Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Acute oral toxicity: LD50 2650 mg/kg bw (standard acute method)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Very concise study, chemical identity of test substance not reported. Diet and environmental conditions not reported. Non GLP study and no Guideline followed, but acceptable basic data.
Qualifier:
equivalent or similar to guideline
Guideline:
other: Federal Hazardous Substance Act (FHSA)
Deviations:
no
Principles of method if other than guideline:
The acute oral toxicity of Cinnamon leaf oil in the rat was assessed. Rats were treated with Cinnamon leaf oil by oral administration at 5 doses (1640, 2050, 2560, 3200, and 5000 mg/kg), 10 rats per dose. The animals were observed daily during test days 1-14, and mortality and clinical signs were recorded. Based on the results an LD50 was established.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Fasting period before study: 16-18 h prior to testing
- Diet (e.g. ad libitum): ad libitum
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
No data
Doses:
1640, 2050, 2560, 3200, and 5000 mg/kg
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs
Statistics:
The LD50 and 95% confidence limit were calculated, if possible, by the method of Litchfield, J.T. Jr., & F. Wilcoxon JPET 96:99, 1949 or Horn, H.J. Biometrics 12:311, 1956.
Preliminary study:
Not applicable
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
ca. 2 650 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 2160-3140 mg/kg (95% confidence interval)
Mortality:
Mortality during the course of the study: 1640 mg/kg: none; 2050 mg/kg: 3/10; 2560 mg/kg: 7/10; 3200 mg/kg: 5/10, and 5000 mg/kg: 10/10 (for details see 'Any other information on results')
Clinical signs:
other: The following symptoms were recorded: 5000 mg/kg - piloerection, lethargy, loss of righting reflex; 3200, 2560, 2050 mg/kg - lethargy, loss of righting reflex; 1640 mg/kg - none
Gross pathology:
No data
Other findings:
No data

Distribution of Mortality

Dose(mg/kg) 

Death (No. of animals) 

Observation Day 1

 2

 4

5

6

7

8

9

10

11

12

13

14

 1640

 0/10

 0

 0

 0

 0

 0

 0

 0

 0

 0

 0

 0

 0

 0

 0

 2050

 3/10

 2

 1

 0

 0

 0

 0

 0

 0

 0

 0

 0

 0

 0

 0

 2560

 7/10

 4

 3

 0

 0

 0

 0

 0

 0

 0

 0

 0

 0

 0

 0

 3200

 5/10

 2

 2

 1

 0

 0

 0

 0

 0

 0

 0

 0

 0

 0

 0

 5000

 10/10

 8

 2

 0

 0

 0

 0

 0

 0

 0

 0

 0

 0

 0

Interpretation of results:
other: not classified
Remarks:
based on CLP criteria
Conclusions:
The median lethal dose of Cinnamon leaf oil after oral administration to rats, observed over a period of 14 days, is: LD50 (rat) = 2650 (2160-3140) mg/kg. The substance does not have to be classified according to the EU classification criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).
Executive summary:

The acute oral toxicity of Cinnamon leaf oil in the rat was assessed. Rats were treated with Cinnamon leaf oil by oral administration at 5 doses (1640, 2050, 2560, 3200, and 5000 mg/kg), 10 rats per dose. The animals were observed daily during test days 1-14, and mortality and clinical signs were recorded. The following symptoms were recorded: 5000 mg/kg - piloerection, lethargy, loss of righting reflex; 3200, 2560, 2050 mg/kg - lethargy, loss of righting reflex; 1640 mg/kg - none. Mortality during the course of the study: 1640 mg/kg: none; 2050 mg/kg: 3/10; 2560 mg/kg: 7/10; 3200 mg/kg: 5/10 and 5000 mg/kg: 10/10. The median lethal dose of Cinnamon leaf oil after oral administration to rats, observed over a period of 14 days, is: LD50 (rat) = 2650 (2160-3140) mg/kg. The substance does not have to be classified according to the EU classification criteria outlined in 67/548/EEC and 1272/2008.

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 650 mg/kg bw

Additional information

An acute oral toxicity was performed according to the standard acute method. Rats were treated with Cinnamon leaf oil by oral administration at 5 doses (1640, 2050, 2560, 3200, and 5000 mg/kg), 10 rats per dose. The animals were observed daily during test days 1-14, and mortality and clinical signs were recorded. Based on the results an LD50 of 2650 mg/kg bw was established.

A supporting study was available in which cinnamon leaf oil was administered dermally to New Zealand White rabbits. A limit dose of 5000 mg/kg bw did not result in mortality, and the LD50 was determined to be >5000 mg/kg bw.

Justification for classification or non-classification

Based on the available information, cinnamon leaf oil has been shown to be of low acute toxicity when applied via the oral and dermal route. Therefore, the substance cinnamon leaf oil does not need to be classified for acute toxicity according to the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).