3-Oxabicyclo[3.1.0]hexan-2-one, 4-hydroxy-6,6-dimethyl-, (1R,4R,5S)-

Genetic toxicity: in vitro

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:

August 2001

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)

GLP compliance:

yes

Type of assay:

in vitro mammalian chromosome aberration test

Test material

Test material information

Constituent 1

Reference substance name:

(1R, 4R, 5S) 4-hydroxy-6,6-dimethyl-3-Oxabicyclo[3.1.0]hexan-2-one

EC Number:

619-753-7

Cas Number:

73611-02-6

Molecular formula:

C7H10O3

IUPAC Name:

(1R, 4R, 5S) 4-hydroxy-6,6-dimethyl-3-Oxabicyclo[3.1.0]hexan-2-one

Method

Species / strain

Species / strain / cell type:

Chinese hamster Ovary (CHO)

Details on mammalian cell type (if applicable):

- Type and identity of media: Chinese hamster ovary cells obtained from the University of Leiden 1987
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254-induced S9 enzymes prepared from liver of adult male Fischer rat

Test concentrations with justification for top dose:

20, 39, 78, 156, 313, 625, 1250, 2500, 5000 ug/ml

Controls

Negative solvent / vehicle controls:

yes

Remarks:

Cultures were subjected to same experimental manipulations as the treated cultures

Positive controls:

yes

Remarks:

cyclophosphamide (CPH), in the presence of S9 mix and methyl methanesuphonate (MMS) in the absence of S9 mix

Results and discussion

Test results

Species / strain:

Chinese hamster Ovary (CHO)

Vehicle controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Biocartol was toxic to Chinese hamster ovary cells in vitro in both the presence and absence of S9 mix. It was tested to teh maximum permitted concentration of 5000 ug/ml. Toxicity was noted at 1250 -5000 ug/ml in the presence of S9 mix and at 5000 ug/ml in the absence of S9 mix.

Biocartol induced structural chromosomal aberrations in the presence of S9 mix at a concentration of 1250 ug/ml.

It was concluded that biocartol was clastogenic when tested with Chinese hamster ovary sells in vitro in the presence of S9 mix. This response was observed at a concentration deemed toxic to cells.