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Diss Factsheets

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1964
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1964
Report date:
1964

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
according to guideline
Guideline:
other: repeated insult patch test procedure suggested by Draize (Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, published 1959 by The Association of Food and Drug Officials of the United States, p. 52)
Version / remarks:
1959
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-phenylpropan-1-ol
EC Number:
214-379-7
EC Name:
2-phenylpropan-1-ol
Cas Number:
1123-85-9
Molecular formula:
C9H12O
IUPAC Name:
2-phenylpropan-1-ol
Test material form:
liquid

Method

Type of population:
general
Ethical approval:
confirmed, but no further information available
Subjects:
The test was initiated on 43 subjects, of whom 37 completed the program. The age and sex distribution among those completing the test is tabulated below.
Males: 11
1 male (16-20 years old)
3 males (31-40 years old)
6 males (41-50 years old)
1 male (51-60 years old)
Females: 26
6 females (16-20 years old)
3 females (21-30 years old)
7 females (31-40 years old)
7 females (41-50 years old)
1 female (51-60 years old)
2 females (60 years old)
Controls:
none
Route of administration:
dermal
Details on study design:
The test procedure was an adaptation of the repeated insult patch test procedure suggested by Draize (Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, published 1959 by The Association of Food and Drug Officials of the United States, p. 52).
The test patch was a one-inch square of Webril (absorbent non-woven cotton fabric) affixed to the center of a 1 x 3-inch strip of adhesive elastic bandage material. The test bandages were specially prepared by Duke Laboratories, Inc. Immediately before application to each subject 0.5 mL of sample was added to the Webril swatch and the bandage was then placed on the subject's upper arm. Six to nine different samples were tested simultaneously on each group of subjects, and the order in which they were applied was rotated from one subject to the next. The subjects removed the bandages 2h hours after application.
(Early in the test program a large number of subjects was similarly tested with 95% ethanol on similar test patches, and a smaller number was tested with similar samples and with alcohol applied under closed patches. The results of these experiments, which are the subject of a separate report, demonstrated that closed patch exposures caused frequent strong reactions, even to alcohol alone, and that alcohol on the semi-open test patch adapted caused essentially no irritation.)

Results and discussion

Results of examinations:
Under the conditions of this-test Sample SJ 1286-H caused little or no primary irritation.
None of the 37 subjects tested was sensitized by the sample.

Any other information on results incl. tables

Individual reaction scores and group totals for each scoring session are shown in Table I. In this Table the numeral column headings refer to applications as numbered in the preceding section. The columns A and A' designate first and second scorings of the challenge.

Symbols other than scores appearing among the data have the following meanings:

M: Applied to second site after a strong test reaction.

M-1: Applied to third site after second strong test reaction.

R: Applied to second site because of tape reaction or for other reason irrelevant to test.

S: Returned to original site after an "R" move.

M-R: Moved once because of test reaction and once for other reasons.

X: Not applied because of test reaction.

XR: Not applied for reasons irrelevant to test.

L: Test patch lost soon after application.

Sm: "Small" patch, using reduced amount of sample for safety.

-: Subject absent.

*: Residual reaction to earlier application, after an absence, not included in score totals.

( ): Flaring or persistent reactions on sites not patched at preceding session, reported only when of special interest.

N.P.: Number of subjects not included in score totals (X, XR, L, -, *).

Subjects 10, 12, 24 and 86 were tested with closed patches for the first three applications, with the regular semi-Open patches thereafter.

Individual scores of experiments

 Subject  application scores

 

 

 

 

 

 

 

 

 challenge scores

 

 

 1

 2

 3

 4

 5

 6

 7

 8

 9

 A

 A'

 10

 0

 0

 0

 0

 0

 0

 0

 0

 0

 0

 0

 12

 0

 0

 0

 0

 0

 0

 0

 0

 0

 0

 0

 16  0  0  0  0  0  0  0  0  0  0  0
 18  0  0  0  0  0  0  0  0  0  0  0
 24  0  XR  XR  -  -  XR  0  0  0  0  0
 50  0  0  0  0  0  0  0  0  0  0  0
 64  0  0  0  0  0  0  0  0  0  0  0
 86  0  0  R 0  R 0  R 0  S 0  0  0  0  1  -
 1D  0  0  0  0  0  -  * 0  0  0  0  0
 9D  0  0  0  R 0  -  * R 0  S 0  0  0  0  -
 16D  0  0  0  0  0  0  0  0  0  0  -
 26D  0  0  0  1  R 0  S 0  0  0  0  0  0
 29D  0  1  0  1  0  0  0  0  0  0  0
 42D  0  0  0  0  0  0  0  0  1  0  0
 45D  0  0  0  R 0  R 0  S 0  0  0  0  0  0
 46D  0  0  0  R 0  R 0  -  * R 0  S 0  0  0  0
 48D  0  0  0  0  0  0  0  0  0  0  0
 65D  0  0  0  0  0  0  0  0  0  0  0
 72D  0  0  0  0  0  0  0  0  0  0  0
 73D  0  0  0  0  0  0  0  0  0  0  0
 91D  0  0  0  0  0  0  0  0  0  0  0
 118D  0  0  0  0  -  * 0  0  0  0  0  0
 122D  0  0  0  0  0  0  0  0  0  0  0
 130D  0  0  0  0  0  0  0  0  0  0  0
 134D  0  0  0  0  0  0  0  0  -  0  0
 136D  0  0  0  0  0  0  0  0  0  0  0
 139D  0  0  0  0  0  0  0  0  0  0  0
 152D  0  -  * 0  0  0  0  0  0  R 0  0  0
 154D  0  0  0  0  0  0  0  0  0  0  0
 173D  0  0  0  0  0  0  0  0  0  0  0
 174D  0  0  0  0  0  0  0  0  0  0  -
 176D  0  0  0  0  -  * 0  0  0  0  0  0
 182D  0  0  0  0  0  0  0  0  0  0  0
 183D  0  -  * 0  0  0  0  0  0  0  0  0
 188D  0  0  0  0  0  0  0  0  0  0  -
 189D  0  0  0  0  0  0  0  0  0  0  0
 190D  0  0  0  0  0  0  0  0  0  0  0
 Totals score 0  37  33 34  34  33  31  35  37  35  36  32
 Totals score 1  0  1  0  2  0  0  0  0  0  1  0
 N.P.  0  3  3  1  4  6  2  0  1  0  5

Applicant's summary and conclusion

Conclusions:
Under the conditions of this-test Sample SJ 1286-H caused little or no primary irritation. None of the 37 subjects tested was sensitized by the sample.