2-Propen-1-one, 3-(dimethylamino)-1-(3-pyridinyl)-

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study has been performed according to OECD and/or EC guidelines and according to GLP principles

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

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:

-

EC Number:

434-770-8

EC Name:

-

Cas Number:

55314-16-4

Molecular formula:

C10 H12 N2 O1

IUPAC Name:

3-(dimethylamino)-1-(pyridin-3-yl)prop-2-en-1-one

Details on test material:

Name of test material (as cited in study report): STI571 Y5a
- Substance type: Brown solid
- Physical state: Solid
- Analytical purity: 98.6%
- Lot/batch No.: 992301
- Expiration date of the lot/batch: 01 July 2001
- Stability under storage conditions: Stable
- Storage condition of test material: In refrigerator in the dark
- Stability in water: Not indicated

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

During the limit test samples were taken from 100 mg/l and the blank-control for analysis.

Sampling: Frequency: At the start and the end of the 96-hour test period.
Volume: 10 ml from the approximate centre of the test vessels.
Storage: Samples were stored in a deep-freezer until analysis.
sample pre-treatment:
All samples were stored in a deep freeze. On the day of analysis, the frozen samples were defrosted at room temperature.

The entire volume of each sample (10 ml) was transferred quantitatively into a 20 ml volumetric flask using mobile phase. The flasks were filled up to the mark with mobile phase. If necessary, the solutions were further diluted with 50/50 (v/v) mobile phase/ISO-medium to obtain concentrations within the calibration range. Due to the limited stability of the test substance solutions, all solutions were analysed immediately after pretreatment.

Test solutions

Vehicle:

no

Details on test solutions:

The batch of STI571 Y5A tested was a brown solid with unknown purity and completely soluble in test medium at the concentrations tested.
Preparation of test solutions started with two solutions of 100 mg/l. STI571 Y5A readily dissolved at 100 mg/l.

Test organisms

Test organisms (species):

Cyprinus carpio

Details on test organisms:

TEST ORGANISM
- Common name: Carp (Cyprinus carpio, Teleostei, Cyprinidae)
- Source: Zodiac, proefacc, "De Haar Vissen", Wageningen University and Research Centre, The Netherlands
- Length at study initiation (length definition, mean, range and SD): Limit test: 2.25 ± 0.18 cm
- Weight at study initiation (mean and range, SD): Limit test: 0.32 ± 0.08 g
- Feeding during test: no feeding
ACCLIMATION
- Acclimation period: At least 12 days after delivery
- Acclimation conditions (same as test or not): same as the test
- Feeding: Daily with pelleted fish food (Trouvit)
- Health during acclimation (any mortality observed): In the batch of fish used for the test, mortality during the seven days prior to the start of the test was less than 5%.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test conditions

Hardness:

250 mg CaCO3/l

Test temperature:

Between 19.5 and 22.0 °C

pH:

Between 7.5 and 8.1

Dissolved oxygen:

between 6.5 and 9.6 mg/l

Nominal and measured concentrations:

Nominal concentrations: 0, 0.1, 1.0, 10 and 100 mg/l
Measured:Analysis of the samples showed that measured concentrations were in agreement with nominal and remained stable during the 96-hour test period.( T=0h 98% and T=96h 100%)

Details on test conditions:

TEST SYSTEM
- Test vessel: 5 and 7 liters, all-glass, containing respectively 2 and 5 liters of test solution
- Aeration: The test media were not aerated, except between days 1 and 2, and days 3 and 4.
- No. of organisms per vessel: 7 fish for the control and highest concentration, 3 for the lower concentrations
- No. of vessels per concentration (replicates):1
- No. of vessels per control (replicates):1
- Biomass loading rate: medium Loading 0.45 or 0.48 g fish/liter, i.e. 7 fish per 5 liters or 3 fish per 2 liters of test medium.


TEST MEDIUM / WATER PARAMETERS
ISO-medium, formulated using Milli-Ro water (tap-water purified by reverse osmosis; Millipore Corp., Bedford, Mass., USA) with the following composition:
Ca2+ 80 mg/l
Mg2+ 12 mg/l
Na+ 15 mg/l
K+ 3 mg/l
Cl- 145 mg/l
SO42- 49 mg/l
HCO3- 47 mg/l
Hardness is 250 mg CaCO3/l
- Intervals of water quality measurement: Dissolved oxygen content pH and temperature, Daily in all vessels with surviving fish, beginning at the start of the test (day 0).
OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 hours photoperiod daily
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :LC50 t= 96 H
TEST CONCENTRATIONS
- Limit study: 0.1, 1.0, 10 and 100 mg/l.

Reference substance (positive control):

yes

Remarks:

pentachlorophenol

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

96 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

meas. (initial)

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:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

Behavioral abnormalities: no abnormalities were observed
- Mortality of control: No mortality in control
- Abnormal responses: no abnormal responses were observed

Results with reference substance (positive control):

The 24h-LC50 for carp exposed to PCP was 0.18 mg/l with 0% mortality at 0.15 mg/l and 100% mortality at 0.22 mg/l.

The 96h-LC50 for carp exposed to PCP was already reached after 48 hours of exposure and was 0.14 mg/l with a 95 % confidence interval between 0.13 and 0.18 mg/l.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Under the conditions of the present test STI571 Y5A induced no lethal effects in carp at or below 100 mg/l. Hence, the 96h-LC50 for carp exposed to STI571 Y5A was greater than 100 mg/l, the regulatory limit concentration.