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

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to aquatic invertebrates

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.2 (Acute Toxicity for Daphnia)

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Remarks:

HPLC-UV

Details on sampling:

at the beginning and at the end of testing

Vehicle:

no

Remarks:

Use of ultrasonic bath

Test organisms (species):

Daphnia magna

Details on test organisms:

- Name: Daphnia magna STRAUS, parthenogenetic females
- Source: Strain of Bundesgesundheitsamt Berlin
- Age: 6 - 24 h
- Maintenance and Acclimatisation: A population of parthenogenetic females of synchronized age structure has been maintained in the test facility under constant temperature conditions (20 +/- 1 °C) at a 16 : 8 hour light-dark photoperiod (illumination: < 1000 lux). The culture water (so-called 'M4 medium') was partly renewed once a week. The Daphnia were exclusively fed with unicellular green algae (Desmodesmus subspicatus) 'ad libitum'. Mortalities of parent Daphnia during the culture period were recorded daily in a semi-quantitative way. The neonates were separated from their parent Daphnia by filtration prior to the acute test.
- Culture and dilution water: Reconstituted water (so-called 'M4 medium') was used for the maintenance of the test animals and the preparation of stock and test solutions of the test item.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

14.8 °dH

Test temperature:

21.0 - 21.2 °C

pH:

8.1

Dissolved oxygen:

9.2 - 9.3 mg/L

Nominal and measured concentrations:

nominal: 100 mg/L
measured: 112 and 115 mg/L

Details on test conditions:

- Test vessels: glass beakers covered with watch glasses
- Experimental design: 1 test concentration plus 1 control, 10 neonates per vessel, 2 replicates per concentration/control
- no feeding during the exposure period
- static system
- Method of initiation: neonates were placed in prepared media
- Photoperiod: 16 h light : 12 h dark
- Aeration: none
- Test item concentration/s: 100 mg/L
- Method of administration: stock solution
- Medium renewal: none
- Duration of exposure: 48 hours
- Criteria of effects: The criterion of adverse effects used in this study was the item-induced the loss of locomotory actions of the neonates, observed after 24 and 48 hours.

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

EC0

Effect conc.:

>= 114 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

act. ingr.

Basis for effect:

mobility

Validity criteria fulfilled:

yes

Remarks:

In the control <= 10 % of the daphnids should have been immobilised; dissolved oxygen concentration at the end of the test >= 3 mg/L in control and test vessels

Conclusions:

No toxic effects against daphnids were observed at a limit test concentration of 100 mg/L for the test substance after 48 h.

Executive summary:

A study was performed to assess the acute toxicity of the test substance to daphnids under static conditions as described in the Council Regulation (EC) No 92/69, Method C.2 'Acute toxicity for Daphnia' (1992)..

The daphnids were exposed to a limit test concentration of nominally 100 mg/L of the test substance dissolved in water (10 neonates/vessel, 2 replicates/concentration).

Observations were made on the swimming ability and the immobilisation rate, respectively, after 24 and 48 hours of exposure. The following value was determined EC0 >= 114 mg/L (arithmetic mean of measured concentration).

No toxic effects against daphnids were observed at a limit test concentration of 100 mg/L.

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March-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:

other: ISO 14669 (1999) Water Quality - Determination of acute lethal toxicity to marine copepods (Copepoda; Crustacea)

Qualifier:

according to guideline

Guideline:

other: ISO 5667-16 (1998) Water Quality Sampling – Guidance on biotesting of samples

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):

other aquatic crustacea: Acartia tonsa

Test type:

static

Water media type:

saltwater

Limit test:

no

Total exposure duration:

48 h

Test temperature:

20 +- 2°C

pH:

8.12-8.14

Dissolved oxygen:

89-98 %

Salinity:

36 ‰

Nominal and measured concentrations:

Range finding test: Nominal noncentration (mg/L) 1, 10, 100 and 1000, Analytical concentrations (mg/L) 1, 9, 98, 980
Definitive test: Nominal concentrations (mg/L) 10, 32, 100, 320 and 1000 , Analytical concentrations (mg/L) 9, 30, 90, 310, 950

Details on test conditions:

TEST SYSTEM
- Test vessel: Tests were conducted in 100 ml capacity borosilicate glass crystallising dishes, each containing 50 mL of test medium covered with soda glass watch covers.
- Aeration: yes

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Natural seawater was supplied by pump from Scapa Flow, Orkney and was UV sterilised and filtered to 0.2 μm. The salinity of the seawater was 36 ±4 ‰.

TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 1, 10, 100 and 1000 mg/L (Nominal)
- Results used to determine the conditions for the definitive study: yes

Reference substance (positive control):

yes

Remarks:

3,5-Dichlorophenol

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

85 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

492 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality

Results with reference substance (positive control):

- Results with reference substance valid? Yes
- Mortality: yes
- LC50: 1.05 mg/L

Validity criteria fulfilled:

yes

Conclusions:

FOE-hydroxy exhibited a 48h LC50 value of 85 mg/L (Water Accommodated Fractions (WAFs)) to the marine copepod Acartia tonsa in the aqueous phase.

Executive summary:

FOE-hydroxy exhibited a 48h LC50 value of 85 mg/L (Water Accommodated Fractions (WAFs)) to the marine copepod Acartia tonsa in the aqueous phase.

Description of key information

A study was performed to assess the acute toxicity of the test substance to daphnids under static conditions as described in the Council Regulation (EC) No 92/69, Method C.2 'Acute toxicity for Daphnia'(1992)..

The daphnids were exposed to a limit test concentration of nominally 100 mg/L of the test substance dissolved in water (10 neonates/vessel, 2 replicates/concentration).

Observations were made on the swimming ability and the immobilisation rate, respectively, after 24 and 48 hours of exposure. The following value was determined EC0 >= 114 mg/L (arithmetic mean of measured concentration).

No toxic effects against daphnids were observed at a limit test concentration of 100 mg/L.

FOE-hydroxy exhibited a 48h LC50 value of 85 mg/L (Water Accommodated Fractions (WAFs)) to the marine copepod Acartia tonsa in the aqueous phase.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

114 mg/L

Marine water invertebrates

Marine water invertebrates

Effect concentration:

85 mg/L

Additional information

EC50 for freshwater invertebrates should read "> 114 mg/L".