3β-hydroxyandrost-5-en-17-one acetate

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:

2017-06-09 to 2017-08-11

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: Guidance document on aquatic toxicity testing of difficult substances and mixtures, OECD series on testing and assessment number 23, December 14, 2000

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: M16GB2547
- Expiration date of the lot/batch: 2018-07-01 (retest date)
- Purity test date: 2016-10-28 (certificate of analysis release date)

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
- Stability under test conditions: not indicated
- Solubility and stability of the test substance in the solvent/vehicle: not indicated

Analytical monitoring:

yes

Details on sampling:

- Sampling method: singular samples for possible analysis were taken from the approximate centre of the test vessels from all test concentrations and the control at the start and the end of the first and the last renewal period. Volume was 2.0 mL.
- Sample storage conditions before analysis: the samples were stored in a freezer. Additionally, reserve samples of 2.0 mL were taken for possible analysis.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A saturated solution (SS) was prepared at a loading rate of 100 mg/L applying 3 days of magnetic stirring at room temperature followed by filtration through a 0.45 µm membrane filter (RC55, Whatman). The filter was pre-conditioned with a small volume of test solution that was discarded. The obtained filtrate was used as the highest concentration. The lower test concentrations were prepared by subsequent dilutions of the highest concentration in test medium.
- Controls: yes
- Evidence of undissolved material (e.g. precipitate, surface film, etc): final test solutions were clear and colourless

Test organisms (species):

Cyprinus carpio

Details on test organisms:

TEST ORGANISM
- Common name: Carp
- Source: Zodiac, proefacc, "De Haar Vissen", Wageningen University and Research Centre, The Netherlands
- Length at study initiation (length definition, mean, range and SD): range-finding test: 3.8 ± 0.2 cm, Final test: 3.1 ± 0.2 cm
- Weight at study initiation (mean and range, SD): range-finding test: 0.78 ± 0.18 g, Final test 0.40 ± 0.08 g
- Feeding during test: no

ACCLIMATION
- Acclimation period: at least 12 days after delivery
- Acclimation conditions (same as test or not): yes
- Type and amount of food: pelleted fish food
- Feeding frequency: daily
- Health during acclimation (any mortality observed): mortality less than 5% seven days before test

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

not reported

Test temperature:

20-24°C ± 2°C

pH:

6.0-8.5 ± 1

Dissolved oxygen:

6.6-9.2 mgO2/L

Salinity:

not relevant

Conductivity:

not indicated

Nominal and measured concentrations:

Range-finder:
Nominal concentrations: 1.0%, 10 and 100% of SS (prepared at a loading rate of 100 mg/L, 1.0 and 10 % not analysed))
Measured concentrations at t=0h: 1.11 mg/L
Measured concentrations at t=24h: 0.669 mg/L
Measured concentrations at t=96h: 0.0307 mg/L

Final test:
Nominal concentrations: undiluted SS at 100 mg/L
Measured concentrations at t=0h (fresh): 0.906 mg/L
Measured concentrations at t=0h (old): 0.531 mg/L
Measured concentrations at t=0h (fresh): 0.970 mg/L
Measured concentrations at t=96h (old): 0.339 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: beaker
- Material, size, headspace, fill volume: 10 L, all-glass filled with 5 L test solution
- Aeration: not during the test
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.56 g fish/L

OTHER TEST CONDITIONS
- Photoperiod: 16h light daily

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Fish were considered to be dead when no reaction was observed after touching the caudal peduncle and visible breathing movements were absent.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: none (limit test)
- Range finding study: yes
- Test concentrations: 1%, 10% and 100% of a saturated solution with nominal loading rate 100 mg/L
- Results used to determine the conditions for the definitive study: yes

Reference substance (positive control):

yes

Remarks:

pentachlorophenol

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 100% v/v saturated solution, equivalent to a loading rate of 100 mg/L

Details on results:

- Mortality of control: none
- Other adverse effects control: no
- Mortality observed at the limit test concentration: none
- Other effects observed at the limit test concentration: none

Results with reference substance (positive control):

- Results with reference substance valid? yes
- EC50/LC50: 96-h LC50 = 0.32 mg/L (95% CL 0.22-0.46 mg/L).

Reported statistics and error estimates:

No LC50 could be calculated because no mortality was observed in this study (LC50 > maximum concentration tested).

Validity criteria fulfilled:

yes

Conclusions:

The acute toxicity of T008506 to carp was determined in a 96-hour semi-static limit test according to OECD guideline 203. Under the conditions of the present study, the 96-h LC50 exceeded the arithmetic mean measured concentration of 0.63 mg/L obtained in saturated solution prepared at a loading rate of 100 mg/L. The results of the test can be considered reliable without restriction.

Description of key information

The study of Tobor-Kaplon (2017), investigating the acute toxicity of T008506 in carp according to OECD guideline 203, was considered as the key study for endpoint coverage. An LC50 > 100 mg/L (test concentration based on loading rate) was obtained after an exposure of 96 hours in a static test in freshwater. Based on the results it can be considered that T008506 is not harmful to fish.

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