4-(4-methoxyphenyl)butan-2-one

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:

2016-07-18 to 2016-07-22

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

1992

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Version / remarks:

2008

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 38 mg/L
- Sampling method: 0.5 mL sample diluted with mobile phase (0.95 mL)
- Sample storage conditions before analysis: 6+/- 2°C

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: direct pipetting into the test vessel. Test media were mixed with an ultraturrax (1 min at 12000rpm)

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Danio rerio, Zebrafish
- Source:All fish used were gained at the test facility from one single brood stock.
- Length at study initiation: 2.74 cm (2.7-2.8 cm)
- Weight at study initiation: 0.181 g (pooled)


ACCLIMATION
- Acclimation period: 12 days
- Acclimation conditions: same as test
- Type and amount of food during acclimation: 4% of the fish body weight per feeding day, fish food:sera vipan food
- Feeding frequency during acclimation: 3 times per week
- Health during acclimation: mortality < 5%. No disease treatment administered.

FEEDING DURING TEST: None

Test type:

static

Water media type:

freshwater

Remarks:

tap water of local origin

Limit test:

yes

Total exposure duration:

96 h

Hardness:

63 mg/L CaCO3

Test temperature:

22.7 +/- 0.1, measured at start and every 24h

pH:

7.2 to 7.8, measured at start and every 24h

Dissolved oxygen:

97 to 100 % oxygen saturation, no less than 60% of air saturation value.

Conductivity:

174 µS/cm

Nominal and measured concentrations:

Nominal concentrations: 38 mg/L
Measured concentration (0 h): 40.7 mg/L
Measured concentration (96 h): 37.8 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: glass aquaria
- Type: open
- Material, size, headspace, fill volume: 13 L glass aquaria (25.5 x 18 x 28 cm), filled with 10 L
- Aeration: gentle aeration
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: tap water, filtered over activated charcoal and aerated at least 24h
- Chlorine: removed by aeration
- Alkalinity: 0.6 mmol/L
- Acidity: 0.1 mmol/L
- Culture medium different from test medium: no
- Intervals of water quality measurement: measured quarterly

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16h light, 8h dark
- Light intensity: 7-750 Lux

EFFECT PARAMETERS MEASURED
- Parameters: mortality and other visible abnormalities (swimming behaviour, loss of equilibrium, pigmentation etc.).
- Frequency: 4, 24, 48, 72 and 96 h

TEST CONCENTRATIONS
- Justification for using less concentrations than requested by guideline: Limit test
- Test concentrations: 38 mg/L
- Results used to determine the conditions for the definitive study: EC50 value in algae toxicity test was 38 mg/L and the EC50 in Daphnia acute toxicity test was > 100 mg/L. No range finding study was conducted.

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 38 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other:

Remarks:

Nominal concentrations verified by measurements

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

>= 38 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other:

Remarks:

Nominal concentrations verified by measurements

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

> 38 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other:

Remarks:

Nominal concentrations verified by measurements

Details on results:

- Behavioural abnormalities: No abnormalities observed in control and at 38 mg/L
- Mortality of control: 0
- Mortality at 38 mg/L: 0
- Other adverse effects control: None
- Other adverse effects at 38 mg/L: None
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: Solution remained visibly clear.

Sublethal observations / clinical signs:

Observations in the Test Vessels:

Nominal conc. (mg/L)	Effect*	Number of fish effected at observation time (hours)
		4	24	48	72	96
38.0	(1)	7/7	7/7	7/7	7/7	7/7
Control	(1)	7/7	7/7	7/7	7/7	7/7

* The numbers in brackets correspond to the following observations:

(1) = Normal behavior

 

 

Cumulative mortality (%) in the Test Vessels:

Nominal conc. (mg/L)	Cumulative mortality at observation time (hours)
	4	24	48	72	96
38.0	0	0	0	0	0
Control	0	0	0	0	0

 

 

Measured exposure concentrations during the Definitive Test:

Sampling date	2016-07-18 Start of the exposure (0 hours)		2016-07-22 End of the exposure (96 hours)
Start of analysis	2016-07-18		2016-07-22
Nominal conc. (mg/L)	Measured conc. (mg/L)	%	Measured conc. (mg/L)	%
38.0	70.7	107	37.8	100
Control	< LOQ		< LOQ

 

Validity criteria fulfilled:

yes

Remarks:

Validity criteria were checked and fulfilled.

Conclusions:

In a static limit test, the 96h LC50 value for fish was determined to be above 38.0 mg/L (treshold approach). At this concentration, no mortality was observed, resulting in a LC0 of > 38.0 mg/L.

Executive summary:

The acute toxicity of the test item to fish (zebrafish) was determined according to OECD 203. In a static test, 7 fish were exposed to a limit concentration of 38.0 mg/L for 96 h. The selection of the treshold test concentration was based on the results of an algae toxicity test, yielding a EC50 of 38 mg/L and a Daphnia acute toxicity test which resulted in a EC50 > 100 mg/L. The test concentrations were analytically verified (HPLC-DAD) after 0 and 96 hours from the fresh and corresponding old media.

The recovery rates in freshly prepared media (0 hours) and the corresponding old media (96 hours) were 107 and 100 % of the nominal values.

No mortality or no abnormal behaviour was observed at 38 mg/L. Hence, it was concluded that the LC50 (96h) is > 38 mg/L.

Description of key information

The acute toxicity of the test item to fish (zebrafish) was determined according to OECD 203. In a static test set-up, 7 fish were exposed to a treshold concentration of 38.0 mg/L for 96 h. The selection of the treshold test concentration was based on the results of an algae toxicity test, yielding a EC50 of 38 mg/L and a Daphnia acute toxicity test which resulted in a EC50 > 100 mg/L. As no effects were observed at the treshold concentration, it was concluded that the LC50 (96h) is > 38 mg/L. This outcome shows that the fish is not the most sensitive species.