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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

Constituent 1
Reference substance name:
Cinnamon bark oil
IUPAC Name:
Cinnamon bark oil
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.

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:
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).