Pregna-1,4-diene-3,20-dione, 6-fluoro-11-hydroxy-16-methyl-21-[(1-oxopentyl)oxy]-, (6.alpha.,11.beta.,16.alpha.)-

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

03 Apr to 10 May 2017

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

No analytical verification of test item concentrations.

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

no

Remarks:

on customer request the study was conducted without analysis

Vehicle:

no

Remarks:

Auxiliaries: ultrasonic bath, magnetic stirrer and folded filter

Details on test solutions:

Pre-treatment of test item and preparation of test item concentration
- 1.2 mg of the test item in 1 litre of dilution water, treated for 1 h in an ultrasonic bath and stirred for 24 h on a magnetic stirrer
- undissolved particles removed by filtration using a folded filter (pore size 7-12 μm)
- measured pH 7.7
- 50 mL of the solution were taken and diluted with 0.5 mL of dilution water resulting in a final concentration of 1.0 mg/L

Test organisms (species):

Daphnia magna

Details on test organisms:

- Name: Daphnia magna STRAUS, parthenogenetic females
- Source: Strain of Bundesgesundheitsamt Berlin
- Maintenance and Acclimatisation: A population of parthenogenetic females of synchronized age structure has been maintained for more than 20 years in the test facility under constant temperature conditions (20 +/- 2 °C) at a 16 : 8 hour light-dark photoperiod (light intensity: < 20 μE x m-2 x s-1). The culture water (so-called 'M4 medium') was partly renewed once a week. The Daphnia were exclusively fed unicellular green algae (Desmodesmus subspicatus) 'ad libitum'. Mortalities of parent Daphnia during the culture period were recorded daily. The neonates were separated from their parent Daphnia by filtration prior to the acute test.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

14.3 °dH

Test temperature:

20 +/- 2 °C

pH:

7.8 - 8.0

Dissolved oxygen:

8.0 - 8.1 mg O2/L

Nominal and measured concentrations:

1 mg/L (nominal concentration)

Details on test conditions:

- Test vessels: 100 mL glass beakers covered with watch glasses holding 5 neonates in 50 mL of test medium
- Experimental design: 1 test concentration plus 1 control, 5 neonates per vessel, 4 replicates per concentration/control
- no feeding during the exposure period
- Method of initiation: neonates were placed in prepared media
- Photoperiod: 16 h light : 8 h dark
- Aeration: none
- Method of administration: direct weighing
- Medium renewal: none
- Criteria of effects: item-induced alteration of the normal mobility behaviour and the loss of locomotory actions of the neonates, observed at 24 and 48 hours

Duration:

48 h

Dose descriptor:

EC0

Effect conc.:

>= 1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC100

Effect conc.:

> 1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

No visible effects on behaviour and appearance of daphnids have been observed during exposure period.

Abiotic parameters at test start and test end

 

nominal test conc. [mg/L]	test start (0 h)				test end (48 h)
	Temp. [°C]	Oxygen [mg/L]		pH	Temp [°C]	Oxygen [mg/L]	pH
Control	20.4	8.0		7.9	20.0	8.1	8.0
1.0	20.0	8.1		7.8	20.0	8.1	7.8

 

Validity criteria for the measurement of the short-term toxicity to aquatic invertebrates:

Target condition according to guideline:	Actual condition according to the study:	Validity criteria met:
Young daphnids, aged less than 24 hours at the start of the test, are exposed to the test substance at a range of concentrations for a period of 48 h.	Neonates were used in this test.	Yes
In the control, including the solubilising agent, not more than 10 % of the daphnids should have been immobilized. (Not more than 10 % of the control daphnids should show immobilisation or other signs of disease or stress, for example, discoloration or unusual behaviour such as trapping at surface of water)	In the control 0% mortaility an no other adverse effects were observed.	Yes
At least five test concentrations should be used. They should be arranged in a geometric series with a separation factor preferably not exceeding 2.2. The highest concentration tested should preferably result in 100 % immobilization, and the lowest concentration tested should preferably give no observable effect.	One test concentration was used (limit test). EC0 and EC100 were determined.	Yes

Validity criteria fulfilled:

yes

Remarks:

See "Any other information on results incl. tables"

Conclusions:

No toxic effects of Fluocortolon-21-Valerat against Daphnia were observed at a limit test concentration of 1.0 mg/L (nominal concentration) after 48 h.

Executive summary:

The study was conducted in accordance with the Council Regulation (EC) No 440/2008, Method C.2 ‘Acute toxicity for Daphnia’ (2008) which is equivalent to OECD Guideline for Testing of Chemicals No. 202 'Daphnia sp., Acute Immobilisation Test' (adopted April 13, 2004).

The Daphnia were exposed to a limit test concentration of nominally 1.0 mg/L of Fluocortolon-21-Valerat dissolved in dilution water ina static test for 48 h. Auxiliaries used to prepare the test media were an ultrasonic bath, a magnetic stirrer and a folded filter. During the test a temperature range of 18 - 22 °C was maintained in the test vessels, with a maximum temperature fluctuation of +/- 1 °C in each individual test. The temperature, the pH and the oxygen values were measured at the beginning and end of the test

Observations were made on the swimming ability and the immobilisation rate, respectively, after 24 and 48 hours of exposure. No toxic effects were observed. Thus, the 48h-EC50 was determined to be > 1.0 mg/L (nominal concentration).

 

Description of key information

In accordance with with the Council Regulation (EC) No 440/2008, Method C.2 ‘Acute toxicity for Daphnia’ (2008) daphnids were exposed to a limit test concentration of nominally 1.0 mg/L of Fluocortolon-21-Valerat dissolved in dilution water. Observations were made on the swimming ability and the immobilisation rate, respectively, after 24 and 48 hours of exposure.

No toxic effects against Daphnia were observed at a limit test concentration of 1.0 mg/L under exposure conditions. The EC50 after 48 h was determined to be > 1.0 mg /L (nominal concentration).

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Dose descriptor:

EC50

Effect concentration:

> 1 mg/L