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Diss Factsheets

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2006-12-15 to 2006-12-20
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: It is hereby declared that all tests were made in accordance with the "revised OECD principles of good laboratory practice".

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
yes
Remarks:
No analytical determination of the content of the test item in the test solutions during the test was made.
GLP compliance:
yes (incl. QA statement)
Remarks:
2007-01-12

Test material

Constituent 1
Reference substance name:
Montanov L
IUPAC Name:
Montanov L
Details on test material:
Batch: T63645
Appearence: pearls of wax
Purity: ES >99%
Stability: water 96h
Solubility: water <0.1 g/L
Production date: 2006-09-08
Expiry date: 2008-03-08
Storage: in a closed cessel at room temperature (20 +/- 5°C)

Sampling and analysis

Analytical monitoring:
no
Details on sampling:
Concentrations: 1 / 10 / 100 mg/L
As the solubility lies below 100 mg/L, the water accomodated fraction was prepared for the test this was done by weighing the nominal load, adding the corresponding amount of dilution water and shaking vigorously for 24 hours. The resulting solution was filtrated through paper filters (specification "white band").

Test solutions

Vehicle:
no

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
Variety: Hamilton-Buchanan
Age: sexually immature young fish, length 2 +/- 1 cm
The animals were obtained from a commercial supplier. Befor being used for the test, the fish were kept for 14 days under test conditions. During this period, mortality didn't surpass 5%.

Study design

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

Test conditions

Hardness:
1.08 mmolL
Test temperature:
20.8-22.9°C
pH:
7.1-7.9
Dissolved oxygen:
stayed above 8.5 mg/L
Nominal and measured concentrations:
1 / 10 / 100 mg/L
Details on test conditions:
Before the test
Medium: chlorine-free tap water
Feeding: three times a day with warmwater fishfood and daphnia, totalling to about 1-2% of body weight per day
Medium renewal: twice a week
Photo period: 12/12 hours, using neon tubes
Temperature: 23 +/- 1°C

During the test
Date: December 16th-20th, 2006
Duration: 96 hours
Loading: 1 fish/L
Vessels: glass aquaria, maximal volume 10 L
Aeration: accomplished with glass tubes, frequency of bubbles 1/s
Feeding: none
Photo period: 12/12 hours, using neon tubes
Temperature: 23 +/- 1°C
pH adjustment: none
Replicates: one vessel, each containing 7 L test solution and 7 fish
control: one vessel, containing 7 L dilution water and 7 fish
Observations were made avery 24 hours, measuring pH and O2-concentration of the old and new test solution in each vessel and documentating mortailities or abnormal behaviour.
Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Duration:
24 h
Dose descriptor:
NOEC
Effect conc.:
ca. 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
24 h
Dose descriptor:
LC100
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
ca. 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
48 h
Dose descriptor:
LC100
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
72 h
Dose descriptor:
NOEC
Effect conc.:
ca. 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
72 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
72 h
Dose descriptor:
LC100
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
ca. 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
No mortality occured in the control.
the concentration of dissolved oxygen stayed above 8.5 mg/L or 99% throught the test.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
24-96h NOEC= 100 mg/L
24-96h LC50> 100 mg/L
24-96h LC100> 100 mg/L
Executive summary:

Determination of the acute toxicity of Montanov L against Danio rerio Hamilton Buchanan following EU-method C.1 resp. OECD guideline 203.

This study was performed in order to evaluate the toxic potential of Montanov L towards freshwater fish, using Danio rerio Hamilton-Buchanan. The study was performed for notification purpose.

The study was conduced in accordance with the following guidelines:

OECD guidelines for the testing of chemicals n°203 "fish acute toxicity test"

EU-guideline C.1 "akute toxizität für fische"

As the solubility lies below 100 mg/L, the water accomodated fraction was prepared for the test this was done by weighing the nominal load, adding the corresponding amount of dilution water and shaking vigorously for 24 hours. The resulting solution was filtrated through paper filters (specification "white band").

The test was performed as a limit test using the concentration 100 mg/L. for each concentration, seven fish were exposed to the test item for 96 hours.

In the treatment and the control, no fish showed any signs of morbidity at the end of the test. The pH and the oxygen value of the water remain normal.

The following results for the test item Montanov L were determined.

24-96h NOEC= 100 mg/L

24-96h LC50> 100 mg/L

24-96h LC100> 100 mg/L