Registration Dossier

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

Administrative data

Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Analogues used for read across have been defined in OECD Toolbox (version 1.1.02).

Data source

Reference
Reference Type:
other: report on read-across
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Principles of method if other than guideline:
Analogues used for read across have been defined in OECD Toolbox (version 1.1.02). The reporting form for analogue approach is attached.
GLP compliance:
not specified
Type of assay:
in vitro mammalian chromosome aberration test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
The reporting form for analogue approach is attached.

Method

Species / strain
Species / strain / cell type:
not specified
Metabolic activation:
with
Metabolic activation system:
S-9 mix

Results and discussion

Test results
Species / strain:
not specified
Metabolic activation:
with
Genotoxicity:
negative
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

I.Read across prediction

·       Chromosomal aberration

-  Chromosomal aberration with S9

Analogues used for read across and TIMES prediction have been defined in Toolbox by using the following categorization profiles:

  1. Organic Functional group (Cycloalkene and methyl)
  2. Account all endpoints due to no enough observed data
  3. Subcategorize by DNA binding-remove
  4. Subcategorize by Chemical elements

As a result the following analogues have been defined

     Analogue 1:

CAS 5989-27-5

 Analogue 2:

CAS 7235-40-7   Beta-Carotene

 Analogue 3:

CAS 16219-75-3 bicyclo_2.2.1_hept-2-ene,_5-ethylidene-

The read across analysis based on the properties of analogues shows that this chemical is NOT Chromosomal aberrating.

The reporting form for analogue approach is attached.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with metabolic activation

Read across analysis shows that Camphene is negative against chromosomal aberrations with S9 and is in domain.
Executive summary:

Analogues used for read across have been defined in OECD Toolbox (version 1.1.02). Read across analysis shows that Camphene is negative against chromosomal aberrations with S9 and is in domain.