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
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
4 800 mg/kg bw
Quality of whole database:
One acute oral toxicity study was available for each of the substances used in the registration dossier of delta-3-carene, i.e. delta-3-carene, alpha pinene and camphene. They showed LD50 of 4800, 3700 and >5000 mg/kg bw, respectively. Although these studies were old and briefly described, they all show consistent results about all these structure-related substances.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
One acute oral toxicity study was available for each of the substances used in the registration dossier of delta-3-carene, i.e. delta-3-carene, alpha pinene and camphene. They showed LD50 >5000, >5000 and >2500 mg/kg bw, respectively. Although these studies were old and briefly described, they all show consistent results about all these structure-related substances. Morevover, the low dermal toxicity is consistent with and confirmed by the low oral toxicity found with all these substances.

Additional information

One acute oral toxicity study was available for each of the substances used in the registration dossier of delta-3-carene, i.e. delta-3-carene, alpha pinene and camphene. They showed LD50 of 4800, 3700 and >5000 mg/kg bw, respectively. Although these studies were old and briefly described, they all show consistent results about all these structure-related substances.

One acute oral toxicity study was available for each of the substances used in the registration dossier of delta-3-carene, i.e. delta-3-carene, alpha pinene and camphene. They showed LD50 >5000, >5000 and >2500 mg/kg bw, respectively. Although these studies were old and briefly described, they all show consistent results about all these structure-related substances. Morevover, the low dermal toxicity is consistent with and confirmed by the low oral toxicity found with all these substances.


Justification for selection of acute toxicity – oral endpoint
No robust study summary was chosen for this endpoint because a weight of evidence approach was adopted; therefore, it was not possible to select only one of the studies used for this endpoint.

Justification for selection of acute toxicity – inhalation endpoint
No study was available and it was not necessary to provide one because acute toxicity is already assessed via two different routes of exposure. Acute toxicity studies by oral and dermal routes showed very low toxicity, with high LD50 values.

Justification for selection of acute toxicity – dermal endpoint
No robust study summary was chosen for this endpoint because a weight of evidence approach was adopted; therefore, it was not possible to select only one of the studies used for this endpoint.

Justification for classification or non-classification

For all substances, oral and dermal LD50 are higher than 2000 mg/kg bw in rats and rabbits, respectively, therefore the registered substance does not need to be classified for acute toxicity according to Directive 67/548/CEE and CLP Regulation (EC) N° 1272/2008.