Essential oil of Cedarwood Texas obtained from the wood of Juniperus mexicana (Cupressaceae) by distillation - Terpenes

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

- Principle of test: A single 5000 mg/kg bw dose of Cedarwood Virginia oil was administered by oral gavage to 10 male Wistar rats. The animals were observed for 14 days.

GLP compliance:

no

Remarks:

pre-glp

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Juniper, Juniperus virginiana, ext.

EC Number:

285-370-3

EC Name:

Juniper, Juniperus virginiana, ext.

Cas Number:

85085-41-2

IUPAC Name:

Essential oil of Cedarwood obtained from the wood of Juniperus virginiana (Cupressaceae) by steam distillation

Test material form:

liquid: viscous

Details on test material:

CAS 85085-41-2
For specific details on test material if available - See in RSS
Name of test material (as cited in study report or in reference): Cedarwood Virginia oil; Cedarwood oil Virginia or Virginia oil

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- h No.of test material: Sample marking: 73-9

Test animals

Species:

rat

Strain:

Wistar

Sex:

not specified

Administration / exposure

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: Daily
- Necropsy of survivors performed: not specified
- Other examinations performed: general symptomatology

Results and discussion

Effect levels

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

None

Clinical signs:

other: slight lethargy

Gross pathology:

not specified

Other findings:

not specified

Applicant's summary and conclusion

Interpretation of results:

other: not classified

Remarks:

based on CLP criteria

Conclusions:

The oral LD50 of Cedarwood Virginia oil was determined to be higher than 5000 mg/kg bw. Based on the available information, the test substance does not need to be classified for acute oral toxicity, according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP).

Executive summary:

A single 5000 mg/kg bw dose of Cedarwood Virginia oil was administered by oral gavage to 10 male Wistar rats. The animals were observed for 14 days. Mortality was not noted. Slight lethargy was seen in animals dosed with the test material. The oral LD50 value of Cedarwood Virginia in rats was established as exceeding 5000 mg/kg body weight, under the conditions of this study. Based on the available information, the test substance does not need to be classified for acute oral toxicity, according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP).