Trehalose

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

5 Jun. 2006 - 14 Jul. 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

according to guideline

Guideline:

other: Draize Assay Repeat Insult Patch Test (RIPT)

Principles of method if other than guideline:

A modified Draize Assay Repeat Insult Patch Test (RIPT). A four (4) week induction or insult
period with ten (10) product applications and readings is followed by a ten (10) to fourteen (14) day
rest period. The rest period is followed by a five (5) day challenge period used to determine
sensitization. The challenge period involves product application, removal and evaluation after
forty-eight (48) and ninety-six (96) hours after application.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Trehalose

EC Number:

202-739-6

EC Name:

Trehalose

Cas Number:

99-20-7

Molecular formula:

C12H22O11

IUPAC Name:

trehalose

Test material form:

solid: crystalline

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 5I131
- Expiration date of the lot/batch: 12. Sep. 2008
- Purity test date: 26. Sep. 2005

RADIOLABELLING INFORMATION (if applicable)
non

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under test conditions: assumed stable
- Solubility and stability of the test substance in the solvent/vehicle: soluble and assumed stable
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: assumed non-reactive

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
The clinical sample was prepared by the following method:
1) 120 g of Trehalose 100 was accurately weighed into a 500 ml plastic bottle.
2) Distilled water was added until the total weight was 400g.
3) The Trehalose 100 was completely dissolved.
4) The sample solution divided into 2 bottles of 200 g each.
5) Samples were sent to IRSI via one-day shipment.

Method

Type of population:

general

Ethical approval:

confirmed and informed consent free of coercion received

Subjects:

- Number of subjects exposed: 56, completed 53
- Sex: male and female
- Age: 18 to 70
- Race: Caucasian (96.2 %), Multi (3.8 %)
- Demographic information: Age Mean (years) 46.54 +- 15.09
ADVERSE EXPERIENCES
There were two (2) adverse experiences recorded during this study.

Subject # I Description & Severity I Date of Onset I Outcome/Status I Relationship to Product
6014 I Bronchitis-Mild I 07/12/06 I Ongoing/Completed I None
6049 I Two (2) broken knuckles-Mild I 06126106 I Ongoing/ Completed I None

Subject number 6014 reported seeing her physician on 07/12/06 for a cough. Subject was
diagnosed with Bronchitis and prescribed a regimen of Azithromycin® (250mg) from
07112106 through 07116106.
Subject number 6049 reported breaking two (2) knuckles on her left hand on 06126106.
Symptoms were not treated while the subject was emolled in the study.

Clinical history:

Clinical History not stated for each subject.
Following Criteria for Exclusion apply:
1. Females who are pregnant, lactating or planning a pregnancy.
2. History of asthma or emphysema.
3. History of insulin-dependent diabetes.
4. History of psoriasis or significant active skin pathology.
5. History of sensitivity to the product type(s) being tested.
6. Participation in similar studies within the past thirty (30) days.
7. A recently acquired sunburn on the patch application sites.
8. Use of any medication which \vould confound study results.
9. Missing more than two (2) patch applications during the induction/insult phase.
10. Employees of IRSI, the Sponsor or any cosmetic or phannaceutical manufacturer.
11. Any abnormal pigmentation which may interfere with evaluations.

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: Occlusive patches will be with a Finn chamber® alone if the
material is solid or semi-solid. If liquid, the material will be placed on a 7mm filter paper
disk in the chamber
- Vehicle / solvent: water
- Concentrations: 120 g Trehalose and 280 g water as stock solution
- Volume applied: 0.01 7-0.025ml
- Testing/scoring schedule: Test material will be applied three (3) times a week (Monday, Wednesday, Friday) to the
same site on the scapular back for a total of ten (10) such applications (see Appendix I). At
the end of each 48 hour period (72 hours on the weekend), subjects report for a reading of
the patch site,
- Removal of test substance: not stated
- Other:

EXAMINATIONS
- Grading/Scoring system:
0 = No reaction (negative reading)
1 = Erythema throughout the entire patch area
2 = Erythema and edema
3 = Erythema, edema and vesicles
4 = Erythema, edema and bullae
Additional notations may be made as follows:
X = Site discontinued
T = Suffix indicating Tape Reaction .
• = Other (specify under comments)
- Statistical analysis: not specified
- Other:

Results and discussion

Any other information on results incl. tables

No reactions noted during induction or challange phase.

Applicant's summary and conclusion

Conclusions:

In conclusion, under the conditions employed in this study, and in the absence of any reactions,
during the induction and challenge phases, no evidence of irritation or sensitization to Trehalose
was observed.

Executive summary:

The objective of the present study was to assess the skin sensitization potential of Trehalose

when applied to the skin of human subjects in accordance with a modified Draize Assay. The

study was initiated on June 5. 2006 and completed on July 14, 2006. Fifty-six (56) subjects were

enrolled and fifty-three (53) subjects completed the study. Three (3) subjects discontinued due

to personal reasons. Two (2) adverse experiences were recorded during the study. The adverse

experiences were not related to treatment and the subjects completed the study.