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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Between 02 February 1994 and 18 March 1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Good clinical practices (GCP) statement; uses one of a number of acceptable methods but criteria for subject selection was not described.

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
Test guideline
Guideline:
other: no guideline stated
Principles of method if other than guideline:
To determine the irritation and/or sensitization potential of the test article after repeated application under semi-occlusive patch test conditions to the skin of human subjects (non-exclusive panel).
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test Article: OS#13463M (Total Base Number = 85)
Description: Brown viscous liquid

Method

Type of population:
general
Ethical approval:
confirmed and informed consent free of coercion received
Subjects:
Fifty-three (53) subjects, 8 males and 45 females, ranging in age from 24 to 63 years were em:paneled for this test.
The subjects were informed of the nature of the test, including possible adverse reactions.
Written informed consent was obtained.
Additionally, the subjects were considered dependable and able to read and understand instructions. The subjects did not exhibit any physical or dermatological condition that would have precluded application of the test article.
Clinical history:
The subjects did not exhibit any physical or dermatological condition that would have precluded application of the test article.
Route of administration:
dermal
Details on study design:
Induction Phase
The Induction Phase was initiated on: February 2, 1994.
A sufficient quantity of the test article to cover the test site 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 to Scanpor (Allerderm) semi-occlusive surgical tape which was applied to the back of each subject, between the scapulae and waist, adjacent to the spinal mid-line.
The subjects were instructed to remove the patch 24-hours after application. Twenty-four hour rest periods followed the Tuesday and Thursday removals and 48-hour rest periods followed each Saturday removal. The site was scored by a trained examiner just prior to the next patch application. This procedure was repeated every Monday, Wednesday and Friday until nine (9) applications of the test article had been made.
Procedurally, if a subject developed a positive reaction of a 2-level erythema or greater during the Induction phase or, at the discretion of the Study Director, if the skin response warranted a change in site, the patch would be applied to a previously unpatched, adjacent site for the next application. If a 2-level reaction (or greater) occurred at the new site, no further apllications would be made. However, any reactive subjects would be subsequently
Challenge patch tested.

Challenge Phase
After a rest period of approximately two weeks (no applications of the test article), the Challenge patch was applied to a previously unpatched (virgin) test site. The site was scored 24 and 72-hours after application. All subjects were instructed to report any delayed skin reactivity which might have occurred after the final Challenge patch reading. When warranted, selected test subjects were called back to the Clinic for additional examinations and scoring to determine possible increases or decreases in Challenge patch reactivity.
The final Challenge patch reading was made on: March 18, 1994.

Results and discussion

Results of examinations:
Test Article: OS #13463M (@ 10% in White Mineral Oil)

See Table for Individual Scores (attachment 1)

Forty-eight (48) subjects completed the test procedure. Five (5/53) subjects discontinued for personal reasons unrelated to the conduct of the study. Discontinued panelist data are shown up to the point of discontinuation, but are not used in the Results, Discussion or Conclusions sections of this final report. A total of 3/48 (6.3%) of the subjects exhibited sensitization responses.
Subject no. 1 was discontinued due to Induction patch dermal reactivity suggestive of a moderate-grade, induced allergic contact dermatitis. This skin reactivity pattern was characterized by five (5) consecutive negative (0) Induction patch responses, followed by moderate (2-level) erythema. Following a change in patch site, moderate (2-level) 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 nos. 2 and 42 exhibited similar Induction patch reactivity 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:
Under the conditions of a repeated insult (semi-occlusive) patch test procedure, Test Article: OS #13463M (@ 10% in Mineral Oil) (Total Base Number = 85) induced dermal reactivity suggestive of moderategrade allergic contact dermatitis in 3/48 test subjects.
Executive summary:

To determine the irritation and/or sensitization potential of the test article after repeated application under occlusive patch test conditions to the skin of human subjects (non-exclusive panel).

Fifty-three (53) subjects, 8 males and 45 females, ranging in age from 24 to 63 years were em:paneled for this test

The 9 Repeated Insult (semi-occlusive) Patch Test (9 RIPT) was conducted.

Under the conditions of a repeated insult (semi-occlusive) patch test procedure, Test Article: OS #13463M (@ 10% in Mineral Oil) (Total Base Number = 85) induced dermal reactivity suggestive of moderategrade allergic contact dermatitis in 3/48 test subjects.