Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Predates GLP and OECD guidelines, minor restrictions, available as unpublished report

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
No method guideline specified
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of test material (as cited in study report): Ethasan

Method

Type of population:
general
Subjects:
- Number of subjects exposed: 50
Controls:
None
Route of administration:
dermal
Details on study design:
A series of fifteen alternate-day applications, each of 24 hours’ duration, were scheduled to be carried out.
A lintine disc was moistened with the test material, prepared at 50% w/v in dimethylphthalate. This patch was placed on a predesignated site, covered, and sealed with overlapping strips of Blenderm tape. The patch was kept intact for twentyfour hours. At the end of 24 hours, the seal was broken and the patch removed. The skin sites were examined and gross changes, if present, were graded on a scale of 1 to 4. Absence of any visible skin changes was assigned a 0 value.
After the patch was removed, the site was rested for 24 hours. The site was then re-examined to determine if any changes had occurred since the previous examination. If the contact site manifested no change, the test material was re-applied to the same site. If significant irritation (2+ or greater) was observed, the investigator, at his discretion, had the option of either resting the individual or of applying the test material to a new site for the next contact period.
This cycle was repeated in this manner on Mondays, Wednesdays, and Fridays. On weekends, a 48-hour rest period was permitted between removal and re-application of the test material.
After the fifteenth application, the participants were rested for two weeks before being challenged. The sites of contact used previously were challenged with the test material for 24 hours under occlusion. After removal of the patches, the sites were examined immediately and following at intervals of 24 and 48 hours.

Results and discussion

Results of examinations:
Skin changes accompanying application N°1 through 15:
Dose level 50%
No. with + reactions 1
Total no. in group 50
Clinical observations Slight erythema

Challenge
Dose level 50%
No. with + reactions 0
Total no. in group 50
Clinical observations None

Applicant's summary and conclusion