Volatile oil of Ginger, obtained from the roots of Zingiber officinalis (Zingiberaceae) by selective supercritical CO2 extraction

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

May 1972

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Well documented pre-guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1972

Report date:

1972

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

- five male and five female albino rats of the Sherman-Wistar strain - The animals were starved for 24 hours before dosing.

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Ginger Oil

Cas Number:

8007-08-7

IUPAC Name:

Ginger Oil

Test material form:

liquid

Details on test material:

Batch number: RIFM-72-4-156 GINGER OIL 335

Test animals

Species:

rat

Strain:

other: Sherman-Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Fasting period before study: 24 hours
- Diet (e.g. ad libitum): ad libitum after exposure
- Water (e.g. ad libitum): ad libitum after exposure
- Acclimation period: 7 days

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

No data

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

other: Mild signs of morbidity soon after dose administration. Full recovery 24 hours later.

Applicant's summary and conclusion

Interpretation of results:

other: not classified

Remarks:

based on CLP criteria (Annex I of 1272/2008/EC)

Conclusions:

The oral LD50 value of Ginger oil in rats was established to be higher than 5000 mg/kg bw, under the conditions of this study. The substance therefore does not need to be classified according to the classification criteria outlined in Annex I of the CLP Regulation 1272/2008/EC.

Executive summary:

Ginger oil was evaluated for acute oral toxicity in rats in a study similar to OECD TG 401. Two groups, consisting of five male and five female albino rats of the Sherman-Wistar strain, were set aside and observed for a period of one week for acclimatisation. The animals were then starved for 24 hours. Doses at 5000 mg/kg bw were administered by means of a syringe and stomach tube. Following this, the animals were allowed food and water ad libitum during a fourteen-day observation period. No mortality occurred, mild signs of morbidity soon after dose administration. The treated rats recovered fully 24 hours later. The oral LD50 value of Ginger oil in rats was established to be higher than 5000 mg/kg bw, under the conditions of this study.

The substance therefore does not have to be classified for acute oral toxicity according to the classification criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).