Cinnamomum zeylanicum, ext.

Acute Toxicity: oral

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

Test material information

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:

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

Any other information on results incl. tables

Distribution of Mortality

Dose(mg/kg)	Death (No. of animals)	Observation Day 1	2	3	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	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.