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Diss Factsheets
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EC number: 701-219-0 | CAS number: 15174-47-7
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: This study was conducted in accordance with the intent and purpose of Good Clinical Practice regulations described in CFR 21, Part 50 (protection of Human Subjects - Informed Consent)
- Principles of method if other than guideline:
- Repeated Insult Patch Test (occlusive)
- GLP compliance:
- yes
Test material
- Reference substance name:
- (E)-2-methyl-3-phenylprop-2-enal
- Cas Number:
- 15174-47-7
- IUPAC Name:
- (E)-2-methyl-3-phenylprop-2-enal
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- human
- Details on test animals or test system and environmental conditions:
- One hundred and three (103) subjects, 73 females and 30 males, ranging in age from 18 to 69 years were empanelled for this test.
Test system
- Type of coverage:
- occlusive
- Amount / concentration applied:
- Approximately 0.3 m1 of the test articles were placed onto 25 mm Hill Top Chambers (occlusive) patch, which were applied to the back of each subject between the scapulae and waist, and to the left of the spinal mid-line.
- Duration of treatment / exposure:
- Induction Phase
Patches were applied every Monday, Wednesday and Friday until 9 applications of the
test article had been made.Subjects were instructed to return to the Testing Facility on Tuesday and
Thursday for supervised removal of patches applied on Monday and Wednesday. Patches applied on
Friday were removed by the test panelist approx. 24hrs after application.
The sites were scored just prior to the next patch application. Procedurally, if a
subject developed a positive reaction of 2-level (moderate) erythema or greater during the Induction phase
or, at the discretion of the Principal Investigator, if the skin response warranted a change in site, the patch
was applied to a previously unpatched, adjacent site for the next application. If a 2-level reaction (or
greater) occurred at the new site, no further applications were made. However, all reactive subjects were
subsequently Challenge patch tested
Challenge Phase
After a rest period of approx. 2 weeks (no applications of the test article), Challenge patches were
applied to previously unpatched test sites. The subjects returned to the Testing Facility 24 hours
later for supervised removal of the Challenge patches. The sites were scored 24, 48, and 72hrs after
application. A dermatologist was present at the 72-hour observation period [(except for Subj. Nos.: 26 and
30 who were unable to be seen by the dermatologist. Subj. Nos.: 81 and 98 were seen by the dermatologist
at the 48 hour evaluation due to starting the Challenge phase of the study 1 day later. In the opinion
of the Principal Investigator, the data for Subj. No.: 26, 30, 81 and 98 is considered useable for the
purposes of this study)]. All subjects were instructed to report any delayed skin reactivity that might have
occurred after the fmal Challenge patch reading. When warranted, selected test subjects were called back
to the Clinic for additional examinations and scoring to determine possible increases or deccreases in Challenge patch reactivity
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- other: human subjects
- Time point:
- 72 h
- Remarks on result:
- other: Test Article did not induce clinically meaningful irritation or show any evidence of induced allergic contact dermatitis in 75 human subjects.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: 24, 48, & 72 hour scores not specified
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: 24, 48, & 72 hour scores not specified
Any other information on results incl. tables
Seventy-five (75) subjects satisfactorily completed the test procedure. Twenty-seven (27) test panelists [Subj. Nos.: 7, 20, 21, 24, 25, 31, 34, 45, 47, 49,51,54,55,58,62,70,71,72,73,76,77,87,92,93, 100, 102 and 103] were discontinued for reasons unrelated to the conduct of the study. One (I) test panelist [Subj. No.: 64] was discontinued due to technician error. Discontinued panelists data are shown, up to the point of discontinuation, but are not used in the Results and Discussion or Conclusions sections of this final report.
Transient and non-transient, barely perceptible (+) to mild (I-level) non-specific patch test patch test irritant (non-cumulative) responses (occasionally accompanied by mild to moderate dryness, mild edema and scab formation) were observed on twenty-six (34.7% of the test population) test panelists [Subj. Nos.: 4, 8,11,15,17,18,19,29,36,37,39,40,41,43,50,69,79,80, 84, 86, 88, 91, 94, 96, 97 and 101] during the Induction and/or Challenge phases of the study. One test panelist [Subj. No.: 29] exhibited mild dryness with no observed erythema during the Challenge phase of the study. One test panelist [Subj. No.: 59] exhibited a mild papular response with no observed erythema during the Challenge phase of the study.
None of these responses were considered evidence of clinically meaningful irritation. Nor were they considered allergic in nature.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Criteria used for interpretation of results: expert judgment
- Conclusions:
- In a reliable (Klimisch 1) study under the conditions of a Repeated Insult Patch Test (occlusive), the Test Article did not induce clinically meaningful irritation or show any evidence of induced allergic contact dermatitis in 75 human subjects.
The test article Alpha methyl cinnamic aldehyde should not be labelled as R38 irritating to skin
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