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EC number: 939-618-9 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 April 2006 to 19 May 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Labor, Notifications No. 77 and 67
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction Mass of (1R)-1-[(1S)-3,3-dimethylcyclohexyl]ethyl formate and (1R,2S)-2,6,6-trimethylcycloheptyl formate
- EC Number:
- 939-618-9
- Cas Number:
- 25225-08-5
- Molecular formula:
- C11H20O2
- IUPAC Name:
- Reaction Mass of (1R)-1-[(1S)-3,3-dimethylcyclohexyl]ethyl formate and (1R,2S)-2,6,6-trimethylcycloheptyl formate
- Test material form:
- liquid
Constituent 1
Method
- Target gene:
- S. typhimurium TA1535: hisG46 rfa uvrB; S. typhimurium TA1537: hisC3076 rfa uvrB; S. typhimurium TA98: hisD3052 rfa uvrB pKMl01; S. typhimurium TA100: hisG46 rfa uvrB pKM101; E. coli WP2 uvrA: trp
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9
- Test concentrations with justification for top dose:
- Dose-range finding test 1: a total of 6 doses consisting of 5000 μg/plate as the highest dose and 5 lower doses diluted with a geometric progression of 4 were employed.
Dose-range finding test 2 and main test: the highest dose at 78.1 μg/plate without S9 and 313 μg/plate with S9 and each lower 5 doses diluted with a geometric progression of 2. - Vehicle / solvent:
- - Solvent used: DMSO
- Justification for choice of solvent: the test substance was insoluble in distilled water at 50 mg/mL, but it was soluble in DMSO at 50 mg/mL. The test substance solution of 50 mg/mL prepared with DMSO was considered to be stable as there was no change in colour no heat generation at room temperature within 2 hours after preparation.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- other: 2-(2-furyl)-3-(5-nitro-2-furyl) acrylamide (TA98, TA100 and WP2uvrA without S9); 2-methoxy-6-chloro-9-[3-(2-chloroethyl)-aminopropylamino]acridine x 2 HCl (TA1537 without S9); 2-aminoanthracene (all strains with S9)
- Remarks:
- TA1535 without metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS: triplicate plates for the negative control group and duplicate plates per dose for the substance treatment groups and the positive control groups
DETERMINATION OF CYTOTOXICITY:
- Method: bacterial growth inhibition - Evaluation criteria:
- The test substance was judged positive when the number of revertant colonies increased to twice or more that in the negative control in a concentration-dependent manner and also the reproducibility of the test results was obtained. In all other cases it was judged negative.
- Statistics:
- No statistical methods were used.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
In dose-range finding test 1 the number of revertant colonies in the test substance treatment groups was less than twice that in the solvent control. Precipitation of the test substance was not observed at any doses. The bacterial growth inhibition was observed at >78.1 μg/plate in all test strains without S9 and >313 μg/plate with S9.
In dose-range finding test 2 the number of revertant colonies in the test substance treatment groups was less than twice that in the solvent control. Precipitation of the test substance was not observed at any doses. The bacterial growth inhibition was observed at >78.1 μg/plate in all test strains without S9, >156 μg/plate in TA100, TA1535, TA98 and TA1537 and >313 μg/plate in WP2uvrA with S9.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
In the main test the number of revertant colonies in the test substance treatment groups was less than twice that in the solvent control. Precipitation of the test substance was not observed at any doses. The bacterial growth inhibition was observed at >78.1 μg/plate in all test strains without S9, >156 μg/plate in TA100, TA1535, TA98 and TA1537 and >313 μg/plate in WP2uvrA with S9.
Applicant's summary and conclusion
- Conclusions:
- The substance gave negative results in an Ames test wih S. typhimurium TA98, TA100, TA1535 and TA1537 and E. coli WP2 uvr A, both with and without metabolic activation (OECD TG 471).
- Executive summary:
An in vitro mutagenicity test using bacteria was performed according to OECD TG 471, and in compliance with GLP. The ability of the substance to induce mutations was investigated using Salmonella typhimurium strains TA100, TA1535, TA98 and TA1537 and E. coli strain WP2 uvr A using a pre-incubation method in the presence and absence of a metabolic activation system (S9 mix). In the absence of the S9, the highest dose tested was 78.1 µg/plate, while in the presence of S9 mix it was 313 µg/plate based on two dose-range finding tests. No precipitation was observed at any dose level with and without S9 mix. The bacterial growth inhibition was observed at > 78.1 μg/plate in all test strains without S9, > 156 μg/plate in TA100, TA1535, TA98 and TA1537 and > 313 μg/plate in WP2uvrA with S9. The numbers of revertant colonies in the test substance treatment groups were less than two times that in each negative control in all test strains, both with and without metabolic activation. Therefore the substance was concluded to give negative results in the Ames test.
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