Registration Dossier
Registration Dossier
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EC number: 282-013-3 | CAS number: 84082-68-8 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Myristica fragrans, Myristicaceae.
Endpoint summary
Administrative data
Description of key information
Acute toxicity by inhalation: LC50 >4.9 mg/L (equivalent or similar to OECD 403)
Key value for chemical safety assessment
Acute toxicity: via inhalation route
Endpoint conclusion
- Dose descriptor:
- LC50
- Value:
- 4.9 mg/m³ air
Additional information
An acute inhalation study was performed equivalent or similar to OECD403. Male and female rats were exposed to 4.9 mg/L nutmeg oil (measured concentration) for 4 hr. Observed clinical signs were irritant effects, abnormal respiratory pattern, and abnormal body position. No effects were observed on mortality, body weight organ weights, microscopic and macroscopic pathology. Based on these results, the LC50 was determined to be >4.9 mg/L.
An acute oral toxicity study is included as a supporting study. In this study, rats were exposed to different doses of nutmeg oil, and an LD50 of 2620 mg/kg bw is observed. As the study report is limited and insufficient details on methods are provided, the study is regarded a supporting study, taking into account that this endpoint can be waived as an acute inhalation toxicity study is available.
Furthermore, a supporting study in which mice were exposed to nutmeg oil intraperitoneal. The LD50 was observed to be 2150 µL/kg/24 hr. Observed clinical signs included lost of righting reflex followed by clonic seizures before death, accompanied by periods of running (running-bouncing cyclus).
Justification for classification or non-classification
Based on the available information, nutmeg oil has been shown to be of low acute toxicity when applied via the inhalation route. Therefore, the substance nutmeg oil does not need to be classified for acute toxicity according to the criteria outlined in Annex I of 1272/2008/EC (CLP/EU-GHS) and Annex VI of 67/548/EEC.
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