Eugenol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study design appears to follow OECD guideline 423 (2001) with deviations (older mice should have been used; starting dose was not one of the recommended dosages, and dose volume was not reported).

Data source

Reference

Reference Type:

review article or handbook

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

yes

Remarks:

Older mice should have been used; starting dose was not one of the recommended dosages, and dose volume was not reported

Principles of method if other than guideline:

In the single dose oral toxicity study, groups of five males and five females were administered 180 to 3,000 mg/kg body weight of eugenol in 1% solution of carboxymethylcellulose in saline by gavage.

GLP compliance:

not specified

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Eugenol

EC Number:

202-589-1

EC Name:

Eugenol

Cas Number:

97-53-0

Molecular formula:

C10H12O2

IUPAC Name:

2-methoxy-4-(prop-2-en-1-yl)phenol

Details on test material:

- Name of test material (as cited in study report): eugenol
- Physical state: Liquid
- Analytical purity: >99%
- Lot/batch No.: Lot No. 36483
- Stability under test conditions: Test article in feed is stable for 2 weeks at temperatures as high as 45°C
- Storage condition of test material: Stored at 20 to 24°C

Test animals

Species:

mouse

Strain:

B6C3F1

Sex:

male/female

Details on test animals or test system and environmental conditions:

The male and female B6C3F1 mice were obtained from the NCI Frederick Cancer Research Center (Frederick, Maryland). The B6C3F1 mice used in these studies were produced under strict barrier conditions.
Upon receipt, the animals were isolated for 7-8 days and examined for the presence of parasites or other diseases. The animals were assigned randomly by species and sex to cages and then the cages were assigned randomly to dosed and control groups. The mice were 6-7 weeks old at the beginning of each study.
The mice were housed five per cage in suspended solid-bottom polycarbonate cages covered with Reemay® spun-bonded polyester filters and Dupont style #2024 filters. Hardwood chip bedding was changed twice per week, and feed hoppers (glazed clay) were changed and washed once per week. Cages were washed twice per week in a tunnel cage dish washer at 82°C.
An automatic watering system supplied tap water.
Feed was available ad libitum.
Animal rooms were maintained at 21-23°C and humidity was 30-50%.
Incoming air was filtered through fiberglass roughing filters.
Room air was changed 15 times per hour.
Fluorescent lighting was provided 12 hours per day.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

In the single dose oral toxicity study, groups of five males and five females were administrated 180 to 3,000 mg/kg eugenol in 1% solution of carboxymethylcellulose in saline by gavage. Surviving animals were killed on Day 16.

Doses:

180, 375, 750, 1,500, or 3,000 mg/kg body weight of eugenol in 1% solution of carboxymethylcellulose in saline by gavage

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

see details on oral exposure

Statistics:

no data

Results and discussion

Preliminary study:

not applicable

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

> 1 500 - < 3 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

> 1 500 - < 3 000 mg/kg bw

Based on:

test mat.

Mortality:

One male mouse in the 750 mg/kg body weight dose group died.
Two of the 5 male mice and all 5 female mice in the 3,000 mg/kg body weight dose group died.

Clinical signs:

other: no data

Gross pathology:

no data

Other findings:

No other findings reported.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Executive summary:

In a single dose oral toxicity study, groups of five male and five female mice were administered 180 to 3,000 mg/kg body weight of eugenol in 1% solution of carboxymethylcellulose in saline by gavage. One male mouse in the 750 mg/kg body weight dose group died and two of the five male mice and all five female mice in the 3,000 mg/kg body weight dose group died. The LD50 was considered to be between 1,500 and 3,000 mg/kg body weight.