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EC number: 203-427-2 | CAS number: 106-72-9
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
In vitro Ames: Negative.
In vitro UDS: Negative.
In vivo Micronucleus test: Negative.
Read across Carcinogenicity study: Negative
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 September 2005 - 11 October 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- 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
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
- Vehicle / solvent:
- DMSO (MERCK, D- 64293 Darmstadt; pUiity > 99 % ). The solvent 'vvas chosen because of its solubility properties and its relative non-toxicity to the bacteria.
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylene-diamine, 2-aminoanthracene
- Details on test system and experimental conditions:
- Standard Ames conditions.
- Rationale for test conditions:
- As per Ames original protocol.
- Evaluation criteria:
- Statistical Dunnetts test.
- Statistics:
- Statistical Dunnetts test.
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- 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
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
During the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.
Melonal is considered to be non-mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay. - Executive summary:
This study was performed to investigate the potential of Melonal to induce gene mutations in the plate incorporation test (experiment I) and the pre-incubation test (experiment 11) using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, and TA 100, and the Escherichia coli strain WP2 uvrA.
The assay was performed in two independent experiments both with and without liver microsomal activation. Each concentration, including the controls, was tested in triplicate.
The test item was tested at the following concentrations:
Pre-Experiment/Experiment I and II: 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
The plates incubated with the test item showed reduced background growth at higher concentrations with and without metabolic activation in both independent experiments.
Strong toxic effects, evident as a reduction in the number of revertants, occurred in the test groups with and without metabolic activation in both experiments.
No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with Melonal 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.
Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies.
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.
Therefore, Melonal is considered to be non-mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay.
Reference
DISCUSSION OF RESULTS
The test item Melonal was assessed for its potential to induce gene mutations in the plate incorporation test (experiment I) and the pre-incubation test (experiment 11) using Salmonella typhimurium strains TA 1535, TA 1537, TA 98, and TA 100, and the Escherichia coli strain WP2 uvrA.
The assay was performed in two independent experiments both with and without liver microsomal activation. Each concentration and the controls were tested in triplicate. The test item was tested at the following concentrations:
Pre-Experiment/ Experiment I and II: 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
The plates incubated with the test item showed reduced background growth at the following concentrations (µg/plate):
Strain |
Experiment I |
Experiment II |
||
without S9 mix |
with S9 mix |
without S9 mix |
with S9 mix |
|
TA 1535 |
2500-5000 |
2500-5000 |
333-5000 |
1000-5000 |
TA 1537 |
2500-5000 |
2500-5000 |
333-5000 |
333-5000 |
TA 98 |
2500-5000 |
2500-5000 |
333-5000 |
1000-5000 |
TA 100 |
2500-5000 |
2500-5000 |
333-5000 |
333-5000 |
WP2 uvrA |
2500-5000 |
2500-5000 |
333-5000 |
333-5000 |
Toxic effects, evident as a reduction in the number of revertants, occurred in the test groups with and without metabolic activation at the following concentrations (µg/plate):
Strain |
Experiment I |
Experiment II |
||
without S9 mix |
with S9 mix |
without S9 mix |
with S9 mix |
|
TA 1535 |
5000 |
2500-5000 |
1000-5000 |
1000-5000 |
TA 1537 |
2500-5000 |
2500-5000 |
333-5000 |
1000-5000 |
TA 98 |
2500-5000 |
2500-5000 |
1000-5000 |
1000-5000 |
TA 100 |
2500-5000 |
2500-5000 |
333-5000 |
1000-5000 |
WP2 uvrA |
2500-5000 |
2500-5000 |
5000 |
2500-5000 |
No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with Melonal 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.
Appropriate reference mutagens were used as positive controls. They showed a distinct increase of induced revertant colonies.
In experiment 11, the data in the negative control of strain WP2 uvrA with metabolic activation were slightly above our historical control range. Since this deviation is rather small, this effect is considered to be based upon biologically irrelevant fluctuations in the number of colonies.
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
In vitro Ames: Negative. In vitro UDS: Negative. In vivo Micronucleus test: Negative.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Additional information from genetic toxicity in vitro:
During the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used. Melonal is considered to be non-mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay.
Reading across to Citral, a structural analogue, a two year carcinogenicity study shows Citral was not carcinogenic in F344/N rats or male B6C3Fl mice, implying the material should also not be considered mutagenic. Thus it is inferred that melonal should also be considered non mutagenic.
With this read across information in support of the existing Ames result, Melonal is considered not classified for Mutagenicity.
Justification for selection of genetic toxicity endpoint
GLP study performed on the target substance (not read across)
Justification for classification or non-classification
Based on the evidence provided by the negetive in vitro Ames, in vitro UDS and in vivo micronucleus assays and also the read across to the 2 year carcinogenicity study on structural analog Citral, it can be considered that this substance does not show potential for mutgenicty.
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