Lime (Citrus aurantifolia), ext.

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 1971

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Test was conducted according to methods similar to OECD guideline 401 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:

1971

Report date:

1971

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Lime Oil

IUPAC Name:

Lime Oil

Details on test material:

- Name of test material (as cited in study report): Lime 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
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 150 to 300 grams
- Fasting period before study: overnight
- Housing: individually
- Diet: commercial diet ad libitum
- Water: 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% (w/v or v/v)

Doses:

5 ml/kg = 4.367 g/kg bw

No. of animals per sex per dose:

10 animals/dose

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: toxic signs and mortality were recorded immediately following dosing and once daily thereafter for 14 days.
- Necropsy of survivors performed: yes

Statistics:

The LD50 value was calculated according to Horn's method (Horn, H. J., Biometrics, 12, 311-322, 1956)

Results and discussion

Preliminary study:

Not relevant

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 4 367 mg/kg bw

Remarks on result:

other: (5 ml/kg bw)

Mortality:

No mortality observed

Clinical signs:

other: Bloody crust nose, salivation, lacrimation, and depression

Gross pathology:

At termination, one animal had enlarged right kidney; one had pale kidneys.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 value of lime oil in rats was established as exceeding 4.367 g/kg bw (5.0 ml/kg bw), 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 5 ml/kg bw (4.367 g/kg bw) dose of lime oil was administered orally to 10 rats. The test was conducted according to methods similar to OECD 401 and was performed pre-GLP. Toxic signs and mortality were recorded immediately following dosing and once daily thereafter for 14 days. Necropsy was performed on survivors.

No mortality was observed. Toxic signs included bloody crust nose, salivation, lacrimation, and depression. At termination, one animal had enlarged right kidney; one had pale kidneys. The oral LD50 value of lime oil in rats was established as exceeding 4.367 g/kg bw (5.0 ml/kg bw), 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).