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EC number: 629-661-9 | CAS number: 83834-59-7
- 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
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- Nanomaterial pour density
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- Endpoint summary
- Stability
- Biodegradation
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- 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
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- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
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- Additional toxicological data

Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro transformation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 7, 1984- March 29, 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Test was conducted similar to IARC/NCI/EPA Working Group (1985) Cellular and molecular mechanisms of cell transformation and standardization of transformation assays of established cell lines for the prediction of carcinogenic chemicals: overview and recommended protocols, Cancer Res., 45, 2395-2399., and under GLP Standards, and QA.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.21 (In Vitro Mammalian Cell Transformation Test)
- Version / remarks:
- 1988
- Deviations:
- yes
- Remarks:
- Balb/c 3T3 cells used and in absence of metabolic activation system
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian cell transformation assay
Test material
- Reference substance name:
- 2-ethylhexyl 4-methoxycinnamate
- EC Number:
- 226-775-7
- EC Name:
- 2-ethylhexyl 4-methoxycinnamate
- Cas Number:
- 83834-59-7
- Molecular formula:
- C18H26O3
- IUPAC Name:
- 2-Propenoic acid, 3-(4-methoxyphenyl)-, 2-ethylhexyl ester, (2E)-
- Details on test material:
- - Name of test material (as cited in study report): 2-Ethylhexyl 4-methoxycinnamate
- Physical state: liquid
- Analytical purity: no data
- Storage condition of test material: 4°C
Constituent 1
Method
- Target gene:
- Not relevant
Species / strain
- Species / strain / cell type:
- mammalian cell line, other: Balb/c 3T3 clone A31-11
- Details on mammalian cell type (if applicable):
- - Type and identity of media:
Growth media: EMEM-10: Minimal Essential Medium with Earle salts (EMEM) (Gibco). 10 % serum HJ, L-glutamine, NaHCO3
EMEM-5: 5 % serum HJ, L-glutamine, NaHCO3
Treatment medium: EMEM-5
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: no data
- Periodically checked for karyotype stability: not applicable
- Periodically "cleansed" against high spontaneous background: not applicable - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- without
- Metabolic activation system:
- Not applicable (Balb/c 3T3 clone A31-11 have intrinsic metabolic activation)
- Test concentrations with justification for top dose:
- 1.25, 2.5, 5.0, 7.5, 10.0 µg/mL
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 20-Methylcholanthrene (MC)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: about 48 hrs.
- Exposure duration: 3 days
- Expression time (cells in growth medium): about 4 weeks
- Fixation time (start of exposure up to fixation or harvest of cells): 4 to 5 weeks
STAIN (for cytogenetic assays): 10 % Giemsa, 50 % May-Grünwald
NUMBER OF REPLICATIONS: 8 or 15 petri dishes per dose
DETERMINATION OF CYTOTOXICITY
- Method: other: cell survival for each transformation assay
OTHER EXAMINATIONS:
- Other: Determination of transformed foci: Only Type III foci were taken into consideration - Evaluation criteria:
- Petri dishes containing at least one Type III focus were taken as positive dishes.
- Statistics:
- In vitro cell transformation assay: No. of Petri Dishes Cell containing Type III Foci
Cell survival: Mean
Results and discussion
Test results
- Key result
- Species / strain:
- mammalian cell line, other: Balb/c 3T3 clone A31-11
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- 10.0 µg/mL
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- ADDITIONAL INFORMATION ON CYTOTOXICITY: In this test system 2-Ethylhexyl 4-methoxycinnamate was cytotoxic. A 3-day exposure period with 10.0 µg/mL reduced survival of Balb/c 3T3 cells to 63 and 45 percent (first batch) and 41 and 53 percent (second batch).
- Remarks on result:
- other: all strains/cell types tested
Applicant's summary and conclusion
- Conclusions:
- It is concluded that under the experimental conditions described in the report 2-Ethylhexyl 4-methoxycinnamate did not induce mammalian cell transformation in vitro, for both batches tested. Therefore, the substance does not need to be classified as genotoxic according to the criteria outlined in Annex I of 1272/2008/EC.
- Executive summary:
The UVB sunscreen 2-Ethylhexyl 4-methoxycinnamate was evaluated for its ability to induce mammalian cell transformation in vitro. Sensitivity of the test system was shown by using the well-known carcinogen 20-methylcholanthrene (MC) known to induce transformed mammalian cells in vitro. Treatment of Balb/c 3T3 cells with 1.3 µg to 10 µg 2-Ethylhexyl 4-methoxycinnamate per mL for 3 days did not induce cell transformation in vitro, for both batches tested. 10 µg/mL were taken as highest dose tested throughout the experiments because at this concentration survival of Balb/c 3T3 cells was reduced to 50 percent related to the concurrent control cultures. It is concluded that under the experimental conditions described in the report, 2-Ethylhexyl 4-methoxycinnamate did not induce cell transformation in mammalian cells in vitro. Therefore, the substance does not need to be classified as genotoxic according to the criteria outlined in Annex I of 1272/2008/EC.
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