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Diss Factsheets

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
Not specified
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Study report not detailed or referencing any documented guideline followed.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1966
Report date:
1966

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
according to guideline
Guideline:
other: Shelanski and Shelanski (Proceedings of the Toilet Goods Association No. 19, May 1953)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
6,6'-di-tert-butyl-4,4'-butylidenedi-m-cresol
EC Number:
201-618-5
EC Name:
6,6'-di-tert-butyl-4,4'-butylidenedi-m-cresol
Cas Number:
85-60-9
Molecular formula:
C26H38O2
IUPAC Name:
6,6'-di-tert-butyl-4,4'-butylidenedi-m-cresol
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Sample No. 131 - Santowhite Powder, Lot No. NE 10-010

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
50 human subjects utilised.
No further information specified within the report.
Clinical history:
None of the subjects of this test had been utilised previously for patch testing.
No further information specified within the report.
Controls:
Not specified
Route of administration:
dermal
Details on study design:
The test material was applied to linteen discs approximately 0.25 square inches in area. These were then applied to the upper arms of the subjects and held in place with Blenderm tape. After 24 hours the patches were removed and re-actions graded and recorded. A rest period of 24 hours then elapsed after which the patches were re-applied as before. This sequence was repeated until fifteen successive patches had been applied. A two week rest period was then allowed after which a challenge application was applied as before. All applications were made to the same site.

Results and discussion

Results of examinations:
There were no reactions produced by any of the primary application or by the challenge.

Any other information on results incl. tables

Repeated Insult Patch Test with Sample No. 131 – Santowhite Powder, Lot No. NE 10-010 Results

 

Number of subjects negative throughout            50

Number of subjects showing reactions                 0

Number of Application

Number of Reactions in the Grades Indicated*

0

1+

2+

3+

4+

1

50

0

0

0

0

2

50

0

0

0

0

3

50

0

0

0

0

4

50

0

0

0

0

5

50

0

0

0

0

6

50

0

0

0

0

7

50

0

0

0

0

8

50

0

0

0

0

9

50

0

0

0

0

10

50

0

0

0

0

11

50

0

0

0

0

12

50

0

0

0

0

13

50

0

0

0

0

14

50

0

0

0

0

15

50

0

0

0

0

Challenge

50

0

0

0

0

 *Scoring Criteria

0             =            No reaction.

1+          =            Slight erythema.

2+          =            Marked erythema.

3+          =            Marked erythema, edema, with or without a few vesicles.

4+          =            Marked erythema, edema, with vesicles and oozing.

Applicant's summary and conclusion

Conclusions:
Sample No. 131 - Santowhite Powder, as tested, is neither a primary irritant nor a fatiguing agent.
Executive summary:

Sample No. 131 - Santowhite Powder, as tested, is niether a primary irritant nor a fatiguing agent. There was no evidence that the material has any sensitizing action.

In so far as sensitization is concerned, the extrapolation of these results to a general population is limited statistaically by the number of test subjects. In this case, since fifity subjects were used, we may predict with 95% certainty that a least 92% of a general population will not be sensitized by this material.