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 203 with GLP compliance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
1212

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
Test material form:
other: Liquid at room temperature.
Details on test material:
As per IUCLID5 Sections 1.1. 1.2. and 4.1.

Sampling and analysis

Analytical monitoring:
no

Test solutions

Vehicle:
yes
Details on test solutions:
For test concentrations prepared in the range- finding test, stock solutions of the test substance were prepared at concentrations of 10, 50 and 100 mg/L by adding the required nominal amount of test substance in the diluent, laboratory water and mixing the solution for approximately 1 hour and 20 minutes. For test concentrations prepared in the definitive test, stock solutions were prepared for each concentration individually by adding the required nominal amount of test substance in the diluent, and mixing the solution for approximately 3.5 hours.

Test organisms

Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
Rainbow Trout, Oncorhynchus mykiss, were acquired from Trout Lodge Trout Farm (Sumner, Washington). There weight range was 0.157-0.256 gm and length was 21-24mm. All fish were held in the laboratory at least 12 days before being placed on study. The environmental conditions were a 16-hours light/8-hours dark cycle, dissolved oxygen concentration of > 60% saturation and temperature of 14-15°C. In the definitive test, fish were fed daily until 48 hours before the test was started. Fish were not fed during the test.


Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
None.

Test conditions

Hardness:
Total hardness of 90 mg/L CaCO3
Test temperature:
14-15°C
pH:
8.0
Dissolved oxygen:
> 60% saturation
Salinity:
No data
Nominal and measured concentrations:
10, 20, 40, 80 and 160 mg/L nominal
Details on test conditions:
Treatment was conducted in 2-gallon glass aquaria; filled with 8 L of the appropriate solution of moderately hard laboratory freshwate and test substance. The definitive test was conducted using concentrations of 10, 20, 40, 80 and 160 mg/L of the test substance. Each concentration consisted of three replicates of ten fish. Organisms were randomly placed, individually, into each aquarium containing the appropriate concentration of test substance. Three replicates often organisms were not exposed to test substance and served as controls to demonstrate the condition of the test population. At 6, 24, 48, 72 and 96 hours following dosing, each aquarium was examined for mortality, and the number of live fish was recorded. The following measurements were made at dosing and daily afier dosing: dissolved oxygen, temperature, conductivity and pH of the controls and treated containers.


Reference substance (positive control):
no

Results and discussion

Effect concentrations
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
ca. 25.9 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 95% Confidence Limits = 18.3-32.5 mg/L.
Details on results:
Survival at 10 mg/L test substance was 100% at 96 hr. At 20 mg/L test substance survivak was 70% at 96 hr. Dose levels of 40 mg/L and greater resulted in complete mortality. Generally, mortality at the high dose levels was seem to occur within 24 hr of exposure to the test substance.
Reported statistics and error estimates:
The NOEC (No Observed Effect Concentration) of 10 mg/L and LC50 (median lethal concentration) were determined by a commercially available statistical program (ToxCalc Version 5.OTM). The Linear Interpolation mode was selected for the determination in this case.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The test substance was found to have a 96 hr LC50 value of approximately 25.9 mg/L with 95% confidence limits of 18.3-32.5 mg/L for the rainbow trout.
Executive summary:

The test substance, Formaldehyde, polymer with 1,3 -benzenedimethanamine and phenol was evaluated for acute aquatic toxicity to the rainbow trout in an O.E.C.D. test guideline no. 203 study. The test substance was found to have a 96 hr LC50 value of approximately 25.9 mg/L with 95% confidence limits of 18.3-32.5 mg/L for the rainbow trout.