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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1997
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: method and results sufficiently described, although ethical confirmation from ethical committee is not clear; non-GLP, but quality control applied

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline followed
Guideline:
other: Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics, The Association of Food and Drug Officials of The United States
GLP compliance:
no

Test material

Constituent 1
Details on test material:
Batch no. 7002; no purity indicated

Method

Type of population:
general
Ethical approval:
not specified
Remarks:
it was only stated that an institutional review board was present consisting of 5 or more individuals chosen from within the company and from the local community
Subjects:
- Number of subjects exposed: 102
- Sex: 10 male and 96 female
- Age: 18-78 years
- Race: 84 Caucasian, 19 Hispanic, 3 Asian
- Demographic information: no information, but probably from within the vicinity of the test lab, which was situated in New City, NY, USA
- Other:
Subjects were included, if:
- they were not currently under a doctor's care
- were not at the time of the study and had not for a period of 30 days prior to induction been under the influence of medication
- they were 18 year of age or older and had completed and signed the AMA Medical Questionnaire and Informed Consent document relating to the specific study to which they are subscribing
- they were not pregnant or lactating or did not intend to become pregnant within the next 60 days
Clinical history:
Each subject completed an extensive medical form before the study.
Controls:
non-treated skin
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: repeat insult patch test:

ADMINISTRATION
- Type of application: occlusive
- Description of patch: Parke-Davis Hypoallergenic Readi Bandages (20 x20 mm Webril affixed to the center of a 40 x 40 mm adhesive bandage) or the equivalent
- Vehicle / solvent: silicone
- Concentrations: 10%
- Volume applied: 0.2 ml or 0.2 g of the test material; total volume not given
- Testing/scoring schedule:
Induction: nine 24-hour applications on every Monday, Wednesday and Friday for 3 consecutive weeks; oedema is estimated by evaluation of the treated skin with respect to the contour of the unaffected normal skin; scoring is done just before the next application (which is 10-14 days after application 9);
Challenge: once 10-14 days after last induction to a previously unexposed test site; reactions are scored 24 and 48 hours after application
- Removal of test substance: patch was removed 24 hours after application

EXAMINATIONS
- Grading/Scoring system: no effect, barely perceptible, mild, moderate, marked or severe; challenge grades are compared to the nine sensitizing doses
- Statistical analysis: not applicable

Results and discussion

Results of examinations:
No adverse reactions of any kind were noted during the course of the study.

Applicant's summary and conclusion

Conclusions:
The test substance, when tested at 10% dilution in silicone, is not a skin sensitizer.
Executive summary:

Hundred-and-two volunteers were tested by repeat insult patch test for skin sensitization. No adverse reaction of any kind was noted during the course of the study. The test substance, when tested at 10% dilution in silicone, is not a skin sensitizer.