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EC number: 685-515-4 | CAS number: 10309-37-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- human patch test
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Appraisal of the Safetv of Chemicals in Food, Drugs and cosmetics, published by The Association of Food and Drug Officials of The United States
- Deviations:
- yes
- Remarks:
- 100 panelists tested, not the 200 cited in the reference; nine inductive patchings employed, not the ten cited in the reference under occlusive patch conditions
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 4-[(1E,3S)-3-ethenyl-3,7-dimethylocta-1,6-dien-1-yl]phenol
- EC Number:
- 685-515-4
- Cas Number:
- 10309-37-2
- Molecular formula:
- C18H24O
- IUPAC Name:
- 4-[(1E,3S)-3-ethenyl-3,7-dimethylocta-1,6-dien-1-yl]phenol
Constituent 1
Test animals
- Details on test animals or test system and environmental conditions:
- Age Range: 18 - 68
Sex
Male: 30
Female: 81
Race
Caucasian: 68
Hispanic: 16
Asian: 6
African American: 21
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: not required
- Vehicle:
- other: corn oil
- Controls:
- no
- Amount / concentration applied:
- 2% and 5% in corn oil
0.2 ml of the diluted test material was dispensed onto the occlusive hypoallergenic patch. - Number of animals:
- 111 for each concentration
- Details on study design:
- Subjects are requested to bathe or wash as usual before arrival at the facility.
The patch was applied directly to the skin of the infrascapular regions of the back to the right or left of the midline and the subject was dismissed with instructions not to wet or expose the test area to direct sunlight.
After 24 hours the patch was removed by the panelist at home.
This procedure was repeated until a series of nine consecutive 24 hour exposures have been made for every Monday, Wednesday and Friday for three consecutive weeks.
ln the event of an adverse reaction, the area of erythema and edema is measured. The edema is estimated by the evaluation of the skin with respect to the contour of the unaffected normal skin. Reactions are scored just before applications two through nine and the next test date following application nine.
Subjects were then given a 10 - 14 day rest period after which a challenge or retest dose was applied once to a previously unexposed test site. The retest dose is equivalent to any one of the original nine exposures. Reactions are scored 24 and 48 hours after application.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: result from human patch test
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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