1-methylpiperidine-2-ethanol

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:

2018-08-07 - 2018-08-13 (experimental phase)

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

OECD Guideline for Testing of Chemicals No. 202, adopted 13. Apr. 2004:
”Daphnia sp., Acute Immobilisation Test“

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Version / remarks:

Commission Regulation (EC) No. 440/2008, Method C.2. “Daphnia sp. Acute Immo-bilisation Test”, adopted 30. May 2008

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-methylpiperidine-2-ethanol

EC Number:

208-554-7

EC Name:

1-methylpiperidine-2-ethanol

Cas Number:

533-15-3

Molecular formula:

C8H17NO

IUPAC Name:

2-(1-methylpiperidin-2-yl)ethanol

Test material form:

liquid

Specific details on test material used for the study:

The test item was stored in a closed vessel dark and dry at room temperature at 20 ± 5°C.

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 0 and 100 mg/l. All samples were diluted 800 fold in dilution water into the range of the calibration for measurement.
- Sample storage conditions before analysis: no

Test solutions

Vehicle:

no

Remarks:

dilution water was used

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A solution containing 101 mg/L in dilution water was prepared. The solution was used for the test.
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): none stated

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Strain/clone: Daphnia magna STRAUS Berlin
- Source:
Origin: Umweltbundesamt Berlin
In-house breeding since: 27. September 2007
Daphnia magna is bred in the laboratory throughout the year. The animals are kept for the use in toxicity tests. They multiply by parthenogenesis, thus being genetically identical. The husbandry is performed similar to the method described in the OECD guideline
- Feeding during test: no
Vessels: preserving glasses, nominal volume 2 L
Medium: M4-Medium (recipe of ELENDT)
Food: green algae (Desmodesmus subspicatus)
Medium renewal: twice a week
Photo period: 16/8 hours, using neon tubes
Temperature: 20 ± 2 °C

METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES:
Selection of Daphnia
18.25 hours before the start of the test, the adult animals were separated from the young. 0.75 hours before test start, the adults were caught with the help of a glass tube, and the newborn daphnia, aged between 0 and 17.5 hours, were sieved from the medium and immediately placed into a beaker containing dilution water. After the settling-in period, animals which showed no apparent damage were used for the test.
Switching from M4-medium (husbandry) to dilution water (test) has been shown not to cause any detrimental effects for test daphnia.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Post exposure observation period:

none

Test conditions

Hardness:

Resulting hardness in mmol/L: 2.502
Resulting hardness in mg CaCO3/L: 250

Test temperature:

20.3 – 20.8°C

pH:

7.7 - 9.7

Dissolved oxygen:

8.8 - 8.9 mg/L

Nominal and measured concentrations:

0, 100 mg/L (nominal)
The concentration to be tested was based on the result of a non-GLP pre-test (0% immobilisation at 1 / 10 / 100 mg/L (nominal) as well as in the blank control)
The measured concentration at the beginning of the test was at 105% of the nominal concentration and after 48 hours the measured concentration was 104% of the nominal con-centration. Therefore, the determination of the biological results was based on the nominal concentration.

Details on test conditions:

TEST SYSTEM
- Test vessel: glass beakers, nominal volume 50 mL, tall shape, containing 20 ± 5 mL test solution
- Aeration: After preparation, the dilution water was aerated.
- Renewal rate of test solution (frequency/flow rate): none
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

OTHER TEST CONDITIONS
- Adjustment of pH: No. After preparation, the dilution water was aerated and the pH was measured. The pH was 7.8.
- Photoperiod: 16/8 light/dark
- Light intensity: neon tubes

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
After 24 and 48 hours, the immobilised daphnia were counted.
The pH, the concentration of dissolved oxygen and the content of the test item in the test vessels were measured at the beginning and at the end of the test.

VEHICLE CONTROL PERFORMED: n/a

RANGE-FINDING STUDY
- Test concentrations / Results used to determine the conditions for the definitive study: The concentration to be tested was based on the result of a non-GLP pre-test (0% immobilisation at 1 / 10 / 100 mg/L (nominal) as well as in the blank control)

Reference substance (positive control):

yes

Remarks:

Potassium dichromate K2Cr2O7 (CAS No. 7778-50-9) was used as positive control in a current reference study to assure that the test conditions are reliable.

Results and discussion

Effect concentrations

Effect concentrations 1

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 3

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 4

Duration:

48 h

Dose descriptor:

LOEC

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

- Mortality of control: 5%
- Abnormal responses: none
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no
- Effect concentrations exceeding solubility of substance in test medium: none

Results with reference substance (positive control):

- Results with reference substance valid? yes
- Limit test: no
- Dose-response test: yes
- ECx: The 24h-EC50i value was determined as 1.9 mg/L. The value was within the requested range for the 24h-EC50 between 0.6 - 2.1 mg/L of potassium dichromate K2Cr2O7 as specified in the OECD guideline

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The study was conducted under GLP according to OECD guideline 202 and EU method C.2 on the registered substance itself. The method is to be considered scientifically reasonable with no deficiencies in documentation or deviations from the guidelines, the validity criteria were met. Hence, the results can be considered as reliable to assess the toxicity of MPA towards daphnids.
The study was performed as a limit test using one concentration at 100 mg/L (nominal). For the test concentration and the blank control, 20 daphnia were exposed to the test item for 48 hours in a static test system. After 24 and 48 hours, the immobilised daphnia were counted. One of the exposed animals was immobilised in the blank control as well as in the test solution. Hence, the EC50 was determined as > 100 mg/l.
Based on the obtained results, MPA does not need to be classified as toxic to the environment, neither acutely nor chronic, according to the Regulation (EC) No. 1272/2008.

Executive summary:

The study was conducted under GLP according to OECD guideline 202 and EU method C.2 on the registered substance itself. One valid experiment was performed.

The study was performed as a limit test using one concentration at 100 mg/L (nominal). For the test concentration and the blank control, 20 daphnia were exposed to the test item for 48 hours in a static test system. After 24 and 48 hours, the immobilised daphnia were counted.

One of the exposed animals was immobilised in the blank control as well as in the test solution.

Potassium dichromate K2Cr2O7 (CAS No. 7778-50-9) was used as positive control in a current reference study to assure that the test conditions are reliable.

At the beginning and at the end of the test, the content of the test item in the test solutions was determined using LC-MS-MS-determination. The concentration determined at the start of the test was 105 % of the nominal concentration. At the end of the test the determined concentration was 104 % of the nominal concentration.

Therefore, the determination of the biological results was based on the nominal concentration.

The following results were determined for the test item 2-(1-methylpiperidin-2-yl) ethanol, (MPA) (species: Daphnia magna).

48h-NOEC ≥ 100 mg/L
48h-LOEC > 100 mg/L
24h-EC50 > 100 mg/L
48h-EC50 > 100 mg/L

MPA does not need to be classified as toxic to the environment, neither acutely nor chronic, according to the Regulation (EC) No. 1272/2008.