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Toxicological information

Exposure related observations in humans: other data

Administrative data

exposure-related observations in humans: other data
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11 - 15 Oct 1999
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test procedure comparable to national standards

Data source

Reference Type:
study report
Report date:

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:
GCP Compliance

Test material

Constituent 1
Chemical structure
Reference substance name:
Isononanoic acid, C16-18 (even numbered)-alkyl esters
EC Number:
Cas Number:
Molecular formula:
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


Ethical approval:
confirmed and informed consent free of coercion received
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)

- 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

- 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)

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

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

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

Applicant's summary and conclusion

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