Registration Dossier

Toxicological information

Sensitisation data (human)

Currently viewing:

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
02.12.1991 to 10.01.1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Human Patch test to determine whether the test material was capable of sensitising the skin of human s under controlled patch test conditions.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Type of population:
other: humans
Ethical approval:
not specified
Subjects:
- Age at study initiation: 18 to 78 years
- Number of subjects: 100
Clinical history:
Not specified
Controls:
Challenge and positive controls were not included.
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
1st application: Induction undiluted semiocclusive (0.2ml)
2nd application: Challenge undiluted semiocclusive (0.2ml)

One hundred subjects were employed in this study. Semi-occlusive, 2 cm x 2 cm Webril pad patches were applied to the infrascapular area of the back, either to the right or left of the midline. The induction phase consisted of application of the test material every 48 hours for a total of nine applications (applications made on Friday were not evaluated until Monday, prior to the re-application of test material) with the occlusive patch being removed after 24 hours. The test sites were evaluated prior to each application. Following the ninth evaluation, the subjects were dismissed for a 14-day rest period. After the rest period, identical patches were applied to sites previously unexposed to test material. These patches were removed 24 hours after application and were evaluated 48 hours and 72 hours after application. Each person was considered a complete case and used for evaluation of the material if they had six or more applications and subsequent readings during the first phase and at least one reading during the final phase.
Following the second application of the test material, a significant number of subjects developed superficial epidermal erosion. It was decided to change the occlusive patch condition to semiocclusive, applying the material to the same site beginning with the third application.




EXAMINATIONS
These patches were removed 24 hours after application and were evaluated 48 hours and 72 hours after application. Each person was considered a complete case and used for evaluation of the material if they had six or more applications and subsequent readings during the first phase and at least one reading during the final phase.

Results and discussion

Results of examinations:
Under the conditions employed in this study, there was no evidence of skin sensitisation to the test material. Following 24-hour semiocclusive application of 0.2 ml undiluted test material did not result in any sensitisation reaction in any of the 100 human subjects tested.

Applicant's summary and conclusion

Conclusions:
In a well conducted human patch test hexamethyldisiloxane was not sensitising to the skin of human volunteers. The study is well documented, meets generally accepted scientific principles and is acceptable for assessment.