Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study done to guideline, in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report date:
2014

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
Principles of method if other than guideline:
The test article was evaluated in the initial mutagenicity assay at doses of 5.00, 16.0, 50.0, 160, 500, 1600, and 5000 g/plate with and without S9. An independent confirmatory assay was subsequently performed at doses of 157, 313, 625, 1250, and 2500 g/plate with and without S9. Positive and vehicle controls were evaluated concurrently, and all test and control articles were evaluated in triplicate plates.
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of 3,5-diethyl-2,5-dimethyl-cyclohex-2-en-1-one and 3,5-diethyl-5,6-dimethylcyclohex-2-en-1-one
EC Number:
943-554-7
Molecular formula:
C12H20O
IUPAC Name:
Reaction mass of 3,5-diethyl-2,5-dimethyl-cyclohex-2-en-1-one and 3,5-diethyl-5,6-dimethylcyclohex-2-en-1-one
Details on test material:
The chemical name stated in the report is Diethyl dimethyl cyclohex-2-en-1-one. This can be considered the same substance as the Givaudan Azarbre quality, as firstly they both share the same CAS number. Secondly, the Certificate of Analysis in this test report identifies two main meaks at 52% and 37% which would be the two constituents as identified in Givaudan's Azarbre reaction mass substance (Reaction mass of 3,5-diethyl-2,5-dimethyl-cyclohex-2-en-1-one and 3,5-diethyl-5,6-dimethylcyclohex-2-en-1-one ).

Method

Target gene:
- S. typhimurium: Histidine gene
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
Rat liver S9-mix

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
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 without metabolic activation
negative with metabolic activation

These results indicate that Diethyl dimethyl cyclohex-2-en-1-one is negative in the Bacterial Reverse Mutation Assay when tested up to 5000 μg/plate with and without S9 metabolic activation and under the conditions of this protocol.
Executive summary:

These results indicate that Diethyl dimethyl cyclohex-2-en-1-one is negative in the Bacterial Reverse Mutation Assay when tested up to 5000 μg/plate with and without S9 metabolic activation and under the conditions of this protocol.