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EC number: 203-121-9 | CAS number: 103-54-8
- 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 vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27.07.2016-09.06.2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD guideline 442E h-CLAT
- Version / remarks:
- Dec 2015
- Deviations:
- yes
- Remarks:
- The cytotoxicity measurement and estimation of the CV75 by XTT test instead of flow cytometry. The reactivity check for the qualification of the cells conducted with positive control (DNCB) and negative control (lactic acid) but without nickel sulfate.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hessen Ministerium für Umwelt, Klimatschutz, Landwirtschaft und Verbraucherschutz; Wiesbaden.
- Type of study:
- activation of dendritic cells
Test material
- Reference substance name:
- Cinnamyl acetate
- EC Number:
- 203-121-9
- EC Name:
- Cinnamyl acetate
- Cas Number:
- 103-54-8
- Molecular formula:
- C11H12O2
- IUPAC Name:
- cinnamyl acetate
Constituent 1
- Specific details on test material used for the study:
- purity: 99.3
In vitro test system
- Details on the study design:
- TEST SYSTEM
- Cell line: THP-1 cells; human monocytic leukemia cell line
- Source: ATCC, #TIB-202 (provided by LGC Standards GmbH, Germany)
TEST-SUBSTANCE PREPARATION
- Concentrations: 1st, 2nd and 3rd experiment: 75.4, 90.4, 108.5, 130.2, 156.3, 187.5, 225 and 270 μg/mL
- Stock: 2x concentration of the highest concentration stock solution
- Vehicle: culture medium
- Reason for vehicle: The h-CLAT was performed in an aqueous test system.
CONTROLS
- Vehicle control (VC): DMSO in culture medium, final concentration 0.2%
- Isotype control:10 μL FITC-labelled anti-CD86, CD54 antibody or mouse IgG1
- Positive control: DNCB final concentration: 2 and 3 μg/mL
MEDIUM
- Culture medium: RPMI-1640 supplemented with 10 % FBS (v/v), 0.05 mM 2-mercaptoethanol, 4.5 g/L glucose, 1% (v/v) sodium pyruvate, 1% (v/v) L-glutamineand appropriate antibiotics (100U/mL of penicillin and 100μg/mL of streptomycin)
- FACS Buffer: PBS with 0.1% (w/v) BSA
EXPERIMENTAL PROCEDURE
- Replicates:7
- Experiments: 3
- Exposure period: 24 ± 1 hours
- Preparation of cells: THP-1 cells were thawed and cultured in complete RPMI-1640 supplemented with 10 % FBS (v/v), 0.05 mM 2-mercaptoethanol, 4.5 g/L glucose, 1% (v/v) sodium pyruvate, 1% (v/v) L-glutamineand appropriate antibiotics (100 U/mL of penicillin and 100 μg/mL of streptomycin) (<= 30 passage)
ANALYSIS
- FACS: cell staining and flow cytometric analysis
DATA EVALUATION
- Relative fluorescence intensity: RFI (%) = ( MFI of chemical-treated cells - MFI of chemical-treated
isotype control cells) / (MFI of vehicle control cells - MFI of vehicle isotype control cells) * 100
- Relative cell viability: % relative cell viability = (cell viability of test substance treated cells / mean cell
viability of vehicle control treated cells) * 100
ACCEPTANCE CRITERIA
- In the positive control (DNCB), RFI values of both CD86 and CD54 should exceed the positive criteria (CD86 ≥ 150% and CD54 ≥ 200%) and the cell viability should be > 50%
- In the DMSO solvent control, RFI values compared to the medium control of both CD86 and CD54 should not exceed the positive criteria (CD86 ≥ 150% and CD54 ≥ 200%)
- For medium and DMSO controls, the MFI ratio of CD86 and CD54 to isotype control should be > 105%
- For the test item resulting in negative outcome, the cell viability at the1.2 × CV75 should be less than 90%. (If the cell viability at the 1.2 × CV75 is more than 90% for a positive tested test item, the data will be acceptable. If 5mg/mL in saline, 1mg/mL in DMSO or the highest soluble concentration will be used as the maximal test concentration instead of CV75-based concentration, the data for test item are accepted independent by the cell viability.)
- The cell viability of at least 4 concentrations in each experiment should be ≥50%.
EVALUATION RESULTS
- The test item is tested in 2 independent runs.
- If the RFI of CD86 is ≥ 150% and/or if the RFI of CD54 is ≥ 200% in both independent run data, the test item is considered to be positive in the h-CLAT. Otherwise it is considered to be negative in the h-CLAT.
- In case of different results in both runs, a third run has to be performed. If the RFI of CD86 is ≥ 150% at any concentration in at least 2 of 3 independent run data, or if the RFI of CD54 is ≥ 200% in at least 2 of 3 independent run data, the test item is considered to be positive.
- Otherwise it is considered to be negative.
Results and discussion
In vitro / in chemico
Resultsopen allclose all
- Key result
- Run / experiment:
- other: CD86
- Parameter:
- other: RFI
- Value:
- 150
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks on result:
- other: As this slight increase was observed only in 1 out of 3 independent runs, the test item is considered negative in the h-CLAT.
- Key result
- Run / experiment:
- other: CD54
- Parameter:
- other: RFI
- Value:
- 200
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks on result:
- other: As this slight increase was observed only in 1 out of 3 independent runs, the test item is considered negative in the h-CLAT.
Any other information on results incl. tables
Results of the first h-CLAT run for the Test Item:
Concentration (μg/mL) | RFI (%) CD 54 Antibody | RFI (%) CD 86 Antibody | Cell Viability (%) | |
Medium Control |
100.0 | 100.0 | 100.0 | |
DMSO Control | 100.0 | 100.0 | 100.0 | |
Positive Control (DNCB) |
2.0 | 967.1* |
504# |
87.6 |
3.0 | 1230* |
402.9# |
70.2 |
|
Test Item | 75.4 |
120.6 |
96.6 |
88.2 |
90.4 | 114.3 |
119.0 |
95.0 |
|
108.5 | 139.7 |
108.0 |
93.0 |
|
130.2 | 154.0 |
117.2 |
88.4 |
|
156.3 | 187.3 |
135.1 |
84.3 |
|
187.5 |
214.3* |
153.4# |
91.4 |
|
225P |
271.4* |
175.9# |
88.5 |
|
270P | 395.2* |
223.6# |
76.6 |
Pprecipitation/phase separation (oily droplets), are excluded from the evaluation
*RFI value of CD54 exceeded the positive criterion (CD54 ≥ 200%)
#RFI value of CD86 exceeded the positive criterion (CD86 ≥ 150%)
Results of the second h-CLAT run repetition for the Test Item:
Concentration (μg/mL) | RFI (%) CD 54 Antibody | RFI (%) CD 86 Antibody | Cell Viability (%) | |
Medium Control |
100.0 | 100.0 | 100.0 | |
DMSO Control | 100.0 | 100.0 | 100.0 | |
Positive Control (DNCB) |
2.0 | 246.4* | 236.5# | 74.7 |
3.0 | 243.8* |
732.2# |
65.4 |
|
Test Item | 75.4 |
105.8 |
80.8 |
84.3 |
90.4 | 95.7 |
82.3 |
91.5 |
|
108.5 | 97.8 |
96.9 |
88.9 |
|
130.2 | 116.5 |
93.8 |
87.9 |
|
156.3 | 116.5 |
91.5 |
83.3 |
|
187.5P |
133.8 |
115.4 |
88.5 |
|
225P |
146.8 |
122.3 |
76.9 |
|
270P | 214.4* |
194.6# |
67.7 |
Pprecipitation/phase separation (oily droplets), are excluded from the evaluation
*RFI value of CD54 exceeded the positive criterion (CD54 ≥ 200%)
#RFI value of CD86 exceeded the positive criterion (CD86 ≥ 150%)
Results of the third h-CLAT run for the Test Item:
Concentration (μg/mL) | RFI (%) CD 54 Antibody | RFI (%) CD 86 Antibody | Cell Viability (%) | |
Medium Control |
100.0 | 100.0 | 100.0 | |
DMSO Control | 100.0 | 100.0 | 100.0 | |
Positive Control (DNCB) |
2.0 | 238.5* | 271# |
84.0 |
3.0 | 272.4* |
347.8# |
79.3 |
|
Test Item | 75.4 |
106.9 |
124.5 |
94.1 |
90.4 | 108.1 |
127.9 |
93.0 |
|
108.5 | 100.0 |
109.8 |
89.5 |
|
130.2 | 113.4 |
145.6 |
102.4 |
|
156.3 | 111.0 |
146.1 |
99.1 |
|
187.5 |
121.1 |
130.4 |
92.7 |
|
225P |
135.4 |
169.6# |
87.0 |
|
270P | 174.8 |
219.1# |
77.8 |
Pprecipitation/phase separation (oily droplets), are excluded from the evaluation
*RFI value of CD54 exceeded the positive criterion (CD54 ≥ 200%)
#RFI value of CD86 exceeded the positive criterion (CD86 ≥ 150%)
Applicant's summary and conclusion
- Interpretation of results:
- other: h-CLAT prediction: negative (no activation of dendritic cells) according to OECD 442E
- Conclusions:
- The test item with a log Pow of 2.7 did not activate THP-1cells up to a test item concentration of 156.3 μg/mL (limited by precipitation, oily droplets) under the test conditions of this study. The test item is therefore considered to be negative for the respective key event of the sensitisation Adverse Outcome Pathway (AOP).
- Executive summary:
This in vitro Human Cell Line Activation Test (h-CLAT) was performed to assess the skin sensitizing potential of the test item dissolved or suspended in culture medium when administered to THP-1 cells for 24 ± 0.5 hours. The concentration of test item for the main experiment (h-CLAT) was previously determined by two XTT tests.
Cytotoxic effects were observed following incubation with the test item starting with the concentration of 312.5μg/mL test item up to the highest tested test item concentration (2500 μg/mL; maximum attainable concentration) in both XTT tests. In addition, the test item concentrations ≥ 312.5 μg/mL showed oily droplets. The mean CV75 value of both XTT tests was calculated as 222.85μg/mL.
The following concentrations of the test item (dissolved in culture medium) were tested in the main experiment (h-CLAT): 75.4, 90.4, 108.5, 130.2, 156.3, 187.5, 225 and 270 μg/mL.
The test item with a log Pow of 2.7 was tested in 3 valid independent runs. The second run was repeated since the treatment time was not in the guideline recommended range.The RFI of CD54 was greater than the threshold of 200% in at least one concentration in 2 out of 3 independent runs. Furthermore, the RFI of CD86 was greater than the threshold of 150% in at least one concentration in all 3 independent runs. However, precipitations (oily droplets) were observed in the two highest (225 and 270 μg/mL; runs 1 and 3) and three highest (187.5, 225 and 270 μg/mL; run 2) test item concentrations, which were therefore excluded from the evaluation of the respective run.
Taking this in consideration, the RFI of CD86 and CD54 were slightly higher than 150% and 200%, respectively at 187,5 μg/mL in the first run.
As this slight increase was observed only in 1 out of 3 independent runs, the test item is considered negative in the h-CLAT.
In the DMSO solvent control, RFI values compared to the medium control of both CD86 and CD54 did not exceed the positive criteria (CD86 ≥150% and CD54 ≥ 200%).
The RFI values of the positive controls (DNCB) for CD86 and CD54 exceeded the positive criteria (CD86 ≥ 150% and CD54 ≥ 200%) and the relative cell viability was > 50%.
In conclusion, the test item with a log Pow of 2.7 did not activate THP-1cells up to a test item concentration of 156.3μg/mL (limited by precipitation, oily droplets) under the test conditions of this study.
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