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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

Constituent 1
Chemical structure
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.