Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The test was carried out in accordance to the OECD Guideline on Testing of Chemicals No. 203 "Fish, Acute Toxicity Test", 1992, with no deviations reported.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guidelineopen allclose all
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:
Swiss Federal Department of the Interior

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Triol
- Physical state: white solid
- Analytical purity: 99.5 % (LC), 99.8 % (DSC)
- Lot/batch No.: 6262/ZTN/03/N/08/001/003
- Expiration date of the lot/batch: 1 December 2000
- Stability under test conditions: not specified in water
- Storage condition of test material: in refridgerator at 4 +/- 3 °C, protected from sunlight
- Other:

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
Duplicate samples, both from the test medium and the control, were taken from the approximate center of the aquaria without mixing of the test media just before the test and after 48 and 96 hours. Samples were deep-frozen (at -20 °C) immediately after sampling.

Test solutions

Vehicle:
no
Details on test solutions:
The medium of the only test concentration of nominal 100 mg/L was freshly prepared in two batches. The amounts of 701 and 800 mg of the test item were completely dissolved in 7000 and 8000 mL test water, respectively, by ultrasonic treatment for 30 minutes and stirring of one hour at room temperature. Then, the two batches were combined in the aquarium by intense mixing.

Test organisms

Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Common name: Rainbow trout
- Strain:
- Source: P. Hohler, trout breeding station Zeiningen, Switzerland
- Age at study initiation (mean and range, SD):
- Length at study initiation (length definition, mean, range and SD): 5.3 +/- 0.5 cm
- Weight at study initiation (mean and range, SD): 1.5 +/- 0.1 g
- Method of breeding:
- Feeding during test
- Food type: No feeding during test.
- Amount:
- Frequency:


ACCLIMATION
- Acclimation period: Fish were held in the laboratories of RCC for about five weeks. They were acclimated for one week at the testing conditions before the test started.
- Acclimation conditions (same as test or not): Same as test condtions
- Type and amount of food: HOKOVIT 502, 1.2 mm, H.U. Hofmann AG, Bützberg, Switzerland
- Feeding frequency:
- Health during acclimation (any mortality observed): Less than 5 % of the fishes died, all fish used in the test were healthy.

Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h

Test conditions

Hardness:
2.5 mmol/L as CaCO3
Test temperature:
13-14 °C
pH:
7.8
Dissolved oxygen:
9.5-9.7 mg/L
Salinity:
0.8 mmol/L
Nominal and measured concentrations:
Nominal: 100 mg/L; measured (before start of experiment): 104 mg/L; measured (after 96 hours): 104 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: glass, 15 L test medium
- Aeration: slight aeration during test
- Renewal rate of test solution (frequency/flow rate): no renewal
- No. of organisms per vessel: seven randomly selected
- No. of vessels per concentration (replicates): one
- No. of vessels per control (replicates): one
- Biomass loading rate: less than 0.8 g fish wet weight per liter


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: deionised tap water
- Total organic carbon:
- Particulate matter:
- Metals:
- Pesticides:
- Chlorine:
- Alkalinity: 0.8 mmol/L
- Ca/mg ratio: 4.1
- Conductivity:
- Culture medium different from test medium:
- Intervals of water quality measurement:


OTHER TEST CONDITIONS
- Adjustment of pH:
- Photoperiod: 16 hours light, eight hours darkness
- Light intensity: 50 to 500 Lux


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

Results and discussion

Effect concentrations
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Basis for effect:
mortality
Details on results:
In the control and in the test medium of 100 mg/L all fish survived until the end of the test and no signs of intoxication were observed.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The 96-hour NOEC and the 96-hour LC0 of Triol determined in rainbow trout were determined to be at least 100 mg/L.
Executive summary:

A limit test was performed under static conditions during 96 hours in accordance to the OECD Guideline No. 203 to demonstrate that the test item has no toxic effects on the test animals up to a concentration of nominal 100 mg/L.

The analytically determined mean test article concentration was 104 mg/L at the start and 104 mg/L at the end of the test. Consequently, the test article was stable during the test period of 96 hour under the test conditions, and the reported biological results are based on the nominal concentration of the test article.

The pH in the test media and the control ranged from 7.8 to 8.0, the oxygen concentration was always 9.5 mg/L or higher, and thus higher than 60 % oxygen saturation. The water temperature ranged from 13 to 14 °C.

In the control and in the test medium with a concentration of Triol of 100 mg/L, all fish survived until the end of the test and no signs of intoxication were observed. Therefore, the 96 -hour NOEC and the 96 -hour LC0 are at least 100 mg/L.

No remarkable observations were made concerning the appearance of the test media. All test media were clear solutions throughout the entire test duration.