Registration Dossier
Registration Dossier
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EC number: 601-499-3 | CAS number: 117933-89-8
Genetic toxicity: in vitro
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:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-(2,4-Dimethylcyclohex-3-ene-1-yl)-5-methyl-(1-methylpropyl)-1,3-dioxane
- EC Number:
- 601-499-3
- Cas Number:
- 117933-89-8
- Molecular formula:
- C17H30O2
- IUPAC Name:
- 2-(2,4-Dimethylcyclohex-3-ene-1-yl)-5-methyl-(1-methylpropyl)-1,3-dioxane
- Test material form:
- liquid
Constituent 1
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.
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