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Ecotoxicological information

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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Qualifier:
equivalent or similar to
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 concentrationsopen allclose all
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
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
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.