Cajuput, ext.

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1964

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Only short abstract available

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:

Unnamed

Year:

1964

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Osborne-Mendel rats were administered with Cajeput oil by oral gavage and animals were observed for two weeks. LD50 was computed by the method of Litchfield & Wilcoxon (1949).

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Cajuput, ext.

EC Number:

287-316-4

EC Name:

Cajuput, ext.

Cas Number:

85480-37-1

IUPAC Name:

1,3,3-trimethyl-2-oxabicyclo[2.2.2]octane; 2-(4-methylcyclohex-3-en-1-yl)propan-2-ol

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): Cajeput oil

Test animals

Species:

rat

Strain:

Osborne-Mendel

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Fasting period before study: Ca. 18 h prior to treatment
- Diet: Food, ad libitum
- Water, ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

No data

Doses:

No data

No. of animals per sex per dose:

No data

Control animals:

no

Details on study design:

No data

Statistics:

- LD50 with 95 % confidence limits was calculated with use of Litchfield-Wilcoxon's method.

Results and discussion

Preliminary study:

None

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

3 870 mg/kg bw

Based on:

test mat.

95% CL:

3 360 - 4 450

Mortality:

- Mortality was observed between 4 h and 9 days after test item administration.

Clinical signs:

other: - Scrawny appearance and wet posterior were observed. - Depression persisted in some animals for as long as 3 days.

Gross pathology:

- Gross pathology showed pale, nutmeg liver in treated animals.

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:

Under the test conditions, the oral LD50 for Cajeput oil is higher than 2000 mg/kg bw in rats therefore it is not classified according to the Annex VI to the Directive 67/548/EEC and the Regulation (EC) No. 1272/2008 (CLP).

Executive summary:

In an acute oral toxicity study, Osborne-Mendel rats were administered with Cajeput oil by oral gavage and then observed for clinical signs and mortality for two weeks. LD50 was computed by the method of Litchfield & Wilcoxon (1949).

Mortality was observed between 4 h and 9 days after test item administration. Scrawny appearance and wet posterior were observed. Depression persisted in some animals for as long as 3 days. Gross pathology showed pale, nutmeg liver in treated animals. In this study, the oral LD50 of test item was 3870 mg/kg bw (confidence limits of 3360-4450) in rats.

 

Under the test conditions, the oral LD50 for Cajeput oil is higher than 2000 mg/kg bw in rats therefore it is not classified according to the Annex VI to the Directive 67/548/EEC and the Regulation (EC) No. 1272/2008 (CLP).