Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1969-12-22 to 1970-02-09
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards with accpetable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970
Report Date:
1970

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
according to
Guideline:
other: Repeated insult method approved by the United States Food and Drug Administration, known as the Draize technique.
Deviations:
not specified
GLP compliance:
not specified
Remarks:
Study pre-dates GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
impurity
Type:
impurity
Test material form:
liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report): Giv 2-1334; Lemonile

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
TEST SUBJECTS
- Age at study initiation: 18 to 70 years
- Sex: 38 female, 16 male (completed the full study)
Clinical history:
- No subject was accepted into the study with active dermatological conditions or other discernable illnesses.
- Previous sensitivities or history of allergies were not considered to be reasons for rejection, but were noted for any value such information could have in interpreting the results of the study.
Route of administration:
dermal
Details on study design:
PILOT STUDY
A routine precautionary study was performed to check the primary irritative potentialities of the material by applying it in the same manner as the main study on a pilot group of 10 subjects. After 24 hours of exposure there were no complaints of itching, burning or other paresthesias so the patches were allowed to remain in situ undisturbed for another 24 hours after which they were removed.

TYPE OF TEST(S) USED: closed patch test (epicutaneous test)

ADMINISTRATION
The initial site of application was the inner surface of the right deltoid area. When these patches were removed 48 hours after application, the next application was made to the inner surface of the left deltoid area. The third application was made to the original site of the first application and the fourth application was made to the site of the second application. Thus, the cycle of rotation of the sites of application was alternately between the inner surfaces of the right and left deltoid areas for a total of 10 sensitisation applications. The concluding challenge tests were applied in precise duplicates to the inner surface of each deltoid area.
There then followed a 2 week rest period after the application of the last sensitisation test.
The challenge test series was then applied in an identical manner in which the sensitisation applications were made, except that the tests were applied in duplicate, one set of eight patches to the inner surface of each deltoid area. These challenge test applications were then removed and a 48 hour reading was recorded. The patches were not re-applied. Instead, a loosely applied cover of plain sterile gauze was made to protect the test site area from washing, scratching or other interference with the development of any delayed reactions. On the following day a 72 hour or delayed reading was recorded to complete the study.
- Type of application: occlusive
- Description of patch: Absorbent patch were secured by means of overlying strips of impervious adhesive tape which were then further occluded with additional strips of similar tape.
- Vehicle / solvent: Dimethyl phthalate
- Concentrations: 2.0% solution by weight
- Volume applied: 0.5 cm3 (0.5 mL)
- Duration: 48 hours contact (72 hours over the weekend)
- Testing/scoring schedule: The patches remained in situ for 48 hours and were then removed, at which time readings were recorded.
- Removal of test substance: Prior to the application of each test series, including the challenge tests, the application sites were cleansed with an ether-acetone mixture to remove any sebum or foreign material.

EXAMINATIONS
- Grading/Scoring system:
- Statistical analysis:
- Other:

Results and discussion

Results of examinations:
PILOT STUDY
No signs of irritation were observed after 48 hours.

MAIN STUDY
No positive reactions or adverse effects were seen in any test subject.

Applicant's summary and conclusion

Conclusions:
Lemonile is not considered to be sensitising to human skin when tested as a 2% solution by weight.