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

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:

2016

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

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 organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

Daphnia magna (Straus), clone 5, aged from 3.5 to 20 hours old, female.

Study design

Test type:

static

Water media type:

not specified

Limit test:

no

Total exposure duration:

48 h

Post exposure observation period:

Not specified

Test conditions

Hardness:

2.5 mmol/L (= 250 mg/L) as CaCO3

Test temperature:

water temperature of 19 to 21°C

pH:

7.9 to 8.8

Dissolved oxygen:

8.3 to 8.9 mg/L

Nominal and measured concentrations:

Nominal concentrations: 100, 45.5, 20.7, 9.4 and 4.3 mg test item/L

Details on test conditions:

Photoperiod: 16 h light - 8 h dark; light intensity: 400 to 590 lux
Controlled environment room

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Results and discussion

Effect concentrations

Effect concentrations 1

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

<= 57.1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Key result

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

<= 4.3 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 3

Key result

Duration:

48 h

Dose descriptor:

LOEC

Effect conc.:

<= 9.4 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

After 48 hours of exposure no immobilisation of the test animals was observed in the control and in the test item concentration of 4.3 mg test item/L. At the concentration of 9.4 mg test item/L, two animals were immobile. In the test item concentration of 20.7 mg test item/L five animals were immobile. At the test item concentration of 45.5 mg test item/L seven animals were immobile and at the concentration of 100 mg test item/L 14 animals were immobilized.

Results with reference substance (positive control):

24h EC50 = 1.58 mg/L, 48h EC50 = 0.986 mg/L
NOEC = 0.5 mg/L (at 24 and 48 hours), LOEC = 1.0 mg/L (at 24 and 48 hours).
The value of 24h EC50 indicates that the sensitivity of the Daphnia is consistent with the level proposed by the OECD 202 guideline (EC50-24 h between 0.6 and 2.1 mg potassium dichromate/L).

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Based on the experimental results for Noroxycodone, the 48-hour NOEC was determined to be 4.3 mg test item/L. The 48-hour LOEC was determined to be 9.4 mg test item/L and the 48-hour EC50 value was calculated to be 57.1 mg test item/L.