Oils, cinnamon

Acute Toxicity: dermal

Administrative data

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.

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 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

Test material

Test material information

Constituent 1

Reference substance name:

Cinnamon bark oil (ceylon)

IUPAC Name:

Cinnamon bark oil (ceylon)

Test material form:

not specified

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:

rabbit

Strain:

other: Albino

Sex:

not specified

Details on test animals or test system and environmental conditions:

No data

Administration / exposure

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

Results and discussion

Effect levels

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:

other: No data

Gross pathology:

No data

Other findings:

No data

Any other information on results incl. tables

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).

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria

Remarks:

in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC)

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).