2-[3-(4-propyl-heptyl)-morpholin-4-yl]-ethanol hydrochloride

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

Study period:

September 06, 2016 - October 17, 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

ISO 6341 (Water quality - Determination of the Inhibition of the Mobility of Daphnia magna Straus (Cladocera, Crustacea))

Deviations:

no

Principles of method if other than guideline:

Determine the acute aquatic toxicity of the substance.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2-[3-(4-propylheptyl)morpholin-4-yl]ethan-1-ol hydrochloride

EC Number:

688-947-1

Cas Number:

98092-92-3

Molecular formula:

C16H34NClO2

IUPAC Name:

2-[3-(4-propylheptyl)morpholin-4-yl]ethan-1-ol hydrochloride

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

Test item name: Delmopinolo HCl
Batch number: 2510468
Internal number: 2929564-001
Chemical name 2-[3-(4-propylheptyl)-4-morpholinyl) ethanol hydrochloride (1:1)
Purity : 100.3% w/w

Stability under storage conditions: protect from moisture

Storage condition: The test item will be stored at room temperature without particular precaution to avoid the light exposure following Test Substance Data Sheet (TSDS) supplied by the Sponsor.

Sampling and analysis

Analytical monitoring:

not specified

Details on sampling:

not specified

Test solutions

Vehicle:

yes

Details on test solutions:

The test medium was prepared as follows: prior to the test start, 250 mL of a 100.0 mg/L test item stock solution were prepared by direct weighing into reconstituted water (0.0250 g of test item into 250 mL of reconstituted water). The obtained solution appeared clear and transparent with the test item completely solubilized; pH was measured and then, from this stock solution, the test item solutions were prepared by dilution with reconstituted water as reported in Table 1 and they were clear and transparent.

After pH and oxygen concentration check, the test started.

A negative control with only reconstituted water was also tested.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

The study was performed on the freshwater crustacean Daphnia magna Straus. A strain of this species was supplied by MicroBioTests Inc., Belgium in December 2011 (batch number: DM290911).
Since that time, the clone has been bred in the laboratories of the Test Facility under conditions identical to those of the test, with regard to temperature, light and water quality, so that no acclimation was needed prior to testing. It was daily fed with a fixed amount of the laboratory cultured green algae Pseudokirchneriella subcapitata (formerly Selenastrum capricornutum) and with a suspension of the yeast Saccharomyces cerevisiae. At the test start the organisms used in the test were less than 24 hours old and were not first brood progeny.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test conditions

Hardness:

Water Hardness: 140 - 250 mg/L as CaCO3

Test temperature:

Test temperature: 19.9 – 20.1 °C

pH:

pH of test medium: test start: 7.28 – 7.73; test end: 7.62 – 7.86

Dissolved oxygen:

The dissolved oxygen concentration in the negative control and in the test item solutions was always higher than 5.0 mg/L according to OECD Guideline N 202 that provides a
minimum oxygen concentration of 3.0 mg/L.

Salinity:

CaCl2 × 2H2O: 2.0 mmol/L (= 294.0 mg/L)
MgSO4 × 7H2O: 0.5 mmol/L (= 123.3 mg/L)
NaHCO3: 0.771 mmol/L (= 64.8 mg/L)
KCl: 0.078 mmol/L (= 5.8 mg/L)
Water Hardness: 140 - 250 mg/L as CaCO3
Alkalinity: 0.8 mmol/L
Ratio of Ca : Mg = 4 : 1 (based on molarity)
Na : K = 10 : 1 (based on molarity)

Conductivity:

Not specified

Nominal and measured concentrations:

Nominal test item concentration (mg/L)
1.0, 1.7, 3.1, 5.6, 10.0 mg/L

Details on test conditions:

Concentration and solution preparation
The test concentrations were chosen in accordance with the results of a pre-test (rangefinding test), whose relevant Raw Data were archived under the code of the present study. The main test included five test item concentrations in a geometric series, namely 1.0, 1.7, 3.1, 5.6 and 10.0 mg/L.

Experimental conditions
The test was performed in glass beakers filled with 40 mL of test medium. The beakers were closed to reduce test item evaporation, water loss and to avoid dust entry into the solutions. The test vessels were labelled with the internal study number and all necessary additional information to ensure unmistakable identification. For the test item concentrations and for the negative control, 20 daphnids were used divided into four replicates of five daphnids each. The daphnids were randomly distributed to the test
vessels at test initiation. The daphnids loading rate was lower than one daphnid per 2 mL of test solution, as required by guideline OECD No. 202, 2004. The test glass beakers were incubated in an environmental test chamber; they were randomly distributed and were replaced every day during the test.

Temperature:
The incubation temperature was continuously monitored during the course of the study by a PT100 probe installed in the environmental test chamber. It was in the range 19.9 – 20.1°C with a mean value of 20.0 °C and a standard deviation of 0.02 °C. The temperature range provided by OECD guideline is 20 ± 2°C. The temperature values during the test were within the provided range and did not vary more than 1°C during the test period.

Light: a 16 hours light and 8 hours darkness daily photoperiod. The measured values were in the range 1321 – 1373 Lux, according to provided range (1000-1500 Lux).
Test duration: 48 hours.

Range-finding study
1.0, 10.0, 100.0 mg/L

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Key result

Duration:

24 h

Dose descriptor:

EC0

Effect conc.:

ca. 1.7 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Key result

Duration:

24 h

Dose descriptor:

EC100

Effect conc.:

> 10 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 3

Key result

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

> 10 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 4

Key result

Duration:

24 h

Dose descriptor:

NOEC

Effect conc.:

ca. 3.1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 5

Key result

Duration:

48 h

Dose descriptor:

EC0

Effect conc.:

ca. 1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 6

Key result

Duration:

48 h

Dose descriptor:

EC100

Effect conc.:

> 10 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Effect concentrations 7

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

ca. 3.1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 8

Key result

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

ca. 1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

A full test was performed to evaluate the effect of the test item Delmopinolo HCl on Daphnia magna under static conditions. The daphnids were observed for immobility after 24 and 48 hours of exposure. The observed immobilization data in the test item concentrations and in the negative control are observed.In the negative control 0% of immobilization was observed and no daphnid was trapped on the test water surface or showed other signs of disease or stress. These values comply with the validity criteria of the test, that provide a maximum immobilization or a maximum number of daphnids showing distress signs of 10% in the negative control at the end of the test.

Results with reference substance (positive control):

Not performed.

Any other information on results incl. tables

Immobilization effect of test item to Daphnia magna

Nominal test item concentrations (mg/L)	Number of Daphnia tested	N° of immobilized Daphnia 24 h	N° of immobilized Daphnia 48 h	% of immobilized Daphnia 24 h	% of immobilized Daphnia 48 h
0.00 (negative control)	20	0	0	0	0
1.0	20	0	0	0	0
1.7	20	0	5	0	25
3.1	20	1	10	5	50
5.6	20	6	15	30	75
10.0	20	9	19	45	95

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The acute toxicity of test item Delmopinolo HCl was tested on Daphnia magna under static conditions.

The EC0, the EC100, the EC50 value, calculated in terms of nominal test item concentrations, after 24 and 48 hours of exposure, were as follows:
- EC50 (24h): > 10.0 mg/L
- EC50 (48h): 3.1 mg/L

According to CLP Regulation criteria, the EC50 (48h) is included in the range > 1 up to ≤ 10 mg/l; therefore the substance is classified as Aquatic Chronic 2; H411.

Executive summary:

Delmopinolo HCl is classified as Aquatic Chronic 2; H411 according to acute toxicity to daphnia magna in a 48-hour immobilization test under static exposure.