Registration Dossier

Administrative data

Description of key information

All studies available show  oral LD50 equal to or higher than 3700 mg/kg bw in rats.
All studies available show dermal LD50 equal to or higher than 2000 mg/kg bw in rabbits.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
3 700 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
2 000 mg/kg bw

Additional information

Acute oral toxicity studies are available for the following structurally related substances: alpha-pinene, beta-pinene, delta-3-carene, turpentine oil and camphene. They show LD50 of 3700, > 5000, 4800, 3956 and > 5000 mg/kg bw, respectively. Although these studies are old and briefly described, they all show consistent results about all these structure-related substances.

Acute dermal toxicity studies are also available for each of the following substances: alpha-pinene, beta-pinene, delta-3-carene, turpentine oil and camphene. They show LD50 > 5000, > 5000, > 5000, > 2000 and > 2500 mg/kg bw, respectively. Although these studies are old and briefly described, they all show consistent results about all these structurally related substances. Morevover, the low dermal toxicity of these substances is consistent with and confirmed by the low oral toxicity.

Justification for classification or non-classification

Oral and dermal LD50 are higher than 2000 mg/kg bw in rats and rabbits, respectively, therefore (-)-beta pinene does not need to be classified for acute toxicity according to the Annex VI to the Directive 67/548/CEE and the CLP Regulation (EC) No 1272/2008.

However, based on its viscosity, (-)-beta-pinene is classified for aspiration hazard Category 1 according to Regulation (EC) No 1272/2008 (hydrocarbon with a kinematic viscosity of less than 20.5 mm2/s at 40°C) and as harmful "R65: may cause lung damage if swallowed" according to Directive 67/548/EEC.