Eucalyptus globulus, ext.

Acute Toxicity: oral

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-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

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

Test material information

Constituent 1

Reference substance name:

Eucalyptus globulus, ext.

EC Number:

283-406-2

EC Name:

Eucalyptus globulus, ext.

Cas Number:

84625-32-1

Molecular formula:

Not relevant for a UVCB substance.

IUPAC Name:

Essential oil of Eucalyptus globulus (Myrtaceae) obtained from leaves and branches by distillation

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 or test system 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:

other: Restraint of growth was observed in each surviving mouse.

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).