250 mL vessel with 150 mL
headspace). Freshly prepared control and test media was analysed on Day 0. After 48 hours, media in specified vessels prepared on Day 0 and left under test conditions for the duration of the definitive test, were analysed. The vessels specified for analysis did not contain test organisms.

Samples were extracted into hexane using liquid-liduid extraction (10 mL sample shaken with 10 mL of hexane).
Vehicle:
no
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Strain: Straus
- Age at study initiation: less than 24 hours old
- Method of breeding: parthenogenesis
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
180 mg/L as CaCO3
Test temperature:
20.2 - 20.4°C
pH:
7.75 - 7.85
Dissolved oxygen:
96 - 100% ASV (Air saturation value)
Nominal and measured concentrations:
Nominal: 0 (Control), 6.25, 12.5, 25, 50, 100 mg/L
Initial measured: 0 (no test material detected), 2.45, 4.63, 11.1, 21.9, 42.9 mg/L
Measured concentrations after 48 hours: 0, 0.194, 0.390, 0.752, 1.86, 3.56 mg/L

Geometric mean concentration (initial and 48-hour values): 0, 0.7, 1.3, 2.9, 6.4, 12.4 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel:250 mL glass bottles. Fill volume = 100 mL, headspace = 150 mL. Bottles were sealed after addition of the test material
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- Biomass loading rate: 20 mL medium per organism

TEST MEDIUM / WATER PARAMETERS
Softened Elendt M4 medium to comply with Method 850.1010 (Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids) of the US Environmental Protection Agency, OPPTS Public Drafted, April 1996.

OTHER TEST CONDITIONS
- Photoperiod: 16 hours light / 8 hours dark
- Light intensity: Approximately 400 lux

EFFECT PARAMETERS MEASURED : Daphnia were considered to be immobile if they were unable to swim within approximately 15 seconds following gentle agitation of the test vessel. The numbers of mobile, immobile and floating Daphnia were counted approximately 24 and 48 hours after the start of the study.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2
- Range finding study
- Test concentrations: First range-finding study = 10, 100, and 1000 mg/L; second range-finding study = 0.01, 0.1, 1, 10, and 100 mg/L.
- Results used to determine the conditions for the definitive study: Yes
Reference substance (positive control):
no
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
11.1 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
6.4 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
35.8 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: 95% Confidence limits = 33.1 - 42.9 mg/L
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
21.9 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mobility
Reported statistics and error estimates:
Note that the original study report indicated effect levels (EC50 and NOEC) in terms of the initial measured concentrations. Effect concentrations were recalculated as the geometric mean of initial and 48-hour (expired) concentrations.
Validity criteria fulfilled:
yes
Conclusions:
In terms of geometric mean concentrations (fresh and 48-hour expired media), the 48-hour EC50 of 2-bromo-3,3,3- trifluoropropene for the immobilisation of Daphnia magna was 11.1 mg/L and the ‘no-observed effect concentration’ was 6.4 mg/L.

Description of key information

EC50, 48 hours, Daphnia Magna = 11.1 mg/L

NOEC, 48 hours, Daphnia Magna = 6.4 mg/L

Key value for chemical safety assessment

EC50/LC50 for freshwater invertebrates:
11.1 mg/L

Additional information

An acute toxicity test in Daphnia Magna was conducted (Huntingdon Life Sciences, 2013) to determine the effect of 2-Bromo-3,3,3-trifluoroporopene on aquatic invertebrates following short-term exposure. The study was conducted according to EC test method C2, OECD method 202, and US EPA OPPTS Method 850.1010; the study was performed in compliance with GLP. The test was performed under static conditions; the test vessels were sealed but included a headspace.

In terms of initial measured concentrations, the 48-hour EC50 of 2-bromo-3,3,3- trifluoropropene for the immobilisation of Daphnia magna was 35.8 mg/L (95% confidence limits of 33.1 and 42.9 mg/L) and the ‘no-observed effect concentration’ was 21.9 mg/L.

The observed effect concentations were recalculated as the geometric mean values of the measured values at the start and end of the exposure period; in terms of mean measured values the EC50 was 11.1 mg/L and the NOEC was 6.4 mg/L.