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EC number: 815-500-1 | CAS number: 1853175-99-1
Toxicological information
Genetic toxicity: in vitro
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:
- 2 015
- Report Date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes (incl. certificate)
- Type of assay:
- bacterial reverse mutation assay
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Specific details on test material used for the study:
- Designation in test facility : 15070801G
Date of receuip: 08/07/2015
Conditions at receipt : room temperature, proper conditions
Appearance Colourless liquid
Composition 2-(3,3-DIMETHYLCYCLOHEX-1-ENYL)-2,5,5-
TRIMETHYL-1,3-DIOXANE
Molecular formula C15H26O2
Molecular weight 238.37 g/mol
Purity Sum of isomers: 98.5%
Homogeneity Homogeneous
Stability H2O: not stated; EtOH: not stated; acetone: not stated;
CH3CN: not stated; DMSO: not stated
Solubility H2O: < 0.1 g/L; EtOH: > 1 g/L; acetone: > 1 g/L; CH3CN:
unknown; DMSO: < 0.1 g/L
Production date Mar. 2015
Expiry date Mar. 2016
Storage Room temperature: 20 ± 5 °C, keep away from light
Name : MADERAL ZA1076
Batch n°100026324
Method
- Target gene:
- TA97a : hisD6610 ; uvrB ; rfa ; pKM101
TA98 : hisD3052 ; uvrB ; rfa ; pKM101
TA100 : hisG46 ; uvrB ; rfa ; pKM101
TA102 : hisG428 ; rfa ; pKM101 ; pAQ1
TA1535 : hisG46 ; uvrB ; rfa
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 97
- Remarks:
- TA 97a
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Species / strain / cell type:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix, rat-liver S9-mix induced by Aroclor 1254
- Test concentrations with justification for top dose:
- The test item is only soluble in ethanol in a concentration of 50 g/L, the chosen concentrations are above.
- First experiment : 5 concentrations (50, 150, 500, 1500, 5000 µg/plate)
- Second experiment : 6 concentrations (156, 313, 625, 1250, 2500, 5000 µg/plate) - Vehicle / solvent:
- ethanol. (the test item is only soluble in ethanol)
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- other: 4-Nitro-1,2-phenylene Diamine, 2-Amino-Anthracene
- Remarks:
- 3 replicates / Stock solutions of the substance diluted to effect an application volume of 0.1 mL/plate
- Details on test system and experimental conditions:
- First experiment : Plate incorporation method
Second experiment : pre-incubation method
Cell density : 10^9 cells/mL, correlating to 100 colonies/plate after dilution
Duration ???
Number of replications :
First test : 3 / strain and concentration
Second test: 3 / strain and concentration
Culture of bacteria :
All strain of Salmonella typhimurium were stored as lyophilisates in the fridge at 2-8 °C. 8 h before the start of each experiment, one lyophilisate per strain to be used was taken from the fridge to inoculate a culture vessel containing nutrient broth. After incubation overnight at 37 ± 1 °C, the cultures were used in the experiment. During the test, the cultures were stored at room temperature as to prevent changes in the titre.
Prepation of media and solutions :
In the days before each test, the media and solutions were prepared. - Statistics:
- Not specified
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 97
- Remarks:
- TA97a
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Executive summary:
The genetic toxicity in vitro was performed according to the OECD Guideline 471 (Bacterial Reverse Mutation Assay). The test item was considered as not mutagenic and not pro-mutagenic.
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