Potassium hexadecyl hydrogen phosphate

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1988-06-29 until 1988-08-04

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

Males and females participants ranging in age from 25 to 65 years are empaneled for the test. The amount applied of test material to each test patch unit is approximately 0.2 mL applied in an occlusive manner. The induction phase includes 9 subsequent applications with a rest period of 24 hours (2 times in a week and 48 hours (1 time per week). Same application site is used for all 9 applications unless a positive reaction of a 2 – level erythema appears, than a new application site is used. When a 2 – level erythema appears in the new site, no further applications would be made. After a rest period of 10 to 21 days, the Challenge patch was applied to a previously unpatched (virgin) site. The site was scored 24 and 48 hours after application.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Potassium hexadecyl hydrogen phosphate

EC Number:

242-768-1

EC Name:

Potassium hexadecyl hydrogen phosphate

Cas Number:

19035-79-1

Molecular formula:

C16H35O4P.K

IUPAC Name:

potassium hexadecyl hydrogen phosphate

Test material form:

liquid

Method

Type of population:

general

Ethical approval:

confirmed, but no further information available

Controls:

Not applicable

Route of administration:

dermal

Results and discussion

Results of examinations:

SYMPTOMS
- Frequency, level, duration of symptoms observed: Minimal, faint, uniform or spotty erythema. By one participant during the induction phase only and by the other during the challenge phase.

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 2 / 53
- Number of subjects with negative reactions: 51 / 53

Any other information on results incl. tables

A total of 53 subjects satisfactorily completed the test procedure (one (1) subject discontinued for personal reasons unrelated to the conduct of the study). Scattered, transient, barely perceptible (+) non-specific patch test responses were observed on 2/53 test panelists during the induction or challenge phases of the study. One of these 2 subjects was unable to report to the clinic at 72-hrs., but verbally stated that the (+) reaction had disappeared at 72-hrs. Based on this report, neither of these non-specific responses were considered to be irritant or allergic in nature.

Applicant's summary and conclusion

Conclusions:

Under the conditions of a repeated insult (occlusive) patch test procedure. The test substance (6 %) did not induce irritant or allergic contact dermatitis in human subjects.

Executive summary:

A total of 54 subjects, 14 males and 40 females, ranging in age from 25 to 65 years were empaneled for irritation / sensitisation test. The subjects were informed of the nature of the test, including possible adverse reactions. Written informed consent was obtained.

9 Repeated Insult (occlusive) Patch Test (9 RIPT) of the test substance (6 %) was conducted as follows:

Induction Phase

The Induction Phase was initiated on: June 29, 1988.

The amount of test material applied to each test patch unit was approximately 0.2 mL.

The test material was placed onto a Parke-Davis Readi-Bandage(R) occlusive patch, which was applied to the back of each subject between the scapulae and waist, adjacent to the spinal mid-line.

The subjects removed the patch 24 hours after application. Twenty-four hour rest periods followed the Tuesday and Thursday removals and 48-hour rest periods followed the Saturday removal. The site was scored by a trained examiner just prior to the next patch application. This procedure was repeated every Monday, Wednesday and Friday until nine (9) applications of the test material had been made.

Procedurally, if a subject develops a positive reaction of a 2-level erythema or greater during the Induction phase or, at the discretion of the Study Director, if the skin response warranted a change in site, the patch would be applied to a previously unpatched, adjacent site for the next application. If a 2-level reaction (or greater) occurred on the new site, no further applications would be made. However, any reactive subjects would be subsequently challenge patched with the test material.

Challenge Phase

After a rest period of 10 to 21 days (no further application of the test material), the Challenge patch was applied to a previously unpatched (virgin) site. The site was scored 24 and 48 hours after application. The panelists were asked to report to the laboratory any delayed reaction which might have occurred after the last reading.

A total of 53 subjects satisfactorily completed the test procedure. One subject discontinued for personal reasons unrelated to the conduct of the study. Discontinued panelist data are shown up to the point of discontinuation, but are not used in the Results, Discussion or Conclusions sections of this final report.

Scattered, transient, barely perceptible (assigned as +, see in "any other information on materials and methods) non-specific patch test responses were observed on 2/53 test panelists during the Induction or Challenge phases of the study. One of the two panelists was unable to report to the clinic at 72-hrs., but verbally stated that the (+) reaction had disappeared at 72-hrs.

Based on this report, neither of these non-specific responses were considered to be irritant or allergic in nature.