Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
november 2006-december 2007
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: from read across based on grouping of substances

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)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Alcohols, C16-18
EC Number:
267-008-6
EC Name:
Alcohols, C16-18
Cas Number:
67762-27-0
IUPAC Name:
heptadecan-1-ol
Constituent 2
Reference substance name:
Hexadecyl D-glucoside
EC Number:
259-220-2
EC Name:
Hexadecyl D-glucoside
Cas Number:
54549-27-8
IUPAC Name:
54549-27-8
Constituent 3
Reference substance name:
Octadecyl D-glucoside
EC Number:
248-686-2
EC Name:
Octadecyl D-glucoside
Cas Number:
27836-65-3
IUPAC Name:
octadecyl hexopyranoside
Details on test material:
- Name of test material (as cited in study report): MONTANOV 68
- Physical state: solid, powder
- Analytical purity: 100%
- Composition of test material, percentage of components: 67762-27-0, 54549-27-8, 27836-65-3
- Lot/batch No.: T62615
- Expiration date of the lot/batch: 27 June 2008 (re-test)
- Storage condition of test material: at the room temperature

Sampling and analysis

Analytical monitoring:
no

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:
TEST ORGANISM
- 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

Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
observations were made every 24h , measuring pH and O2 concentrations of the old and new test solution in each vessel and documenting mortalities or abnormal behaviour.

Test conditions

Hardness:
1.08 mmol/L
Test temperature:
20.8-22.9 °C
pH:
7.0 -7.9
Dissolved oxygen:
8.8mg/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 16th-20th, 2006
treatments: 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+- °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
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 (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)
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:

- Mortality of control: no mortality occured in the control

Applicant's summary and conclusion

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

This study was performed in order to evaluate the toxic potential of the substance towards freshwater fish, using the species Danio rerio Hamilton Buchanan.

As the substance is poorly soluble in water, the water-accommodated fraction was tester. 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, 7 fishes 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 were normal.

The following results for the test substance were determined:

24 -96h NOEC = 100 mg/L

24 -96h LC50 > 100 mg/L

24 -96h LC100 > 100 mg/L