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EC number: 282-823-7 | CAS number: 84434-23-1
- 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
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- November 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- A valid study is available for the analogue substance 3-(4-tert-butylphenyl)propionaldehyde. The study was performed in line with good scientific principles in basic compliance with agreed protocols, with no or minor deviations from standard testing guidelines. The read-across is considered to be suitable based on the structural and “mechanistic action” similarities between the target substance (3-(4-tert-butylphenyl)acrylaldehyde) and source substance (3-(4-tert-butylphenyl)propionaldehyde) and their similar physico-chemical properties.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- A strain capable of detecting cross-linking mutagens was not included.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Histidine for Salmonella.
- Species / strain / cell type:
- S. typhimurium, other: TA 1535, TA 1537, TA 1538, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver microsomes, S9
- Test concentrations with justification for top dose:
- main test: 0, 1.2, 3.7, 11.1, 33.3 and 100 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Not reported - Untreated negative controls:
- yes
- Remarks:
- Spontaneous mutation rates
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DSMO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- With S9 mix
- Untreated negative controls:
- yes
- Remarks:
- Spontaneous mutation rates
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- Without S9 mix
- Untreated negative controls:
- yes
- Remarks:
- Spontaneous mutation rates
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-Aminobiphenyl
- Remarks:
- with S9 mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 72 hrs
NUMBER OF REPLICATIONS: Triplicate plating.
DETERMINATION OF CYTOTOXICITY
- Method: plates were assessed for numbers of revertant colonies and examined for effects on the growth of the bacterial background lawn. - Evaluation criteria:
- Evaluation criteria:
Not stated - Statistics:
- Not reported
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA 1538, TA 98 and 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
- Positive controls validity:
- valid
- Additional information on results:
- Incorporation of the test material up to non-inhibitory levels did not increase the numbers of his+ reveratnts with any of the five tester strains, either in the presence or in the absence of S-9 mix. At the lower dose levels tested, there were no signs that chemical toxicity interfered with the mutagenicity testing: the background lawn of bacterial growth in control and test plates was comparable. At the higher dose levels (i.e. 33-100 µg/plate) the test material was toxic to the bacteria as revealed by a less dense background lawn of bacterial growth.
From the present results it can be concluded that the test material did not reveal any mutagenic activity in the plate incorporation assay with S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 or TA 100 in the presence or absence of the liver microsome activation system under the test conditions employed in this evaluation.
ANALOGUE APPROACH JUSTIFICATION:
- See attached “Justification for read-across” document for full details.
- In summary, important considerations for the use of read-across for genetic toxicity are: : i) 3-(4-tert-butylphenyl)acrylaldehyde (the target chemical) has similar predicted physico-chemical properties to those predicted and experimentally determined for 3-(4-tert-butylphenyl)propionaldehyde (the source substance), ii) there are structural similarities between the two chemicals and iii) the OECD QSAR Toolbox indicates that the two substances are expected to have similar interactions with biological receptors.
The information reported in this summary is included to demonstrate comparability between the source (3-(4-tert-butylphenyl)propionaldehyde) and target (3-(4-tert-butylphenyl)acrylaldehyde) substance. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'. Remarks: S. typhimurium (TA 1535, TA 1537, TA 1538, TA 98 and TA 100)
- Conclusions:
- Interpretation of results (migrated information):
negative with and without metabolic activation
The test material was considered to be non-mutagenic under the conditions of this test. - Executive summary:
A mutagenicity test was performed with the test material according to a method of Ames et al. (1975) (equivalent to OECD 471).
1) The mutagenic activity of the test material was examined in the Salmonella/microsome mutagenicity test, using a set of five histidine requiring mutants of S. typhimurium (TA 1535, TA 1537, TA 1538, TA 98 and TA 100) and liver homogenate of Aroclor-induced rats.
2) Incorporation of the test material up to non-inhibitory levels did not increase the number of his+ revertants in any of the five tester strains, either in the presence or in the absence of the liver microsome activation system.
3) From the present results it can be concluded that the test material did not reveal any mutagenic activity in the plate incorporation assay with S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 or TA 100 in the presence or absence of the liver microsome activation system under the test conditions employed in this evaluation.
It was concluded that the present results did not reveal any mutagenic activity of the test material in the Salmonella/microsome mutagenicity test.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
A mutagenicity test was performed with the test material according to a method of Ames et al. (1975) (equivalent to OECD 471).
1) The mutagenic activity of the test material was examined in the Salmonella/microsome mutagenicity test, using a set of five histidine requiring mutants of S. typhimurium (TA 1535, TA 1537, TA 1538, TA 98 and TA 100) and liver homogenate of Aroclor-induced rats.
2) Incorporation of the test material up to non-inhibitory levels did not increase the number of his+ revertants in any of the five tester strains, either in the presence or in the absence of the liver microsome activation system.
3) From the present results it can be concluded that the test material did not reveal any mutagenic activity in the plate incorporation assay with S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 or TA 100 in the presence or absence of the liver microsome activation system under the test conditions employed in this evaluation.
It was concluded that the present results did not reveal any mutagenic activity of the test material in the Salmonella/microsome mutagenicity test.
The study was performed to method equivalent to a recognised standardised guideline, the study was assigned a reliability score of 2 in line with the principles defined in Klimisch et al (1997) as the study was performed on a structural analogue of the substance. Due to the structural and mechanistic similarities between the two substances, it was considered appropriate to use data from the source substance to represent the target substance.
Justification for selection of genetic toxicity endpoint
A single valid study was available on a suitable structural analogue. The study was performed to a method equivalent to a standardised guideline. Due to the structural and mechanistic similarities between the target and source substance, it was considered appropriate to use a read-across approach to address the genetic toxicity endpoint.
Justification for classification or non-classification
On the basis that the results from the reverse gene mutation study in bacteria performed with 3-(4-tert-butylphenyl)propionaldehyde, are being used to the support the registration of 3-(4-tert-butylphenyl)acrylaldehyde using a read-across approach, 3-(4-tert-butylphenyl)acrylaldehyde should therefore also be considered as not mutagenic in the reverse gene mutation assay in bacteria.
The available information is not sufficient to determine the classification of the substance in accordance with Regulation 1272/2008 and Directive 67/548/EEC, for genetic toxicity as the available information does not include an evaluation of the cytogenicity of the substance.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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