Registration Dossier

Administrative data

Description of key information

e-Caprolactone was not irritating to the skin of rabbits, but was found to be an eye irritant and should be classified as such under CLP.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin irritation

The primary irritation of e-Caprolactone to rabbit skin was investigated in a GLP study according to OECD method 404 (Janssen, 1991). 0.5 g e-Caprolactone was applied directly to an area of shaved skin on the backs of the rabbits (2x3cm), and held in place for 4 hours using occlusive tape. After removal of the tape the skin was wiped to remove any remaining residue, and observations were made at 0.5, 24, 48 and 72 hours after removal. No erythema or oedema was observed in the rabbits at any time point. Classification as a skin irritant is not required on the basis of this study.

Eye irritation

The primary irritation of e-Caprolactone to the eye of male rabbits was determined in a GLP study according to OECD method 405 (Janssen, 1991). 0.1ml substance was introduced to the conjunctival sac of the left eye of three rabbits (the right eye remained untreated to serve as a control). The eyes of the rabbits were examined and the ocular reactions graded at intervals up to and including 7 days after treatment. Various signs of irritation were observed (corneal opacity, iris lesion, conjunctival erythema, chemosis and discharge), lthough all symptoms were reversible by Day 7. The substance requires classification as an eye irritant according to CLP.


Effects on eye irritation: irritating

Justification for classification or non-classification

No evidence of skin irritation was seen in a guideline study in the rabbit. Evidence of eye irritation sufficient to trigger classification was seen in a guideline study in the rabbit.

The available data indicate that the substance requires classification as an eye irritant according to Regulation (EC) No 1272/2008 (the CLP Regulation) and according to Directive 67/548/EEC. It is classified as an eye irritant and assigned the symbol Xi and the risk-phrase R36 "Irritating to eyes". It is an eye irritant category 2 and is assigned the pictogram GHS07 with the signal word "warning" and the hazard statement H319 "causes serious eye irritation".