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 (Freshwater Alga and Cyanobacteria, 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

Sampling and analysis

Analytical monitoring:
yes
Remarks:
HPLC-UV

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
Post exposure observation period:
Microscopic examination of the shape of the algal cells after 72h was done.
Cell densitiy 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 was 22°C.
pH:
pH was 8.2 to 8.4 at test start and 7.9 to 9.2 at test end.
Dissolved oxygen:
not specified
Nominal and measured concentrations:
A filtrate of nominal 100 mg/L and dilutions of 1:3, 1:9, 1:27 and 1:81, corresponding to following geometric mean measured concentrations of Noroxymorphone: 48.6, 15.5, 4.88, 1.59 and 0.44 mg test item/L.
Details on test conditions:
Continuous illumination (Mean light intensity: 4725 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.:
> 48.6 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
growth rate
Key result
Duration:
72 h
Dose descriptor:
NOEC
Effect conc.:
<= 15.5 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
growth rate
Key result
Duration:
72 h
Dose descriptor:
LOEC
Effect conc.:
<= 48.6 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
growth rate
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
<= 21.1 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
other: yield
Duration:
72 h
Dose descriptor:
NOEC
Effect conc.:
<= 4.88 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
other: yield
Duration:
72 h
Dose descriptor:
LOEC
Effect conc.:
<= 15.5 mg/L
Nominal / measured:
meas. (geom. mean)
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 Noroxymorphone, the 72-hour EyC50 was calculated to be 21.1 mg test item/L, and the 72-hour ErC50 value was calculated to be > 48.6 mg test item/L. The 72-hour NOEyC was determined to be 4.88 mg test item/L and the associated 72-hour LOEyC was 15.5 mg test item/L. The 72-hour NOErC was determined to be 15.5 mg test item/L and the associated 72-hour LOErC was 48.6 mg test item/L.