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: The study was conducted according to the O.E.C.D. test guideline with GLP compliance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
2011

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
As per IUCLID Sections 1.1. 1.2. and 4.1.

Sampling and analysis

Analytical monitoring:
no

Test solutions

Details on test solutions:
Treatment solutions were perpared by adding the necessary amount of the test substance to the treatment aquaria followed by addition of laboratory water to yield nominal concentrations of 7.5, 15, 30, 60 and 120 mg/L. The test substance solutions were mixed for approximately one hour before addition of the test organisms.

Test organisms

Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
the fish were acquired from Trout Lodge Trout Farm (Summer, WA) and placed on-study with a body weight range of 139-377 mg and length of 21-28 mm.

Study design

Test type:
static
Water media type:
freshwater
Total exposure duration:
96 h
Post exposure observation period:
None

Test conditions

Hardness:
100 mg/L CaCO3
Test temperature:
13-16 degrees C
pH:
7.7
Dissolved oxygen:
> 60%
Salinity:
No data
Nominal and measured concentrations:
Nominal concentrations of: 7.5, 15, 30, 60 and 120 mg/L.
Details on test conditions:
Treatment was conducted in triplicate in two gallon glass aquaria containing approximately eight liters of laboratory water with ten fish per aquarium.The loading rate was approximately 1.0 gm fish/L. A ligh/dark cycle of 16-hr light/8-hr dark was maintained. At 6,24, 48, 72 and 96 hr the aquaria were observed for mortality and the number live fish recorded.

Results and discussion

Effect concentrations
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
ca. 11.5 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 11 - 12.9 95% confidence Limits.
Details on results:
Complete mortality was observed at the dose levels of 30, 60 and 120 mg/L with six hours of treatment. Srivival at 15 mg/L was 56.7% at 24 hr and 6.7% at 96 hr. No mortalities were observed at 7.5 mg/L.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The LC50 value for the test substance was determined to be 11.5 mg/L (95% Confidence Limits 11-12.9). The No Observed Effect Concentration (NOEC) was 7.5 mg/L.
Executive summary:

The LC50 value for the test substance, 4,4'-Isopropylidenedicyclohexanol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, to rainbow trout in a static O.E.C.D. test guideline 203 study was 11.5 mg/L with 95% Confidence Limits of 11 -12.9 mg/L. The No Observed Effect Concentration was 7.5 mg/L.