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: There were no circumstances that may have afected the quality or integrity of the study.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
2007-01-12

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Batch n°: T62935
- Appearence: pearls of wax
- Purity: ES>99%
- Solubility: water<0.1g/L
- Storage: room temperature 20 +/- 5°C

Sampling and analysis

Analytical monitoring:
no

Test solutions

Vehicle:
no
Details on test solutions:
As the solubility lies below 100mg/L, the water accomodated fraction was preparared 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 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. Before being used for the test, the fish kept for 14 days under test conditions. During this period, mortality didn't surpass 5%.
Supplier: Weiler's Pet's best, Tumstr. 6, 67433 Neustadt
Date of arrival: September 29th, 2006
Vessels: polyethylene aquaria
Medium: chlorine-free tap water, full composition see annex
Feeding: three times a day with warmwater fishfood and daphnia, totalling to about 1-2% body weight per day
Medium renewal: twice a week
Photo period: twice a week, using neon tubes
Temperature 23 +/- 1°C
Dilution water: good quality drinking water is used.

Study design

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

Test conditions

Hardness:
1.08mmol/L
Test temperature:
21.8-24.5°C
pH:
7.6-8
Dissolved oxygen:
8.3 mg/L
Nominal and measured concentrations:
0 / 1 / 10 / 100 mg/L
Details on test conditions:
General conditions:
duration 96 hours
loading 1fish/L
vessels: glass aquaria, maximal volume 10 L
aeration: accomplished with glass tubes, frequency of bubbles 1/s
feeding: none
photo period: 12/12
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 every 24 hours, measuring pH and O2 concentration of the old and new test solution in each vessel and documentating mortailities or abnormal behaviour.
A fish was considered dead, if no visible movement could be observed, and if touching the caudal peduncle produced no reaction.
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
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
24 h
Dose descriptor:
LC100
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
ca. 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
48 h
Dose descriptor:
LC100
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
72 h
Dose descriptor:
NOEC
Effect conc.:
ca. 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
72 h
Dose descriptor:
LC100
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
ca. 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
no martality occured in the control.
The concentration of dissolved oxygen stayed above 8.3mg/L throught the test.
All validity criteria were met.
The test solution were shaken for 24 hours to guarantee that saturation concentration of the test item had been reached.
As it was not possible to filtrate a sufficient amount of the test solution through the membrane filters, a paper filter was used for the preparation of the test solution.
The result of the test can be considere valid.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:

24 h NOEC = 100 mg/L
24 h LC50 > 100 mg/L
24 h LC100 > 100 mg/L
48 h NOEC = 100 mg/L
48 h LC50 > 100 mg/L
48 h LC100 > 100 mg/L
72 h NOEC = 100 mg/L
72 h LC100 > 100 mg/L
96 h NOEC = 100 mg/L
96 h LC50 > 100 mg/L
96 h LC100 > 100 mg/L
Executive summary:

This study was performed in order to evaluate the toxic potential of Montanov 82 towards freshwater fish, using the species Danio rerio Hamilton-Buchanan. The study was performed under GLP and the test was conduced in accordance to the OECD guideline for the testing of chemicals n°203, "fish acute toxicity test".

As the solubility lies below 100mg/L, the water accomodated fraction was preparared 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 100mg/L. For each concentration, seven fish were exposed to the test item for 96 hours. In the treatment and control, no fish showed any signs of morbidity at the end of the test. The pH and oxygen value of the water were normal.

The following results were determined.

24 -96h NOEC=100mg/L

24 -96h LC50>100mg/L

24 -96h LC100>100mg/L