Levomenol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

05 February 2001 - 17 September 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

1996

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

1996

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

1998

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(-)-alpha-Bisabolol

IUPAC Name:

(-)-alpha-Bisabolol

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, Sandhofer Weg 7, 97633 Sulzfeld
- Age at study initiation: Young adult animals (male animals approx. 8 - 12 weeks, female animals approx. 14 -18 weeks)
- Weight at study initiation: Animais of comparable weight (male animals mean 241 g, female animals mean 202 g)
- Fasting period before study: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
- Housing: Single housing in Stainless steel wire mesh cages
- Diet: Kliba-Labordiät, Provimi Kliba SA, Kaiseraugst, Switzerland, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: Acclimatisation for at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24°C
- Humidity: 30 - 70%
- Photoperiod (dark / light): : 12 h / 12 h

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 40 g/100 mL
- Amount of vehicle: 5 mL/kg
- Justification for choice of vehicle: Olive oil Ph.Eur/DAB had to be used to ensure homogeneity of the preparation.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights shortly before administration (day 0), weekly thereafter and at the end of the study (before fasting period). Recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals. A check for any dead or moribund animal was made twice each workday and once on Saturdays, Sundays and on public holidays.
- Necropsy of survivors performed: yes (Necropsy with gross-pathology examination on the last day of the observation period. Withdrawal of food at least 16 hours before killing with CO2.)

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

No signs of toxicity were observed during clinical examination.

Body weight:

The mean body weights of the dose groups increased throughout the study period.

Gross pathology:

No macroscopic pathologic abnormalities were noted in the animals examined at termination of the study.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study the LD50 of the test substance after oral administration was found to be greater than 2000 mg/kg bw for male and female rats.

Executive summary:

The study was performed according to OECD guideline 423 to assess the acute toxicity following oral administration of the test item in Wistar rats.

Single doses of 2000 mg/kg bw of test material preparations olive oil Ph. Eur./DAB were given to two dose groups of three fasted animals, each (males and females) by gavage in a sequential manner. No mortality occurred. No clinical signs and findings were observed. The mean body weights of the dose groups increased throughout the study period. No macroscopic pathologic abnormalities were noted in the animals examined at the end of the observation period.

Under the conditions of this study the LD50 of the test substance after oral administration was found to be greater than 2000 mg/kg bw for male and female rats.