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Exposure related observations in humans: other data

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exposure-related observations in humans: other data
Type of information:
experimental study
Adequacy of study:
key study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP study with human volunteers, available as unpublished report, minor restrictions in design and/or reporting, but otherwise adequate for assessment.

Data source

Reference Type:
study report
Report Date:

Materials and methods

Type of study / information:
24-h semi-occluded patch study in human volunteers
Endpoint addressed:
skin irritation / corrosion
Principles of method if other than guideline:
A one application, 24-h semi-occluded patch study was conducted to compare the skin irritancy potential of several test articles, including tripropylene glycol. Negative controls of distilled water and mineral oil USP and a positive control of 0.5% sodium lauryl sulfate were also tested. The study was conducted on 33 human volunteers (30 females and 3 males).
GLP compliance:

Test material

Details on test material:
- Name of test material (as cited in study report): tripropylene glycol
- Analytical purity: not specified
- Storage: room temperature


Ethical approval:
confirmed and informed consent free of coercion received
Details on study design:
30 female and 3 male subjects entered and completed the study. The test substance was prepared as a 25% solution in distilled water. 0.2 ml of the solution was placed on the patch pad and applied on the paraspinal region of the back. Eight test articles, in addition to a positive irritant (0.5% sodium lauryl sulfate) and two negative irritant controls (distilled water and mineral oil USP), were tested simultaneously in this study. All skin sites were scored prior to the application, 30 min after the removal of the 24 h application and again 24 h following patch removal.

Results and discussion

Under the conditions of the study, two subjects exhibited mild erythema at the 30 min evaluation; these responses were resolved by the 24-hr evaluation. The irritation was at a level equal to that of the negative control (distilled water). No further signs of irritation were noted in any of the subjects.

Applicant's summary and conclusion