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Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Jun 30 - Aug 16, 2004
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Use of solvents to increase exposure; Pre test for bioaccumulation study. This study was performed according to GLP and the methods applied are fully compliant with OECD TG 203.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
1-ethoxy-2,3-difluoro-4-[(1s,4r)-4-propylcyclohexyl]benzene
EC Number:
605-718-3
Cas Number:
174350-05-1
Molecular formula:
C17H24F2O
IUPAC Name:
1-ethoxy-2,3-difluoro-4-[(1s,4r)-4-propylcyclohexyl]benzene
Test material form:
other: solid

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
0; 24, 48, 72, 96 h

Test solutions

Vehicle:
yes
Details on test solutions:
According to guideline PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)- Chemical name of vehicle (organic solvent, emulsifier or dispersant): SPAN 60- Concentration of vehicle in test medium (stock solution and final test solution(s) at different concentrations and in control(s)):

Dose 1: Test item: 86.4 mg/L , Vehicle: 900 mg/L
Dose 2: Test item: 75.5 mg/L , Vehicle: 900 mg/L
Dose 3: Test item: 51.3 mg/L , Vehicle: 900 mg/L
Dose 4: Test item: 47.7 mg/L , Vehicle: 900 mg/L
Dose 5: Test item: 42.4 mg/L , Vehicle: 900 mg/L
Dose 6: Test item: 31.4 mg/L , Vehicle: 900 mg/L

Control: Positive control: 0.5 mg/L , Vehicle: 900 mg/L
Negative Control: Test item: --, Vehicle: 900 mg/L

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
Weight: 0.2 g
Length: 3.2 cm
Lot: 40501

Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
no

Test conditions

Test temperature:
25.1 +/- 0.2 °C
pH:
7.7
Dissolved oxygen:
7.1 mg/L
Nominal and measured concentrations:
31.4, 42.4, 47.4, 51.3, 75.5, 86.4 mg/L (adjusted with SPAN 60 as vehicle; measured by LC)
Details on test conditions:
10 fish per 4 L
Reference substance (positive control):
not specified

Results and discussion

Effect concentrations
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 86 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 900 mg/L SPAN 60
Details on results:
- Mortality of control: 0 % after 96 hours
Mortality in %
-----------------------------------------------------------
Test material (mg/L) 24 h 48 h 72 h 96 h
-----------------------------------------------------------
31.4 0 0 0 0
42.4 0 0 0 0
47.4 0 0 0 0
51.3 0 0 10 20
75.5 0 10 10 20
86.4 10 20 20 30
-----------------------------------------------------------
SPAN 60 0 0 0 0
-----------------------------------------------------------
Control Group (Vehicle: 900 mg/L): no mortality observed during the study
- Effect concentrations exceeding solubility of substance in test medium:
All concentrations tested were at or above the solubility limit of the pure test substance.

To achive the exposure concentrations, solvent SPAN 60 was used.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The LC50 of the test material with solubilizer is larger than 86.4 mg/L, which is above the limit of water solubility.
Executive summary:

The informtion for this endpoint study record was obtained from an experimental study. The OECD GLP criteria were met and the methods applied are fully compliant with OECD TG 203. The LC50 of the test material with solubilizer exceeds 86.4 mg/L, which is clearly above the limit of water solubility.