Registration Dossier

Administrative data

Description of key information

In GLP in vitro studies using Episkin model, delta-3-carene led to a cell viability of 29.8 ± 1.3 %.

In a GLP in vivo eye irritation study, delta-3-carene was not irritating to eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (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 GLP in vitro studies using Episkin model, exposure of epidermis to delta-3-carene for 15 min lead to a cell viability, measured by MTT conversion, of 29.8 ± 1.3 %.

In a recent GLP in vivo eye irritation study on delta-3-carene performed according to OECD Guideline 405, instillation of delta-3-carene resulted in moderate redness of the conjunctivae associated with severe chemosis in all treated animals after 1 hour of instillation. The irritation completely resolved within 8 days. Mean individual scores at 24, 48 and 72 h after exposure for the 3 rabbits were 0, 0, 0 for cornea score; 0, 0, 0 for iris score; 2, 1.33, 1.33 for conjunctivae score and 2, 1.33, 1 for chemosis score.


Justification for selection of skin irritation / corrosion endpoint:
Only one study available on the registered substance

Justification for selection of eye irritation endpoint:
Only one study available on the registered substance

Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

As the percentage of cell viability obtained in Episkin model was ≤ 50 % for delta-3-carene, it is considered to be irritating to skin. Under the test conditions, delta-3-carene is classified as irritating to skin, R38, according to the criteria of Annex VI to the Directive 67/548/EEC and category 2 according to CLP Regulation (EC) N° 1272/2008.

delta-3 -Carene gave reversible irritating effects on rabbit eyes with irritation scores not high enough to lead to classification according to the criteria of Directive 67/548/EEC and CLP Regulation (EC) N° 1272/2008. Therefore, delta-3-carene is not classified for eye irritation according to Directive 67/548/EEC and CLP Regulation (EC) N° 1272/2008.