Registration Dossier

Administrative data

Description of key information

ε-Caprolactone, oligomeric reaction products with 2,2' oxydiethanol has been tested for skin irritation and eye irritation in rabbits in studies conducted to OECD Test Guidelines 404 and 405 respectively. The substance was not found to be irritating to the skin or the eyes and no classification in respect of these endpoints is required.

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:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

The dermal irritation potential of ε-Caprolactone, oligomeric reaction products with 2,2' oxydiethanol (CAPA 304) was investigated in a study performed according to OECD guideline 404. 0.5 g test material was applied on the clipped skin of 3 New Zealand White male rabbits for 4 hours. Animals were observed at 30-60 minutes and at 24, 48 and 72 hours after patch removal for oedema and erythema. The mean scores calculated for each individual animal tested for erythema and oedema at 24, 48 and 72 hours was 0. No dermal irritation was observed.

Eye irritation

The eye irritation potential of ϵ-caprolactone, oligomeric reaction products with 2,2’-oxydiethanol (CAPA 304) was investigated in a study performed according to OECD guideline 405. 0.1 mL test material was instilled into the left eye of three New Zealand White rabbits. Animals were observed at 1, 24, 48 and 72 hours after dosing under a standard light source. The reactions in the conjunctiva (redness, chemosis and discharge), the iris and the cornea (opacity and area involved) were scored according to the Draize scale. No corneal or iridial effects were noted during the study. Very slight irritation of the conjunctiva and lacrimation was observed in 3 rabbits 1 hour after instillation. This effect disappeared after 24 hours. The calculated mean score for redness, discharge, chemosis, iris and corneal lesions for all animals at 24, 48 and 72h after treatments was 0.

Justification for classification or non-classification

The substance was found to be non-irritating to the skin in a study conducted according to OECD 404 and was non-irritating to the eyes in a study conducted according to OECD 405. Classification for skin or eye irritation is not required according to the criteria of the Annex VI of the Regulation (EC) No 1272/2008 (CLP).