Reaction mass of trimethyl(octadecyloxy)silane and octadecanol

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

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:

1999

Report date:

1999

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Remarks:

patch test

Principles of method if other than guideline:

An informed condent document in compliance with FDA regulations (21 CFR 50) was obtained from each subject prior to entering the study.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of octadecan-1-ol and trimethyl(octadecyloxy)silane

Molecular formula:

CH3(CH2)17OSi(CH3)3

IUPAC Name:

Reaction mass of octadecan-1-ol and trimethyl(octadecyloxy)silane

Test material form:

other: liquid or wax

Method

Type of population:

not specified

Ethical approval:

not applicable

Subjects:

male and female human at age 18+

Route of administration:

dermal

Details on study design:

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

ADMINISTRATION
- Type of application: semiocclusive
- Concentration at induction: Dow Corning Silmogen Carrier - 0.2 mol; Dow Corning Dimethiconol Blend 20 - 0.2 ml; Dow Corning Silky Wax 10 - 0.2 g; Dow Corning Emulsifier 10 - 0.2 ml; Dow Corning Silicone Fluid Q7-9180, 1 cSt. (Supplied as Dow Corning 200 Fluidd, 1 cSt) - 0.2 ml; Dow Corning Silicone Fluid Q7-9180, 1.5 cSt. (Supplied as Dow Corning 200 Fluidd, 1.5 cSt)
- Concentration at challenge: Dow Corning Silmogen Carrier - 0.2 mol; Dow Corning Dimethiconol Blend 20 - 0.2 ml; Dow Corning Silky Wax 10 - 0.2 g; Dow Corning Emulsifier 10 - 0.2 ml; Dow Corning Silicone Fluid Q7-9180, 1 cSt. (Supplied as Dow Corning 200 Fluidd, 1 cSt) - 0.2 ml; Dow Corning Silicone Fluid Q7-9180, 1.5 cSt. (Supplied as Dow Corning 200 Fluidd, 1.5 cSt)
- Description of patch:
A. INDUCTION EXPOSURE
- No. of exposures: 9
- Exposure period: 24 hours
- Test sites: Prior to application of the patches, the sites were outlined with a skin marker e.g. genitan violet. The subjects were requid to remove the patches approximately 24 hours after application, The returned to the facility at 48-hour intervals to have the sites evaluated and identical patches were appl ied to the same sites.
- Control site: When the positive control site had a grade of +D, application of the SLS control was discontinued
- Site: infrascapular area of the back
- Frequency of applications: 48 hour intervals (Patches applied on Friday were removed by subjects after 24 hours and sites were evaluated 72 hours after application on the following Monday) - Duration: 3 weeks - Concentrations:
12-14 day REST PERIOD
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Week 6
- Exposure period: 24 hours
- Test sites: Identical patches were applied to sites previously unexposed to the study material. Patches were removed by subjects after 24 hours and the sites graded after additional 24 and 48 hour periods. - Control group:
- Site: infrascapular area of the back- Concentrations:
- Evaluation (hr after challenge): 48 and 72 hours
OTHER: Rechallenge was not required.

Results and discussion

Results of examinations:

5 subjects exhibited minimal or doubtful erythema with a papular response > 50% to Dow Corning Silky Wax 10 during induction.

Applicant's summary and conclusion

Conclusions:

In a well conducted human patch test conducted according to GLP trimethyl(octadecyloxy)silane was not sensitising to the skin of human volunteers.