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Exposure related observations in humans: other data

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Administrative data

Endpoint:
exposure-related observations in humans: other data
Adequacy of study:
supporting study
Study period:
Between 04 March 1993 and 26 March 1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted in accordance with generally accepted scientific principles but criteria for subject selection was not described.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Type of study / information:
study with volunteers
Endpoint addressed:
skin irritation / corrosion
Test guideline
Qualifier:
no guideline available
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
OS# 16928AJ

Method

Ethical approval:
confirmed and informed consent free of coercion received
Details on study design:
The 48-Hour Patch Test was conducted as follows:
Panel No: 93030
The study was initiated on March 4,1993 and observations (skin reactivity) were made on March 6, 1993 (48-hours) and March 8, 1993 (96-hours).
Panel No: 93037
The study was initiated on March 22,1993 and observations (skin reactivity) were made on March
24, 1993 (48-hours) and March 26, 1993 (96-hours).
Approximately 0.2 ml of each test article was placed onto Parke-Davis Readi-Bandage occlusive patches. The patch test units were applied to the back of each subject for a period of 48-hours.
At the end of the 48-hour contact period, the patch test units were removed at the Clinic and scored for dermal reactivity. A second reading was taken 48-hours later (96-hour post-application).

Dermal responses were recorded using the following 6-point scale:
0 = No evidence of any effect
+ = Barely Perceptible (Minimal, faint, uniform or spotty erythema)
1 = Mild (Pink, uniform erythema covering most of the contact site)
2 = Moderate (Pink-red erythema uniform in the entire contact site)
3 = Marked (Bright-red erythema witNwithout petechiae or papules)
4 = Severe (Deep-red erythema with/without vesiculation or weeping)
All other observed dermal sequelae (Le. edema, dryness, hypo- or hyperpigmentation, etc.) were appropriately recorded and described as mild, moderate or severe.
Exposure assessment:
measured
Details on exposure:
Panel No: 93030
Twenty-seven (27) subjects, 8 males and 19 females, ranging in age from 18 to 67 years, were empaneled to test 1%, 3%, and 10% concentrations of the test articles, including 2 controls.
Panel No: 93037
Twenty-eight (28) subjects, 7 males and 21 females, ranging in age from 18 to 58 years, were empaneled to test 30% and 100% (Neat) concentrations of the test articles, without the controls.
The subjects were informed of the nature of the tests, 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 conditions which would have precluded application of the test articles.

The subjects did not exhibit any physical or dermatological conditions which would have precluded application of the test articles.

Results and discussion

Results:
(See attached Table for Individual Scores - attachment 1)
A total of 27/27 subjects satisfactorily completed the test procedure for Panel no. 93030. A total of 28/28 subjects satisfactorily completed the test procedure for Panel no. 93037. There were no discontinued panelists at any time during the come of the studies.

See attachment 2 for the summarized Mean Initation Scores observed for each of the test articles, at the various concentrations studied.

None of the patch test reactivity observed was considered to be evidence of allergic contact sensitization. All were considered indicative of imtation.
Peak levels of dermal irritation were observed at the 48-hour reading (i.e., following removal of the patch). By the 96-hour reading, overall levels and seventy of reactivity were generally diminished.
Student-Newman-Keuls post-hoc analyses (Appendix - attachment 3) showed the following significant (P 5.05) differences in mean irritation scores observed among all the concentrations tested:

Applicant's summary and conclusion

Conclusions:
Under the conditions of a 48-hour (occlusive) patch test, the following overall (general) ranking of the test articles was observed: OS #65271E >= OS #87926A >= OS#18504G > OS#25348U >= OS#16928AJ (EC# 263-093-9) = OS #67708E = OS #75788B = OS #94982F.

Based on these data, test concentrations of 10% or less are considered to be appropriate and probably tolerable for subsequent repeated insult (occlusive) patch testing (RIFT) for the estimation of potential induced allergic contact sensitization in human subjects.
Executive summary:

To determine and compare the relative primary irritation potential and estimate tolerability for subsequent occlusive RIPT studies of eight (8) test articles when applied to the skin of human subjects for 48-hours under occlusive patches.

Under the conditions of a 48-hour (occlusive) patch test, the following overall (general) ranking of the test articles was observed: OS #65271E >= OS #87926A >= OS#18504G > OS#25348U >= OS#16928AJ (EC# 263 -093 -9) = OS #67708E = OS #75788B = OS #94982F.

Based on these data, test concentrations of 10% or less are considered to be appropriate and probably tolerable for subsequent repeated insult (occlusive) patch testing (RIFT) for the estimation of potential induced allergic contact sensitization in human subjects.