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

Endpoint summary

Description of key information

Acute oral toxicity: LD50 = 3458 mg/kg bw (similar to OECD401)
Acute dermal toxicity: LD50 = 702 mg/kg bw (similar to OECD402)

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:

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.

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

Species:

rat

Strain:

other: Sherman Wistar (albino)

Sex:

male/female

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

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.

		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).

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

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. Therefore, the substance does not need to be classified as acute toxic via the oral route based on the criteria outlined in Annex I of 1272/2008/EC (CLP).

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

3 458 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

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 402 and pre-GLP. Test seems reliable, the test report is very concise but acceptable to fill this endpoint.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

only 2 animals used per dose instead of 5

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Species:

rabbit

Strain:

other: Albino

Sex:

not specified

Details on test animals or test system and environmental conditions:

No data

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: intact and abraded skin

Duration of exposure:

Single exposure

Doses:

321, 455, 641, 905 and 1282 mg/kg bw.

No. of animals per sex per dose:

2

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no

Sex:

not specified

Dose descriptor:

LD50

Effect level:

702 mg/kg bw

Based on:

test mat.

95% CL:

>= 590 - < 834

Remarks on result:

other: 2 out of 2 rabbits showed mortality at a dose of 905 mg/kg bw and above, while no rabbits died in the lower dose groups. The LD50 was calculated based on these results.

Mortality:

No rabbits died in the three lowest dose groups with intact skin (321, 455 and 641 mg/kg bw). All animals (n=2) died within the first 4 days after
exposure in the 905 and the 1282 mg/kg bw dose group.

Clinical signs:

No data

Body weight:

No data

Gross pathology:

No data

Other findings:

No data

Mortality data were 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).

Interpretation of results:

toxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study, 2 out of 2 rabbits showed mortality at a dose of 905 mg/kg bw and higher, while no mortality was observed at 321, 455 and 641 mg/kg bw. Based on these results a LD50 of 702 mg/kg bw was calculated and therefore, the substance should be classified as acute toxic via the dermal route (Category 3 / H311) based on the criteria outlined in Annex I of 1272/2008/EC (CLP).

Executive summary:

The study was performed according to a method similar to the OECD 402 guideline. Twenty albino rabbits (10 with abraded, 10 with intact skin, 2x2 rabbits per dose group) were exposed to 321, 455, 641, 905 or 1282 mg/kg bw cinnamon bark oil. Rabbits were observed for 14 days after treatment.

No mortality was observed in the three lowest dose groups with intact skin (321, 455 and 641 mg/kg bw). Mortality occurred within 4 days after exposure in all rabbits in the 905 and 1282 mg/kg bw dose groups. Based on these results a LD50 of 702 mg/kg bw was calculated and the substance should be classified as acute toxic via the dermal route (Category 3 / H311) given the criteria as outlined in Annex I of 1272/2008/EC (CLP).

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

702 mg/kg bw

Additional information

Acute oral toxicity

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.

Acute dermal toxicity

Acute dermal toxicity was determined according to a method similar to the OECD 402 guideline. Twenty albino rabbits (10 with abraded, 10 with intact skin, 2x2 rabbits per dose group) were exposed to 321, 455, 641, 905 or 1282 mg/kg bw cinnamon bark oil. Rabbits were observed for 14 days after treatment. No mortality was observed in the three lowest dose groups with intact skin (321, 455 and 641 mg/kg bw). Mortality occurred within 4 days after exposure in all rabbits in the 905 and 1282 mg/kg bw dose groups. Based on these results an LD50 of 702 mg/kg bw was calculated.

Justification for selection of acute toxicity – oral endpoint
The selected study is the key study for this endpoint.

Justification for selection of acute toxicity – dermal endpoint
The selected study is the key study for this endpoint.

Justification for classification or non-classification

Based on the available information, Cinnnamon bark oil has shown to be non-toxic after oral exposure. Therefore, the substance does not need to be classified for acute oral toxicity in accordance with the criteria outlined in Annex I of 1272/2008/EC (CLP/EU-GHS).

Based on the available information, Cinnamon bark oil oil has been shown to be toxic in contact with skin. Therefore, the substance needs to be classified for acute dermal toxicity (Category 3 / H311) according to the criteria outlined in Annex I of 1272/2008/EC (CLP/EU-GHS).