Reaction products of 2-methylimidazole and 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane

Short-term toxicity to fish

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:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction products of 2-methylimidazole and 2,2'-[(1- methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane

EC Number:

701-436-0

Molecular formula:

(C15H16O2.C4H6N2.C3H5ClO)x

IUPAC Name:

Reaction products of 2-methylimidazole and 2,2'-[(1- methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

As per IUCLID5 Sections 1.1. 1.2. 1.4. and 4.1.

Sampling and analysis

Analytical monitoring:

no

Test solutions

Vehicle:

no

Details on test solutions:

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 (Laboratory grade water), and mixing the solution for approximately 1 hour.

Test organisms

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

The Rainbow Trout, Oncorhynchus mykiss, were acquired from Trout Lodge Trout Farm (Sumner, Washington). The trout had a weight range of 0.441-0.687 gm and a length of 29-3 5 mm when placed on study. The fish were maintained in 2-gallon glass aquaria; filled with 8 L of moderately hard laboratory freshwater. There was a 16-hours light/8-hours dark cycle, a dissolved oxygen concentration of>60% saturation and temperature of 14-15°C. All the fish for the study were held in the laboratory at least 12 days before they were used for testing and The fish placed on study were held in water of the quality used in the test for at least seven days immediately before testing. The fish were fed daily until 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 85 mg/L CaCO3

Test temperature:

14-15°C

pH:

7.6

Dissolved oxygen:

>60% saturation

Salinity:

No data

Nominal and measured concentrations:

10,20,40, 80 and 160 mg/L nominal.

Details on test conditions:

Each concentration of test substance consisted of three replicates of ten fish. The fish were randomly placed, individually, into each aquarium containing the appropriate concentration of test substance. The loading rate was up to 1.0 gm fish/L. Three replicates of ten 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.

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 160 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

Survival of the fish was approximately 100 % at all concentrations.

Results with reference substance (positive control):

Not applicable.

Reported statistics and error estimates:

The NOEC (No Observed Effect Concentration) and LC50 (median lethal concentration) were determined by a commercially available statistical program (ToxCalc Version 5 .0Th1). Linear Interpolation was selected for the determination in this study..

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The test substance had an LC50 for trout of > 160 mgL under the conditions of the study.

Executive summary:

The test substance, Bisphenol A, epichlorohydrin polymer, 2-methylimidazole condensate, was evaluated for acute toxicity to the Rainbow trout in an O.E.C.D. test guideline 203 study. No mortality was observed in thsi study, Therefore, The test substance had an LC50 for trout of > 160 mgL under the conditions of the study.