Registration Dossier

Ecotoxicological information

Short-term toxicity to fish

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2007-03-26 to 2007-09-03
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
: Certificate issued by the Swiss GLP monitoring authorities
Analytical monitoring:
yes
Details on sampling:
- Sampling method: For the quantification of the actual test substance concentrations, duplicate samples were taken from all test media and the control at the start of the test, after 48 hours test duration and at the end of the study after 96 hours. All samples were taken from the approximate center of the aquaria without mixing the test medium.
- Sample storage conditions before analysis: The samples were deep-frozen immediately after sampling and stored deep-frozen (at about -20 deg C) until analysis. Based on pre-experiments for investigation of the storage stability (without GLP), the test substance proved to be stable in the test water under these storage conditions.
- The concentrations of the test substance were analytically measured in the duplicate test medium samples taken at the start and the end of the test. From the control samples, one of the duplicate samples was analyzed from the corresponding sampling times.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test medium of the nominal concentration of 100 mg/L was prepared by completely dissolving 500.9 mg of the test substance in 5000 mL of test water using stirring for 15 minutes at room temperature. The test medium was freshly prepared just before introduction of the fish (= start of the test).
- Controls: yes
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: zebra fish
- Strain: no data
- Source: The fish were raised in RCC laboratories without any medication.
- Age at study initiation (mean and range, SD): no data
- Length at study initiation (mean and SD): 3.1 +/- 0.2 cm
- Weight at study initiation (mean and SD): 0.25 +/- 0.04 g
- Method of breeding: no data
- Feeding during test: no


ACCLIMATION
- Acclimation period: 1 weeks
- Acclimation conditions (same as test or not): same as test
- Type and amount of food: commercial fish diet (Tetra Min® Hauptfutter, supplied by TETRA-Werke, D-49304 Melle, Germany)
- Feeding frequency: During acclimatization until one day before the start of the test the fish were fed.
- Health during acclimation (any mortality observed): During the last two weeks prior to the test no fish died in the test fish batch and all fish were healthy.

QUARANTINE (wild caught): none
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
none
Hardness:
1.25 mmol (125 mg/L as CaCO3)
Test temperature:
22 °C
pH:
7.4-7.5
Dissolved oxygen:
8.1-8.4
Salinity:
no data
Conductivity:
not indicated
Nominal and measured concentrations:
100 mg/L (nominal); 120 mg/L (mean measured concentration)
Details on test conditions:
TEST SYSTEM
- Test vessel: Glass aquarium with a volume of 5 L
- Type (delete if not applicable): no data
- Material, size, headspace, fill volume: glass aquaria, no data, no data, 5 L
- Aeration: The test water was aerated prior to the preparation of the test media until oxygen saturation was reached. The test media was 'slightly' aeration during the test.
- Type of flow-through (e.g. peristaltic or proportional diluter): not applicable
- Renewal rate of test solution (frequency/flow rate): not applicable
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): not applicable
- Biomass loading rate: 0.35 g fish wet weight/L test medium

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: deionized water (no additional information)
- Total organic carbon: no data
- Particulate matter: no data
- Metals: no data
- Pesticides: no data
- Chlorine: 0.038 mmol KCl (2.9 mg/L)
- Alkalinity: 0.4 mmol/L
- Ca/mg ratio: 4:1 (based on molarity)
- Conductivity: no data
- Culture medium different from test medium: not applicable
- Intervals of water quality measurement: none

OTHER TEST CONDITIONS
- Adjustment of pH: no data
- Photoperiod: 16 h light/8 h dark with a 30-min transition period
- Light intensity: 50-500 Lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- The test fish were observed after approximately 3, 24, 48, 72 and 96 hours test duration for mortality and visible abnormalities.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: not applicable
- Justification for using less concentrations than requested by guideline: A limit test was performed in accordance with the test guidelines to demonstrate that the test substance has no toxic effect on the test fish up to the concentration of 100 mg/L.
- Range finding study: no
- Test concentrations: no data
- Results used to determine the conditions for the definitive study: no data
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
> 120 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
dissolved
Remarks on result:
other: Nominal 100 mg/L
Duration:
96 h
Dose descriptor:
LOEC
Effect conc.:
> 120 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
dissolved
Remarks on result:
other: Nominal 100 mg/L
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
> 120 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
dissolved
Remarks on result:
other: Nominal 100 mg/L
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
> 120 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
dissolved
Remarks on result:
other: Nominal 100 mg/L
Details on results:
- Behavioural abnormalities: no
- Observations on body length and weight: no
- Other biological observations: no
- Mortality of control: no
- Other adverse effects control: no
- Abnormal responses: no
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no
- Effect concentrations exceeding solubility of substance in test medium: no

The analytically determined concentration of the test substance in the test media was 133 and 108 mg/L at the beginning and end of the test.

Validity criteria fulfilled:
yes
Conclusions:
The acute toxicity of T002675 to zebra fish was determined in a 96-h static limit test according to OECD guideline 203. Under the conditions of the present study, the 96-h LC50 exceeded the nominal concentration of 100 mg/L (mean mesured concentration of 120 mg/L). The results of the test can be considered reliable without restriction.

Description of key information

The study of Bätscher (2007), investigating the acute toxicity of T002675 in fisch according to OECD guideline 203, was considered as the key study for endpoint coverage. A LC50 > 120 mg/L (based on mean mesured test concentrations) was obtained after an exposure of 96 hours in a limit static test in freshwater. Based on the results it can be considered that T002675 is not harmful to fish.

Key value for chemical safety assessment

Additional information