Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
From September 21, 2009 to October 30, 2009
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

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:
Repeated insult patch study: 113 human volunteers were topically induced with 9 occluded patches of the test material over a period of 3 weeks followed by a challenge patch after a rest period of 2 weeks and then the application sites were scored for skin irritation.
GLP compliance:
no
Remarks:
GLC compliance

Test material

Constituent 1
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): ST 10 C 09 at 5% in 75% DEP/25% Ethanol
- Physical state: clear colourless liquid
-Storage condition of test material: ambient
- Other: Flash point: 55°F

Method

Type of population:
general
Ethical approval:
confirmed and informed consent free of coercion received
Subjects:
- Number of subjects exposed: 113 (105 completed the study)
- Sex: M: 25 (22.1%), F: 88 (77.9%)
- Age: 18 to 44: 43 (38.1%); 45 to 64: 55 (48.7%), 65 and up: 15 (13.3%)
- Race: Asian: 5 (4.4%); Black: 13 (11.5%); Caucasian: 82 (72.6%); Hispanic: 13 (11.5%)
- Demographic information: none
Clinical history:
Inclusion criteria:
Individuals eligible for inclusion in the study where those who:
1: were males or females, 18 years of age or older, in general good health,
2: 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 effects,
3: were of any skin type or race providing the skin pigmentation would allow discernment of erythema,
4: had completed a medical screening procedure, and
5: had read, understood and signed an informed consent agreement.

Exclusion criteria:
Individuals excluded form participation in the study were those who:
1: had any visible skin disease at the study site which, in the opinion if the investigative personnel, would have interfered with the evaluation
2: were receiving systemic or topical drugs or medication which, in the opinion if the investigative personnel, would have interfered with the study results
3: had psoriasis and/or active atopic dermatitis/eczema
4: were females who were pregnant, planning to become pregnant during the study, or breast-feeding, and/or,
5: had 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: molded plastic chamber patch (25 mm Hilltop Chamber) lined with a non-woven cotton pad. The patch was secured with hypoallergenic tape (Micropore), as needed.
- Vehicle / solvent: DEP/ethanol (75/25)
- Concentrations: 5%
- Volume applied:0.3 mL
- Testing / scoring schedule:
Induction phase: Patches were applied three (3) times per week (Monday, Wednesday, and Friday) for a total of nine (9) applications. After 24 h patches were removed. Sites were evaluated 48 h to 72 h post application for irritation scores.
Challenge phase: Approximately two weeks after the final induction patch application, a challenge patch was applied to a virgin test site, following the same procedure described for induction. The patch was removed after 24 hours and the site scored 48 h and 72 h post-application.

EXAMINATIONS
- 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 related to treatment

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 105
- 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, the test material is not a skin sensitiser at 5% in diethyl phtalate/ethanol (75%/25%).
Executive summary:

A panel of 105 male and female human volunteers completed a repeat insult patch test in which a 5% solution of test material in 75% Diethyl phthalate / 25% Ethanol was 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 2 -week 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 5%.