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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1984
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Original reference in Japanese language; data from English abstract and table only
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
publication
Title:
A Study on Acute Toxicities of Essential Oils Used in Endodontic Treatment
Author:
Ohsumi T, Kuroki K, Kimura T and Murakami Y
Year:
1984
Bibliographic source:
J. Kyushu Dent. Soc. 38(6), 1064-1071

Materials and methods

Principles of method if other than guideline:
LD50 determination in mice following gavage administration.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: oil
Details on test material:
- Name of test material (as cited in study report): Eucalyptus oil

Test animals

Species:
mouse
Strain:
other: ddY
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 18.0-22.0 g
- Fasting period before study: 20 h

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage): 0.1 mL/10 g
Doses:
2200, 2900 , 3700, 4800 and 6200 mg/kg bw
No. of animals per sex per dose:
10 males/dose
Control animals:
no
Details on study design:
- Toxic symptoms and changes in the body weight gain of the surviving mice were observed and the number of death was recorded for 7 days.
Statistics:
- LD50 with 95 % confidence limits was calculated with use of Litchfield-Wilcoxon's method.

Results and discussion

Preliminary study:
Not applicable
Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
3 320 mg/kg bw
Based on:
test mat.
95% CL:
2 770 - 3 980
Mortality:
Mortalities: 10, 20, 70, 90 and 100 % at 2200, 2900 , 3700, 4800 and 6200 mg/kg bw, respectively
Clinical signs:
Restraint of growth was observed in each surviving mouse.
Body weight:
No data
Gross pathology:
No data
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 for eucalyptus oil is higher than 2000 mg/kg bw in mice therefore it is not classified according to the Annex VI to the Directive 67/548/EEC and the CLP Regulation (EC) N° (1272-2008).
Executive summary:

In an acute oral toxicity study, groups (10/dose) of male ddY mice were given a single oral dose of eucalyptus oil diluted in olive oil at 2200, 2900 , 3700, 4800 and 6200 mg/kg bw. Toxic symptoms and changes in the body weight gain of the surviving mice were observed and the number of death was recorded for 7 days.

Mortalities in male were 10, 20, 70, 90 and 100 % at 2200, 2900, 3700, 4800 and 6200 mg/kg bw, respectively. Restraint of growth was observed in each surviving mouse. The oral LD50 for eucalyptus oil was 3320 (2770-3980) mg/kg bw in male mice.

The oral LD50 for eucalyptus oil is higher than 2000 mg/kg bw in mice therefore it is not classified according to the Annex VI to the Directive 67/548/EEC and the CLP Regulation (EC) N° (1272-2008).