Oils, cinnamon

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1972

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test was performed according to methods similar to OECD 401 and pre-GLP. Test seems reliable, but is very concise reported.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1972

Report date:

1972

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

5 male/female used instead of 5 animals/sex

GLP compliance:

no

Remarks:

(pre-GLP)

Test type:

standard acute method

Limit test:

no

Test material

Test material information

1

Reference substance name:

Essential oil of Cinnamon bark obtained from the bark of Cinnamomum zeylanicum, Lauraceae by distillation

EC Number:

943-043-9

Cas Number:

8015-91-6

IUPAC Name:

Essential oil of Cinnamon bark obtained from the bark of Cinnamomum zeylanicum, Lauraceae by distillation

Details on test material:

- Name of test material (as cited in study report): Cinnamon Bark Oil (Ceylon), RIFM-72-8-99
- Physical state: Liquid

Test animals

Species:

rat

Strain:

other: Sherman Wistar (albino)

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

2034, 2543, 3214, 4069 and 5086 mg/kg bw

No. of animals per sex per dose:

3 male, 2 female

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

3 458 mg/kg bw

Based on:

test mat.

95% CL:

>= 2 950 - < 4 069

Remarks on result:

other: 3 out of 5 rats showed mortality at a dose of 3214 mg/kg bw, while no rats died in the lower dose groups. The LD50 was calculated based on these results.

Mortality:

No rats died in the two lowest dose groups (2034 and 2543 mg/kg bw). Mortality occurred in 3 out of 5 rats in the 3214 and 4069 mg/kg bw dose groups. All rats died in the higest dose group (5086 mg/kg bw). All mortality occurred on the first day after exposure.

Clinical signs:

other:

Any other information on results incl. tables

		Day														Mortality after 14 days
Dosage level (mg/kg bw)	Number of test animals	1	2	3	4	5	6	7	8	9	10	11	12	13	14
2034	5	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
2543	5	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
3214	5	3	0	0	0	0	0	0	0	0	0	0	0	0	0	3
4069	5	3	0	0	0	0	0	0	0	0	0	0	0	0	0	3
5086	5	5	-	-	-	-	-	-	-	-	-	-	-	-	-	5

Overview of mortality

Mortality data was evaluated according to the Thompson Moving Average Method as described by Carrol S. Weil in the publication "Tables for Convenient Calculation of Median-Effective Dose (LD50 or ED50) and Instructions in Their Use" (Biometrics, Vol. 8, No. 3, pp. 249 -263, September 1952).

Applicant's summary and conclusion

Interpretation of results:

other: not classified in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC)

Conclusions:

Under the conditions of this study, an LD50 of 3458 mg/kg bw was calculated. Therefore, the substance does not need to be classified as acute toxic via the oral route based on the criteria outlined in 1272/2008/EC (CLP).

Executive summary:

The study was performed according to a method similar to OECD 401. 25 Sherman Wistar (albino) rats (15 male, 10 female) were dosed with varying doses of cinnamon bark oil via oral gavage. Test groups were administered with doses that ranged from 2034 to 5086 mg/kg bw with 5 rats in each group (3 male, 2 female). Rats were observed for 14 days after treatment.

 

No mortality was observed in the two lowest dose groups (2034 and 2543 mg/kg bw). Three out of 5 rats died at 3214 and 4069 mg/kg bw, while all rats died in the highest dose group (5086 mg/kg bw). All deaths occurred within 1 day after exposure. Based on these results a LD50 of 3458 mg/kg bw was calculated.