STI571 F8

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:

2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

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)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Details on test material:

Batch number: 022401

Sampling and analysis

Analytical monitoring:

yes

Remarks:

Actual test substance concentration at the start and after approximately 4, 24, 48, 72 and 96 hours.

Details on sampling:

For determination of the actual test substance concentration samples were taken
immediately before the introduction of the fish and after approximately 4, 24, 48, 72 and 96
hours after begin of exposure.

Test solutions

Vehicle:

no

Details on test solutions:

Identity and concentration of auxiliary solvent for dispersal: No auxiliary solvent was used. The test substance was
dissolved in dilution water.

Test organisms

Test organisms (species):

other: Zebra-fish (Brachydanio rerio)

Details on test organisms:

Species: Zebrafish (Brachydanio rerio).
Supplier: Fa. Amazonas Aquarium, A-2840 Grimmenstein.
Receipt of animals: 22 June 2005.
Length (cm): 2.543 ± 0.053 (mean of control group at the end of study).
Weight (g): 0.436 ± 0.066 (mean of control group at the end of study).
As the allocation of the fish to their groups was performed using a randomisation procedure the size and the weight of the control fish is assumed to be representative for the entity of all fish used.

Study design

Test type:

static

Water media type:

freshwater

Remarks:

Local tap water was mixed 1:1 with deionised water for achieving the appropriate water hardness (total hardness: 250 mg CaCO3 /L, determined in the control vessel).

Limit test:

no

Total exposure duration:

96 h

Test conditions

Hardness:

250 mg CaCO3/L

Test temperature:

Temperature was measured with a general laboratory thermometer.
Temperature: 20 - 21 °C throughout the test period.
Determination of temperature daily.

pH:

pH was determined with a pH-meter (WTW Hand Held Meter, pH 340, WTW G.m.b.H. D-82362 Weilheim i. OB).
pH: between 7.3 and 8.0 in the control medium and between 7.5 and 7.8 in the test substance medium.

Dissolved oxygen:

Dissolved oxygen concentration in % of the air saturation value at the appropriate
temperature was determined with an oxygen meter (Oximeter 537, WTW G.m.b.H. D-82362
Weilheim i. OB).
Dissolved oxygen concentration: At least 90 % of the air saturation value at the appropriate temperature throughout the test period.

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 2

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 3

Duration:

72 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 4

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 5

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

> 100 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 6

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Details on results:

In a preliminary test with 3 fish no fish died when exposed to a test substance concentration
of 100 mg/L. According to the test guideline a limit test may be performed at 100 mg/L in
order to demonstrate that the LC50 value is higher than this concentration.

The quality criteria were fulfilled:
• The mean concentration of the test substance has been satisfactorily maintained over a
test period of 96 hours. After 96 hours of exposure the geometric mean concentration
between the start and the end of the test was 102 % of the starting concentration.
• Constant conditions were maintained (temperature, pH).
• No mortality occurred in the negative control group.
• The dissolved oxygen concentration was higher than 60% of the air saturation value
throughout the test.

Actual test substance concentration
After 48 hours the actual test substance concentration was 103.6 mg/L (103.6 % of the
actual starting concentration) and it was 101.04 mg/L after 72 hours (101.0 % of the actual
starting concentration). At 96 hours the actual test substance concentration was 101.9 mg/L
(101.9 % of the actual starting concentration). The actual test substance concentrations
show that the test substance was stable during the whole experiment. For the 96-hours
exposure period the geometric mean concentration between start and end of the exposure
was 102.3 mg/L. The effective concentrations have been determined and expressed as the
geometric mean of the measured concentrations. This is in accordance with the criteria of the
respective guidelines.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Acute aquatic toxicity: Cat.3