Registration Dossier

Diss Factsheets

Administrative data

Description of key information

PC2414 did not have eye and skin irritation potential nor any skin corrosion potential using the EPISKIN and HCE in vitro screening models. 

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)

Additional information

Initially, a DEREK prediction of PC2414 did not indicate any toxicological effects including eye and skin irritation/corrosion (see attached document below), indicating the need for a tiered testing strategy.

The skin corrosion and skin irritation potential of PC2424 was determined using the in vitro EPISKIN reconstituted human epidermis model (SkinEthic Laboratories, Nice, France). PC2414 was shown to be non-corrosive and non-irritating to skin.

The eye irritation potential of PC2424 was determined using the in vitro SkinEthic Reconstituted Human Corneal model (HCE, SkinEthic Laboratories, Nice, France). This type of study, although not yet formally validated or adopted by regulatory authorities was part of a tiered testing strategy for determining eye irritation at the lower end of irritancy. PC2414 was shown not to be non-irritating to eye.


Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

PC2414 was found to be non-corrosive and non-irritating to skin and eye using the EPISKIN and HCE in vitro screening models. Based on these result, PC2414 is not hazardous and is not classified according to GHS and DSD-DPD and in accordance to the criteria in Council Directive 67/548/EEC and Regulation (EC) 1272/2008.