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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Human volunteer study, available as unpublished report, minor restrictions, but adequate for assessment.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
Principles of method if other than guideline:
Approximately 0.2 ml of the test material was applied as a occluded patch to the upper back of 113 volunteers (as a neat substance for subjects 1-47 only, and as a 50% aqueous solution for the rest of the panel). Patches were applied three times per week (Monday, Wednesday, Friday) for a total of nine applications and were removed 24 hours after application. Approximately 2 weeks after the final induction patch application, a challenge patch was applied to a virgin test site adjacent to the original induction patch site, following the same procedure described for induction. The patch was removed and the site scored 24- and 72-hr post-application.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Propylene glycol (796047C)

Method

Type of population:
general
Ethical approval:
confirmed and informed consent free of coercion received
Subjects:
- Number of subjects exposed: 114
- Sex: male and female
- Age: ranging from 19 to 79 years
:
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)


ADMINISTRATION
- Type of application: occlusive
- Description of patch:1'' x 1'' absorbent pad portion of a clear adhesive dressing
- Vehicle / solvent: distilled water
- Concentrations: 100% and 50%
- Volume applied: ca. 0.2 ml
- Testing/scoring schedule: patches were applied 3 times per week (Monday, Wednesday, Friday) for a total of 9 applications. Following supervise removal and scoring of the first Induction patch, participants were instructed to remove all subsequent Induction patches at home 24 hours after application. The evaluation of this site was made again just prior to re-application. If a participant was unable to report for an assigned test day, 1 makeup day was permitted. This day was added to the Induction period.
Approximately 2 weeks after the final Induction patch application, a Challenge patch was applied to a virgin test site adjacent to the original Induction patch site, following the same procedure described for Induction. The patch was removed and the site scored at the clinic 24 hours and 72 hours post-application.

Results and discussion

Results of examinations:
One hundred and four subjects completed the study. With the exception of one subject, observations remained within normal limits throughout the test interval. One subject was observed to be hypersensitive in an irritant manner, throughout the induction and challenge phases of the study.

Applicant's summary and conclusion