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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:
supporting study
Study period:
From January 22 to 26, 2001.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The test procedure cannot be subsumed under a testing guideline, nevertheless are well documented and scientifically acceptable. The purity of the substance is low.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Procedure based on that described in PROTOCOL RIPT24; ism.13 .DEC.1999.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Type of population:
general
Ethical approval:
confirmed and informed consent free of coercion received
Subjects:
- Number of subjects exposed: 111.
- Sex: 77 female, 34 males.
- Age: 19 - 75 (female), 21 - 91 (males).
Route of administration:
dermal
Details on study design:
ADMINISTRATION
- Test site: left site of the back.
Type of device: occlusive patching devices were used to convey the product to the skin and to maintain it on its assigned site on each subject. These devices consisted of a 2 cm x 2 cm absorbent pad centered on the adhesive-coated surface of a 4 cm x 4 cm water-impermeable plastic film.
Preparation of a patching device: prior to application, the webril pad of a patching device was infused with 150 ml of the test material.

Applying a patching device:
- Each device was positioned on its designated site on a subject with the moistened pad in contact with the skin.
- Firm pressure was applied to the backing of the device to effect intimate contact of the product with the skin and to bond the adhesive of the flanges fast to the surrounding skin.

Removing a patching device and its contents:
- Devices were removed in the clinic by staff personnel approximately twenty-four hours after they were applied.
- A technician peeled the device off as gently as was feasible when a subject returned.

GRADING PROCEDURE:
I) lf no adverse effect was discernable, the technician took no action to change the default "0".
2) If an adverse effect was detected, the technician entered a grade to indicate her assessment of the response's intensity. This entry replaced the default "0".
Grades ≥ or a decrease in value >2 grades, had to be validated.

STAGES OF INFLAMMATION, VISIBLE CHANGE, CLINICAL SIGNIFICANCE has been evaluated.
Limit levels were defined. See table 1.

SCHEDULE PF PROCEDURES
a. Initial/Induction Phase: from week 1 to week 4, application ad observation.
b. Intermediate phase: week 4, examination.
b. Challenge/Diagnostic Phase: from week 5 to week 6, observation.
c. Follow up phase: from week 6 to week 7, information collection.

Results and discussion

Results of examinations:
INITIAL/INDUCTION PHASE
No responses were noted on any of the III subjects who participated in the induction phase of the study. The absence of responses during this phase serves to characterize the product as one that is devoid of clinically significant skin irritating propensities.

CHALLENGE PHASE
No responses were noted on any of the 104 subjects who participated in the challenge phase of the study. The absence of responses during this phase serves to characterize the product as one that is devoid of clinically significant skin-sensitizing propensities.

FOLLOW-UP PHASE
The investigator received no communications from any of the subjects during this period that provided a basis for altering his opinion concerning the safety of the product.

GLOBAL
Under the conditions prevailing in this patch test study, the product was found to be incapable of eliciting clinically significant skin damage on any of the one-hundred-and-eleven individuals concerning whom data were acquired.

Applicant's summary and conclusion

Conclusions:
Non sensitising.
Executive summary:

Method

The skin sensitizing potentials of the test item was assessed in a test on humans, with a procedure based on that described in PROTOCOL RIPT24; ism.13 .DEC.1999, on one-hundred and eleven qualified volunteers.

The regimen called for four twenty-four hour applications of the sample conducted seriatim during each of weeks 1, 2, 3, and 5 on assigned skin sites on the back of each subject.

Examinations of the contacted skin and grading of its condition were conducted within moments after devices containing the sample were removed.

Results

Weeks 1, 2, and 3 formed the Initial or Induction Phase of the regimen.

Data were acquired on one-hundred-and-eleven subjects during this phase.

No adverse effects were detected on any of the subjects during this phase.

The Challenge or Diagnostic Phase of the regimen was conducted during week 5.

Data were acquired on one-hundred and-four subjects during this phase.

No adverse effects were detected on any of the subjects during this phase.

On the basis of the above-cited observations, the test item was found to be devoid of skin-sensitizing propensities that can be detected under the conditions of this patch test procedure.

Conclusion

The investigator concluded that the data do not contraindicate usages entailing conditions of contact commensurate with those that prevailed during the course of the study.