1-methylpiperidine-2-ethanol

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

04 October - 04 November 2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP - guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

533-15-2

IUPAC Name:

533-15-2

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report) : 2-(2-Hydroxyethyl)-1-methylpiperidin
- Physical state : clear, colourless liquid
- Analytical purity : 99.4% (GC)
- Lot/batch No. : 06040032/001
- Expiration date of the lot/batch : 2005-12-31
- Stability under test conditions : yes ; the analytical determinations of the test item showed very good correlation between nominal and measured concentrations and very good recovery rates.
- Storage condition of test material : The test item was stored in a closed opaque glass vessel at room temperature

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Sampling method : Samples were taken at start and at the end of the test

Test solutions

Vehicle:

no

Details on test solutions:

Pre-Test
On the day of the start of the test, a geometric series of three concentrations was prepared by mixing a stock solution containing 1000 mg/L test item with drinking water.
Date : Oct. 4th - Oct. 8th 2005
Treatments : 1 / 10 / 100 mg/L
Duration : 96 hours
Three fish were used for each treatment and for the control.

Main Study
On the day of the start of the test, a stock solution containing 1000 mg/L test item in drinking water was prepared. This solution was used to prepare the treatment.
Date : Oct 31st - Nov. 4th, 2005
Treatment : 100 mg/L
Duration : 96 hours
Seven fish were used for the treatment and for the control.

Test organisms

Test organisms (species):

other: Danio rerio , Hamilton-Buchanan

Details on test organisms:

TEST ORGANISM
- Common name : zebrafish
- Source : Weiler's Pet's best, Turmstr. 6, D-67433 Neustadt, Germany
- Age at study initiation : sexually immature young fish
- Length at study initiation : 2 ± 1 cm
- Feeding during test : none

ACCLIMATION
- Acclimation period : 14 days
- Acclimation conditions : same as test
- Type and amount of food : type not stated , about 1-2 % of body weight per day
- Feeding frequency : three times a day
- Health during acclimation : During this period, mortality didn't surpass 5 %

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test conditions

Hardness:

not stated

Test temperature:

23 ± 1 °C

pH:

7.7 - 9.3

Dissolved oxygen:

7.2 - 8.5 mgO2/L

Nominal and measured concentrations:

The measured concentrations showed very good correlation with the nominal concentrations: measured values were 99 and 103 % of the nominal concentration. The recovery rate after 96 hours was 105 %. Therefore the test item was stated as stable under the conditions of the test and the nominal concentration was used for the determination of the biological resuits.
The measured concentrations of the test item are presented in table 1 at "overall remarks, attachments".

Details on test conditions:

TEST SYSTEM
- Test vessel
- Material, size, headspace, fill volume : Glass aquaria , maximal volume 10 l
- Aeration : accomplished with glass tubes, frequency of bubbles 1/s
- No. of organisms per vessel : 7
- No. of vessels per concentration (replicates) : 1
- No. of vessels per control (replicates) : 1
Observations were made every 24 hours, measuring pH and O2-concentration of the test solution in each vessel and documentating mortalities or abnormal behaviour. In the main study, the real concentration of the test item in the solutions were determined at the start and at the end of the test.
A fish was considered dead, if no visible movement could be observed, and if touching of the caudal peduncle produced no reaction.

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water : Good quality drinking water is used. The composition is analysed yearly by the supplier.
ANALYSIS OF DRINKING WATER
Date of analysis: September 2004 , Performed by: Technologiezentrum Wasser, Karlsruhe
pH : 8.17
oxygen : 10.5 mg/L
conductivity : 249 μS/cm
hardness : 0.943 mmol/L
ortho-phosphate : < 0.1 mg/L
aluminium : < 0.02 mg/L
ammonium : < 0.01 mg/L
bor : < 0.02 mg/L
calcium : 29.5 mg/L
chloride : 12.5 mg/L
iron : < 0.01 mg/L
potassium : 3.1 mg/L
nitrogen (Kjeldahl) : < 1.0 mg/L
magnesium : 5.0 mg/L
mangane : 0.048 mg/L
sodium : 12.0 mg/L
sulphate : 19.7 mg/L
total organic carbon (TOC) : 0.82 mg/L
arsenic : < 0.001 mg/L
lead : < 0.001 mg/L
cadmium : < 0.0001 mg/L
chromium : < 0.001 mg/L
copper : < 0.01 mg/L
cyanide : < 0.01 mg/L
fluoride : < 0.05 mg/L
nickel : < 0.001 mg/L
nitrate : < 1.0 mg/L
nitrite : < 0.01 mg/L
mercury : < 0.05 μg/L
polycyclic aromatic hydrocarbons : < 0.05 μg/L
chlorinated organic compounds : < 0.01 mg/L
pesticides and PCB, PBB : < 0.1 μg/L
antimony : < 0.001 mg/L
selenium : < 0.001 mg/L

OTHER TEST CONDITIONS
- Adjustment of pH : none
- Photoperiod : 12/12 hours using neon tubes

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 2

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities :
None of the fish died or showed any signs of morbidity.

- Other biological observations:
see Biological results at "any other information on results incl. tables".

- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values:
At the beginning and at the end of the test, the content of the test item in the test solutions was determined using HPLC. The recovery after 96 hours was 105 % of the start concentration and the correlation between nominal and measured concentration was very good (99 and 105 %). Therefore, the test item was stated as stable under the conditions of the test and the determination of the results was based an the nominal concentration.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Remarks:

The mortality in the control may not exceed 10% at the end of the test. No mortalities occurred in the control; dissolved O2 concentration must be at least 60 % throughout the test. Concentration of dissolved oxygen stayed above 84% throughout the test.

Conclusions:

The study is regarded as a valid guideline study with certificated GLP compliance. For the test substance the following results were reported :
96h NOEC : 100 mg/L
96h LC50 : > 100 mg/L

Executive summary:

This study was performed in order to evaluate the toxic potential of 2-(2-Hydroxyethyl)-1- methylpiperidin towards freshwater fish, using the species Danio rerio HAMILTON BUCHANAN.

The study was conducted in accordance with the following guidelines:

-OECD Guidelines for the Testing of Chemicals No. 203, adopted July 17th 1992 „Fish, Acute Toxicity Test"

-EU-Guideline C.1 "Akute Toxizität für Fische"

In the initial experiment, four concentrations of the test item in a geometric series (spaced by factor 10, the highest being 100 mg/L) were used. For each concentration, three fish were exposed to the test item for 96 hours. No fish showed any signs of morbidity at the end of the test at all tested concentrations. The pH and the oxygen value of the water were normal.

The main study was performed as a limit test at the concentration 100 mg/L. None of the fish died or showed any signs of morbidity.

At the beginning and at the end of the test, the content of the test item in the test solutions was determined using HPLC. The recovery after 96 hours was 105 % of the start concentration and the correlation between nominal and measured concentration was very good (99 and 105 %). Therefore, the test item was stated as stable under the conditions of the test and the determination of the results was based on the nominal concentration.

The following results for the test item 2-(2-Hydroxyethyl)-1-methylpiperidin were determined:

96h NOEC : 100 mg/L

96h LC50 : > 100 mg/L