m-bis(2,3-epoxypropoxy)benzene

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

Study period:

N/A

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 490 (In Vitro Mammalian Cell Gene Mutation Tests Using the Thymidine Kinase Gene)

Deviations:

not applicable

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)

Deviations:

not applicable

GLP compliance:

no

Type of assay:

in vitro mammalian cell gene mutation test using the Hprt and xprt genes

Test material

Test material information

Constituent 1

Reference substance name:

m-bis(2,3-epoxypropoxy)benzene

EC Number:

202-987-5

EC Name:

m-bis(2,3-epoxypropoxy)benzene

Cas Number:

101-90-6

Molecular formula:

C12H14O4

IUPAC Name:

2-({3-[(oxiran-2-yl)methoxy]phenoxy}methyl)oxirane

Test material form:

liquid: viscous

Method

Target gene:

tk and hprt

Species / strain

Species / strain / cell type:

mouse lymphoma L5178Y cells

Metabolic activation:

without

Test concentrations with justification for top dose:

0.7 µg/ml (first test) and 0.4 µg/ml

Controls

Untreated negative controls:

no

Positive control substance:

ethylmethanesulphonate

Results and discussion

Test results

Key result

Species / strain:

mouse lymphoma L5178Y cells

Metabolic activation:

without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

not applicable

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

Whilst m-bis(2,3-epoxypropoxy)benzene did not induce mutagenic changes at the hprt locus, the mutagenic response at the tk locus is clear, and thus the compound can be considered to be mutagenic.

Executive summary:

M-bis(2,3-epoxypropoxy)benzene was exposed to mouse L5178Y cells at doses up to 0.7 µg/ml to determine mutagenicity at two gene loci: tk and hprt. The test compound induced clear mutagenic responses at the tk locus, reaching higher numbers of colonies that the positive control at the top doses (238 vs 197), however, there was no clear response at the hprt locus.

M-bis(2,3-epoxypropoxy)benzene can therefore be considered to be mutagenic.