Registration Dossier
Registration Dossier
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EC number: 284-635-0 | CAS number: 84961-46-6 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Cinnamomum cassia, Lauraceae.
Endpoint summary
Administrative data
Description of key information
Acute oral toxicity: LD50>2000 mg/kg bw (similar to OECD 420)
Acute dermal toxicity: LD50=332 mg/kg bw (similar to OECD 402)
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 332 mg/kg bw
Additional information
Acute oral toxicity
The key study was a standard acute limit test, in which a single dose of Cassia oil (2000 mg/kg bw) was administered by oral gavage to 5 female Wistar rats. One animal was found dead one day after dosing, but no other mortality was observed up to 14 days after application. Based on these results, the oral LD50 was established to be >2000 mg/kg bw. A supporting study is available that confirms the LD50 is over 2000 mg/kg bw.
Acute dermal toxicity
Two studies were available for this endpoint, which were used in a Weight of Evidence approach:
The first available study was a standard acute test, in which 10 albino rabbits (2 per dose level) were exposed to a single dose of Cassia oil (168, 332, 600, 1323, 2625 mg/kg bw, calculated from mL/kg based on density). At the lowest dose none of the animals died, but at the dose level of 332 mg/kg bw, 1 of two animals (50%) died. At the higher dose levels all animals died. Based on the mortality rates the dermal LD50 was established to be 332 mg/kg bw.
The second study was performed according to an equivalent of guideline OECD 402 (acute dermal toxicity) but with a deviating dose (1000 mg/kg bw instead of 2000 mg/kg bw). 5 male and 5 female New Zealand White rabbits were selected. A single dose of the test article was applied for 24 hours. Eight of ten animals survived. Two males died on day 3 of the observation period. The LD50 was therefore determined to be greater than 1000 mg/kg body weight.
Based on the results of these two studies (WoE approach) it was decided to use the lowest reported LD50 of 332 mg/kg bw as the starting point for classification.
Justification for classification or non-classification
Based on the available information, the substance does not need to be classified for Acute Oral Toxicity in accordance with the criteria outlined in Annex I of 1272/2008/EC (CLP/EU-GHS).
Based on the available information, the substance needs to be classified for Acute Dermal Toxicity (Category 3 / H311) in accordance with the criteria outlined in Annex I of 1272/2008/EC (CLP/EU-GHS).
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