1-Heptanol, 2-propyl-, 1,1'-carbonate

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

2007-01-03 to 2007-02-09

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Read across (justification for read across see IUCLID chapter 13) No GLP study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

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:

Repeated Insult Patch Test (Protocol No. 1.01)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

868839-23-0

EC Number:

617-930-3

Cas Number:

868839-23-0

IUPAC Name:

868839-23-0

Constituent 2

Reference substance name:

Propylheptyl Caprylate

IUPAC Name:

Propylheptyl Caprylate

Test material form:

other: liquid

Method

Subjects:

- 115 participants (110 subjects completed the study)
- Age at study initiation: ranging in age from 16 to 78 years
- sex: female/male

Controls:

no

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: Repeated Insult Patch Test (Protocol No. 1.01)

ADMINISTRATION
- Type of application: occlusive
- Vehicle / solvent: unchanged (no vehicle)
- Concentrations: 0.2 mL of the test material

Methodology: The upper back between the scapulae served as the treatment area. Approximately 0.2 mL of the test material, or an amount sufficient to coverthe contact surface, was applied to the 3/4" x 3/4" absorbent bad portion of an adhesive dressing. This was then applied to the appropriate treatment site to form an occlussive patch.

- Induction phase:
Patches were applied three per week for a total of nine applications. The site was marked to ensure the continuity of patch application. Following supervised removal and scoring of the first Induction patch, participants were instructed to remove all subsequent Induction patches at home, twenty-four 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, one makeup day was permitted. This day was added to the Induction period.

-Challenge Phase:
Approximately two 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 twenty-four and seventy-two hours post-application. Should an invidual have exhibited a response during this test phase, a Rechallenge Patch Test would have been scheduled to confirm the previously recorded reaction.

Results and discussion

Results of examinations:

With one exception, observations remained within normal limits throughout the test interval. It was noted that one subject exhibited a moderate to mild response with dryness and edema twenty-four, seventy-two and ninety-six hours post-challenge application. This reactive subject was requested to return for follow-up (Rechallenge) investigation to better define the nature and respoducility of the response.
Rechallenge results:
Observations for all treated areas remained negative throughout this test interval.