Grapefruit, ext.

Acute Toxicity: dermal

Administrative data

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.

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 402 (Acute Dermal Toxicity)

Deviations:

not specified

GLP compliance:

no

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:

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

Administration / exposure

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).

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 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.

Applicant's summary and conclusion

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).