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Toxicological information

Acute Toxicity: oral

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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

Constituent 1
Chemical structure
Reference substance name:
Eugenol
EC Number:
202-589-1
EC Name:
Eugenol
Cas Number:
97-53-0
Molecular formula:
C10H12O2
IUPAC Name:
4-allyl-2-methoxyphenol
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 levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
> 1 500 - < 3 000 mg/kg bw
Based on:
test mat.
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:
no data
Body weight:
The mean body weights of the mice and the mean weight change of the group ± standard error of the mean is reported ( see the field "illustration")
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.

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