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EC number: 226-749-5 | CAS number: 5462-06-6
- 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:
- 06 Jul 2004 to 15 Jul 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline 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)
- Version / remarks:
- July 21 1997
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Cytotest Cell Research GmbH (RCC-CCR), In den Leppsteinswiesen 19, D-64380, Rossdorf
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 3-(p-methoxyphenyl)-2-methylpropionaldehyde
- EC Number:
- 226-749-5
- EC Name:
- 3-(p-methoxyphenyl)-2-methylpropionaldehyde
- Cas Number:
- 5462-06-6
- Molecular formula:
- C11H14O2
- IUPAC Name:
- 3-(4-methoxyphenyl)-2-methylpropanal
- Test material form:
- liquid
Constituent 1
Method
- Target gene:
- Histidine gene
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S9 induced with phenobarbital and ß-Napthoflavone
- Test concentrations with justification for top dose:
- Pre-experiment
3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
The pre-experiment is reported as main experiment l, since the following criteria are met: Evaluable plates (>0 colonies) at five concentrations or more in all strains used.
Main experiment I (plate incorporation test): 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
Main experiment II (pre-incubation assay) without S9 mix: 1; 3; 10; 33; 100; 333; 1000; and 2500 µg/plate
Main experiment II (pre-incubation assay) with S9 mix: 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate - Vehicle / solvent:
- ethanol (>99%)
Controls
- Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 100 µL ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: see section "Any other information on materials and methods incl. tables"
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
Experiment I: in agar (plate incorporation)
Experiment II: preincubation
DURATION:
- Preincubation period: 60 minutes
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS: triplicates
OTHER EXAMINATIONS:
The colonies were counted using the AUTOCOUNT (Artek Systems Corporation, BIOSYS GmbH, D-61184 Karben). The counter was connected to an IBM AT compatible PC with printer which printed out both, the individual and mean values of the plates for each concentration together with standard deviations and enhancement factors as compared to the spontaneous reversion rates. Due to reduced background growth, the colonies were partly counted manually. - Evaluation criteria:
- Acceptability of the Assay:
The Salmonella typhimurium reverse mutation assay is 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 our historical data
- the positive control substances should produce a significant increase in mutant colony frequencies
Evaluation of Results:
A test item is considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA 98, TA 100, and TA 102) or thrice (strains TA 1535 and TA 1537) the colony count of the corresponding solvent control is observed.
A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration.
An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.
A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative and solvent controls such an increase is not considered biologically relevant. - Statistics:
- A statistical analysis of the data is not required
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA 98, TA 100, 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
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No precipitation of the test item occurred up to the highest investigated dose.
RANGE-FINDING/SCREENING STUDIES:
To evaluate the toxicity of the test item a pre-experiment was performed with strains TA 1535, TA 1537, TA 98, TA 100, and TA 102. Eight concentrations were tested for toxicity and mutation induction with each 3 plates. The pre-experiment is reported as main experiment l, since the following criteria are met: Evaluable plates >0 colonies) at five concentrations or more in all strains used.
HISTORICAL CONTROL DATA
- Positive historical control data: The historical range of positive controls was exceeded in strain TA 1537 (experiment I) with metabolic activation. This effect indicates the sensitivity of the strains rather than compromising the assay.
- Negative (solvent/vehicle) historical control data: In experiment I, with metabolic activation, the number of colonies did not quite reach the lower limit of our historical control data in the solvent control of strain TA 102. Since this deviation is rather small, this effect is judged to be based upon biological fluctuations and has no detrimental impact on the outcome of the study.
Any other information on results incl. tables
Distinct toxic effects, evident as a reduction in the number of revertants (below the factor of 0.5) were observed at the following concentrations (µg/plate):
Strain |
Experiment I |
Experiment Il |
||
|
without S9 mix |
with S9 mix |
without S9 mix |
with S9 mix |
TA 1535 |
1000 - 5000 |
1000 - 5000 |
1000, 2500 |
2500, 5000 |
TA 1537 |
1000 - 5000 |
5000 |
1000, 2500 |
2500, 5000 |
TA 98 |
2500, 5000 |
5000 |
2500 |
2500, 5000 |
TA 100 |
1000- 5000 |
5000 |
1000, 2500 |
2500, 5000 |
TA 102 |
333 - 5000 |
333 - 5000 |
1000, 2500 |
1000 - 5000 |
Applicant's summary and conclusion
- Conclusions:
- The test substance had, under the present test conditions, no ability to induce mutations in the bacterial reverse mutation assay according to OECD 471.
- Executive summary:
The mutagenic activity of the test substance was evaluated in accordance with OECD 471 (1997) and GLP principles. The test was performed according to the plate incorporation (experiment 1) and pre-incubation method (experiment 2), in the absence and presence of S9-mix. 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 evaluable plates (> 0 colonies) were obtained at five concentrations or more in all strains used. In both experiment 1 and 2, reduced background growth was observed with and without S9 mix at higher concentrations in all strains (Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100, and TA 102). No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with the test substance at any dose level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance. Adequate vehicle and positive controls were included. Based on the results of this study it is concluded that the test substance is not mutagenic in the bacterial reverse mutation assay.
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