2-Propenoic acid, 2-fluoro-, methyl ester

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13/7/15 to 31/7/15

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Recently conducted study performed to OECD guideline and under GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Sampling method: Fresh test media (0 & 72h) from bulk preparation, old test media (24 & 96h)
- Sample storage conditions before analysis: analysed on day of receipt

Vehicle:

no

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: Rainbow trout
- Strain: No data
- Source: Brow Well Fisheries Ltd, Skipton, Yorkshire, UK
- Age at study initiation (mean and range, SD): No data
- Length at study initiation (length definition, mean, range and SD): 4.9 cm (SD 0.2 cm)
- Weight at study initiation (mean and range, SD): 1.58g (SD 0.27g)
- Method of breeding: No data
- Feeding during test: Not fed

ACCLIMATION
- Acclimation period: 7d
- Acclimation conditions (same as test or not): No data
- Type and amount of food: Commerical trout pellets
- Feeding frequency: No data
- Health during acclimation (any mortality observed): None

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

No data

Test temperature:

14 - 15oC

pH:

7.3 - 7.8

Dissolved oxygen:

5.4 - 9.2mg/L
Minimum DO recorded 5.4 mg/L (52% ASV) in control 'old' test media

Salinity:

No data

Nominal and measured concentrations:

Nominal concentrations (mg/L): 0 (control), 2.2, 4.5, 10, 22 45; Analytical concentrations (mg/L): 0 (control), 2.2, 4.2, 8.8, 20, 38 (mean fresh media concn

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume: glass, 20 L, no headspace, 20 L
- Aeration: None
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): 1
- Biomass loading rate:

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:
- Total organic carbon:
- Particulate matter:
- Metals:
- Pesticides:
- Chlorine:
- Alkalinity:
- Ca/mg ratio:
- Conductivity:
- Culture medium different from test medium:
- Intervals of water quality measurement:

OTHER TEST CONDITIONS
- Adjustment of pH:
- Photoperiod:
- Light intensity:

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :

TEST CONCENTRATIONS
- Spacing factor for test concentrations:
- Justification for using less concentrations than requested by guideline:
- Range finding study
- Test concentrations:
- Results used to determine the conditions for the definitive study:
TEST SYSTEM
- Test vessel: 20L glass
- Type: closed
- Material, size, headspace, fill volume: Glass, 20L, no headspace, 20L fill volume, sealed
- Aeration: None
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1 (no replicates)
- No. of vessels per control (replicates): 1 (no replicates)
- Biomass loading rate: 0.55g/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Dechlorinated tap water
- Total organic carbon: No data
- Particulate matter: No data
- Metals: No data
- Pesticides: No data
- Chlorine: No data
- Alkalinity: No data
- Ca/mg ratio: No data
- Conductivity: No data
- Intervals of water quality measurement: No data

OTHER TEST CONDITIONS
- Adjustment of pH: None
- Photoperiod: 16:8 Light:Dark
- Light intensity: No data

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :

TEST CONCENTRATIONS
- Spacing factor for test concentrations: x2
- Results used to determine the conditions for the definitive study: OECD 201 72h Algae; OECD 202 48h Daphnia magna

Reference substance (positive control):

no

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

13 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 95% CI (10-17)

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

6.1 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: -

Duration:

72 h

Dose descriptor:

LC50

Effect conc.:

6.1 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: -

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

6.1 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: -

Details on results:

- Behavioural abnormalities: None
- Observations on body length and weight: no data
- Other biological observations: None observed
- Mortality of control: None
- Other adverse effects control: None
- Abnormal responses: None
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: None
- Effect concentrations exceeding solubility of substance in test medium: None

Sublethal observations / clinical signs:

Results based on average measured 'new' concentrations (mg/L)

Time (h)	LC50 (mg/L)	95% CI	NOEC (mg/L)	LOEC (mg/L)
24	13	10 - 17	8.8	20
48	6.1	-	4.2	8.8
72	6.1	-	4.2	8.8
96	6.1	-	4.2	8.8

Validity criteria fulfilled:

no

Remarks:

DO <60% ASV in some 'old' test media

Conclusions:

The 96 hour LC50 value of the test substance was determined to be 6.1 mg/L, under semi-static condicitons. Results based on average measured 'new' concentrations.

Executive summary:

The 96–hour-acute toxicity of 2-propenoic acid to rainbow trout (Oncorhynchus mykiss) was studied under semi-static conditions. The study was conducted in accordance with EU method C.2 and OECD guideline 202, in compliance with GLP. 

Fish were exposed to a control and nominal test concentrations of 2.5, 4.5, 10, 22 and 45mg/L for 96 hours. 

Analytical measurements at 0 and 72 hour 'new' test solutions ranged from 74 – 105% of nominal. Analytical measurements at 24 and 96 hour old test solutions ranged from 76 – 96% of nominal.  Dissolved oxygen % ASV <60% in some 'old' test solutions but this is not considered to have affected the test result and the test is considered valid.

The results are expressed in terms of mean measured 'new' test concentrations. Observations for mortality and sub-lethal effects were made daily. The 96–hour LC50 value was 6.1 mg/L (not possible to calculate 95% CI).  The 96–hour NOEC based on mortality was 4.2 mg/L.  There were no sub-lethal effects observed.

This study is classified as acceptable and satisfies the guideline requirements for an acute toxicity study with freshwater fish.

Results Synopsis

Test Organism: Rainbow trout (Oncorhynchus mykiss), mean weight 1.58g, mean length 4.9 cm

Test Type: Semi-static, sealed vessels, no aeration

LC50: 6.1 mg/L (95% C.I. could not be calculated)

NOEC: 42 mg/L

LOEC 8.8 mg/L

Description of key information

The Key Study reported a 96 hour LC50 value for the toxicity of 2 -propenoic acid, 2 -fluoro, methyl ester to the freshwater fish Oncorhynchus mykiss of 6.1 mg/L, under semi-static conditions. The results were based on average measured concentrations (Sacker, 2015).

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

6.1 mg/L

Additional information

The 96-hour LC50 for 2-propenoic acid, 2-fluoro, methyl ester in rainbow trout (Oncorhynchus mykiss) was 6.1 mg/l under semi-static conditions in sealed vessels with no aeration. No mortality was observed at measured concentrations of 2.2 and 4.2 mg/L. No symptoms of toxicity (sub-lethal effects) were observed.