Registration Dossier

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
The sample was sent to Ramachandra Innovis, Sri Ramachandra medical Centre, Chennai-600116,
Type of information:
experimental study
Adequacy of study:
key study
Study period:
25 days
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Results and discussion

Test results
Key result
Species / strain:
other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity, but tested up to precipitating concentrations
Vehicle controls validity:
not specified
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: no gene mutations observed

Applicant's summary and conclusion

Conclusions:
2-(2,4-Dimethylcyclohex-3-ene-1-yl)-5-methyl-(1-methylpropyl)-1,3-dioxane did not induce gene mutation by base pair changes or frameshifts in the genome of the strains used during the study .
The complete study was performed in compliance with OECD guidelines number 471, Section 4.