Gon-4-ene-3,17-dione, 13-ethyl-

Short-term toxicity to aquatic invertebrates

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

(+)-13-Ethylgon-4-ene-3,17-dione

EC Number:

606-833-1

Cas Number:

21800-83-9

Molecular formula:

C19H26O2

IUPAC Name:

(+)-13-Ethylgon-4-ene-3,17-dione

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Test item: Levodione
CAS number: 21800-83-9
Physical state: Solid, crystalline powder
Colour: White
Storage: At a temperature of 15 to 30 °C

Sampling and analysis

Analytical monitoring:

yes

Test solutions

Vehicle:

yes

Details on test solutions:

Preparation of stock solution:
The preparation of stock and test solutions was based on the preliminary non GLP range finding test [9]. As the Range Finding Test was not performed in compliance with the GLP-Regulations it is excluded from the Statement of Compliance in the final report, but the raw data of this test are archived under the study code of present study. For the stock solution 100.21 mg of test item was measured into 1 000 ml Elendt M4 medium. The suspension was stirred for 24 hours. After stirring the suspension was filtered through a 0.2 μm WhatmanTM ME24 (Mixed cellulose ester) filter. The first 20 ml filtrate was disposed. The concentration of the test item in the filtrate (stock solution) was determined by UHPLC. The measured value was 40.65 mg/L.
Preparation of test solutions
Six dilution levels were prepared by mixing appropriate volume of Elendt M4 medium and stock solution of the test item. The maximum separation factor between of test vessels was 1.6. The following table shows the preparation of the different dilution levels. The volume of the prepared test solutions was 300 ml.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

Test species: Daphnia magna Straus
Age: < 24 hours neonates
Origin: National Institute of Environmental Health
Date of arriving: 16 May 2013
Culture conditions: The test species is maintained in Elendt M4 medium with culture conditions at 21±1 °C and a light/dark cycle of 16/8 hours with light intensities of less than 1000 Lux. The cultures are fed with centrifugalized green alga (Pseudokirchneriella subcapitata) cells daily at weekdays.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test conditions

Test temperature:

The temperature inside the thermostat at the test vessels was measured and registered continuously by Extech SD200 thermometer and datalogger.

pH:

The pH was measured at the beginning and at the end of the test. At the beginning of the test the pHwas measured from the remaining test solutions of the concurrent test vessels at each dilution levels. At the end of the test the pH was measured in each test vessel.

Dissolved oxygen:

The dissolved oxygen was measured at the beginning and at the end of the test. At the beginning of the test the dissolved oxygen was measured from the remaining test solutions of the concurrent test vessels at each dilution levels. At the end of the test the dissolved oxygen was measured in each test vessel.

Nominal and measured concentrations:

In the test the following nominal concentrations were applied: 6.78; 10.84; 16.26; 24.39; 33.88 and 40.65 mg/L. The following actual concentrations were calculated from the measured values in the test: 6.65; 10.70; 16.02; 24.09; 33.67 and 40.61 mg test item/L.

Details on test conditions:

The test was maintained under static conditions for a period of 48 hours. At the start of the study each test vessels contained 50 ml of test solutions and five young daphnids. In the test four replicates total of 20 animals at each test concentration level were investigated. The test vessels were covered with plastic lids and were kept in thermostat at 21 ± 1 °C with a 16/8 hours light/dark cycle. Each control vessels containing five young daphnids in Elendt M4 medium were prepared in four replicates and kept under the same static conditions. The number of immobilised and abnormally behaved daphnids was recorded after 24 and 48h. A daphnia is considered to be immobile if it is not able to swim within 15 seconds after a gentle agitation of the test vessel. The daphnids were not fed during the test.

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

24.4 mg/L

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Duration:

48 h

Dose descriptor:

other: EC20

Effect conc.:

16.05 mg/L

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 3

Duration:

48 h

Dose descriptor:

EC10

Effect conc.:

12.89 mg/L

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 4

Duration:

48 h

Dose descriptor:

NOEC

Remarks on result:

not determinable

Details on results:

The No Observed Effect Concentration (NOEC) and Lowest Observed Effect Concentration (LOEC) of the test item were determined with Fisher’s exact binominal test with Bonferroni correction by ToxRat® software. The results were not applicable to the data obtained.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

In this Daphnia sp., Acute Immobilisation Test for Levodione the results indicated that the test item is hazardous to the aquatic environment and classified into the third acute toxic hazardous category [GHS Acute aquatic hazard Category Acute III. – 48 hr EC50 (for Crustacea) > 10 mg/L but ≤ 100 mg/L].