Methyl 3-pyridyl ketone

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:

18 Octobre - 05 November 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well-documented GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

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

Test material

Test material information

Constituent 1

Reference substance name:

Methyl 3-pyridyl ketone

EC Number:

206-496-7

EC Name:

Methyl 3-pyridyl ketone

Cas Number:

350-03-8

Molecular formula:

C7H7NO

IUPAC Name:

1-(pyridin-3-yl)ethan-1-one

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): 3-Acetylpyridine
- Physical state: transparent liquid
- Storage condition of test material: keep cool and dry, 15-25°C, avoid light, product is hygroscopic

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
Not applicable.

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

In the beginning and the end of total test the determination of test substance concentration was performed by means of HPLC in solutions with the highest and the lowest test substance concentration. The solutions before addition of fish (as control of nominal concentration) and the solutions containing fish immediately after its addition were analysed at the beginning of test. The test solutions with test organisms were analysed at the end of test.

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
Whereas the test substance is soluble in water the basic solution was prepared in dilution water. The concentrations of solutions used in the preliminary and total test were obtained by diluting the basic solution with dilution water.

Preliminary test :
The test solutions were prepared by dosing of appropriate volumes of basic solution into a 1000 mL volumetric flasks and replenishment with dilution water to mark. Content of each volumetric flask was transferred into a 2 L flask.
Dilution water was prepared from distilled water with conductivity of 0.167 mS/m.
-pH of dilution water : 7.79
-Oxygen content : 8.7 mg/L at temperature of 21.1 °C.
-Basic solution of test substance : 100.0 mg/L in dilution water
-Basic solution dosing : 1000, 600, 200, 100, 75, 50 and 25 mL in 1000 mL of dilution water
On the basis of preliminary test results the total test was performed.

Total test :
The total test was carried out at 7 concentrations of the test substance concurrently with control test (without addition of test substance). The total volume each of testing mixtures and control was 4000 mL and 10 pieces of fish were used.
Dilution water was prepared from distilled water with conductivity of 0.248 mS/M.
-pH of dilution water : 7.91
-Oxygen content : 8.4 mg/L at temperature of 21.1°C
-Content of (Ca + Mg) ions : 2.66 mmol/L
-Basic solution of test substance : 100.0 mg/L in dilution water
-Basic solution dosing : 220, 200, 180, 160, 140, 120, and 100 mL in 4000 mL of dilution water

Test organisms

Test organisms (species):

Poecilia reticulata

Details on test organisms:

TEST ORGANISM
- Common name: Guppy
- Source: BioTest s.r.o., Konärovice (Czech Republic)
- Date of delivery : 29.09.2004
- Age at study initiation: 3-4 months
- Length at study initiation: 2.0 - 3.0 cm
- Feeding during test: no

ACCLIMATION
- Acclimation period: Fish were acclimatized for 7 days in dilution water; they were not fed during 72 hours before the test.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Post exposure observation period:

No details are reported.

Test conditions

Hardness:

Total test : Content of (Ca + Mg) ions: 2.66 mmol/L

Test temperature:

22±2°C, with a variation of ± 1°C at each individual test.

pH:

7.58 - 7.91

Dissolved oxygen:

7.0 - 8.7 mg/L

Salinity:

Not applicable

Nominal and measured concentrations:

Nominal concentrations at total test : 2.5, 3.0, 3.5, 4.0, 4.5, 5.0 and 5.5 mg/L
Measured concentrations at start of test (without organisms) : 2.425 mg/L and 5.360 mg/L
Measured concentrations at start of test (with organisms) : 2.428 mg/L and 5.302 mg/L
Measured concentrations at end of test (with organisms) : 2.392 mg/L and 5.183 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: Preliminary test : 2 L flask containing 1000 mL test solution ; Total test : flask (size not stated) containing 4000 mL test solution
- Aeration: no
- Renewal rate of test solution : The solutions were not renewed during 96 hours.
- No. of organisms per vessel: 3 fish for the preliminary test ; 10 fish for the total test
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:
Standard dilution water was prepared just before the test by admixing 2.5 mL stored solutions A, B, C and D in 1000 mL of distilled water.
A = 117.6 g CaCl3x2H20 in 1L distilled water
B = 49.3 g MgSO4x7H20 in 1L distilled water
C = 25.9 g NaHCO3 in 1L distilled water
D = 2.3 g KCl in 1L distilled water


OTHER TEST CONDITIONS
- Adjustment of pH: no
- Lighting : daylight

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

3.97 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 95% CL : 3.33-4.62 mg/L

Effect concentrations 2

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

3 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 3

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

5.5 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

The calculation of LC50 was performed by means of software „Toxicity" (product of Water Research Institute, Ostrava, Czech Republic). The nominal concentrations at the beginning of the test without organisms as input ones were used.

Results with reference substance (positive control):

The sensitivity of the test species and correctness of test performance is periodically verified in three-month period by testing the reference substance,potassium dichromate.
The results of verification test with K2Cr2O7, carried out in period from 18.10. to 22.10.2004, are the following:
48 h - LC50 = 129 mg/L (confidential limit: 99 -158 mg/L)
96 h - LC50 = 111 mg/L (confidential limit: 100-123 mg/L)
The inhibition of test organisms in the reference substance solution meets criteria determined by the interlaboratory tests. The results of the last interlaboratory test arranged by Centre for Assessment of Laboratories of T.G.Masaryk Water Research Institute Prague in 2003 for potassium dichromate were: 96 h - LC50 = 94.9 - 155 mg/L .

Reported statistics and error estimates:

No details are reported.

Any other information on results incl. tables

Sublethal observations / clinical signs:

Table 1: Fish mortality - preliminary test (18.10. to 22.10.2004)

		Concentration (mg/L)
		100	60	20	10	7.5	5.0	2.5	C
Number of fish	48 hours	0	0	0	0	0	1	3	3
Mortality %	48 hours	100	100	100	100	100	66.6	0	0
Number of fish	96 hours	0	0	0	0	0	0	3	3
Mortality %	96 hours	100	100	100	100	100	100	0	0

Table 2: Fish mortality - total test (01.11. to 05.11.2004)

Nominal concentration	mg/L	5.5	5.0	4.5	4.0	3.5	3.0	2.5	C
Measured concentration	mg/L	5.4						2.4	C
Number of fish	24 hours	10	10	10	10	10	10	10	9
Mortality %	24 hours	0	0	0	0	0	0	0	10
Number of fish	48 hours	10	10	10	10	10	10	10	9
Mortality %	48 hours	0	0	0	0	0	0	0	10
Number of fish	72 hours	6	8	8	10	9	10	10	9
Mortality %	72 hours	40	20	20	0	10	0	0	10
Number of fish	96 hours	0	1	2	5	8	10	10	9
Mortality %	96 hours	100	90	80	52	20	0	0	10

Measured concentration is rounded off to one decimal place.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Remarks:

Well-documented GLP guideline study

Conclusions:

The study was conducted under GLP according to OECD guideline 203 on the registered substance itself. The method is to be considered scientifically reasonable with no deficiencies in documentation or any deviations, the validity criteria are fulfilled. Hence, the results can be considered as reliable to assess the toxicity of 3-Acetylpyridine to fish.
The study is regarded as a valid guideline study with GLP compliance. According to the reported LC50 value (3.97 mg/L) the test substance 3-Acetylpyridine does not need to be classified as hazardous to aquatic environment.

Executive summary:

The test substance, 3-Acetylpyridine, was tested for acute toxicity on fish Poecilia reticulata.The test was performed according to EU method C.1. - Acute toxicity for fish, which is analogous to OECD Test Guideline No. 203. in a static freshwater test. The study was conducted under GLP compliance. The test duration was 96 hours with substance concentrations of 2.5, 3.0, 3.5, 4.0, 4.5, 5.0 and 5.5 mg/L. A temperature of 21 °C was held constant, the pH value was 7.7 - 7.8 at the beginning of the experiment. A content of (Ca + Mg) ions of 2.66 mmlol/L was determined. During the test the pH values ranged from 7.6 to 7.8 and the oxygen content was measured in a range of 7.0 - 8.7 mg/L . The fish mortality was detected each 24 hours throughout the test.

Test results:

96h-LC0 = 3.0 mg/L

96h-LC100 = 5.5 mg/L

96h-LC50 = 3.97 mg/L

3-Acetylpyridine does not need to be classified as hazardous to the aquatic environment. This is based on an LC50 (96h) of 3.97 mg/L and the fact that the substance is very soluble in water, readily biodegradable, has a BCF <<500 and a log Kow <<4.

For a substance, for which adequate chronic toxicity data are not available, with an 96 hr LC50 (for fish) between > 1 to ≤ 10 mg/L, classification as Aquatic Chronic Category 2 according to Regulation (EC) No 1272/2008 would only be necessary, if the substance at the same time is not rapidly degradable and/or the experimentally determined BCF ≥ 500 (or, if absent, the log Kow ≥ 4); this is not the case for 3 -Acetylpyridine.

There is no indication given that the results from this study are not reliable, the data requirements according to REACh Annex VII are met and no need for further testing was identified.