Registration Dossier

Administrative data

Description of key information

Skin irritation / corrosion: Two reliable studies were available for this endpoint (one Klimisch 1 and one Klimisch 2). The study of Mallory (1985) was considered to be the key study. Based on this study, propylene carbonate should not be classified as irritating to the skin.
Eye irritation: Four reliable studies were available (four Klimisch 1 studies). Johnson (2001) was chosen as the key study. Based on this study, propylene carbonate is classified as irritating to eyes (category 2).

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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation / corrosion:

Mallory (1985) studied skin corrosion and skin irritation by applying propylene carbonate on the trunk of 6 New Zealand White rabbits in occlusive conditions (shaved and abraded skin), according to OECD guideline 404. Exposure lasted for 24 hours and observations were performed at 24 and 72 hours. Lesions were scored according to the Draize system and a primary dermal irritation index of 0.2 was calculated. After 72 hours all animals appeared normal.

No in vitro skin corrosion/irritation study is performed as reliable in vivo data was already available.

Eye irritation:

Johnson (2001) investigated the eye irritation effects of 0.1 mL ULTRAPURE propylene carbonate in 3 male New Zealand White rabbits (1 to 2 seconds of exposure). The study was performed according to OECD guideline 405, EU Method B.5 and EPA OPPTS 870.2400.

According to the criteria laid down in the CLP Regulation (EC) 1272/2008, propylene carbonate is classified as an eye irritant substance category 2 (irritating to eyes) as the mean redness score is 2 at 24, 48 and 72 hours in 2 of the 3 animals tested and the effects are fully reversible within 10 days. This study was designated as key study as the most pure grade was tested: 100% propylene carbonate. Other studies on eye irritation were performed with reagent grade of propylene carbonate.

No in vitro eye corrosion/irritation study is performed as reliable in vivo data was already available. Moreover, the study does not need to be conducted as the available information indicates that the criteria are met for clasification as irritating to eyes.

Justification for classification or non-classification

According to the criteria laid down in the CLP (EC) Regulation 1272/2008, propylene carbonate should not be classified as irritating to the skin.

Based on the available data and according to the criteria laid down in the CLP Regulation (EC) 1272/2008, propylene carbonate is classified as an eye irritant substance category 2 (irritating to eyes).