Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
From 2001-03-05 to 2001-05-24

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

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:
yes
Remarks:
Good Clinical Practices

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
liquid
Details on test material:
- Physical state: clear colourless liquid
- 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: males (21.2 %) and female (78.8 %)
- Age: 18.6 to 70.6
- Race: Asian (1.8 %), Black (0.9 %), Caucasian (86.7 %), Hispanic (9.7 %), Other (0.9 %)
- Demographic information: none
Clinical history:
Inclusion criteria:
- individuals free of any systemic or dermatologic disorder which, in the opinion of the investigative personnel, would have interfered with the study results
- individuals of any skin type or race providing the skin pigmentation would allow discernment of erythema.

Exclusion criteria:
- individuals with any visible skin disease at the study site which, in the opinion if the investigative personnel, would have interfered with the evaluation
- individuals receiving systemic or topical drugs or medication which, in the opinion if the investigative personnel, would have interfered with the study results
- individuals with psoriasis and/or active atopic dermatitis/eczema
- females who were pregnant, planning a pregnancy or nursing a child
- individuals with a known sensitivity to cosmetics fragrances, skin care products or topical drugs as related to products 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: non-porous, plastic film adhesive bandage with a 2 cm x 2 cm Webril pad affixed with hypo-allergenic tape (Micropore) as needed.
- Vehicle / solvent: diethyl phtalate
- Concentrations: 20 %
- Volume applied: 0.2 mL
- Testing/scoring schedule:
Induction phase: 9 consecutive applications, 48-hour intervals (72-hour if weekend)
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

Any other information on results incl. tables

none

Applicant's summary and conclusion

Conclusions:
Under the condition of the study, ST 04 C 91 is not a skin sensitiser at 20% in diethyl phtalate. The NESIL /NOAEL is determined to be 2.3 µg/cm².
Executive summary:

A panel of 108 male and female human volunteers participated in a repeat insult patch test in which a 20% solution of ST 04 C 91 in Diethyl phthalate applied to the back of the subjects under occlusive patches. During the induction phase nine patch were applied, separated by a 48-hour interval. The patches were removed 24 hours after application. Following a 14-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 ST 04 C 91 at 20%.

A No Expected Sensitisation Induction level (NESIL) or NOAEL can be derived from this study as follows:

Single 0.2 mL 20% test material induction dose (relative density = 0.938) <=>0.00938 mg

Area of exposure: 2 cm x 2 cm = 4 cm²

NESIL or NOAEL = applied dose / area of exposure = 0.00938 / 4 = 0.0023 mg/cm²= 2.3 µg/cm²

The NESIL / NOAEL is determined to be 2.3 µg/cm².