Grapefruit, ext.

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

August 21, 2006 - September 29, 2006

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The clinical study was conducted following applicable guidelines and regulations in conformance with ICH Guidelines E6 for Good Clinical Practice and requirements provided in 21 CFR parts 50 and 56.

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: ICH Guideline E6

Deviations:

not specified

Principles of method if other than guideline:

A repeated insult patch test was performed in 106 male and female subjects. Nine induction treatmens were followed by a challenge treatment after a 2-wk rest period. Dermal reactions were evaluated after 24, 48, and 72 hrs.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Grapefruit oil

IUPAC Name:

Grapefruit oil

Details on test material:

- Name of test material (as cited in study report): Grapefruit flower oil, morocco
- Lot/batch No.: confidential
- Other: 1% in DEP/ethanol (3:1)

Method

Type of population:

general

Controls:

- Control group: same subjects receiving distilled water instead of test substance (control substance: distilled water, 1% in DEP/ethanol)

Route of administration:

dermal

Results and discussion

Results of examinations:

SYMPTOMS: 1 subject showed barely perceptible erythema at the 2nd reading 48 hours after challenge.

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 1 out of 106

Any other information on results incl. tables

Reading	Hours after challenge	Group	Dose level	No. with + reactions	Total no. in group	Clinical observations
1st reading	24	test group	0.055 cc/cm2 test substance	0	106
2nd reading	48	test group	0.055 cc/cm2 test substance	1	106	1 subject showed barely perceptible erythema
other: 3rd reading	72	test group	0.055 cc/cm2 test substance	0	106
1st reading	24	negative control	0.055 cc/cm2 distilled water	0	106
2nd reading	48	negative control	0.055 cc/cm2 distilled water	0	106
other: 3rd reading	72	negative control	0.055 cc/cm2 distilled water	0	106

Applicant's summary and conclusion

Conclusions:

Grapefruit oil did not have sensitising properties in the repeated insult patch test, under the conditions of this test.

Executive summary:

In a repeated insult patch test, the sensitising properties of Grapefruit oil were investigated. Humans were induced with 0.2 cc test material (0.055 cc/cm2) by occluded patch applied to the upper back. Distilled water was used as control substance. The patches were applied to the same site for a total of 9 applications during the induction period. Following an approximately 2-week rest period, challenge patches were applied to previously untreated test sites on the back. After 24 hours, the patches were removed and evaluated for dermal reactions. Re-evaluation was performed at 48 and 72 hours. 106 subjects completed the study, none of them showed sensitisation. Based on the EU criteria outlined in 1272/2008/EC and 67/548/EEC, Grapefruit oil is not a sensitiser.