Oligomeric reaction products of 4,4'-propane-2,2-diyldiphenol and 2-methyloxirane and 2-(chloromethyl)oxirane

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15 July 1997 - 25 August 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant study conducted in accordance with international guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals

Deviations:

no

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

460-230-6

EC Name:

-

Cas Number:

36484-54-5

IUPAC Name:

Oligomeric reaction products of 4,4'-propane-2,2-diyldiphenol and 2-methyloxirane and 2-(chloromethyl)oxirane

Details on test material:

- Name of test material (as cited in study report): EP-4000S, Chemical name: Polyoxyalkylene diglycidylether
- Physical state: extremely pale yellow viscous liquid
- Lot/batch No.: 02067
- Storage condition of test material: ambient temperature (<25°C), under artificial light

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A

Metabolic activation:

with and without

Metabolic activation system:

S9 (rat liver homogenate metabolising system)

Test concentrations with justification for top dose:

Range finding study: 0, 50, 150, 500, 1500, 5000 µg/plate (with and without metabolic activation)
Main study: 0, 50, 150, 500, 1500, 5000 µg/plate (with and without metabolic activation)

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO
-Justification for choice of solvent/vehicle: Soluble at 50mg/mL

Controls

Controls 1

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

Positive controls:

yes

Positive control substance:

N-ethyl-N-nitro-N-nitrosoguanidine

Remarks:

at 2µg/plate for WP2uvrA, at 3µg/plate for TA100 and at 5µg/plate for TA1535

Controls 2

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

at 80µg/plate for TA1537

Controls 3

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

Positive controls:

yes

Positive control substance:

4-nitroquinoline-N-oxide

Remarks:

at 0.2µg/plate for TA98

Controls 4

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

Positive controls:

yes

Positive control substance:

other: 2-Aminoanthracene

Remarks:

Used for all strains in the presence of metabiloc activation (all S9 plates).

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Preincubation period: approximately 10hrs
- Exposure duration: 48hrs

NUMBER OF REPLICATIONS: 3

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

no cytotoxicity, but tested up to precipitating concentrations

Positive controls validity:

valid

Test results 2

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Positive controls validity:

valid

Additional information on results:

All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies, both with and without metabolic activation.

Any other information on results incl. tables

The test material caused no visible reduction in the growth of the bacterial background lawn at any dose level. The test material, therefore, tested up to the maximum recommended dose level of 5000µg/plate. A precipitate was observed at 5000µg/plate, this did not prevent the scoring of revertant colonies.

A dose-related, reproducible and statistically significant increase in revertant colony frequency was observed to several of the tester strains (both with and without metabolic acivation) with doses of the test material beginning at 150µg/plate.

The mutagenic responses were predominantly observed to those tester strains sensitive to base-pair substitution in the genetic material.

The test material was, therefore, considered to be mutagenic under the conditions of this test.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
positive

The test material, EP-4000S, was considered to be mutagenic under the conditons of this test.