Oxybis(methyl-2,1-ethanediyl) diacrylate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in mammalian cells

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: meets generally accepted scientific standards, well documented and acceptable for assessment

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Unnamed

Year:

1984

Report date:

1983

Reference 2

Reference Type:

other: communication

Title:

TSCA Section 8(E) Substantial risk notice for dipropyleneglycol diacrylate (DPGDA)

Author:

EPA

Year:

1982

Bibliographic source:

TSCATS/OTS0503681

Report date:

1982

Materials and methods

Principles of method if other than guideline:

Diproypleneglycol diacrylate was tested in the L5178Y TK+/- Mouse Lymphoma Mutagenesis assay with and without exogenous metabolic activation by Aroclor induced rat liver microsomes.

GLP compliance:

yes

Type of assay:

mammalian cell gene mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Oxybis(methyl-2,1-ethanediyl) diacrylate

EC Number:

260-754-3

EC Name:

Oxybis(methyl-2,1-ethanediyl) diacrylate

Cas Number:

57472-68-1

Molecular formula:

C12H18O5

IUPAC Name:

oxydipropane-1,2-diyl bisacrylate

Details on test material:

- Name of test material (as cited in study report): A209415
- Physical state: liquid
- Analytical purity: no data

Method

Target gene:

thymidine kinase (TK) gene

Species / strain

Species / strain / cell type:

mouse lymphoma L5178Y cells

Metabolic activation:

with and without

Metabolic activation system:

S-9 mix

Test concentrations with justification for top dose:

initial toxicity determination: with and without S-9 mix: 0.001, 0.01, 0.1, 1.0, 10, 100 µl/ml
MLMA assay: without S-9 mix: 0.0013 - 0.01 µl/ml; with S-9 mix: 0.013 - 0.1 µl/ml

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: [ethanol]
- Justification for choice of solvent/vehicle: none given

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

ethylmethanesulphonate

Controls 2

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

7,12-dimethylbenzanthracene

Details on test system and experimental conditions:

METHOD OF APPLICATION: in medium


DURATION
- Exposure duration: 4 hours
- Expression time (cells in growth medium): 2 days
- Selection time (if incubation with a selection agent): 10-12 days
- Fixation time (start of exposure up to fixation or harvest of cells): after 10-12 days


SELECTION AGENT (mutation assays): 5-trifluorothymidine


DETERMINATION OF CYTOTOXICITY
- Method: relative total growth

Evaluation criteria:

Positive - if there is a positive dose response and one or more of the three highest doses exhibit a mutant frequency which is two-fold greater than the
background level.
Equivocal - if there is no dose response but any one or more doses exhibit a two-fold increase in mutant frequency over background.
Negative - if there is no dose response and none of the test cultures exhibit mutant frequencies which are two-fold greater than background.

Statistics:

All mutant frequency and toxicity data calculations were performed using a Texas Instruments TI-59 calculator.

Results and discussion

Test results

Species / strain:

mouse lymphoma L5178Y cells

Metabolic activation:

with and without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.