Registration Dossier

Administrative data

Description of key information

Acute toxicity oral:
- Standard acute method (rat): LD50 > 5000 mg/kg bw (equivalent or similar to OECD401, limit test))
Acute toxicity dermal:
- Standard acute method (rabbit): LD50 > 5000 mg/kg bw (equivalent or similar to OECD402, limit test)

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:
5 000 mg/kg bw

Additional information

In the acute oral toxicity study, a single dose of 5000 mg/kg bw Mandarin oil was given orally to 10 male Wistar rats. Animals were observed 3-4 hours post dosing and once daily thereafter for 14 days for mortality, toxicity and pharmacological effects. No deaths occurred, resulting in a LD50 > 5000 mg/kg bw.

In the acute dermal toxicity study, a single 24-hour application of 5000 mg/kg bw Mandarin oil was applied to the clipped abdominal skin of 7 rabbits weighing 2.0-3.0 kg. The animals were wrapped with a gauze patch and plastic, secured with tape. Following exposure, the binders were removed and daily observations made for mortality, toxicity and pharmacological effects for a period of 14 days. No animals died during the course of the study, resulting is a LD50 > 5000 mg/kg bw.

Justification for classification or non-classification

Based on the key information for both oral and dermal acute toxicity, the substance Mandarin 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.