Registration Dossier

Administrative data

Description of key information

No corrosion or irritation data are available; studies of corrosivity and irritation in vitro and in vivo cannot be performed with the submission substance.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no study available

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The submission substance is a clear yellow insoluble resin.  A sample of the substance was liquefied by heating to 80°C for three hours; however the sample immediately solidified on cooling.  Due to the physical characteristics of the substance, it cannot be applied to the skin membranes or corneas used in the in vitro studies and simiallry cannot be applied to the rabbit skin or eye.  The studies of irritation and corrosion are therefore waived on grounds of technical feasibility.

Additional information on the skin irritation potential of the substance are available from the LLNA in groups of five mice treated by topical application to the ears on three consecutive days (Days 1 -3). In an irritation pre-screen, very slight irritation of the ears was shown by mice treated with the substance (50% in acetone/olive oil) on Days 3 and 4. In the main study, very slight or well defined erythema of the ears was observed in several mice treated with 25% and in all mice treated with 50% on Days 2 -5. Alopecia between the ears and neck was also noted for all mice treated with 50% on Days 4 -6. No signifciant variations in ear thickness were observed during the observation period. The results of this study therefore indicate that the substance has some skin irritation potential, but that this is not significant and is not sufficient to result in classification taking into account the nature of the application pattern.

Justification for classification or non-classification

No data are available; the substance [Epoxypropyl neodecanoate, oligmeric reaction products with cyclohexane-1,2-dicarboxylic anhydride and propylidenetrimethanol] cannot be tested for corrosion or irritation due to its physical properties. Additional data from the mouse LLNA show some skin irritation potential, but not sufficient to result in classification. The substance is not classified for corrosion or irritation according to CLP.