Estr-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:

2016

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:

not applicable

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

Sampling schedule:
- Control : at 24 hours
- Test concentrations : at 0, 24, 48, and 72 hours in the freshly prepared media and at 24, 48,72 and 96 hours in the media after 24 hours of exposure

Vehicle:

no

Details on test solutions:

PRETREATMENT OF THE TEST SUBSTANCE:
- 1000 mg of the test item were added to 10 litres of dilution water
- treated for 1 h in an ultrasonic bath and stirred for 24 h on a magnetic stirrer
- Undissolved particles were removed by filtration using a folded filter with a pore size of 7-12 µm

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

- Source : Interaquaristik.de Shop (Germany)
- Date supplied : 2016-01-11
- Acclimatisation : Stock held since 2016-01-11 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) : 2.82 cm (S.D. = 0.19 cm)

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

12.7 °dH (227 mg/L CaCO3)

Test temperature:

21.5-21.7 °C (concerning the highest test concentration)

pH:

7.9 (concerning the highest test concentration)

Dissolved oxygen:

8.6-8.8 mg/L (concerning the highest test concentration)

Salinity:

n.a.

Nominal and measured concentrations:

Effective concentrations ranged from 87.3 % to 101.1 % of nominal values in the freshly prepared media and from 71.3 % to 95.2 % of nominal values in the media after 24 hours of exposure.

Details on test conditions:

EXPOSURE CONDITIONS:
- Test vessels: glass aquaria holding 5 L of test media covered by glass plates
- Experimental design: 5 test concentration plus 1 control
- Number of test species: 7 fish per test concentration
- Feeding during the exposure period: none
- Method of initiation: fish were placed in prepared media
- Loading: 0.33 g body weight (wet weight) per litre
- Photoperiod: 16 h light: 8 h dark
- Temperature: 21.1 to 21.7 °C
- Aeration: gentle aeration via narrow glass tubes
- Test item concentration/s: 1.56, 3.13, 6.25, 12.5 and 25 mg/L
- Method of administration: stock solution
- Medium renewal: daily
- 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

Reference substance (positive control):

not required

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

17.6 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

12.5 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

25 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

All results are expressed in terms of nominal concentrations, because the relevant test item concentrations for the calculation of LCx-values were within the range of 80%-120% recovery during the test. Effective concentrations ranged from 87.3 % to 101.1 % of nominal values in the freshly prepared media and from 71.3 % to 95.2 % of nominal values in the media after 24 hours of exposure.

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 hours of exposure a LC50 of 17.634 mg/L was determined. All results are expressed in terms of nominal concentrations.

Executive summary:

A study was performed to assess the acute toxicity to Danio rerio under static conditions. The study was conducted 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). A group of seven fish of the recommended size was exposed to 5 test concentration (1.56, 3.13, 6.25, 12.5 and 25 mg/L) dissolved in dilution water. Auxiliaries used to prepare the test media were an ultra turrax, a magnetic stirrer and a folded filter. Observations were made on the number of dead fish and the incidence of sub-lethal effects after 2, 24, 48, 72 and 96 hours of exposure. After 96 hours of exposure a LC50 of 17.634 mg/L was determined. All results are expressed in terms of nominal concentrations, because the relevant test item concentrations for the calculation of ECx-values were within the range of 80%-120% recovery during the test. Effective concentrations ranged from 87.3 % to 101.1 % of nominal values in the freshly prepared media and from 71.3 % to 95.2 % of nominal values in the media after 24 hours of exposure. This toxicity study is classified as acceptable and satisfies the guideline requirements for the acute fish study.

Description of key information

The acute toxicity of the substance to fish (Danio rerio) was investigated in a semi-static test according to EEC methods for Determination of Ecotoxicity Annex to Directive 92/69/EEC (O.J. No. L383A, 29.12.92) Part C, Method 1 "Acute toxicity for Fish". After 96 hours of exposure a LC50 of 17.6 mg/L was determined. All results are expressed in terms of nominal concentrations.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

17.6 mg/L

Additional information

The relevant test item concentrations for the calculation of ECx-values were within the range of 80%-120% recovery during the test. Effective concentrations ranged from 87.3 % to 101.1 % of nominal values in the freshly prepared media and from 71.3 % to 95.2 % of nominal values in the media after 24 hours of exposure.