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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 2003-01-20 to 2003-02-27

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
2003

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Occlusive repeated insult patch study in humans
GLP compliance:
no
Remarks:
The test is in compliance with Good Clinical Practice

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): ST 27 C 02 at 10 % in diethyl phthalate
- Physical state: clear colourless liquid
- Stability under test conditions: no data
- Storage condition of test material: ambient

Method

Type of population:
general
Ethical approval:
confirmed and informed consent free of coercion received
Subjects:
- Number of subjects exposed: 108 subjects completed the study (113 were enrolled)
- Sex: 18 males and 95 female
- Age: 20.4 to 70.6 years
- Race: asian 1 %; black, 1 %; caucasian 93 %, hispanic, 18 %.
- Demographic information: no data
Clinical history:
Inclusion criteria: individuals eligible for inclusion in the study were those who:
- were males or females, 18 years of age or older, in general good health;
- were free of any systemic or dermatologic disorder which, in the opinion of the investigative personnel, would have interfered with the study results or increased the risk of adverse events;
- were of any skin type or race providing the skin pigmentation would allow discernment of erythema:
- had completed a patch study Medical Screening form as well as a Medical/personal History form; and
- had read, understood and signed an informed consent agreement.

Exclusion criteria: individuals excluded from participation in the study where those who:
- had any visible skin disease at the study site which, in the opinion if the investigative personnel, would have interfered with the evaluation;
- were receiving systemic or topical drugs or medication which, in the opinion if the investigative personnel, would have interfered with the study results;
- had psoriasis and/or active atopic dermatitis/eczema;
- were females who were pregnant, planning to become pregnant during the study, or breast-feeding; and/or
- had a known sensitivity to cosmetics, skin care products or topical drugs as related to the material being evaluated.
Controls:
none
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive
- Description of patch: 2 cm x 2 cm Webril pad attached to a non-porous, plastic fim adhesive bandage (3M medical tape), secured with hypoallergenic tape (Micropore) as needed.
- Vehicle / solvent: diethyl phtalate
- Concentrations: 10 %
- Volume applied: 0.2 mL
- Testing/scoring schedule:
Induction phase: 9 consecutive applications, 48-hour intervals (72-hour if weekend). Subject who were absent during the 3-week, 9-patch induction phase received a make-up(MU) patch at the last induction visit. The MU applications were graded 48 hours later at the MU visit or were recorded as N9G (no ninth grading).
Rest period: 10-15 days
Challenge phase: during the 6th week of the study
- Removal of patches: approximately 24 hours after each application
- Other: patches applied to the infrascapular area of the back, either to the right or left of the midline

EXAMINATIONS
During induction sites were evaluated at 48-hour intervals (72-hour if weekend). After challenge, evaluations were done after 48 and 72 hours.
Grading/Scoring system:
- = No reaction
? = Minimal or doubtful response, slightly different from surrounding normal skin
+ = Definite erythema. No oedema
++ = Definite erythema. Definite oedema.
+++ = Definite erythema. Definite oedema and vesiculation.

Statistical analysis: none

Results and discussion

Results of examinations:
SYMPTOMS
- Frequency, level, duration of symptoms observed: none

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 108
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0
One non-product-related adverse event occurred (sprain/fracture of the left foot).

Any other information on results incl. tables

no other information

Applicant's summary and conclusion

Conclusions:
Under the condition of the study, the test material is not a skin sensitiser at 10 % in diethyl phtalate.
Executive summary:

A panel of 113 male and female human volunteers participated in a repeat insult patch test in which a 15% solution of test material in Diethyl phthalate applied to the back of the subjects under occlusive patches. 108 subjects completed the study. During the induction phase nine patches were applied, separated by a 48-hour interval. The patches were removed 24 hours after application. Following a 10 -15 day rest period, a challenge patch was applied and the sites scored 48 and 72 hours after application.

Under the conditions employed in this study, there was no evidence of sensitisation to the test material at 10 %.