Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
(E,E,E)-2,7-dimethylocta-2,4,6-trienedial
EC Number:
225-756-0
EC Name:
(E,E,E)-2,7-dimethylocta-2,4,6-trienedial
Cas Number:
5056-17-7
Molecular formula:
C10H12O2
IUPAC Name:
(E,E,E)-2,7-dimethylocta-2,4,6-trienedial
Test material form:
liquid

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Metabolic activation:
with and without

Results and discussion

Test results
Species / strain:
other: TA98, TA100, TA1535, TA1537 and TA102
Remarks:
all negative
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, C10-Dial did not cause gene mutations by base pair changes or frameshifts in the genome of the tester strains used.
Therefore, C10-Dial is considered to be non-mutagenic in this bacterial reverse mutation assay.
Executive summary:

In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, C10-Dial did not cause gene mutations by base pair changes or frameshifts in the genome of the tester strains used.

Therefore, C10-Dial is considered to be non-mutagenic in this bacterial reverse mutation assay.