(17ß)-3-Hydroxyestra-1,3,5(10)-trien-17-yl acetate

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:

2018

Report date:

2018

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:

(17β)-3-Hydroxyestra-1,3,5(10)-trien-17-yl acetate

EC Number:

605-722-5

Cas Number:

1743-60-8

Molecular formula:

C20H26O3

IUPAC Name:

(17β)-3-Hydroxyestra-1,3,5(10)-trien-17-yl acetate

Test material form:

solid: crystalline

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. 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 200.10 mg of test item was measured into 2 000 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 100 ml filtrate was disposed. The concentration of the test item in the filtrate (stock solution) was determined by UHPLC. The measured value was 0.17 mg/L.

Preparation of test solutions:
Five 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 1.2. 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 of thermostat was recorded daily and registered continuously by Extech datalogger. 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 pH was 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: 0.17; 0.16; 0.15; 0.14 and 0.11 mg/L. The following actual concentrations were calculated from the measured values in the test: 0.12; 0.12; 0.11; 0.09 and 0.07 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

Key result

Duration:

48 h

Dose descriptor:

EC50

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

not determinable

Details on results:

The NOEC and LOEC were also not determined.

Applicant's summary and conclusion

Validity criteria fulfilled:

no

Remarks:

As the measured concentrations are based on a non GLP conform validation the toxicity results must be interpreted by precaution

Conclusions:

In this Daphnia sp., Acute Immobilisation Test for Estradiol-17ß-acetate the results indicated that the test item is not hazardous to the aquatic environment up to its solubility concentration. As the test item had not got any toxic effect up to its solubility concentration the values of EC10, EC20 and EC50 could not be determined.