Litsea cubeba, ext.

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Test was conducted according to methods similar to OECD guideline 401 (limit test) and was performed pre-GLP. A concise description of the protocol is available and results are reported clearly.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

1

Reference substance name:

Essential oil obtained from the fruits of Litsea cubeba (Lour.) Pers. by distillation

EC Number:

943-438-6

Cas Number:

90063-59-5

IUPAC Name:

Essential oil obtained from the fruits of Litsea cubeba (Lour.) Pers. by distillation

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: approximately 200 g
- Fasting period before study: 16-18 hrs
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

No data available

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

10 males

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: Daily
- Necropsy of survivors performed: yes
- Other examinations performed: symptomatology

Results and discussion

Preliminary study:

Not relevant

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

Mortality was observed in one rat.

Clinical signs:

other: No effects observed

Gross pathology:

Necropsy performed: lungs red throughout in one rat

Other findings:

Not reported

Applicant's summary and conclusion

Interpretation of results:

other: not classified

Remarks:

according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP)

Conclusions:

The oral LD50 value of Litsea Cubeba Oil in rats was established as exceeding 5000 mg/kg body weight, under the conditions of this study. The substance therefore does not need to be classified according to the classification criteria outlined in Annex VI of 67/548/EEC (DSD) and Annex I of 1272/2008/EC (CLP).

Executive summary:

A single 5000 mg/kg bw dose of Litsea Cubeba oil was administered by oral gavage to 10 male Wistar rats. The animals were observed for 14 days. No symptoms were noted. Mortality was observed in one rat. The oral LD50 value of Litsea Cubeba oil in rats was established as exceeding 5000 mg/kg body weight, under the conditions of this study. The substance therefore does not have to be classified according to the classification criteria outlined in Annex VI of 67/548/EEC (DSD) and Annex I of 1272/2008/EC (CLP).