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: Guideline study conducted under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): PM 1265 (internal company product designation) and Cyclobutanediol, 2,2,4,4-Tetramethyl
- Substance type: production sample
- Physical state: solid
- Lot/batch No.: TS060505
- Storage condition of test material: Ambient conditions

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
Samples were collected from each treatment and control group at approximately 0, 48 and 96 hours of the test to measure concentrations of the test substance. At each sampling interval, approximately 10 mL of solution was collected from mid-depth in each test chamber and pooled by treatment group. All samples were placed in glass vials and processed immediately for analysis.

Test solutions

Vehicle:
no
Details on test solutions:
Test solutions were prepared in two replicate test chambers for each treatment group by dissolving PM-1265 in dilution water (well water) at nominal concentrations of 7.5, 15, 30, 60 and 120 mg/L. Each solution was stirred for two to three minutes using a top-down electric mixer. All test solutions appeared clear and colorless at test initiation and termination.

Test organisms

Test organisms (species):
Pimephales promelas
Details on test organisms:
Fathead minnows used in the test were juveniles obtained from Chesapeake Cultures, Hayes, Virginia. Identification of the species was verified by the supplier. All fish used in the test were from the same source and year class, and the length of the longest fish measured was no more than twice the length of the shortest. The average total length of 10 negative control fish measured at the end of the test was 2.4 cm, with a range of 2.3 to 2.5 cm. The average wet weight (blotted dry) of 10 negative control fish measured at the end of the test was 0.11 grams, with a range of 0.07 to 0.13 grams. Loading was defined as the total wet weight of fish per liter of test water and was 0.07 g fish/L. The fathead minnows were held for at least 14 days prior to the test in water from the same source and at approximately the same temperature as used during the test. Daily during the holding period, the fish were fed a commercially-prepared diet supplied by Zeigler Brothers, Inc., Gardners, Pennsylvania, supplemented with brine shrimp nauplii (Artemia sp.) supplied by Brine Shrimp Direct, Ogden, Utah. The fish were not fed for at least two days prior to the test or during the test. During the 2-week period prior to the test, no mortalities occurred and the fish showed no signs of disease or stress. At test initiation, the fathead minnows were collected from the culture tank and impartially distributed one and two at a time to the test chambers until each contained 10 fish.

Study design

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

Test conditions

Hardness:
134 mg/L as CaCO3
Test temperature:
22 ± 1C
pH:
8.3 to 8.5
Dissolved oxygen:
≥7.4 mg/L (85% of saturation)
Salinity:
Specific Conductance 320 μmhos/cm
Nominal and measured concentrations:
Nominal concentrations selected for use in this study were 7.5, 15, 30, 60 and 120 mg/L.
Mean measured test concentrations for this study were 6.9, 14, 25, 57 and 112 mg/L
Details on test conditions:
Fathead minnows were exposed to a geometric series of five test concentrations and a negative control (dilution water) for 96 hours under static conditions. Two replicate test chambers were maintained in each treatment and control group, with 10 fathead minnows in each test chamber, for a total
of 20 minnows per test concentration. Nominal test concentrations selected were 7.5, 15, 30, 60 and 120 mg PM-1265/L. Test chambers were 25-L stainless steel aquaria containing approximately 15 L of test solution. The depth of the test water in a representative test chamber was 17.4 cm. The chambers were indiscriminately positioned in an environmental chamber designed to maintain the desired test temperature throughout the test period. Mean measured test concentrations were determined from samples of test water collected from each treatment and control group at test initiation, at the approximate mid-point of the test and at test termination. Fathead minnows were impartially assigned to exposure chambers at test initiation. Observations of mortality and other signs of toxicity were made approximately 5.5, 24, 48, 72 and 96 hours after test initiation. The cumulative percent mortality observed in the treatment groups was used to determine LC50 values at 24, 48, 72 and 96 hours.

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 112 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
>= 112 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
Fathead minnows exposed to PM-1265 at concentrations ≤ 112 mg/L appeared normal with no mortality or overt signs of toxicity.

Applicant's summary and conclusion

Executive summary:

Fathead minnows (Pimephales promelas) were exposed under static conditions for 96 hours to five mean measured concentrations of PM-1265 ranging from 6.9 to 112 mg/L. The 96-hour LC50 value was >112 mg/L, the highest concentration tested. Fathead minnows exposed to PM-1265 at concentrations 112 mg/L appeared normal with no mortality or overt signs of toxicity. The no-mortality concentration and NOEC were both 112 mg/L.