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Toxicological information

Skin irritation / corrosion

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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:
2006
Reference Type:
study report
Title:
Unnamed
Year:
2007

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

Constituent 1
Chemical structure
Reference substance name:
4-[(1E,3S)-3-ethenyl-3,7-dimethylocta-1,6-dienyl]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-dienyl]phenol

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