Bergamot, ext.

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1970

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test was conducted according to methods similar to OECD guideline 402 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:

1970

Report date:

1970

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

Study was performed prior to implementation of OECD guideline 401 but methodology used is regarded comparable.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Bergamot oil - furocoumarin free

IUPAC Name:

Bergamot oil - furocoumarin free

Details on test material:

- Name of test material (as cited in study report): substance HHKF (bergamot furocoumarin free)
- Physical state: clear liquid

Test animals

Species:

rabbit

Strain:

other: albino

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation:1400-1750 grams

ENVIRONMENTAL CONDITIONS
No data available

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Type of wrap if used: Saran wrap and bandages

REMOVAL OF TEST SUBSTANCE
- Washing (if done): test material was removed (method unspecified)
- Time after start of exposure: 24 hrs

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):20,000 mg/kg bw

VEHICLE
No vehicle was used

Duration of exposure:

24 hrs

Doses:

20000 mg/kg bw

No. of animals per sex per dose:

3 animals, sex unknown

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: animals were observed daily for signs of systemic toxicity; body weight gain and dermal erythema and/or edema was scored daily.
- Necropsy of survivors performed: gross autopsy at termination of the study (day 7)
- Other examinations performed: on day 5 blood samples were taken for hematology and clinical chemistry. Hematology included: erythrocyte, leucocyte and differential leucocyte counts; hematocrit and hemaglobin assessment. Clinical chemistry included serum glutamic oxaloacetic transaminase (SGOT); glucose; blood urea nitrogen (BUN); serum alkinase phosphatase (SAP); total serum protein; serum albumin; bilirubin; lactic acid dehydrogenase (LDH); cholesterol, serum calcium; serum phosphate and uric acid.

Statistics:

No data available

Results and discussion

Effect levels

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 20 000 mg/kg bw

Based on:

test mat.

Mortality:

No animals died during the study.

Clinical signs:

other: All subject showed mild erythema following the 24-hour exposure period, but edema was not observed. Erythema persisted in all three animals during the experimental period.

Gross pathology:

No gross signs of toxicity were observed.

Other findings:

Hematology and clinical chemistry were within normal limits and comparable to control values.

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 Bergamot oil in rabbits was established at exceeding 20000 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:

In an acute dermal toxicity test, performed according to a method comparable to OECD guideline 402, three albino rabbits were exposed to bergamot oil. Test animals were partially shaved. Bergamot oil was applied to the shaved skin under occlusion at an undiluted dosage of 20000 mg/kg bw. After 24 hours exposure, excess oil was removed and animals were observed for 7 days. Body weight, systemic toxicity and dermal irritation were recorded daily. On day 5 blood was drawn to determine hematology and clinical chemistry. At day 7, all animals were sacrificed and gross pathology was performed.

Bergamot oil did not produce mortality under the conditions of this study. All subjects developed mild erythema but edema was not observed. There were no gross signs of systemic toxicity and body weight gain, hematology and clinical chemistry were within normal limits and comparable to control values. Under the conditions of this study, the LD50 for dermal toxicity was established at > 20000 mg/kg bw. The substance therefore does not have to be classified according to the classification criteria as outlined in Annex VI of 67/548/EEC (DSD) and Annex I of 1272/2008/EC (CLP).