Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
- 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 vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 23, 1983 - April 11, 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test was conducted similar to OECD guideline 474, and in compliance with GLP Standards
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- yes
- Remarks:
- Treatment Schedule
- GLP compliance:
- yes
- Type of assay:
- mammalian erythrocyte micronucleus test
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
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: Füllinsdorf Albino SPF, outbred strain
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Institute of Biological and Medical Research, CH-4414 Füllinsdorf
- Age at study initiation: approx. 6 - 8 weeks
- Weight at study initiation: female: 29.3 g, male: 31.8 g
- Assigned to test groups randomly: no
- Housing: Maximum number of animals per cage: 6
- Diet: Nafag 850-cubes ad libitum
- Water: Basel tap water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): conventional air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Solvent used: rape oil
- Concentration of test material in vehicle: different concentrations at standard dose volume of 0.1 mL/kg bw applied - Duration of treatment / exposure:
- 30 hours
- Frequency of treatment:
- Twofold dosing (over two cell cycles/30 hours)
Doses / concentrationsopen allclose all
- Dose / conc.:
- 1 000 mg/kg bw/day
- Remarks:
- Basis: actual ingested
- Dose / conc.:
- 2 500 mg/kg bw/day
- Remarks:
- Basis: actual ingested
- Dose / conc.:
- 5 000 mg/kg bw/day
- Remarks:
- Basis: actual ingested
- No. of animals per sex per dose:
- 3
- Control animals:
- yes, concurrent no treatment
- Positive control(s):
- Procarbazine hydrochloride (3 male animals used)
- Justification for choice of positive control(s): known to induce micronuclei in erythrocytes of mice
- Route of administration: orally
- Doses / concentrations: 50 mg/kg bw
Examinations
- Tissues and cell types examined:
- bone-marrow; polychromatic erythrocytes (PCE)
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: The dose of 5000 mg/kg is the highest applicable one as determined by preliminary experiments.
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): subacute repeated dosing over two cell cycles (approximately 30 hours in the mouse); twofold oral application of 1000, 2500 and 5000 mg 2-Ethylhexyl 4-methoxycinnamate per kg bodyweight 30 and 6 hours prior to sacrifice of the mice.
DETAILS OF SLIDE PREPARATION: Four bone-marrow smears per animal were prepared according to the method of Schmid (Schmid W., Mut. Res. 31, 1975, 9). The slides were coded and 24 hours after the preparation they were fixed in absolute methanol and stained with May-Grünwald-Giemsa.
METHOD OF ANALYSIS: For each animal 2000 polychromatic erythrocytes were examined in a double blind fashion. Only cells with clearly identifiable anomalies were recorded as cells containing micronuclei. Micronuclei contained in mature erythrocytes were recorded separately, but not taken into the statistical evaluation. - Evaluation criteria:
- A positive result: a statistically significant dose-related increase in the number of micronucleated polychromatic erythrocytes in the bone marrow of treated mice.
- Statistics:
- The results were evaluated by means of the Jonckheere-test (A.R. Jonckheere, Biometrica 41, 1954, 133) and the U-test (F. Wilcoxon et al., Biometrics 19, 1963, 58).
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Remarks:
- The dose of 5000 mg/kg is the highest applicable one as determined by preliminary experiments.
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Other: The dose of 5000 mg/kg is the highest applicable one as determined by preliminary experiments.
RESULTS OF DEFINITIVE STUDY
- Induction of micronuclei (for Micronucleus assay): No compound-related increase of micronuclei observed
Any other information on results incl. tables
Absence of proportion of immature erythrocytes (PCE) among total erythrocytes.
Absence of data on Preliminary test.
No result data on solvent control (rape oil).
Applicant's summary and conclusion
- Conclusions:
- After twofold oral application of 1000, 2500 and 5000 mg/kg bodyweight, 2-Ethylhexyl 4-methoxycinnamate induces neither chromosome breaks nor mitotic non-disjunctions in bone marrow cells of mice. 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:
2-Ethylhexyl 4-methoxycinnamate, a UV-B sunscreen, was evaluated for a potential induction of chromosome breaks and/or mitotic non-disjunctions in vivo by means of the micronucleus test.
After twofold oral application of 1000, 2500 and 5000 mg 2-Ethylhexyl 4-methoxycinnamate per kg bodyweight 30 and 6 hours prior to sacrifice of the mice, no compound related increase of micronuclei could be observed. The dose of 5000 mg/kg is the highest applicable one as determined by preliminary experiments.
It is therefore concluded that under the experimental conditions described in this report, 2-Ethylhexyl 4-methoxycinnamate induces neither chromosome breaks nor mitotic non-disjunctions in mouse bone-marrow cells. Therefore, the substance does not need to be classified as genotoxic according to the criteria outlined in Annex I of 1272/2008/EC.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.

EU Privacy Disclaimer
This website uses cookies to ensure you get the best experience on our websites.