Androst-4-ene-3,17-dione

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:

07 to 14 May 2013

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

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

Sampling schedule:
- Stock solution: each day
- Control: in the freshly prepared media after 0 and 24 hours and in the medium after 24 hours of exposure
- Test concentration: in the freshly prepared media after 0 and 24 hours and in the media after 0 and 24 hours of exposure

Vehicle:

no

Details on test solutions:

Test item concentration:
- 500 mg of the test item were added daily to 5 litres of dilution water, treated for 1 h in an ultrasonic bath and stirred for 1 h on a magnetic stirrer
- Undissolved particles were removed by filtration using a folded filter (pore size of 7-12 µm)
- pH: 7.8-8.0
- the test concentration was determined analytically by HPLC

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

- Source: Aqua KloeGer (Germany)
- Date of birth: --
- Date supplied: 2013-04-09
- Acclimatisation: Stock held since 2013-04-09 and acclimatised to the test conditions since then
- Temperature: 20 - 24 °C
- Dissolved oxygen: > 5 mg/L
- Feeding: Commercial fish food, daily. Feeding discontinued 24 h prior to test start.
- Mortalities during acclimatisation period: < 5 %
- Medication: none
- Mean standard length (n = 42): 3.16 cm (S.D. = 0.24 cm)

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

14.4 °dH (257 mg/L CaCO3)

Test temperature:

21.4-21.6 °C (after 96 hrs)

pH:

7.9 (after 96 hrs)

Dissolved oxygen:

8.5-8.7 mg/L (after 96 hrs)

Salinity:

n.a.

Nominal and measured concentrations:

nominal: 0.43, 0.94, 2.1, 4.5, 10 mg/L
Effective concentrations ranged from 89.3 % to 98.9 % % of nominal values at 0 hours and from 65.1 % to 89.5 % of nominal values at 24 hours under semi static conditions.

Details on test conditions:

Exposure conditions
- Test vessels: glass aquaria holding 5 L of test media covered by glass plates
- Experimental design: 5 test concentrations plus 1 control
- 7 fish per test concentration
- no feeding during the exposure period
- Method of initiation: fish were placed in prepared media
- Loading: 0.46 g body weight (wet weight) per litre
- Photoperiod: 16 h light: 8 h dark
- Temperature: 21.4 to 22.2 °C
- Aeration: gentle aeration via narrow glass tubes
- Test item concentration: 0.43, 0.94, 2.10, 4.55 and 10 mg/L
- Method of administration: stock solution
- Medium renewal: daily
- 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 2, 24, 48, 72 and 96 hours, type and incidence of sub lethal effects compared with control fish were observed.

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

8.609 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

All results are expressed in terms of geometric mean measured concentrations. Effective concentrations ranged from 89.3 % to 98.9 % % in the freshly prepared media and from 65.1% to 89.5 % in the media after 24 hours of exposure.

Sublethal observations / clinical signs:

Validity criteriaaccording to OECD 203:

Target condition according to guideline:	Actual condition according to the study:	Validity criteria met:
in the control(s) (dilution water control, solvent control), the mortality should not exceed 10% (or one fish, if fewer than 10 control fish are tested) at the end of the exposure	The mortality in the controls did not exceed 10 % by the end of the test.	Yes
the dissolved oxygen concentration should be ≥60% of the air saturation value in all test vessels throughout the exposure	The dissolved oxygen concentration remained above 60 % of the air-saturation value throughout the exposure period.	Yes
The pH should not vary by more than one unit.	The pH did not vary by more than 1 unit.	Yes

 

Validity criteria fulfilled:

yes

Remarks:

mortality in the controls < 10% by the end of the test; dissolved oxygen concentration above 60% of the air-saturation value throughout the exposure period; pH did not vary by more than 1 unit

Conclusions:

After 96 h a LC50 of 8.609 mg/l was measured for Androstendion towards fish. The result is expressed in terms of geometric mean measured concentrations. Effective concentrations ranged from 89.3 % to 98.9 % % in the freshly prepared media and from 65.1% to 89.5 % in the media after 24 hours of exposure.

Executive summary:

The study was conducted under semi static conditions in accordance with Council Regulation (EC) No 440/2008, Method C.1 'Acute toxicity for Fish' (2008) which is in most parts equivalent to the OECD Guideline for Testing of Chemicals No. 203 'Fish, Acute Toxicity Test' (1992). Groups of seven fish of the recommended size were exposed to a range of concentrations, nominally 0.43, 0.94, 2.10, 4.55 and 10 mg/L of Androstendion dissolved in dilution water. Auxiliaries used to prepare the test media were an ultrasonic bath, a magnetic stirrer and folded filters. Observations were made on the numbers of dead fish and the incidence of sub-lethal effects after 2, 24, 48, 72 and 96 hours of exposure. This toxicity study is classified as acceptable and satisfies the guideline requirements for the acute fish study.

Description of key information

After 96 h a LC50 of 8.609 mg/l was determined. The result is expressed in terms of geometric mean measured concentrations.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

LC50

Effect concentration:

8.609 mg/L