Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
December, 1969 - February, 1970
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Not a validated method for determining skin irritation or skin sensitisation, but provides reliable supporting information for “in-use” concentrations using a “standard practice” applied to ingredients for consumer formulations. As only 2% is tested, no conclusion can be drawn for the 100% substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970
Report Date:
1970

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The method followed in this study was that of the repeated insult method approved by the Food and Drug Administration and known as the Draize technique.
GLP compliance:
no
Remarks:
not present at the time of performance.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): Giv 2-3907 Folenox
- Chemical name: Isolongifolene Epoxide

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
- 16 males and 38 females volunteers (62 were treated, 8 dropped)
- ages varied from 18 to 70 years
- No person was accepted with active dermatologic conditions or other descernible illness
Clinical history:
No data
Route of administration:
dermal
Details on study design:
PRE-TEST:
In a pilot group with 10 subjects, the test material was applied in closed patch test to the inner surface of the left deltoid area. 48 hours later, the patch was removed and the reading was recorded. When no objective manifestations of irritation developed after the reading, the full sensitization study was planned.

MAIN STUDY:
The procedure consists in the repeated application cyclicly closed patch tests with 0.5 mL of test solution being applied to individual absorbent patch.The patch was then applied to the area to be tested in a definite fixed sequence. The patch was then secured by means of overlying strips of impervious adhesive tape which was then further occluded with additional overlying strips of similar tape. The patch was allowed to remain in situ for 48 hours and then removed, at which readings were recorded.
The initial site of application of the patch was the inner surface of the right deltoid area. When it was removed 48 hours after application, the next application was made to the inner surface of the left deltoid area. The third application was made to the original site of the first application, the inner surface of the right deltoid area, and the fourth application was made to the site of the second application on the medial surface of the left deltoid area. Thus the cycle of rotation of the sites of application was alternately between the inner surfaces of the right and left deltoid areas for a total of ten applications. The concluding challenge tests were applied in precise duplicates to the inner surface of each deltoid area, 2 weeks after the induction fase finished for 48 hours.

Results and discussion

Results of examinations:
The 54 subjects demonstrated responses during the induction series. These responses varied from a plus minus reaction to a plus one reponse. Because all these reactions were of very mild type, because none of them were repeated in any individual, and because the challenge tests produced no reactions, one must assume that these reactions are neither irritative nor allergic in origin.

Any other information on results incl. tables

Other effects: Adhesive tape reactions occurred.

Applicant's summary and conclusion

Conclusions:
Under the conditions of a repeated occlusive patch test procedure, the 2% test material Folenox produced one very mild reaction during the induction phase. The challenge phase produced no reactions. No conclusions can de drawn on the 100% test substance.