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Toxicological information

Genetic toxicity: in vitro

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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 guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 490 (In Vitro Mammalian Cell Gene Mutation Tests Using the Thymidine Kinase Gene)
Deviations:
not applicable
Qualifier:
equivalent or similar to
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

Reference
Name:
Unnamed
Type:
Constituent
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.