Grapefruit, ext.

Endpoint summary

Description of key information

Acute oral toxicity:
LD50 > 5000 mg/kg bw (standard acute method, limit test; similar to OECD 401)
Acute dermal toxicity:
LD50 > 5000 mg/kg bw (standard acute method, limit test; similar to OECD 402)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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.

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

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

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).

Preliminary study:

Not relevant

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.

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).

Endpoint conclusion

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

other justification

Justification for data waiving:

other:

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

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 402 (limit test) and was performed pre-GLP. A concise description of the protocol is available and results are acceptable as basic data.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

not specified

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

rabbit

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

No data
TEST ANIMALS
- Weight at study initiation:2.0-3.0 kg (in general)
- Housing: 2 per cage in suspended wire mesh cages. Bedding was placed beneath the cages
- Diet: Fresh Purina Rabbit Chow (Diet #53-21) ad libitum
- Water: ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: abdomen
- % coverage: 10%
- Type of wrap if used: gauze patch, torsi wrapped with plastic and secured with tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): test site was wiped
- Time after start of exposure: 24 hrs

TEST MATERIAL
- Amount(s) applied: 5000 mg/kg bw

Duration of exposure:

24 hrs

Doses:

5 g/kg

No. of animals per sex per dose:

10 animals/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observation
- Necropsy of survivors performed: no
- Other examinations performed: symptomatology and skin irritation

Statistics:

The LD50 and 95% confidence intervals were calculated (if possible).

Preliminary study:

Not relevant

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

1 out of 10 rabbits died on day 8

Clinical signs:

other: No effects observed

Gross pathology:

Not performed

Other findings:

Skin irritation:
Slight redness - 6/10
Moderate redness - 2/10
Slight edema - 7/10
Moderate edema - 3/10
No information on scoring system used.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The dermal LD50 value of grapefruit oil in rabbits 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 dermally to 10 rabbits. The test was conducted according to methods similar to OECD 402 (limit test) and was performed pre-GLP. The animals were observed for 14 days. One animal out of 10 died on day 8. Slight to moderate redness and oedema was noted in the majority of the animals. The dermal LD50 value of grapefruit oil in rabbits 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).

Endpoint conclusion

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Additional information

Acute oral toxicity was tested in a standard acute limit test, in which a single dose of grapefruit oil (5000 mg/kg bw) was administered orally to 10 rats.

The animals were observed up to 14 days after application. One animal died on day 1. No other mortality was observed. The oral LD50 was established to be >5000 mg/kg bw.

 

Acute dermal toxicity was also tested in a standard acute limit test, in which 10 rabbits were exposed to a single dose of grapefruit oil (5000 mg/kg bw) dermally. The animals were observed up to 14 days after application. One animal died on day 9. No other mortality was observed. Slight to moderate redness and oedema was noted in the majority of the animals. The dermal LD50 was established to be > 5000 mg/kg bw.

Justification for classification or non-classification

Based on the available information, grapefruit oil has been shown to be of low acute toxicity when applied via the oral and dermal route. Therefore, the substance grapefruit oil does not need to be classified for acute toxicity according to the criteria outlined in Annex I of 1272/2008/EC (CLP/EU-GHS) and Annex VI of 67/548/EEC.