Registration Dossier

Administrative data

Description of key information

Skin sensitisation: No reliable studies were available for this endpoint (only 7 K4 studies). Based on these K4 studies and FDA studies performed in humans, it can be predicted that at least 93% of the general population will not be sensitized by propylene carbonate. Therefore, it is not needed to perform further testing. .

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

No further testing on propylene carbonate should be performed as sensitisation data are available of 50 human volunteers. The Food and Drug Research Laboratories incorporated (1972) reported that under completely occluded conditions, 5 and 10 Wt. % of propylene carbonate in water, were not capable of eliciting visible skin changes consistent with the criteria deemed characteristic of a primary irritant, fatiguing agent, or sensitizer in any of the 50 subjects (see IUCLID section 7.10.4 'Sensitisation data (humans)).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

According to the available data and the criteria of the CLP Regulation, propylene carbonate should not be classified for skin sensitisation.