p-mentha-1,4(8)-diene

Endpoint summary

Description of key information

In an in vitro irritation study on human reconstructed epidermis model, performed according to the OECD Guideline No 439 and GLP, mean relative cell viability for terpinolene monoconstituent was 84.2 ± 2.2 %. 
In an in vivo eye irritation study performed in rabbits according to OECD Guideline No 405, the mean scores obtained with terpinolene monoconstituent at 24, 48 and 72 h were 0.0 for cornea, 0.1 for iris, 0.7 for conjunctivae and 0.8 for chemosis. 

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

In an in vitro skin irritation study performed according to the OECD 439 Guideline and GLP, 10 µL of terpinolene monoconstituent were applied topically to reconstructed human epidermis model (3 epidermis units/dose) for 15 min at room temperature. Cell viability was assessed with MTT. Mean relative cell viability for terpinolene monoconstituent was 84.2 ± 2.2 %. The result was therefore negative and the substance is not irritating to skin.

In an eye irritation study conducted according to OECD 405 Guideline and GLP, 4 female New Zealand White rabbits were exposed to 0.1 mL of undiluted terpinolene monoconstituent in one eye. The calculated mean scores for each individual lesions for all animals at three scoring times (24, 48 and 72 h) were as follows: 0.0 for cornea score; 0.1 for iris score; 0.7 for conjunctivae score and 0.8 for chemosis score. All the signs were resolved within 7 days after treatment. The substance is therefore not irritating to eyes.

There is no requirement to conduct additional skin and eye irritation tests with terpinolene monoconstituent, as negative results were obtained in appropriate systems.

Justification for selection of skin irritation / corrosion endpoint:
Only one study available for this endpoint.

Justification for selection of eye irritation endpoint:
Only one study available for this endpoint.

Justification for classification or non-classification

In an in vitro skin irritation study performed on reconstructed human epidermis according to OECD 439 Guideline, cell viability was > 50 %. Therefore terpinolene monoconstituent is not classified for skin irritation according to Directive 67/548/EEC and CLP Regulation (EC) No 1272/2008.

In an in vivo eye irritation study performed according to OECD 405 Guideline, reversible slight irritating effects were observed on rabbit eyes with irritation scores not high enough to lead to classification. Therefore, terpinolene monoconsituent is not classified for eye irritation according to Directive 67/548/EEC and CLP Regulation (EC) No 1272/2008.