Propane-1,2-diol

Exposure related observations in humans: other data

Administrative data

Endpoint:

exposure-related observations in humans: other data

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

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other: Non-GLP study with human volunteers, available as unpublished report, minor restrictions in design and/or reporting, but otherwise adequate for assessment.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

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

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 monopropylene 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:

no

Test material

Test material information

Constituent 1

Reference substance name:

Propane-1,2-diol

EC Number:

200-338-0

EC Name:

Propane-1,2-diol

Cas Number:

57-55-6

Molecular formula:

C3H8O2

IUPAC Name:

propane-1,2-diol

Details on test material:

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

Method

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

Results:

Under the conditions of the study, monopropylene glycol exhibited mild irritation compared to that of the positive control. Thirteen subjects exhibited mild to moderate erythema at the 30 min evaluation. Three of these subjects responses were resolved by the 24-hour evaluation. The ten remaining subjects exhibited mild erythema and four subjects exhibited mild erythema and peeling at the 24-hour evaluation.