Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2006-11-12 to 2007-02-15
Reliability:
1 (reliable without restriction)

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)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: solid, pearls of wax
- Composition: arachidyl alcohol 50-60%, behenyl alcohol 25-35%, behenyl glucoside 10-20%
- Analytical purity: dry extract >99%
- Lot/batch No.: T62435
- Expiration date of the lot/batch: 14 June 2008 (re-test)
- stability : 96h in water
- solubility : water<0.1 g/L
- Storage condition of test material: at the room temperature

Sampling and analysis

Analytical monitoring:
no
Details on sampling:
no specific analytic method available

Test solutions

Vehicle:
no
Details on test solutions:
As the solubility lies below 100 mg/L, the water-accommodated 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.

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
- Common name: Danio rerio (Hamilton Buchanan)
- Age at study initiation (mean and range, SD): sexually immature young fish
- Length at study initiation (length definition, mean, range and SD): 2 +/- 1cm
- 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 h

Test conditions

Hardness:
1.08 mmol/L
Test temperature:
21.8 - 24.5°C
pH:
7.6 to 8.0
Dissolved oxygen:
8.3 mg/L
Nominal and measured concentrations:
100 mg/L
Details on test conditions:
24 hours before the start of the test , food was withheld from the designated test fish.
Date: december 15th-19th, 2006
treatment: 100mg/L
duration: 96 hours
loading: 1 fish/L
Vessels: glass aquaria, maximal volume 10L
Aeration: accomplished with glass tubes, frequency of bubbles 1/S
feeding: none
Photo period:12/12 using neon tubes
temperature: 23+/- 1°C
pH adjustment: none
replicates: one vessels, each containing 7 L test solution and 7 Fishes
control: one vessels, each containing 7 L test solution and 7 Fishes
Observations were made every 24 hours, measuring pH and 02-concentration of the old and new test solution in each vessel and documentating mortalities or abnormal behaviour.
Reference substance (positive control):
not required

Results and discussion

Effect concentrationsopen allclose all
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
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:
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
Details on results:
No mortalities occured in the control.
The concentration of dissolved oxygen stayed above 8.6 mg/L or 100% throughout the test.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
According to an OECD test n°203: LC50 -96h fish > 100 mg/l
Executive summary:

The toxic potential of the substance towards freshwater fish, using the species Danio rerio Hamilton Buchanan. The experiment followed the OCDE 203.

As the test item is poorly soluble in water, the water-accommondate fraction was tested.

This was done by shaking the nominal load with the appropriate amount of drinking water for 24 hours, followed by filtration through a paper filter.

The test was performed as a limit test using the concentration 100 mg/L. For each concentration, seven fishes were exposed to the test substance 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 were normal.

The following results for the tes substance were determined:

24 -96h NOEC = 100 mg/L

24 -96h LC50 > 100 mg/L

24 -96h LC100 > 100 mg/L