Phenol, 4-[(1E,3S)-3-ethenyl-3,7-dimethyl-1,6-octadien-1-yl]-

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

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

2006

Reference 2

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

Test material information

Constituent 1

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

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