Registration Dossier

Administrative data

Description of key information

Skin irritation : Guideline study (OECD 404). No GLP.
Eye irritation : Guideline study (OECD 405) and GLP.
Respiratory irritation : No available data. There was no need yet to carry out a study on respiratory irritation.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin irritation :

During the in vivo skin irritation study, UNDECYLENIC ACID were applied on rabbits patch test. Skin irritating effects were observed, which lead to a classification as "slightly irritating" with mean erythema score equal to 2.35 and mean oedema score equal to 0.48. All erythema were not fully reversible, but oedema yes.

Eye irritation :

The 1999 study on eye irritation with a dose application of 0.1 ml (100mg) revealed that the test substance UNDECYLENIC ACID is irritant when administered by ocular route to rabbits. Acide Undecylenique (0.1g) was placed in the conjunctival sac of the left eye of three male New Zealand White rabbits. Animals were observed for 15 days. Eye irritation was scored and mean values are : chemosis (2.6/4), redness of conjunctival (2/3), iris lesions (0.7/2) and corneal opacity (1.2/4). All oculars reaction were fully reversible in 14 days.


Effects on skin irritation/corrosion: irritating

Effects on eye irritation: irritating

Justification for classification or non-classification

According to EU regulation (EC) No 1272/2008 (CLP) :

Skin irritation:

EU regulation (EC) No 1272/2008 (CLP), acid undecylenic is classified in category 2 on skin irritation.

Justifications : mean erythema score was 2.35 (>2).

Eye irritation:

EU regulation (EC) No 1272/2008 (CLP), acid undecylenic is classified in category 2 on eye irritation.

Justifications : Cornea opacity = 1.2 (>1), conjunctivae score (redness) = 2 (= ou > 2), chemosis = 2.6 (>2). All effects were fully reversible in 15 days.

According to EU Directive 67/584/EEC :

Skin irritation:

In the old EU 67/548/ECC classification system, the classification would be R38, Xi, harmful.

Justification : mean erythema score was 2.35 (>2.3).

Eye irritation:

In the old EU 67/548/ECC classification system, the classification would be R36, Xi, harmful.

Justification : Chemosis score = 2.6 (>2). All effects were fully reversible in 15 days.