Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2016

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Human repeated insult patch test performed according to Harrison Research Laboratories Inc. Standard Protocol #100 and SOPs
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Remarks:
powder
Details on test material:
- Description: White to pale yellow powder
- Storage condition of test material : Dry area, unopened containers, optimum temp. 11-25°C / 52-77°F

Method

Type of population:
general
Ethical approval:
confirmed and informed consent free of coercion received
Remarks:
Legally valid written IRB-approved Informed Consent, in conformity with 21CFR50.25, Subtitle 1
Subjects:
- Number of subjects exposed: 108 subjects completed the test
- Sex: 27 males; 81 females
- Age: 18-70 years
- Race: not reported
- Demographic information: not reported
Clinical history:
Subjects had no pre-existing conditions that would interfere with results as determined by medical history.
Controls:
ethanol/diethyl phthalate (1:3) (HRIPT-5025-2B)
saline (HRIPT-5025-3B)
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: webril/adhesive patch (25 mm Hill Top Chamber System)
- Vehicle / solvent: ethanol/diethyl phthalate (1:3)
- Concentrations: 0.5% in ethanol/diethyl phthalate (1:3)
- Volume applied: Approximately 0.3 mL
- Testing schedule:
Phase I (Induction phase): Total of 9 induction applications (24h) over a period of approximately three weeks
Phase III (challenge phase): 2 weeks after the last induction (rest period), on a new skin site, for 24-hr
- Removal of test substance: Not reported

EXAMINATIONS
Grading/Scoring system: Modified scoring scale of the International Contact Dermatitis Research Group System (Fisher, Alexander A., Contact dermatitis, Lea&Febiger, Philadelphia, 2008:p27)
0 = No visible reaction
± = Faint, minimal erythema
1 = Erythema
2 = Intense erythema
3 = Intense erythema, induration, vesicles
4 = Severe reaction with erythema, induration, vesicles, pustules (may be weeping)
E = Edema
DR = Dryness
P = Peeling
S = Staining
^ = Hyperpigmentation / Hypopigmentation
TR = Tape reaction
C = Change of test site
N9R = No 9th reading
- = No reading
X = Discontinued
- Statistical analysis: None

Results and discussion

Results of examinations:
SYMPTOMS
- Faint, minimal erythema observed in one male, during scoring 5 to 9 of induction phase
- Faint minimal erythema observed in one male during scoring 1 of the challenge phase.
- Faint minimal erythema and dryness observed in one male during scoring 3 and 4 of the challenge phase.

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: 3

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 sensitizer at 0.5% in ethanol/diethyl phthalate (1:3).
Executive summary:

A panel of 108 male and female human volunteers participated in a repeat insult patch test in which the test material at 0.5% in ethanol/diethyl phthalate (1:3) was applied under occlusive patches. During the induction phase nine patches were applied. Two weeks after the last induction application, a challenge patch was applied and the sites scored 24 h (after removal of patch).

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