Lemon, ext.

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1971

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: It was not indicated if the study was performed according to a guideline or under GLP conditions. However, the methods and results are reported concise but complete.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1971

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Lemon, ext.

EC Number:

284-515-8

EC Name:

Lemon, ext.

Cas Number:

84929-31-7

Molecular formula:

Not applicable (a generic molecular formula cannot be provided for this specific UVCB substance).

IUPAC Name:

Essential oil of lemon obtained from the peel of Citrus limonum (Rutaceae) by expression and/or distillation, including cold pressed, distilled, terpenes and essence qualities

Constituent 2

Reference substance name:

Lemon oil

IUPAC Name:

Lemon oil

Details on test material:

- Name of test material (as cited in study report):
- Physical state: Liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.5-3.0 kg
- Housing: Individually
- Diet: Commercial diet
- Water: Ad libitum

ENVIRONMENTAL CONDITIONS
No data

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Not defined
- % coverage: 10% (240 cm2)
- Type of wrap if used: Rubber sleeve with Webril padding

TEST MATERIAL
- Amount(s) applied: 5 ml/kg
- Constant volume or concentration used: yes

Duration of exposure:

24 hours

Doses:

10000 mg/kg bw

No. of animals per sex per dose:

6 (independent of sex)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: Daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, dermal reactions (scored according to Draize)

Statistics:

- Horn's method

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 1 out of 6 animals died during study

Mortality:

1 out of 6 animals died during study

Clinical signs:

other: No toxic signs observed

Gross pathology:

No tissue damage observed at termination

Other findings:

Skin irritation:
- Erythema score between 2-4 in all animals
- Edema score between 1-3 in 4 animals
- Discoloration noted in 1 animal
- Scaling noted in 5 animals
- Eschar formation noted in 5 animals

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study, 1 out of 6 rabbits died after dermal exposure to 10000 mg/kg bw Lemon oil. A LD50 of >10000 mg/kg bw was therefore established and the substance does not need to be classified as acute dermal toxic.

Executive summary:

The study was performed to determine the acute toxicity potential of Lemon oil. 6 male/female rabbits were treated with 10000 mg/kg bw Lemon oil dermally. Clinical signs and dermal reactions were recorded for 14 days, followed by gross necropsy at the end of the observation period.

Under the conditions of this study, 1 out of 6 rabbits died after dermal exposure to 10000 mg/kg bw Lemon oil. A LD50 of >10000 mg/kg bw was therefore established and the substance does not need to be classified as acute dermal toxic.