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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (GLP)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
Qualifier:
according to guideline
Guideline:
EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
Version / remarks:
440/2008/EC
GLP compliance:
yes (incl. QA statement)
Type of assay:
in vitro mammalian chromosome aberration test

Test material

Constituent 1
Chemical structure
Reference substance name:
Dibutyl methylenedithiodi(acetate)
EC Number:
238-289-2
EC Name:
Dibutyl methylenedithiodi(acetate)
Cas Number:
14338-82-0
Molecular formula:
C13H24O4S2
IUPAC Name:
butyl 2-({[(2-butoxy-2-oxoethyl)sulfanyl]methyl}sulfanyl)acetate
Test material form:
other: liquid
Details on test material:
Lot#: 24080
assay: 96.21 area% GC-FID

Method

Species / strain
Species / strain / cell type:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Test concentrations with justification for top dose:
Exp 1: w/wo met.act.: 013, 025, 05., 1.0, 2.5, 5.0 µl/ml
Exp2: w/o met. act: 0.031, 0.063, 0.125, 0.5, 1.0, 2.5, 5.0µl/ml; w. met. act.: 1.0, 2.0, 3.0 4.0 5.0 µl/ml
Vehicle / solvent:
DMSO (Solvent)
Controlsopen allclose all
Untreated negative controls:
yes
Negative solvent / vehicle controls:
other: Solvent
Positive controls:
yes
Positive control substance:
ethylmethanesulphonate
Remarks:
400 and 600 µl/ml in nutrient medium
Positive controls:
yes
Positive control substance:
cyclophosphamide
Remarks:
0.83µl/ml in nutrient medium

Results and discussion

Test results
Species / strain:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity, but tested up to precipitating concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: strain/cell type: ATTC, CCL-93
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

It can be stated that during the described in vitro chromosomal aberration test and under the experimental conditions reported, the test material methylenbis(butl thioglycolate or MBTester) did not induce structural chromosomal aberrations in the used V79 chinese hamster cell line.

Therefore, thet material MBT is considered to be non -clastogenic in this chromosome aberration test.