Registration Dossier
Registration Dossier
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EC number: 277-143-2 | CAS number: 72968-50-4 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Citrus aurantium, Rutaceae.
Endpoint summary
Administrative data
Description of key information
Acute toxicity oral:
- Standard acute method (rat): LD50 > 5000 mg/kg bw (limit test, not according to guideline)
Acute toxicity dermal:
- Standard acute method (rabbit): LD50 > 8.5 g/kg bw (limit test, not according to guideline)
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
Acute toxicity: via dermal route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 8 500 mg/kg bw
Additional information
In the acute oral toxicity study, a single dose of 5000 mg/kg bw bitter orange oil was given orally to 10 male/female rats. The animals were observed for 14 days. No mortality occured, resulting in a LD50 > 5000 mg/kg bw.
In the acute dermal toxicity study, two rabbits were exposed to a single 48 -hour application of 10 ml/kg bw bitter orange oil. No animals died during the course of the study, resulting is a LD50 > 8.5 g/kg bw.
Justification for classification or non-classification
Based on the key information for both oral and dermal acute toxicity, the substance bitter orange oil does not need to be classified as acute toxic according to the EU classification criteria outlined in 1272/2008/EC and 67/548/EEC.
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