Registration Dossier

Ecotoxicological information

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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 201 (Alga, Growth Inhibition Test)
Qualifier:
equivalent or similar to
Guideline:
EU Method C.3 (Algal Inhibition test)
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 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 concentrationsopen allclose all
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
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
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
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
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
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.