Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12/1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study followed the procedure laid down in OECD Guideline for Testing Chemicals, No. 203, "Fish, Acute Toxicity Test", 1992, and Commission Directive92/69/EEC, Part C.1, 1992.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

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
Details on test material:
- Name of test material (as cited in study report): Actinol
- Physical state: White solid
- Analytical purity: 99.5 %
- Lot/batch No.: 410016
- Expiration date of the lot/batch: 31 July 2000
- Stability under test conditions: for maximal 5 days
- Storage condition of test material: At room temperature
- Other:

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
For the analyses of the test substance concentrations in the static test, duplicate samples were taken from the freshly prepared test medium and the control just before the start of the test.
To confirm the maintenance of the test substance concentration throughout the test duration, duplicate samples from the test medium of the single test concentration and the control were taken after 48 hours and 96 hours (end of test).
The concentrations of the test substance Actinol were analysed immediately after sampling.

Test solutions

Vehicle:
not specified
Details on test solutions:
To produce the test water, analytical grade salts were dissolved in deionised water to obtain the following nominal concentrations: CaCl2 x 2H2O: 2.0 mmol/L (294 mg/L); MgSO4 x 7 H2O: 0.5 mmol/L (123 mg/L); NaHCO3: 0.75 mmol/L (65 mg/L); KCl 0.075 mmol/L (5.8 mg/L). The only test substance concentration tested was nominal 100 mg/L test water.

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebra fish
- Strain:
- Source: Zoohaus Schaub, Liestal, Switzerland
- Age at study initiation (mean and range, SD):
- Length at study initiation (length definition, mean, range and SD): 3.3 +/- 0.3 cm
- Weight at study initiation (mean and range, SD): 0.38 +/- 0.07 g
- Method of breeding:
- Feeding during test
- Food type: TETRA MIN Hauptfutter, TETRA-Werke, Melle, Germany
- Amount:
- Frequency:


ACCLIMATION
- Acclimation period: 8 weeks
- Acclimation conditions (same as test or not): 1 week
- Type and amount of food:
- Feeding frequency:
- Health during acclimation (any mortality observed): During the last 8 weeks prior to the test no fish died and all fish were healthy.


QUARANTINE (wild caught)
- Duration:
- Health/mortality:

Study design

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

Test conditions

Hardness:
2.5 mmol/L (250 mg/L) as CaCO3
Test temperature:
22-23 °C
pH:
7.9 at start of test
7.6 from 48 to 96 hours
Dissolved oxygen:
8.9 mg/L at start
8.6 mg/L at 48 hours
8.2 mg/L at 72 hours
8.3 mg/L at 96 hours
Salinity:
0.8 mmol/L
Nominal and measured concentrations:
The nominal concentration was 100 mg/L. The measured concentration ranged from 93 to 103 mg/L.

Results and discussion

Effect concentrations
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
99 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
dissolved
Basis for effect:
other: no signs of intoxication
Details on results:
The 96-hour NOEC and th 96-hour LC0 might even be higher than the concentration of nominal 100 mg/L (measured mean 99 mg/L), but concentrations in excess of 100 mg/L have not been tested, according to the guidelines. The 96-hour LOEC and 96-hour LC50 were clearly higher than 100 mg/L. These values could not be quantified due to the absence of toxicity of Actinol at the tested concentration.

Any other information on results incl. tables

no other information

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
A limit test was performed with the test substance Actinol, which demonstrated that the test substance has no toxic effect on the test fish (Brachydanio rerio) up to the test concentration of nominal 100 mg/L.
Executive summary:

The acute toxicity of the test substance Actinol to zebra fish (Brachydanio rerio) was determined in a 96 -hour static test according to the Commission Directive 92/69/EEC, Annex Part C.1, 1992, and the OECD Guideline for Testing of Chemicals No. 203, 1992.

A limit test was performed in accordance with the guidelines, which demonstrated that the test substance has no toxic effect on the test organisms up to and including the concentration of nominal 100 mg/L. Thus, the only concentration tested was nominal 100 mg/L and a control.

The analytically determined mean test substance concentration varied in the range of 93 to 103 % of the nominal value. The total mean concentration measured was 99 % of the nominal concentration. Consequently, the test substance was stable during the test period of 96 hours under the test conditions, and the reported biological results are based on the nominal concentration of the test substance.

In the control and at the test concentration of 100 mg/L, no mortality or other signs of intoxication were determined during the test period of 96 hours.

Therefore, the 96 -hour NOEC (highest concentration tested without toxic effects after the exposure period), and the 96 -hour LC0 of Actinol to zebra fish were determined to be at least 100 mg/L. These values might even be higher than this concentration, but concentrations in excess of 100 mg/L have not been tested, according to the guidelines. The 96 -hour LOEC and the 96 -hour LC50 were clearly higher than 100 mg/L. These values could not be quantified due to the absence of toxicity of Actinol at the tested concentration.