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

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

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 202 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 202 (Daphnia sp. Acute Immobilisation 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

Constituent 2

Reference substance name:

68002=42-6

IUPAC Name:

68002=42-6

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 concentration prepared in the limit test, a stock solution was prepared at a concentration of 100 mg/L by adding the required nominal amount of test substance in the diluent, moderately hard synthetic freshwater and mixing the solution for approximately 1.5 hours.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

The Daphnia were maintained in the STILLMEADOW, Inc. culture laboratory in 250-mL glass beakers; filled with 200 mL of the appropriate solution
moderately hard synthetic freshwater. There was a 16 hours light/8 hours dark cycle with dissolved oxygen concentration of 60-105% saturation at dosing and a temperature of 21°C. The Daphnids were no greater than 24 hours old at initiating of dosing and they were not fed during the test.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Post exposure observation period:

none

Test conditions

Hardness:

Total hardness of 220 mg/L CaCO3.

Test temperature:

21°C

pH:

7.7

Dissolved oxygen:

60-105% saturation

Salinity:

No data, freshwater

Nominal and measured concentrations:

100 mg/L nominal.

Details on test conditions:

Following randomization, ten Daphnids were placed into each beaker. A limit test was conducted using a concentration of 100 mg/L of the test substance and consisted of three replicates of ten daphnids. Three replicates of ten daphnids were not exposed to test substance and sewed as controls to demonstrate the condition of the test population. At 24 and 48 hours following dosing, each beaker was examined for immobility, and the number of mobile daphnids was recorded.

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

A mobility rate of 100% was observed in the control organisms and organisms treated with 100 mg/L of test substance at 24 and 48 hr.

Reported statistics and error estimates:

The NOEC (No Observed Effect Concentration) and EC50 (median effective concentration) were determined by a commercially available statistical program (ToxCalc Version 5.0). The Probit estimation model was selected for the determination in this study.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The EC50 for immobility of the Daphnids in this study was > 100 mg/L (Limit dose) at 24 and 48 hr. No immobility was observed in the treatred cultures.

Executive summary:

The test substance, Bisphenol A, epichlorohydrin polymer, 2-methylimidazole condensate, was evaluated for the potential to immobilize Daphnia in an O.E.C.D. test guideline 202 study. The EC50 for immobility of the Daphnids in this study was > 100 mg/L (Limit dose) at 24 and 48 hr. No immobility was observed in the treatred cultures.