5-ethylpyridine-2-ethanol

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

31 October - 14 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

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:

5-ethylpyridine-2-ethanol

EC Number:

226-024-3

EC Name:

5-ethylpyridine-2-ethanol

Cas Number:

5223-06-3

Molecular formula:

C9H13NO

IUPAC Name:

2-(5-ethylpyridin-2-yl)ethan-1-ol

Test material form:

other: viscous liquid

Details on test material:

- Name of test material (as cited in study report) : 5-Ethyl-2-(2-hydroxyethyl)-pyridin
- Physical state : clear , viscous liquid
- Analytical purity : 96,5%
- Lot/batch No. : 07040163/102
- Expiration date of the lot/batch : 2005-12-15
- Storage condition of test material : room temperature , closed original container , protected from light

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations : Samples of the test item group were taken at test start and after 96 hours .

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method : The concentration of the test solution was 100 mg/l . 400 mg test item and 4 l test water (Composition see at " any other information on materials and methods incl. tables ") were mixed and the preparation was used for the test .

Test organisms

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name : zebra-fish
- Source : Labor- und Zierfischzuchtbetrieb Gunter Rosenhainer , D-06766 Thalheim
- Age at study initiation (mean and range, SD) : no data
- Length at study initiation : average 3,4 cm
- Weight at study initiation (mean and range, SD) : no data
- Feeding during test : none

ACCLIMATION
- Acclimation period : 7 days
- Acclimation conditions : same as test
- Type and amount of food : frozen Cyclops
- Feeding frequency : five or six times a week
- Health during acclimation : no fish died during holding

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test conditions

Hardness:

CaCO3 : 208 ppm

Test temperature:

21,2 - 21,9°C , checked daily

pH:

7,2 - 8,6 , checked daily

Dissolved oxygen:

80 - 100% , checked daily

Nominal and measured concentrations:

nominal : 0 and 100 mg/l (see at " any other information on materials and methods incl. tables ")

Details on test conditions:

TEST SYSTEM
- Test vessel :
- Material, size, headspace, fill volume : glass fish tank , containing 4 L test solution
- Aeration : no
- Renewal rate of test solution : The test medium remained unchanged throughout the duration of the test
- No. of organisms per vessel : 10
- No. of vessels per concentration (replicates) : 1
- No. of vessels per control (replicates) : 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water : aerated reconstituted water
c(Ca++) = 1,54 mmol/l
c(Mg++) = 0,54 mmol/l
CaCO3 = 208 ppm
For detailed information see at " any other information on materials and methods incl. tables "

OTHER TEST CONDITIONS
- Adjustment of pH : no
- Photoperiod :15 hours light , 9 hours dark

EFFECT PARAMETERS MEASURED : mortality and visible abnormalities after 1, 2, 24 hours and in the further course of the investigation daily up to 96 hours

TEST CONCENTRATIONS
- Test concentrations : 100 mg/l

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities : The fish showed no visible abnormalities
- Mortality of control : no

Any other information on results incl. tables

Sublethal observations / clinical signs:

Analysis of the test preparations sampled at test start and after 96 hours showed the measured test concentrations to be near nominal (107 - 110%).

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Remarks:

The mortality in the control did not exceed 10% ; the dissolved oxygen concentration was at least 80% ; constant conditions concerning the test item concentration were maintained throughout the test

Conclusions:

The acute toxicity of 5-Ethyl-2-(2-hydroxyethyl)-pyridin to Zebra-fish (Brachydanio rerio) was tested in a limit test (static test procedure) according to the guideline 92/69/EEC . For the toxicity test the fish were exposed to the test item in a concentration of 100 mg/l for 96 hours. No mortality occurred in the control and the test group during the test. The fish showed no visible abnormalities. The LC50(96h) fish is greater than 100 mg/l. The test item is not acute toxic to fish. According to the Appendix 6 to Directive 2001/59/EU a classification of the test item is not required .

Executive summary:

The acute toxicity to fish of 5-Ethyl-2-(2-hydroxyethyl)-pyridin was tested according to EU Method C.1 (Acute Toxicity for Fish) in a limit test (static test procedure) with Zebra-fish (Brachydanio rerio) as test organisms. The study was conducted under certificated GLP compliance. The limit test was conducted at a concentration of 100 mg/L. The acclimatisation period of the fish was conducted for 7 days. The fish were fed frozen cyclops which was discontinued 24 h prior to the start of the test period. There was no mortality in the 7 days prior to the start of the test and the fish had a mean standard length of 3.4 cm. The test vessels were maintained at 21.2 -21.9°C with a photoperiod of 15 h light and 9 h darkness for a period of 96 h. The test vessels were not aerated. The water temperature, pH and dissolved oxygen concentrations were recorded daily throughout the test. In order to check the concentration of the test item during the test period the content in the test solution was measured by HPLC analysis. Samples of the test item group were taken at test start and after 96 hours. The fish were inspected after 1, 2, 24 hours and in the further course of the investigation daily up to 96 hours. No mortalities occurred during the test both in control and test group and the fish showed no visible abnormalities, therefore the LC50 was greater than 100 mg/L. The test item is not acute toxic to fish. According to the Appendix 6 to Directive 2001/59/EU a classification of the test item is not required.