(5α)-4,5-epoxy-14-hydroxy-3-methoxymorphinan-6-one

Toxicity to aquatic algae and cyanobacteria

Administrative data

Endpoint:

toxicity to aquatic algae and cyanobacteria

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:

2016

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 201 (Alga, Growth Inhibition Test)

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method C.3 (Algal Inhibition test)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

(5α)-4,5-epoxy-14-hydroxy-3-methoxymorphinan-6-one

EC Number:

260-887-7

EC Name:

(5α)-4,5-epoxy-14-hydroxy-3-methoxymorphinan-6-one

Cas Number:

57664-96-7

Molecular formula:

C17H19NO4

IUPAC Name:

(1S,5R,13R,17S)-17-hydroxy-10-methoxy-12-oxa-4-azapentacyclo[9.6.1.0^{1,13}.0^{5,17}.0^{7,18}]octadeca-7(18),8,10-trien-14-one

Test material form:

solid

Details on test material:

brown color

Sampling and analysis

Analytical monitoring:

yes

Remarks:

HPLC-UV

Test solutions

Details on test solutions:

The test medium of the highest test concentration of nominal 80 mg test item/L was prepared by dissolving 40 mg test item into 500 mL test water. Adequate volumes of this test medium were diluted with test water to prepare the test media of the other desired test concentrations. The different test concentrations were 80.0, 25.3, 8.0, 2.5, 0.8 mg of Noroxycodone/L.
There was also a control solution composed of reconstituted water.

Test organisms

Test organisms (species):

Pseudokirchneriella subcapitata (previous names: Raphidocelis subcapitata, Selenastrum capricornutum)

Details on test organisms:

Recently renamed as Raphidocelis subcapitata (KORSHIKOV). The algae were supplied by the „S
ammlung von Algenkulturen, Albrecht-von-Haller-Institut für Pflanzenwissenschaften, Universität Göt
tingen", 37073 Göttingen, Germany.
Endpoints: Yield and growth rate of the algae

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

72 h

Remarks on exposure duration:

A microscopic examination of the shape of the algal cells was done after 72 hours. The cell density on each observation time was determined by spectrophotometric measurement. A stat istical analysis was then conducted.

Post exposure observation period:

A microscopic examination of the shape of the algal cells was done after 72 hours.
The cell density on each observation time was determined by spectrophotometric measurement. A statistical analysis was then conducted.

Test conditions

Hardness:

0.24 mmol/L (= 24 mg/L) as CaCO3

Test temperature:

water temperature of 22°C

pH:

8.2 to 8.7 at test start and 8.2 to 9.2 at test end

Dissolved oxygen:

not specified

Salinity:

not specified

Conductivity:

not specified

Nominal and measured concentrations:

Nominal concentrations: 80.0, 25.3, 8.0, 2.5, 0.8 mg of Noroxycodone/L.

Details on test conditions:

continuous illumination and mean light intensity of 5377 lux

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Results and discussion

Effect concentrations

Effect concentrations 1

Key result

Duration:

72 h

Dose descriptor:

EC50

Effect conc.:

<= 38.1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth rate

Effect concentrations 2

Key result

Duration:

72 h

Dose descriptor:

NOEC

Effect conc.:

<= 8 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth rate

Effect concentrations 3

Key result

Duration:

72 h

Dose descriptor:

LOEC

Effect conc.:

<= 25.3 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth rate

Effect concentrations 4

Duration:

72 h

Dose descriptor:

NOEC

Effect conc.:

<= 0.8 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: yield

Effect concentrations 5

Duration:

72 h

Dose descriptor:

LOEC

Effect conc.:

<= 2.5 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: yield

Effect concentrations 6

Duration:

72 h

Dose descriptor:

EC50

Effect conc.:

18.4 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: yield

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Based on the experimental results, for Noroxycodone, the 72-hour EyC50 was calculated to be 18.4 mg test item/L and the 72-hour ErC50 value was calculated to be 38.1 mg test item/L. The 72-hour NOEyC was determined to be 0.8 mg test item/L and the associated 72-hour LOEyC was 2.5 mg test item/L. The 72-hour NOErC was determined to be 8.0 mg test item/L and the associated 72-hour LOErC was 25.3 mg test item/L.