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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:
key study
Study period:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented , meets generally accepted scientific principles. However the page concerning the discussion of the results is missing from the report file.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

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:
The study was a human repeat insult patch test according to a method based that of Shelanski and Shelanski ( See free text 'Details on study design').
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid - liquid: aqueous solution

Method

Type of population:
general
Ethical approval:
other: All subjects were required to complete a questionnaire before the start of the study and to sign a standard consent form.
Subjects:
- Number of subjects exposed: 84
- Sex: 77 women, 7 men
- Age: from 18 to 61 and more
- Race: no data
- Demographic information: no data
- Other: See Table 1 for a breakdown of the sexes and ages of the volunteer panel.


Clinical history:
- Subjects with skin conditions such as eczema, psoriasis or a dermatitis on the upper arm at the time of test were excluded from the test.
Controls:
None reported.
Route of administration:
dermal
Details on study design:
The main study was run in 2 stages, with 21 subjects starting the test ahead of the main group in case alterations in concentrations of test materials were necessary.
The test material at 2% (v/v) in distilled water w as applied in 0.5 ml aliquots to a 0.75" square Webril pad located down the centre line of a piece of Blenderm tape. Three other materials were also tested on the same panellists resulting in a 4 product scheme. The results from these materials were reported separately.
The patch was applied down the dorsal surface of the upper arm of each subject and held in place (when necessary) by additional strips of Blenderm or Dermicel adhesive tape. Subjects were instructed to keep the patches dry and to remove and discard them after 24 hours.

The test materials were applied in 4 different orders (reading from the top of the arm, 1234, 2341, 3412, 4123) at random among the panel to eliminate position and order bias. The patch order was maintained throughout the trial by use of a colour coded card bearing the subject's name and panel number, and containing details of the initial location of the patch and of relocation or termination of the testing of any materials.

Patches were applied on Monday, Wednesday and Friday of the first 3 weeks, called the "induction" or "insult" period. Patches were re-applied to the same site unless reaction to a substance or adhesive necessitated relocation, in which case an adjacent location was chosen. Subjects who were absent once during the insult period received a make-up patch (MU) on the fourth Monday. The test sites were scored before application of each subsequent patch and on the fourth Monday after the final insult patch.

Fourteen days after the final insult patch (i.e. the Monday of the sixth week of the test), challenge patches were applied to both arms of each subject.

Results and discussion

Results of examinations:
The test material caused some degree of irritation in most volunteers and it was therefore concluded that test conditions were conducive to the induction of a sensitised state should such be likely to occur in the panellists. The concentration of the material was maintained throughout the preliminary and main panels. The test material produced no reaction at challenge which was indicative of skin sensitisation.
The test material produced no reaction at challenge which was indicative of skin sensitisation.

Any other information on results incl. tables

A total of 73 volunteers completed the full test.The conclusion of the test was based these volunteers.

Applicant's summary and conclusion

Conclusions:
In the 73 volunteers that completed the full test, the test material produced no reaction at challenge which was indicative of skin sensitisation.
Executive summary:

A human repeat insult patch test was performed with a 75% aqueous dilution of the test substance according to the method based on that of Shelanski and Shelanski. A total of 84 volunteers took part in the test. The panel included 77 women and 7 men ageing from 18 to 61 years and more. 73 panellists completed the full test.

A patch loaded with 0.5 ml of 2% v/v test material in distilled water was applied down the dorsal surface of the upper arm of each subject. Subjects were instructed to keep the patches dry and to remove and discard them after 24 hours. Patches were applied on Monday, Wednesday and Friday of the first 3 weeks, called the "induction" or "insult" period. Patches were re-applied to the same site unless reaction to a substance or adhesive necessitated relocation, in which case an adjacent location was chosen.

The test sites were scored before application of each subsequent patch and on the fourth Monday after the final insult patch.14 days after the final insult patch, challenge patches were applied to both arms of each subject. Scoring were done 48 and 96 hours after patch removal.

The test material caused some degree of irritation in most volunteers and therefore it was concluded that test conditions were conducive to the induction of a sensitised state should such be likely to occur in the panellists. The concentration of the material was maintained throughout the study. The test material produced no reaction at challenge which was indicative of skin sensitisation. Therefore, it was concluded that the substance was not sensitising in humans.