Registration Dossier

Diss Factsheets

Toxicological information

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
Study period:
11 - 15 Oct 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test procedure comparable to national standards

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Type of study / information:
Epicutaneous Patch Test - Single Application 24 h Patch Test according to COLIPA.
Endpoint addressed:
skin irritation / corrosion
Principles of method if other than guideline:
The trial was based on the method described by Frosch and Kligman (Frosch et al., 1979) and conducted according to the protocol "Single Application 24 h Patch Test" of the sponsor.
GLP compliance:
yes
Remarks:
GCP Compliance

Test material

Constituent 1
Chemical structure
Reference substance name:
Isononanoic acid, C16-18 (even numbered)-alkyl esters
EC Number:
601-141-6
Cas Number:
111937-03-2
Molecular formula:
Unspecified
IUPAC Name:
Isononanoic acid, C16-18 (even numbered)-alkyl esters
Details on test material:
- Name of test material (as cited in study report): isononanoic acid, C16-18-alkyl ester
- Physical state: colourless liquid
- Analytical purity: no data
- Storage condition of test material: at room temperature
- Expiration date of the lot/batch: 04 Oct 2000

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: 20
- Sex: 9 female, 11 male
- Age: 21.7-70.7 years (range); 44.5 ± 13.1 years (mean ± SD)
- Type of application: occlusive
- Concentrations: 20% and undiluted test substance
- Exposure duration: 24 h
Exposure assessment:
not specified
Details on exposure:
TYPE OF TEST: patch test (epicutaneous test)

ADMINISTRATION
- Site: intact back skin, on the left and right side of the spine
- Description of patch: 1.1 cm²
- Vehicle / solvent: ethanol
- Volume applied: 75 µL
- Testing/scoring schedule: the skin was examined 6, 24, 48 and 72 hours after patch removal
- Removal of test substance: after 24 hours exposure any test substance residues were carefully removed with a tissue paper
- Other: at least 5 days before start of the study any kind of UV-exposure and treatment with leave-on products on the patch sites had been avoided

EXAMINATIONS
- Grading/scoring system: equivalent to the Draize scoring system (erythema, edema, maximum grade 4); squamation and fissuration were also graded
- Other: lightening of the test room was standardised by illumination with 2 day-light neon tubes (Osram L58W/12) installed vertically on a wall at a distance of approximately 70 cm between the tubes
Skin gradings were performed double-blind; the visual scoring was performed without knowledge of the code of the material (other test substances were tested in parallel)

CONTROLS:
1. Vehicle only: ethanol
2. Texapon N28 (1% AS)
3. SDS 0.5%

OTHER:
The product was applied to the patch sites by using FinnChamber on Scanpor plasters with an application are of 1.1 cm². The protective film was removed from the plaster and 75 µL (or the equivalent) of the test solution was applied in the aluminium capsule using a pipette. A filter paper disk was used as a carrier. Plasters were attached to the clean, dry and intact back skin of the volunteers.

Results and discussion

Results:
Following dermal application of 20% and undiluted test substance preparations, no skin irritations were observed (see attached tables).

Applicant's summary and conclusion

Conclusions:
Single dermal exposure for 24 hours under occlusive conditions to the test substance at 20% concentration or as 100% undiluted product did not result in skin reactions. According to EU classification criteria, no classification for skin irritation is required.
CLP: not classified
DSD: not classified