Registration Dossier

Administrative data

Description of key information

In GLP in vitro studies on human reconstructed epidermis model, mean relative cell viability of alpha-pinene, (-)-beta-pinene and delta-3-carene was 39.6 ± 5.6, 38.5 ± 3.5 and 29.8 ± 1.3 %, respectively. 
In an in vivo eye irritation study performed with (-)-beta-pinene in rabbits according to OECD Guideline No 405, 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, 0 for cornea score; 0, 0, 0 for iris score; 1, 1, 2 for conjunctivae score and 1.3, 1, 1 for chemosis score.
In an in vivo eye irritation study performed with delta-3-carene in rabbits according to OECD Guideline No 405, 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, 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.

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)

Additional information

In GLP in vitro studies on Episkin model, alpha pinene, (-)-beta-pinene or delta-3-carene were applied topically to reconstructed human epidermis model (3 epidermis units/dose) for 15 min at room temperature. Mean relative cell viability was 39.6 ± 5.6, 38.5 ± 3.5 and 29.8 ± 1.3%, respectively.

The results were therefore positive and the substances are irritating to skin.

In an eye irritation study conducted according to OECD 405 Guideline and GLP, 3 male New Zealand White rabbits were exposed to 0.1 mL of undiluted (-)-beta-pinene 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, 0 for cornea score; 0, 0, 0 for iris score; 1, 1, 2 for conjunctivae score and 1.3, 1, 1 for chemosis score. All the signs were resolved within 7 days after treatment. The substance is therefore not irritating to eyes.

In an eye irritation study conducted according to OECD 405 Guideline and GLP, 3 female New Zealand White rabbits were exposed to 0.1 mL of undiluted delta-3-carene 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, 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. All the signs were resolved within 7 days after treatment. The substance is therefore not irritating to eyes.


Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

In an in vitro skin irritation study performed on reconstructed human epidermis, cell viability was ≤ 50 %. Therefore, (-)-beta pinene is classified as "R38: Irritating to skin", according to Directive 67/548/EEC and as skin irritant category 2 according to 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, (-)-beta-pinene is not classified for eye irritation according to Directive 67/548/EEC and CLP Regulation (EC) No 1272/2008.