Acetamide, N-(4-fluorophenyl)-2-hydroxy-N-(1-methylethyl)-

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May-August 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Qualifier:

according to guideline

Guideline:

other: OSPAR Commission 2006 Part B. Protocol for a fish acute toxicity test

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: all test concentrations and control sampled
- Sample storage conditions before analysis: below 5 °C

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: FOE-hydroxy was characterised as poorly soluble and test solutions were therefore prepared by Water Accommodated Fractions (WAFs).
- Evidence of undissolved material (e.g. precipitate, surface film, etc): Floating particles

Test organisms (species):

Cyprinodon variegatus

Details on test organisms:

TEST ORGANISM
- Common name: Sheephead minnow
- Age at study initiation: 10-15 weeks

Test type:

semi-static

Water media type:

saltwater

Limit test:

no

Total exposure duration:

96 h

Test temperature:

20 +- 2°C

pH:

7.98-8.19

Dissolved oxygen:

96.1-99.9 %

Salinity:

32.7-34.7 ‰

Nominal and measured concentrations:

Range finding test: Nominal noncentration (mg/L) 1, 10, 100 and 1000
Definitive test: Nominal concentrations (mg/L) 10, 18, 32, 56 and 100 , Analytical concentrations (mg/L) 10, 17, 32, 51, 91

Details on test conditions:

TEST SYSTEM
- Test vessel: glass beakers
- Type: open
- Material, size, headspace, fill volume: glass, 5 l in size, filled with 3 l test media(saltwater)
- Aeration: yes, througout test duration
- No. of organisms per vessel: 10
- Biomass loading rate: The maximum loading density cannot exceed 1g fish (wet weight) per litre of medium

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Natural local seawater is pumped to holding tanks from Scapa Flow, Orkney (Latitude 58°50'8.02"N, Longitude 3° 8'10.80"W). The treatment process includes sand filters to remove particulate matter, followed by a 1 µm filter. This water is heated to 20ºC, UV treated, degassed and held at a quantity of 3000 to 5000 litres. The treated seawater is constantly pumped through the Opus laboratory water system and trickle replenished as the water is used.
-Water/test medium change: at 48 h in all test concentrations.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: At least five test concentrations are used in a geometric series with a maximum factor of 1.8 or 3.2; concentrations will depend on range-finding test results.
- Range finding study
- Test concentrations: 1, 10, 100 and 1000 mg/L
- Results used to determine the conditions for the definitive study: yes

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

23 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: none
- Other biological observations: none
- Mortality of control: none
- Other adverse effects control: none
- Abnormal responses: none

Validity criteria fulfilled:

yes

Conclusions:

In the definitive test FOE-hydroxy exhibited a 96h-LC50 of 23 mg/L (Water Accommodated Fractions (WAFs)) to the marine fish Cyprinodon variegatus in the water phase. This test result is based on measured concentrations.

Executive summary:

In the definitive test FOE-hydroxy exhibited a 96h-LC50 of 23 mg/L (Water Accommodated Fractions (WAFs)) to the marine fish Cyprinodon variegatus in the water phase. This test result is based on measured concentrations.

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Remarks:

HPLC-UV

Details on sampling:

Daily

Vehicle:

no

Remarks:

Use of ultrasonic bath (15 min.)

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

- Name: Zebra fish (Danio rerio)
- Source: West Aquarium GmbH (Germany)
- Date of birth: 04.11.1993
- Date supplied: 27.01.1994
- Temperature: 20-24 °C
- Mortalities during acclimatisation period: < 5 %
- Medication: none
- Keeping water: synthetic freshwater according to ISO

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

10.4 °dH

Test temperature:

21.02 - 21.9 °C

pH:

7.7 - 8.2

Dissolved oxygen:

8.3 - 9.5 mg/L

Nominal and measured concentrations:

nominal: 35, 50, 71, 100, 141 and 200 mg/L
measured: 34.1, 49.1, 68.8, 96.5, 137.2, 195.2 mg/L (at the beginning), 34.8, 50.1, 70.2, 100.1, 139.0, 196.6 (at the end)

Details on test conditions:

- Test vessels: glass aquaria holding 5 L of test media covered with glass plates
- Experimental design: 6 test concentration plus 1 control, 10 animals per test concentration
- no feeding during the exposure period
- static system
- Method of initiation: animals were placed in prepared media
- Photoperiod: 16 h light: 8 h dark
- Temperature: 21.2 to 21.9 °C
- Test item concentration/s: 35, 50, 71, 100, 141 and 200 mg/L(nominal concentration)
- Method of administration: direct weighing
- Medium renewal: none
- Duration of exposure: 96 hours
- Criteria of effects: The criterion of death used in this study was the absence of response to physical stimulation. In addition to observations on mortality at 0, 24, 48, 72 and 96 hours, type and incidence of sub-lethal effects compared with control fish were observed.

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

49.6 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

127.7 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

195.9 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Validity criteria fulfilled:

yes

Remarks:

mortality in control <= 10% (or one fish, if fewer than 10 control fish are tested); the dissolved oxygen concentration should be ≥60% of the air saturation value in all test vessels throughout the exposure;

Conclusions:

An 96h-LC50 of 98.6 was determined for the test substance towards fish as geometric mean of LC0/LC100.

Executive summary:

A study was performed to assess the acute toxicity of the test substance to Danio rerio under static conditions in accordance with Council Regulation (EC) Method C.1 'Acute toxicity for Fish' (1992).

Groups of ten fishes were exposed to test concentration of 35 to 200 mg/L (nominal concentration) of the test substance. Auxiliaries used to prepare the test media was an ultrasonic bath.During the test a temperature range of 20 - 24°C was be maintained in the test vessels, with a maximum temperature fluctuation of +/- 1°C in each individual test. pH and oxygen values are measured at the beginning of the test and every 24 hours thereafter.

Observations were made on the numbers of dead fish and the incidence of sub-lethal effects after 0, 24, 48, 72 and 96 hours of exposure.

The following values were determined after 96 h: LC0 = 49.6 mg/L and LC100 = 195.9 mg/L as arithmetic means of the analytical determined concentrations, the LC50 of 98.6 mg/L was determined as geometric mean of LC0/LC100.

Description of key information

A study was performed to assess the acute toxicity of the test substance to Danio rerio under static conditions in accordance with Council Regulation (EC) Method C.1 'Acute toxicity for Fish' (1992).

Groups of ten fishes were exposed to test concentration of 35 to 200 mg/L (nominal concentration) of the test substance. Auxiliaries used to prepare the test media was an ultrasonic bath.During the test a temperature range of 20 - 24°C was be maintained in the test vessels, with a maximum temperature fluctuation of +/- 1°C in each individual test. pH and oxygen values are measured at the beginning of the test and every 24 hours thereafter.

Observations were made on the numbers of dead fish and the incidence of sub-lethal effects after 0, 24, 48, 72 and 96 hours of exposure.

The following values were determined after 96 h: LC0 = 49.6 mg/L and LC100 = 195.9 mg/L as arithmetic means of the analytical determined concentrations, the LC50 of 98.6 mg/L was determined as geometric mean of LC0/LC100.

In the definitive test FOE-hydroxy exhibited a 96hr LC50 of 23mg/L (Water Accommodated Fractions (WAFs)) to the marine fish Cyprinodon variegatus in the water phase. This test result is based on measured concentrations.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

98.6 mg/L

Marine water fish

Marine water fish

Effect concentration:

23 mg/L