Registration Dossier
Registration Dossier
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EC number: 610-461-5 | CAS number: 495-61-4
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Additional information
Acute oral toxicity
In the key study for acute oral toxicity, the single oral (gavage) application of Bisabolene (unknown isomer composition) up to a dose of 5000 mg/kg bw/day to male and female Sprague-Dawley rats, did not result in mortality, evident clinical signs or gross pathological findings (BASF 1979; 77/442). Accordingly, the LD50 is set above 5000 mg/kg bw/d. In support, no mortality was observed in 10 rats after application of 5000 mg/kg bw Bisabolene (not further specified) in an acute oral toxicity study with limited documentation (RIFM 1974; MB 74-598). Overall, beta-Bisabolene is considered virtually not toxic after single ingestion based on the data available.
Acute inhalative toxicity
No key study is available for acute inhalative toxicity of beta-Bisabolene. However, in a supporting inhalation risk test, a saturated atmosphere of Bisabolene (unknown isomer composition) was generated by bubbling 200 l/h air at 20 ° C through a test substance column of about 5 cm above a fritted glass disc in a glass cylinder (BASF 1979; 77/442). Sprague-Dawley rats were exposed (whole body) with the saturated atmosphere (estimated concentration; 13.74 mg/l based on test substance weight loss) for 7 hours. No mortality, clinical signs or gross pathological findings were observed up to 14 days after exposure.
Acute dermal toxicity
No key study is available for acute dermal toxicity of beta-Bisabolene. Mortality was observed in 1/10 rabbits 10 days after application of 5000 mg/kg bw Bisabolene (not further specified) in an acute dermal toxicity study with limited documentation (RIFM 1974; MB 74-598). No clinical signs were observed, however, slight erythema and slight edema was found in 4/10 and 1/10 animals, respectively. The single dermal (occlusive) application of 200 mg/kg bw Bisabolene (unknown isomer composition) on shaved back skin of Vienna White rabbits for 24 hours did not result in any mortality up to 4 days after application (BASF 1979; 77/442). Erythema and edema were observed 24h after application of Bisabolene, which remained until the end of the observation period (4 days). Overall, beta-Bisabolene is considered virtually not toxic after single dermal exposure in a weight of evidence available.
Justification for classification or non-classification
The present data on acute oral and dermal toxicity do not fulfill the criteria laid down in regulation (EU) 1272/2008, and therefore, a non-classification is warranted. According to UN-GHS, the test substance does not need to be classified.
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