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Sensitisation data (human)

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sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
01 Aug 2001 - 17 Jan 2002
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented GCP study meeting basic scientific principles.

Data source

Reference Type:
study report
Report date:

Materials and methods

Type of sensitisation studied:
Study type:
study with volunteers
Test guidelineopen allclose all
according to guideline
other: 21 CFR Part 312
according to guideline
other: 21 CFR Part 50
according to guideline
other: 21 CFR Part 56
Principles of method if other than guideline:
Repeated Insult Patch Test of Y-15099 in Human Subjects (Modified Draize)
GLP compliance:
GCP (good clinical practices)

Test material

Details on test material:
- Name of test material (as cited in study report): Y-15099
- Physical state: pale yellow liquid
- Analytical purity: 95.8%
- Purity test date: 2001-10-02
- Lot/batch No.: 18244-52
- Storage condition of test material: at room temperature


Type of population:
Ethical approval:
confirmed and informed consent free of coercion received
- Number of subjects exposed: 108, but only 98 subjects completed the study
- Sex: Male and female subjects
- Age: 18 - 75 years (mean age 47.9 years)
- Race: The majority of subjects were Caucasian woman
Clinical history:
Study population inclusion criteria:
- 18 years of age or older, ingeneral good health
- free of any systemic or dermatologic disorder which, in the opinion of the investigative personnel, would have interfered with the study results or increase the risk of adverse events
- skin type or race providing the skin pigmentation would allow discernment of erythema
- completion of a patch study medical screening form as well as a medical/personal history form
- consent agreement
Study population exclusion criteria:
- visible skin disease
- systemic or topical drugs or medication interfering with the study
- asthma
- pregnancy/breast feeding
- known sensitivity to silicone, siloxane, silane, or cosmetics, skin care products, or topical drugs as related to the material being evaluated
Positive control sides were treated with sodium lauryl sulfate 0.1% w/v aqueous solution and Texapon K-1296 (Lot No. 15044).
Route of administration:
Details on study design:
TYPE OF TEST(S) USED: standard repeated insult patch test (epicutaneous test) ;

- Type of application: semiocclusive
- Number of exposures: 9 at 48-hour intervals (= 18-day period). Before each exposure, application sites were evaluated.
- Duration of exposure: 24 hours
- Description of patch: 2 cm x 2 cm Webril pad, fixed with hypoallergenic tape (Micropore).
- Vehicle / solvent: none
- Concentrations: undiluted
- Volume applied: 0.2 mL
- Application site: infrascapular area of the back, either to the right or left of the midline

When the positive control site to assess subject compliance had a grade of +D, application of SLS 0.1% aqueous solution control was discontinued.

- Type of application: semiocclusive
- Number of exposures: 1, after a 10-15 day resting period.
- Duration of exposure: 24 hours
- Application site: previously unexposed site
- Evaluation of application site: 24 and 48 hours after application

Compliance control only: material evaluated under occlusive patch conditions was applied to a 2 cm x 2 cm Webril pad attached to a non-porous, plastic film adhesive bandage (3M medical tape). The patch was secured with hypoallergenic tape (Micropore) as needed.

- Grading/Scoring system: no reaction (.); minimal or doubtful response (?); definite erythema, no edema (+); definite erythema, definite edema (++); definite erythema, definite edema and vesiculation (+++).

Results and discussion

Results of examinations:
- Frequency, level, duration of symptoms observed: One subject experienced a serious non-product-related adverse effect.

- Number of subjects with positive reactions: 1
- Number of subjects with negative reactions: 96
- Number of subjects with equivocal reactions: 1

One subject presented evidence of possible sensitization at challenge. Sensitization was confirmed with rechallenge and provocative use.

Applicant's summary and conclusion

Under the conditions employed in this study, there was evidence of sensitization to Y-15099.
Executive summary:

Y-15099 was evaluated as provided to determine its ability to sensitize the skin of normal volunteer subjects using a semi-occlusive standard repeated insult patch study procedure with nine 24 -hour induction applications and one 24 -hour challenge application. Ninety-eight subjects completed the study.

One subject presented evidence of possible sensitization at challenge. Re-challenge was conducted under semi-occlusive conditions 2 weeks later. Reactions of erythema and oedema with papules were present. Two weeks after completing re-challenge, the subject participated in a Provocative Use phase. Product application was stopped by the subject after 6 applications due to "itching and redness". She was observed the following day and presented erythema and papules spreading beyond the open application area. Sensitization was confirmed with re-challenge and provocative use. Under the conditions employed in this study, there was evidence of sensitization to Y-15099.