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

EC Number:

251-561-5

EC Name:

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

Cas Number:

33522-95-1

Molecular formula:

C16H17NO4

IUPAC Name:

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

Test material form:

solid

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 0.75 to 17.5 hours old, female.
The daphnids introduced in the test were taken from ibacon's in-house laboratory culture

Study design

Test type:

static

Water media type:

other: Reconstituted Water

Remarks:

based on the OECD 202 water composition

Limit test:

yes

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 20°C.

pH:

8.0 to 8.4

Dissolved oxygen:

7.1 to 8.7 mg/L

Nominal and measured concentrations:

Test concentration of nominal 100 mg test item/L, corresponding to a mean measured test concentration of 63.3 mg test item/L.

Details on test conditions:

Photoperiod: 16 h light - 8 h dark; light intensity: 500 to 760 lux.

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Results and discussion

Effect concentrations

Effect concentrations 1

Key result

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

>= 63.3 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Key result

Duration:

48 h

Dose descriptor:

LOEC

Effect conc.:

> 63.3 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 3

Key result

Duration:

48 h

Dose descriptor:

EC50

Remarks on result:

not determinable

Details on results:

After 48 hours of exposure, no immobilisation of the test animals was observed in the control and in the only test concentration of 63.3 mg test item/L (mean measured).
The EC50, EC20 and ED10 were not determinable. The EC50 could not be quantified due to the absence of toxicity of the test item. The NOEC and the LOEC were determined directly from the raw data.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Based on the experimental results, for Noroxymorphone, the 48-hour NOEC was determined to be ≥ 63.3 mg test item/L (mean measured). The 48-hour LOEC was determined to be > 63.3 mg test item/L (mean measured) and the 48-hour EC50 value could not be determined.