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

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:

2017

Report date:

2017

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:

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):

Daphnia magna

Details on test organisms:

Daphnia magna (Straus), clone 5, from 3.5 to 20.5 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 (Elendt "M4")

Limit test:

no

Total exposure duration:

48 h

Post exposure observation period:

Visual observation after 24h and 48h of the mobility of animals after agitation of the test beaker.

Test conditions

Hardness:

2.5 mmol/L (= 250 mg/L) as CaCO3

Test temperature:

20.0-20.6°C (water temperature)

pH:

6.1-6.4

Dissolved oxygen:

6.7-8.8 mg/L

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.
Due to the low limit of water solubility of the test item, a filtrate of nominal 200 mg/L and dilutions of 1:2, 1:4, 1:8, 1:16 of this filtrate were tested. The following mean measured concentrations of the test item were determined: 18.9, 10.0, 5.30, 2.40, 1.27 mg test item/L.

Details on test conditions:

Photoperiod: 16h light-8h dark; light intensity: 620 to 720 lux

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Results and discussion

Effect concentrations

Effect concentrations 1

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

ca. 18 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Key result

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

ca. 2.4 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 3

Key result

Duration:

48 h

Dose descriptor:

LOEC

Effect conc.:

ca. 5.3 mg/L

Nominal / measured:

meas. (not specified)

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 up to and including the test item concentration of 2.40 mg test item/L. At the concentration of 5.30 mg test item/L, one daphnid was immobile. 3 immobile daphnids were observed at a test item concentration of 10.0 mg test item/L. At the highest test item concentration of 18.9 mg test item/L, 11 animals were immobile.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

All reported results refer to 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 48-h NOEC was determined to be 2.40 mg test item/L. The 48-h LOEC was determined to be 5.30 mg test item/L and the 48-h EC50 value was calculated to be 18.0 mg test item/L.