Reaction products of ethylene glycol, epichlorohydrin and sodium hydroxide

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Remarks:

This experimental study was performed only for one constituent (2,2'-[ethylenebis(oxymethylene)]bisoxirane, CAS 2224-15-9, EC 218-746-2) of the UVCB substance.

Adequacy of study:

supporting study

Study period:

Unknown

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

no data on historical controls provided

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-[ethylenebis(oxymethylene)]bisoxirane

EC Number:

218-746-2

EC Name:

2,2'-[ethylenebis(oxymethylene)]bisoxirane

Cas Number:

2224-15-9

Molecular formula:

C8H14O4

IUPAC Name:

2,2'-[ethane-1,2-diylbis(oxymethylene)]dioxirane

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature in the dark
- Stability under test conditions: verified at the end of the study

Method

Target gene:

his operon, trp operon

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Metabolic activation:

with and without

Metabolic activation system:

S9 mix, prepared from the livers of rats treated with phenobarbital and 5-6-benzoflavone

Test concentrations with justification for top dose:

TA100 and TA1535 without S9: 9.77, 19.5, 39.1, 78,1, 156.3, 312.5, 625, 1250, 2500 and 5000 μg/plate
TA100 and TA1535 with S9: 39.1, 78,1, 156.3, 312.5, 625, 1250, 2500 and 5000 μg/plate

WP2uvrA with and without S9: 78,1, 156.3, 312.5, 625, 1250, 2500 and 5000 μg/mL

TA98 and TA1537 with and without S9: 312.5, 625, 1250, 2500 and 5000 μg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: water for injection

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

sodium azide

other: 2AA (2-aminoanthracene) for strains with S9, AF-2 [2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide] for TA98, TA100 and WP2uvrA without S9

Details on test system and experimental conditions:

METHOD OF APPLICATION: in medium; preincubation

DURATION
- Preincubation period: 20 minutes
- Exposure duration: 48 h

NUMBER OF REPLICATIONS: 3 replications

Evaluation criteria:

A test substance was considered positive in the Ames test if:
a) the vehicle control result was within mean ± 2 S.D. according to background data,
b) the positive result was more than 2-fold increase in compared with the vehcile control,
c) the increase was dose-related and reproducible, and
d) there was no other influence on the test system

Statistics:

Mean ± standard deviation

Results and discussion

Test results

Species / strain:

other: TA98, TA100, TA1535 and WP2urvA

Metabolic activation:

with and without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

5000 µg/plate with and without S9 in WP2uvrA

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: no precipitation

RANGE-FINDING/SCREENING STUDIES:
Dose-finding test was performed with 5, 15, 50, 150, 500, 1500 and 5000 μg/plate in all strains.

HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)
- Negative (solvent/vehicle) historical control data: not provided

Any other information on results incl. tables

Table 1.