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Toxicological information

Acute Toxicity: oral

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Administrative data

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.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report date:
1973

Materials and methods

Test guideline
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

Test material

Constituent 1
Reference substance name:
Cinnamomum zeylanicum, ext.
EC Number:
283-479-0
EC Name:
Cinnamomum zeylanicum, ext.
Cas Number:
84649-98-9
Molecular formula:
Not Applicable due to UVCB
IUPAC Name:
Cinnamomum zeylanicum, ext.
Constituent 2
Reference substance name:
Cinnamon leaf oil
IUPAC Name:
Cinnamon leaf oil
Details on test material:
- Name of test material (as cited in study report): Cinnamon leaf oil
- Lot/batch No.: confidential

Test animals

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

Administration / exposure

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.

Results and discussion

Preliminary study:
Not applicable
Effect levels
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:
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
Body weight:
No data
Gross pathology:
No data
Other findings:
No data

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.

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