Hydroxyprogesterone

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:

2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Remarks:

HPLC analysis and UV/VIS-detection

Details on sampling:

Control: at 48 hours
Test concentration/s: 1.9, 9.4 and 100 mg/L at 0 and 48 hours

Vehicle:

no

Details on test solutions:

Pre-treatment of test item and preparation of test item concentrations:
- 100.5 mg of the test item were added to 1 litre of dilution water, treated for 1 h in an ultrasonic bath and stirred for 24 h on a magnetic stirrer
- Undissolved particles of the test item were removed by filtration using a folded filter with a pore size of 7-12 μm
- The pH was measured to be 7.8
- To produce the different test item concentrations appropriate amounts of the stock solution were diluted with dilution water to a volume of 500 mL

Test organisms (species):

Daphnia magna

Details on test organisms:

- Age: 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 in a semi-quantitative way. The neonates were separated from their parent Daphnia by filtration prior to the acute test.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

The hardness of the dilution water used was 13.5 °dH (241 mg/L CaCO3)

Test temperature:

20.4-20.9 °C (concerning the highest test concentration)

pH:

7.8-7.9 (concerning the highest test concentration)

Dissolved oxygen:

9.1 mg/L (concerning the highest test concentration)

Salinity:

n.a.

Conductivity:

No data

Nominal and measured concentrations:

100 mg/L (n): 5.036 mg/L (HPLC-value) after 0 hours of exposure; 4.873 mg/L (HPLC-value) after 48 hours of exposure

Details on test conditions:

EXPOSURE CONDITIONS:
- Test vessels: 100 mL glass beakers covered with watch glasses holding 5 neonates in 50 mL of the test medium
- Experimental design: 7 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
- Temperature of incubation unit: 19.2 to 19.6 °C
- Aeration: none
- Test item concentration/s: 0.88, 1.9, 4.3, 9.4, 20.7, 45.5 and 100 mg/L
- Replicate: For each loading and the control 4 replicates
- Method of administration: stock solution
- Medium renewal: none
- Criteria of effects: The criterion of adverse effects used in this study was the item-induced alteration of the normal mobility behaviour and the loss of locomotory
actions of the neonates, observed at 24 and 48 hours

Reference substance (positive control):

not specified

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

1.045 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95 % confidence limits 0.777–1.420 mg/L

Duration:

48 h

Dose descriptor:

EC0

Effect conc.:

0.094 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC100

Effect conc.:

5.036 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

Effective concentrations ranged from 4.96 % to 5.04 % of nominal values at 0 hours and from 4.75 % to 4.99 % of nominal values at 48 hours.

Validity criteria fulfilled:

yes

Remarks:

(Immobilisation and other abnormalities in the controls did not exceed 10% by the end of the test; dissolved oxygen concentration remained above 3 mg/L throughout the exposure period)

Conclusions:

After 48 hours of exposure an EC50 of 1.045 mg/L was determined. The results are expressed in terms of measured initial concentrations.

Executive summary:

A study was performed to assess the acute toxicity to Daphnia magna STRAUS under static conditions. 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 range of concentrations, nominally 0.88, 1.9, 4.3, 9.4, 45.5 and 100 mg/L dissolved in dilution water. Auxiliaries used to prepare the test media were an ultrasonic bath, a magnetic stirrer and a folded filter. Observations were made on the swimming ability and the immobilisation rate, respectively, after 24 and 48 hours of exposure. After 48 hours of exposure an EC50 of 1.045 mg/L was determined. The results are expressed in terms of measured initial concentrations. Effective concentrations ranged from 4.96 % to 5.04 % of nominal values at 0 hours and from 4.75 % to 4.99 % of nominal values at 48 hours. This toxicity study is classified as acceptable and satisfies the guideline requirements for the acute Daphnia study.

Description of key information

The acute toxicity to daphnia magna was investigated in a static GLP study following OECD 202. After 48 hours of exposure an EC50 of 1.045 mg/L was determined.The results are expressed in terms of measured initial concentrations.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Dose descriptor:

EC50

Effect concentration:

1.045 mg/L

Additional information

Effective concentrations ranged from 4.96 % to 5.04 % of nominal values at 0 hours and from 4.75 % to 4.99 % of nominal values at 48 hours.