9-Octadecenedioic acid

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:

supporting study

Study period:

9 - 11 June 2015

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented study report which meets basic scientific principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Type of study / information:

Epicutaneous patch test, single application for 48 h

Endpoint addressed:

skin irritation / corrosion

Principles of method if other than guideline:

A 30% dilution of the test substance was applied to the back skin of human volunteers for 48 h under occlusive conditions. The skin iritation effects were scored according to the Draize scoring system and the study was performed under Good Clinical Practices conditions.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

802-122-7

EC Number:

802-122-7

IUPAC Name:

802-122-7

Constituent 2

Reference substance name:

Octadec-9-enedioic acid

IUPAC Name:

Octadec-9-enedioic acid

Details on test material:

- Name of test material (as cited in study report): Newdioic 12358
- Physical state: white paste
- Analytical purity: no data
- Batch No.: B1

Method

Ethical approval:

confirmed and informed consent free of coercion received

Remarks:

personal informed consents of the subjects to participate in the study

Details on study design:

- Number of subjects exposed: 11
- Sex: 7 female, 4 male
- Age: 18 - 70 years (range); 41 years (mean)
- Type of application: occlusive
- Concentrations: 30% test substance in glycerin
- Exposure duration: 48 ± 4 h
-Other: monocentric randomised clinical study performed open and defined as a non interventional clinical research project according to the French law 2004-806 of 09/08/2004 relating to the policy of public health

Details on exposure:

TYPE OF TEST: patch test (epicutaneous test)

ADMINISTRATION
- Site: intact back skin
- Description of patch: the test substance was applied to the patch sites by using FinnChamber on Scanpor plasters with an application area of 50 mm². The test solution was applied in the aluminium capsule using a pipette. Plasters were attached to the cleaned, intact back skin of the volunteers.
- Vehicle / solvent: glycerin
- Volume applied: 20 µL
- Testing/scoring schedule: the skin was examined 15 - 30 min after patch removal.

EXAMINATIONS
- Grading/scoring system: equivalent to the Draize scoring system (erythema, edema, maximum grade 4); and dryness, papula, vesicles, bulla, scabs, pruritus, soap effect.

NEGATIVE CONTROL
Water served as the negative control, applied acording to the same protocol as the test substance.

Results and discussion

Results:

Single dermal exposure for 48 hours under occlusive conditions to the test substance at 30% concentration did not result in skin reactions in human volunteers.