Grapefruit, ext.

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:

other: Test was conducted according to methods similar to OECD 401 (limit test) and was performed pre-GLP. A concise description of the protocol is available and results are acceptable as basic data.

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)

Deviations:

not specified

Principles of method if other than guideline:

not applicable

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Grapefruit oil

IUPAC Name:

Grapefruit oil

Details on test material:

- Name of test material (as cited in study report): Grapefruit oil
- Physical state: liquid
- Lot/batch No.: Confidential information

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: healthy male Wistar albino rats
- Weight at study initiation: 200-250 g (in general)
- Fasting period before study: 16-20 hrs
- Housing: 5 per cage in suspended wire mesh cages. Bedding was placed beneath the cages.
- Diet: Fresh Purina Rat Chow (Diet #5012), ad libitum
- Water: ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C):controlled
- Humidity (%):controlled
- Photoperiod (hrs dark / hrs light): 12 hr light/dark cycle

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

no data

Doses:

single dose of 5 g/kg

No. of animals per sex per dose:

10 male animals

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observation
- Other examinations performed: symptomatology

Statistics:

The LD50 and 95% confidence intervals were calculated if possible by the method of Litchfield and Wilcoxon (1949) or Horn (1956).

Results and discussion

Preliminary study:

Not relevant

Effect levels

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

1 out of 10 rats died on day 1

Clinical signs:

other: No effects observed

Gross pathology:

Not performed

Other findings:

Necropsy was not performed.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 value of grapefruit 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 grapefruit oil was administered orally to 10 rats. The test was conducted according to methods similar to OECD 401 (limit test) and was performed pre-GLP. The animals were observed for 14 days. One animal died on the first day. No symptoms were noted. The oral LD50 value of grapefruit 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).