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EC number: 205-627-5 | CAS number: 144-39-8
- 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:
- 29/10/2003 - 28/11/2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and test guideline compliant study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
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
- Reference substance name:
- Linalyl propionate
- EC Number:
- 205-627-5
- EC Name:
- Linalyl propionate
- Cas Number:
- 144-39-8
- Molecular formula:
- C13H22O2
- IUPAC Name:
- 3,7-dimethylocta-1,6-dien-3-yl propanoate
- Reference substance name:
- Unknown impurities
- Molecular formula:
- not applicable
- IUPAC Name:
- Unknown impurities
- Test material form:
- liquid
- Details on test material:
- Internal RCC-CCR Test Item number: S 4135 1 1
Batch Number: 9000519514
Aggregate State at room temperature: Liquid
Colour: Colorless to pale yellow
Purity: 97.1%
Stability in solvent: Not indicated by sponsor
Storage: Room Temperature
Expiration date: June 16, 2004
Constituent 1
impurity 1
Method
- Target gene:
- Reversion to histidine dependence
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital / beta-naphthoflavone induced male Wistar rat liver S9 fraction
- Test concentrations with justification for top dose:
- In the pre-experiment the concentration range of the test item was 3 - 5000 µg/plate. The pre-experiment is reported as experiment I since only minor toxic effects were observed and 5000 µg/plate were chosen as maximal concentration.
The following concentrations were tested:
-Experiments I and II: 33; 100; 333; 1000; 2500; and 5000 ug/plate
-Experiment II a: 10; 33; 100; 333; 666; 1000; 2500; and 5000 ug/plate - Vehicle / solvent:
- Ethanol ( Purity >99%). The solvent was chosen because of its solubility properties and its relative non toxicity to the bacteria.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 2-aminoanthracene, 4-NOPD
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation); preincubation; in suspension; as impregnation on paper disk
DURATION
- Preincubation period: 60 minutes
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: colny numbers, assessment of background lawn - Evaluation criteria:
- This assay was considered acceptable if it meets the following criteria:
-Regular background growth in the negative and solvent control
-the spontaneous reversion rates in the negative and solvent control are in the range of historical data
-the positive control substances should product a significant increase in mutant colony frequencies - Statistics:
- A statistical analysis of the data is not required
Results and discussion
Test resultsopen allclose all
- 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:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- 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:
- valid
- Positive controls validity:
- valid
- 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:
- valid
- Positive controls validity:
- valid
- 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:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- In the first experiment, the plates incubated with the test item showed normal background growth up to 5000 ug/plate with and without S9 in all strains used. In the second experiment bacterial background growth was reduced in strain TA 1535 at 5000 ug/plate without metabolic activation, in strains TA 1537, TA 98, and TA 100 at 2500-5000 ug/plate with and without metabolic activation and in strain TA 102 at 1000-5000 ug/plate with and without metabolic activation. In the repeat experiment IIa - the background growth of strain TA 102 was reduced at 1000-5000 ug/plate.
No substantial increase in the revertant colony numbers of any of the five tester strains was observed following treatment with Linalyl Propionate at any concentration level, neither in the presence nor absence of metabolic activation ( S9 mix). There was also no tendency of higher mutation rtes with increasing concentrations in the range below the generally acknowledged border of biological relevance.
Appropriate reference mutagens were used as positive controls. They showed a distinct increase in induced revertant colonies. The upper limit of the historical control range was exceeded in strain TA 1535 in the second experiment without metabolic activations and in strain TA 1537 with metabolic activation in both experiments as well as strain TA 102 in the first experiment with metabolic activation. This effect is considered to emphasise the sensitivity of the assay rather than compromising the study.
Any other information on results incl. tables
No further information available
Applicant's summary and conclusion
- Conclusions:
- There is no evidence of mutagenicity was seen under the conditions of this study.
- Executive summary:
The potential of linalyl propionate to induce reverse mutation was investigated in an Ames test using Salmonella typhimurium strains TA98, TA100, TA1535, TA1537 and TA 102 in the absence and presence of an exogenous metabolic activation system (phenobarbital / β-naphthoflavone-induced male Wistar rat liver S9 fraction). In an initial (plate incorporation) assay, triplicate cultures of bacterial strains were exposed to the test material (dissolved in ethanol) at concentrations of between 0 and 5000 µg/plate. Exposure to the test material did not result in any significant increase in the numbers of revertant colonies. Results were confirmed in an independently repeated pre-incubation assay. The sensitivity of the assay was demonstrated by the induction of significant increases in numbers of revertant colonies by appropriate positive control compounds. No evidence of mutagenicity was seen under the conditions of this assay.
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