Registration Dossier

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

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:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
Qualifier:
according to
Guideline:
other: Commission Regulation (EC) No 440/2008, L142, Annex Part B, B 17, "In vitro Mammalian Cell Gene Mutation Test", dated May 30, 2008.
Qualifier:
according to
Guideline:
EPA OPPTS 870.5300 - In vitro Mammalian Cell Gene Mutation Test
GLP compliance:
yes
Type of assay:
mammalian cell gene mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline

Method

Species / strain
Species / strain / cell type:
mouse lymphoma L5178Y cells
Test concentrations with justification for top dose:
Experiment I
without metabolic activation:
0.1, 0.2, 0.5, 1.0, 2.0, 3.0, 3.5 and 4.0 mM
and with metabolic activation:
0.1, 0.2, 0.5, 1.0, 2.0, 3.0, 3.5, 4.0 and 4.5 mM
Experiment II
without metabolic activation:
0.1, 0.2, 0.5, 1.0, 1.5, 2.0, 2.5 and 3.0 mM
and with metabolic activation:
0.3, 0.6, 1.1, 2.2, 3.2, 3.7, 4.0 and 4.2 mM
Vehicle / solvent:
1% DMSO
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
methylmethanesulfonate
Evaluation criteria:
-The induced mutant frequency meets or exceeds the Global Evaluation
factor (GEF) of 126 mutants per 106 cells
- A dose-dependent increase in mutant frequency is detected.

Results and discussion

Test results
Species / strain:
mouse lymphoma L5178Y cells
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

In conclusion, in the described mutagenicity test under the experimental conditions
reported, the test item Bornan-2-one (EC# 200-945-0, CAS# 76-22-2) is considered to
be non-mutagenic in the in vitro mammalian cell gene mutation assay (thymidine kinase
locus) in mouse lymphoma L5178Y cells.