Undecanolactone

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15 December 2016 - 20 December 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

Deviations:

yes

Remarks:

The test item was a waxy solid and therefore appropriate sized discs of the test item were prepared by pre moistening with 5 μl of sterile water. Therefore, the methodology for the application of solid test items was followed as closely as possible.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Undecanolactone

EC Number:

254-399-3

EC Name:

Undecanolactone

Cas Number:

39282-36-5

Molecular formula:

C11H20O2

IUPAC Name:

(5E,13E)-icosa-5,13-dienoic acid; 6-tetradecyloxan-2-one

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: RM1004952/1383Q12001
- Expiration date of the lot/batch: 29 April 2017

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature in the dark

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The substance was pressed flat and appropriately sized discs of a similar diameter to the tissues were cut out. The discs had an approximate weight of 60 mg.

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

The test item was pressed flat and appropriately sized discs of a similar diameter to the tissues were cut out. The discs had an approximate weight of 60 mg.

Duration of treatment / exposure:

15 minutes

Duration of post-treatment incubation (if applicable):

42 hours

Number of replicates:

Triplicate.

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Value:

107.5

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Other effects / acceptance of results:

Positive Control: The assay establishes the acceptance criterion for an acceptable test if the relative mean tissue viability for the positive control treated tissues is ≤40% relative to the negative control treated tissues, and the standard deviation (SD) value of the percentage viability is ≤18%.

Negative Control: The assay establishes the acceptance criterion for an acceptable test if the mean OD562 for the negative control treated tissues is ≥0.6 and ≤1.5, and the SD value of the percentage viability is ≤18%.

Substance: The assay establishes the acceptance criterion for an acceptable test if the standard deviation calculated from individual percentage tissue viabilities of the three identically treated tissues is ≤18%.

Any other information on results incl. tables

Item	Mean OD562 of triplicate tissues	± SD of OD562	Relative mean viability (%)	± SD of Relative mean viability (%)
Negative Control Item	0.683	0.026	100	3.8
Positive Control Item	0.066	0.013	9.7	2.0
Substance	0.734	0.045	107.5	6.6

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The substance was classified as non-irritant. The following classification criteria apply: EU CLP Not classified for Irritation.

Executive summary:

In an in vitro skin irritation study human skin tissue (eipdermis keratinocytes) was exposed to the undiluted substance for 15-minutes followed by a 42 -hour incubation period. There was 107.5% tissue viability following the 15-minute exposure point. Resultantly, the test material is considered to be a non-irritant to human skin.