Farnesol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

Study not conducted according to regulatory guideline method or GLP, however study is well-designed and well-reported.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics", by the Staff of the Division of Pharmacology, FDA

Version / remarks:

1959

Deviations:

no

Principles of method if other than guideline:

A single dose of the test material was administered orally to groups of 10 Wistar rats (5 males and 5 females) at doses of 10 mL/kg and 20 mL/kg per group; Animals were observed for clinical signs (motor activity, coordination disturbance, piloerection and diarrhoea) and mortality for 7 days after dosing.

Institute Name IBR
Final Report date 00.11.1976
Results acute oral LD50 (rat) > 20 ml/kg (calc.)
Reliability Rel 2
GLP NO
observed, all symptoms reversible within 3 hours. Rel. 2: According to FDA, 1954, but
not GLP, no batch number and no analytical data on purity, probably technically pure
material was tested;

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Farnesol

EC Number:

225-004-1

EC Name:

Farnesol

Cas Number:

4602-84-0

Molecular formula:

C15H26O

IUPAC Name:

farnesol

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation:120 to 160 g
- Fasting period before study: 16 hours
- Housing: Individual cages
- Diet (e.g. ad libitum): Laboratory standard diet (Ssniff/Intermast), ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 °C ± 1 °C
- Humidity (%): 45 - 55 % RH
- Photoperiod (hrs dark / hrs light): 12 hr light photoperiod

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

10mL/kg or 20mL/kg

No. of animals per sex per dose:

5 males and 5 females per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days

Results and discussion

Preliminary study:

The doses were determined in a range-finding study. A higher dose is not used in the determinative test for volume reasons.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 20 mL/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No mortality was observed at either dose.

Clinical signs:

other: Decreased motor activity, coordination disturbance, piloerection and diarrhoea were observed, however these symptoms were reversible after 3 hours.

Gross pathology:

No pathological changes in cranial, thoracic and abdominal cavities observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 in rat is > 20mL/kg.

Executive summary:

In an acute oral toxicity study, groups of 10 Wistar rats (5 males & 5 females) per group, received doses of 10 and 20 mL test material/kg by gavage and were observed for 7 days thereafter. There were no mortalities or pathologic effects observed. There was decreased motor activity, disturbances of coordination, piloerection and diarrhoea, however all symptoms were reversible within 3 hours. The LD50 was estimated to be > 20 mL/kg. This study is reliable with restrictions (Klimisch 2) as it was conducted according to guideline, however GLP status is unknown.