Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to Guideline and to GCP and adequately reported.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
A nine Repeated Insult (semi-occlusive) Patch Test was conducted. A sufficient quantity of the test material was applied directly to the skin with a cotton-tipped applicator. In addition, a thin layer was placed onto a 2 cm x 2 cm square of Webril cotton fabric affixed semi-occlusive surgical tape which was applied to the back of each subject. Subjects removed the patch 24 hours after application. Twenty-four hours rest followed the Tuesday and Thursday removals and 48 hour rest periods followed each Saturday removal. This continued until 9 applications had been made.

After a rest period of 2 weeks, the challenge patch was applied to a previously unpatched test site. The site was scored 24 and 72 hours after application.
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Brown viscous liquid.

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 8 males 45 females
- Sex: male and female
- Age:
- Race:
- Demographic information:
- Other:
Controls:
None.
Route of administration:
dermal
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: nine
- Exposure period: 24 hours
- Test groups: 8 males, 45 females. 5 subjects discontinued.
- Control group: none
- Site: between the scapulae and the waist, adjacent to the spinal mid line
- Frequency of applications: monday, wednesday, friday
- Duration: 3 weeks
- Concentrations: 10%


B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge:
- Exposure period: 72 hours
- Test groups: 8 males, 45 females
- Control group: none
- Site: previously unpatched site between the scapulae and the waist, adjacent to the spinal mid line
- Concentrations: 10%
- Evaluation (hr after challenge): 24 and 72 hours

Results and discussion

Any other information on results incl. tables

Subject number 1 was discontinued due to induction patch dermal reactivity suggestive of a moderate grade induced allergic contact dermatitis. This skin reactivity pattern was characterised by 5 consecutive negative induction patch responses, followed by moderate erythema. Following a change in patch site, moderate erythema was again elicited, accompanied by papules spreading beyond the actual contact site. This subject was not challenge-patched at the discretion of the Principal Investigator.

Subject numbers 2 and 42 exhibited similar induction patch reativity and did not receive further induction or challenge patches at the discretion of the Principal Investigator. There was no other dermal reactivity observed on any other test subject during the course of the study.

Applicant's summary and conclusion

Conclusions:
Dermal reactivity suggestive of allergic contact dermatitis was observed in 3/48 test subjects. Sensitisation was not elicitied in a substantial number of persons.
Executive summary:

In a dermal sensitization study with sodium 4-icosylbenzenesulfonatein mineral oil, (8 men and 45 women were tested using patch testing. 

 

Contact dermatitis was observed in 3/48 test subjects.  In this study,sodium 4-icosylbenzenesulfonateis not a dermal sensitizer.