Lemon, ext.

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

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 401 (Acute Oral 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): Lemon oil
- Physical state: Liquid
- Lot/batch No.: Confidential information

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 150-300 g
- Fasting period before study: Overnight before exposure
- Housing: Individually
- Diet (e.g. ad libitum): Commercial diet
- Water (e.g. ad libitum): Ad libitum

ENVIRONMENTAL CONDITIONS
No data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50%
- Amount of vehicle (if gavage): 5 ml/kg

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

2 (initially) + 8 (additionally after 14 days), male or female

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

Statistics:

Horn's method (determination of LD50)

Results and discussion

Preliminary study:

Not performed

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality

Mortality:

No mortality occurred during study (10 animals)

Clinical signs:

other: Diarrhea, depression, piloerection, lacrimation

Gross pathology:

No gross findings

Other findings:

Not relevant

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, no mortality occurred in any of the 10 rats treated with 5000 mg/kg bw by oral gavage. An LD50 of >5000 mg/kg bw was therefore established, indicating that Lemon oil does not need to be classified for acute oral toxicity.

Executive summary:

The study was performed similar to OECD401 to determine the acute toxicity potential of Lemon oil. 10 male/female rats (2 initially, with an additional 8) were treated with 5000 mg/kg bw Lemon oil in corn oil by oral gavage. Clinical signs were recorded for 14 days, followed by gross necropsy at the end of the observation period.

No mortality occurred during the study, but some clinical signs were noted: diarrhea, depression, piloerection and lacrimation, which were probably caused by the high level of dosage. No gross findings were observed during gross pathology. Based on these results a LD50 of >5000 mg/kg bw could be established, indicating that Lemon oil does not need to be classified for acute oral toxicity.