2-[4-(1-hydroxy-4-{4-[hydroxy(diphenyl)methyl]piperidin-1-yl}butyl)phenyl]-2-methylpropanenitrile

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:

2017

Report date:

2017

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 201 (Freshwater Alga and Cyanobacteria, Growth Inhibition Test)

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method C.3 (Algal Inhibition test)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2-(4-{1-hydroxy-4-[4-(hydroxydiphenylmethyl)piperidin-1-yl]butyl}phenyl)-2-methylpropanenitrile

EC Number:

811-752-1

Cas Number:

169032-19-3

Molecular formula:

C32 H38 N2 O2

IUPAC Name:

2-(4-{1-hydroxy-4-[4-(hydroxydiphenylmethyl)piperidin-1-yl]butyl}phenyl)-2-methylpropanenitrile

Sampling and analysis

Analytical monitoring:

yes

Remarks:

HPLC-UV

Test organisms

Test organisms (species):

Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)

Details on test organisms:

Strain No. 61.81 SAG.
Cultivated in the laboratories of ibacon ; original source: "Sammlung von Algenkulturen, Albrecht-von-Haller-Institut für Pflanzenwissenschaften, Universität Göttingen", 37073 Göttingen, Germany.

Study design

Test type:

static

Water media type:

other: reconstituted water (OECD medium)

Limit test:

no

Total exposure duration:

72 h

Post exposure observation period:

Microscopic examination of the shape of the algal cells after 72 hours.
Determination of cell density by spectrophotometrical measurement after 24h, 48h, 72h.

Test conditions

Hardness:

0.24 mmol/L (= 24 mg/L) as CaCO3

Test temperature:

22.0-23.3°C (water temperature)

pH:

5.9-6.2

Dissolved oxygen:

Not specified

Nominal and measured concentrations:

A supersaturated stock solution of nominal 200 mg test item/L was prepared by suspending 200 mg test item in 1000 mL test water for preparing the test concentrations.
Due to the low limit of water solubility of the test item, a filtrate of nominal 200 mg/L and dilutions of 1:3, 1:9, 1:27 and 1:81 of this filtrate were tested. The following mean measured concentrations of the test item were determined: 14.6, 5.20, 1.78, 0.600 and 0.178 mg test item/L.

Details on test conditions:

Continuous illumination (mean light intensity: 7298 lux)

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Results and discussion

Effect concentrations

Effect concentrations 1

Key result

Duration:

72 h

Dose descriptor:

EC50

Effect conc.:

ca. 12.4 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

growth rate

Effect concentrations 2

Key result

Duration:

72 h

Dose descriptor:

NOEC

Effect conc.:

ca. 1.78 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

growth rate

Effect concentrations 3

Key result

Duration:

72 h

Dose descriptor:

LOEC

Effect conc.:

ca. 5.2 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

growth rate

Effect concentrations 4

Duration:

72 h

Dose descriptor:

EC50

Effect conc.:

ca. 5.23 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

other: yield

Effect concentrations 5

Duration:

72 h

Dose descriptor:

NOEC

Effect conc.:

ca. 1.78 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

other: yield

Effect concentrations 6

Duration:

72 h

Dose descriptor:

LOEC

Effect conc.:

ca. 5.2 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

other: yield

Details on results:

The 72-h EyC50 (yield) was calculated to be 5.23 mg test item/L and the 72-h ErC50 (growth rate) was calculated to be 12.4 mg test item/L. The 72-h EyC10 (yield) was calculated to be 2.03 mg test item/L and the 72-h ErC10 (growth rate) was calculated to be 4.41 mg test item/L.
The 72-h NOEyC (yield) was determined to be 1.78 mg test item/L and the associated 72-h LOEyC (yield) was 5.20 mg test item/L.
The 72-h NOErC (growth rate) was determined to be 1.78 mg test item/L and the associated 72-h LOErC (growth rate) was 5.20 mg test item/L.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

All reported results refer to mean measured values; the concentrations of the test item were within +/- 20% of the measured initial concentrations during the test.
Based on the experimental results, the 72-h EyC50 (yield) was calculated to be 5.23 mg test item/L and the 72-h ErC50 (growth rate) was calculated to be 12.4 mg test item/L.
The 72-h NOEyC (yield) was determined to be 1.78 mg test item/L and the associated 72-h LOEyC (yield) was 5.20 mg test item/L.
The 72-h NOErC (growth rate) was determined to be 1.78 mg test item/L and the associated 72-h LOErC (growth rate) was 5.20 mg test item/L.