Propane-1,3-diol

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Type of sensitisation studied:

skin

Study type:

other: Repeat Insult Patch Test

Test guideline

Qualifier:

according to guideline

Guideline:

other: "Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics" by J.H. Draize and published by the Association of Food and Drug Officials of the United States

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Propane-1,3-diol

EC Number:

207-997-3

EC Name:

Propane-1,3-diol

Cas Number:

504-63-2

Molecular formula:

C3H8O2

IUPAC Name:

propane-1,3-diol

Details on test material:

- Purity: 99.992%

Method

Type of population:

general

Subjects:

- Number of subjects exposed: 112 volunteers
- Sex: Not reported
- Age: Ranged from 16 - 71 years of age
- Race: Not reported
- Demographic information: Not reported
- Other: All panellists were in good general health and free of any visible skin disease or anomaly in the area to be patched. Each panellist was required to read, understand, and sign an informed consent statement.

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive / semiocclusive /other:
- Description of patch: the test article was applied to a one-inch Lintine disk and placed onto a strip of 2 inch Dermicel hypoallergenic cloth tape. Each portion of the test material was secured in place with a gloved finger to insure proper application. This tape strip was then pressed into place on the upper left arm of each panelist at its designated test site.
- Vehicle / solvent: Test material was tested as supplied.
- Concentrations: 5%, 25%, or 50%
- Testing/scoring schedule and Removal of test substance: The patches were applied to their designated contact sites and remained in place for 24 hours. At the end of this period, the patches were removed and the sites were examined for any dermal response. The panelists were then rested for a 24-hour period after which the skin sites were again examined. New patches were then applied to the same sites as previously used. The second applications were identical to the first and remained in place for 24 hours. This procedure was repeated on Mondays, Wednesdays, and Fridays until a series of 9 applications had been made.

Challenge Phase: After the 9th application, a rest period of approximately 2 weeks elapsed after which a challenge application was applied in the same manner and to the same sites described above. A duplicate challenge application was also applied in the same manner to a virgin site on the other arm. The challenge applications were removed after 24 hours and the sites were examined and graded for signs of irritation or sensitization. A follow-up examination was conducted at 48 hours after the challenge applications.

Results and discussion

Results of examinations:

The test material did not appear to be a primary skin irritant. The test material did not appear to be a fatiguing agent. The test material did not appear to be a sensitizing agent under the study conditions utilized.

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0

Applicant's summary and conclusion

Conclusions:

The test material did not appear to be a primary skin irritant. The test material did not appear to be a fatiguing agent. The test material did not appear to be a sensitizing agent under the study conditions utilized.

Executive summary:

1,3-Propanediol was tested to determine the potential of the test substance, diluted to 5%, 25%, and 50% to cause irritation or delayed contact hypersensitivity in humans. During the induction and challenge phases of the study, the test substance did not produce any adverse skin responses in any of the study participants.

The test material did not appear to be a primary skin irritant. The test material did not appear to be a fatiguing agent. The test material did not appear to be a sensitizing agent under the study conditions utilized.