(+)-bornan-2-one

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:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

Qualifier:

according to guideline

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.

Test guideline 3

Qualifier:

according to guideline

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

Test material information

Constituent 1

Reference substance name:

Bornan-2-one

EC Number:

200-945-0

EC Name:

Bornan-2-one

Cas Number:

76-22-2

Molecular formula:

C10H16O

IUPAC Name:

1,7,7-trimethylbicyclo[2.2.1]heptan-2-one

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.