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Diss Factsheets

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
From June 8 through July 15, 2011

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2011

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Occlusive repeated insult patch study in humans
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
[(2R)-3-methoxy-2-methylpropyl]benzene
Molecular formula:
C11H16O
IUPAC Name:
[(2R)-3-methoxy-2-methylpropyl]benzene
Constituent 2
Chemical structure
Reference substance name:
[(2S)-3-methoxy-2-methylpropyl]benzene
Molecular formula:
C11H16O
IUPAC Name:
[(2S)-3-methoxy-2-methylpropyl]benzene
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): ST 16 C 11 at 50 % in 75% Diethyl Phthalate (DEP) / 25% Ethanol

Method

Type of population:
general
Ethical approval:
confirmed and informed consent free of coercion received
Subjects:
- Number of subjects exposed: 12 subjects completed the study (12 were enrolled)
- Sex: 6 males and 6 females
- Age: 18-54 years
- Race: Asian (4): no data
Clinical history:
No subject was used if he or she exhibited any dermatological or other medical or physical condition that would preclude topical application of the test material. No subject reported using any medication that would interfere with sensitization results. No known pregnant or nursing women were used on this RIPT. No minor subjects were used on this RIPT.
An appropriate clearance period had elapsed since a subject was patched on a RIPT or a photoallergy test before being used in this RIPT.
Controls:
None
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: Patch test

ADMINISTRATION
- Type of application: Occlusive
- Description of patch: a webril/adhesive patch (25 mm Hill Top Chamber System) was used.
- Vehicle / solvent: 75 % Diethyl Phthalate (DEP) / 25 % Ethanol
- Concentrations: 50 %
- Volume applied: 0.3 mL
- Testing/scoring schedule: Subjects participated over a 6-week period involving 3 phases: (1) Induction, (2) Rest, and (3) Challenge.
Induction phase: 9 consecutive applications, 48 h intervals (72 h weekend).
Rest period: Approximately two weeks.
Challenge phase: after two weeks.
- Removal of patches: Approximately 24 h after each application
- Other: Patches were applied to the back, either to the right (challenge) or left (induction) of the midline.

EXAMINATIONS
During induction, sites were evaluated at 48 h intervals (72 h if weekend). After challenge, evaluations were done at 24, 48, 72 and 96 h after application.

Grading/Scoring system:
0 = No visible reaction
+/- = Faint erythema
1 = Erythema
2 = Intense erythema, induration
3 = Intense erythema, induration, vesicles
4 = Severe reaction with erythema, induration, vesicles, pustules (may be weeping)
E = Edema.

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: 12
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0

Any other information on results incl. tables

Twelve subjects between the ages of 18 and 54 were enrolled and twelve subjects completed the study.

During the Induction Phase, one subject exhibited a low-level (+/-) reaction. During the challenge, one other subject exhibited a low-level (+/-) reaction)

Applicant's summary and conclusion

Conclusions:
Under the condition of the study, the test material is not a skin sensitizer at 50 % in 75 % Diethyl Phthalate (DEP) / 25 % Ethanol.
Executive summary:

A panel of 12 male and female human volunteers participated in a repeat insult patch test in which a 50 % solution of test material in 75 % Diethyl Phthalate (DEP) / 25 % Ethanol applied to the back of the subjects under occlusive patches. 12 subjects completed the study. During the induction phase nine patches were applied, separated by a 48 h interval. The patches were removed 24 h after application. Following a 2 -weeks rest period, a challenge patch was applied and the sites scored 24, 48, 72 and 96 h after application.

During the Induction Phase, one subject exhibited a low-level (+/-) reaction. During the challenge, one other subject exhibited a low-level (+/-) reaction).

Under the conditions employed in this study, there was no evidence of sensitisation to the test material at 50 %.

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