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EC number: 203-109-3 | CAS number: 103-41-3
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29.07 - 11.08.2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- (2002)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- (2003)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Benzyl cinnamate
- EC Number:
- 203-109-3
- EC Name:
- Benzyl cinnamate
- Cas Number:
- 103-41-3
- Molecular formula:
- C16H14O2
- IUPAC Name:
- benzyl 3-phenylacrylate
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/Ca/Ola/Hsd
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8-12 weeks
- Housing: maximum 4 mice per cage
- Diet: ad libitum RM1 supplied by Specail Diet Services Limited, Witham, Essex, UK
- Water: ad libitum (automatic system)
- Acclimation period: at least 5 days
- Enrichment: tents, bases and nestlets
ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 3°C
- Humidity: 30-70%
- Air changes: a minimum of 15 changes per hour
- Photoperiod (hrs dark / hrs light): artifical: 12 hours light, 12 hours dark
JUSTIFICATION FOR TEST SYSTEM SELECTION: CBA/Ca mouse was chosen because previous examination of strain difference in lymphocyte proliferation responses to skin sensitisers showed this mouse strain to exhibit the most vigorous response
Study design: in vivo (LLNA)
- Vehicle:
- other: 1:3 ethanol:diethyl phthalate (1:3 EtOH:DEP)
- Concentration:
- 2.5; 5; 10; 25 or 50% w/v
- No. of animals per dose:
- 4
- Details on study design:
- Dose preparation:
- within 24 hours after preparation the doses were used
Test substance
- doses: 25µL of 2.5; 5; 10; 25 or 50% w/v test item in 1:3 EtOH:DEP
- dorsal surface: ear
Vehicle control group: 1:3 EtOH:DEP alone
Procedure:
- daily for 3 consecutive days
- 3 days after last application: injection of 250 µL of phosphate buffered saline (PBS) + 20 µCi of 2.0 Ci/mmol specific activity 3H-methyl thymidine
- 5 hours later animals were killed (inhalation of halothane vapour + cervical dislocation)
- draining auricular lymph nodes were removed and placed in PBS
- preparation of single cell suspension
- cell suspensions were washed and 5% w/v trichloroacetic acid (TCA) was added
- after overnight precipitation at 4°C the pellets obtained by centrifugation were resuspended in TCA and transferred to scintillation vials
- scintillant was added prior to beta-scintillation counting (Packard Tri-Carb Liquid Scintillation Counter)
Clinical observations: daily for signs of systemic toxicity
Body weights: prior to dosing on day 1 and prior to injection on day 6.
Positive control study:
- sensitisation potential of hexylcinnamaldehyde was assessed using the procedure described above
- 25µL of 5; 10 or 25% w/v of hexylcinnamaldehyde in 4:1 acetone:olive oil
- vehicle control group: 4:1 acetone:olive oil alone - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- 5, 10 and 25% w/v in 4:1 acetone:olive oil resulted in a greater than 3-fold increase in isotope incorporation at both 10 and 25% concentrations.
In vivo (LLNA)
Results
- Key result
- Parameter:
- EC3
- Value:
- 18.4
Any other information on results incl. tables
Skin sensitisation potential of the test item:
Conc. of test subst. (% w/v) |
# lymph nodes assayed |
Disintegrations per minute (dpm) |
Disintegrations per lymph node |
Test:control ratio |
0 (vehicle) |
8 |
3254 |
407 |
n/a |
2.5 |
8 |
2546 |
318 |
0.8 |
5 |
8 |
6255 |
782 |
1.9 |
10 |
8 |
6798 |
850 |
2.1 |
25 |
8 |
11875 |
1484 |
3.7 |
50 |
8 |
19113 |
2389 |
5.9 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- The test substance diluted in vehicle 1:3 EtOH: DEP is a skin sensitiser under the conditions of the test. The EC3 value was calculated to be 18.4 % w/v (4600 µg/cm2)
- Executive summary:
In the current study the skin sensitisation potential of the test substance was assessed using the local lymph node assay. The estimated concentration giving rise to a 3-fold increase in lymphocyte proliferation was calculated. The study was performed according to OECD Guideline 429 and GLP.
The test substance was applied as 2.5, 5, 10, 25 or 50% w/v preparations in 1:3 ethanol:diethyl phthalate (1:3 EtOH:DEP). A vehicle control group was similarly treated using 1:3 EtOH:DEP alone. The estimated concentration giving rise to a 3-fold increase in lymphocyte proliferation (EC3) was calculated as percentage dose and µg/cm2.
The test substance had the capacity to cause skin sensitisation when applied as 25 and 50% w/v preparations in 1:3 EtOH:DEP. The EC3 value was estimated to be 18.4% w/v (4600 µg/cm2).
The positive control, hexylcinnamaldehyde, showed the capacity to cause skin sensitisation when applied as 10 or 25% w/v preparations in 4:1 acetone:olive oil, confirming the validity of the protocol used for this study.
According to the Tables 3.4.3 and 3.4.4 of the CLP Regualtion No 1272/2008 the test item is to be classified as a skin sensitiser category 1B because the EC value > 2%.
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