Farnesol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07 December 1982 - 23 December 1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

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

Remarks:

Non-guideline, non-GLP study, however experimental details and results are well-reported.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Acute dermal toxicity was tested in male and female WISW-strain rats. Applications were made on scarified and intact skin and test animals were observed for 14-days for any signs of reaction and mortality.

GLP compliance:

no

Test type:

fixed dose procedure

Limit test:

yes

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
- Strain: BOR: WISW (substrain SPF TNO)
- Weight at study initiation: 190.0 to 258.0 g for males, 160.0 to 205.0 g for females
- Housing: maximum 5 rats per cage
- Diet (e.g. ad libitum): Pellets with added vitamins
- Water (e.g. ad libitum): Aqua fontana fit for human consumption, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2 °C
- Humidity (%): 45 to 55%
- Photoperiod (hrs dark / hrs light): 12 hour photoperiod with fluorescent lighting (120 Lux)

IN-LIFE DATES: From: 7/12/1982 To: 23/12/1982

Administration / exposure

Type of coverage:

other: Scarified and intact skin

Vehicle:

other: white Vaseline

Details on dermal exposure:

TEST SITE
- Area of exposure: Clipped area (8 x 5 cm) on the back of each test animal; one group was abraded with a clean clipper blade to penetrate the horny layer of the epidermis without causing bleeding, while the other group was left intact.
- Type of wrap if used: Dose secured for 24 hours with gauze pads and plastic material

REMOVAL OF TEST SUBSTANCE
- Washing: Substance removed with wet disposable gauze
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied: 2.40 to 3.88 g
- Concentration: 10%
- Constant volume or concentration used: Constant concentration, the application sample was weighed per animal
- For solids, paste formed: yes

Duration of exposure:

24h

Doses:

10%

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical-toxicological signs (modified Irvin-Screening) recorded at 2, 4, 24, 48 and 72 hrs and 7 and 14 days after application; body weight recorded at the start and end of experiment on the surviving animals.
- Necropsy of survivors performed: yes, immediately after all mortalities and upon study completion for the survivors
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Skin alterations (modified Draize-Scheme) recorded at 24 hours and 3, 7 and 14 days after application

Results and discussion

Preliminary study:

Pairs of female rats were scarified and administered with 5 and 15 g/kg bodyweight.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 15 000 mg/kg bw

Based on:

test mat.

Remarks on result:

no indication of skin irritation up to the relevant limit dose level

Mortality:

No mortalities were observed

Clinical signs:

other: The sample did not induce any clinical-toxicological symptoms and no skin alternations were observed.

Gross pathology:

No gross pathological findings were recorded.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The dermal LD50 of 10% farnesol in Vaseline was determined to be > 15 g/kg bodyweight for rat.

Executive summary:

The acute dermal toxicity of 10% farnesol in Vaseline was tested in male and female WISW rats. A single dose of 15 g/kg bodyweight was applied on scarified and intact skin of the test animals and secured for 24 hours. Mortality, clinical signs of toxicity, changes in bodyweight, skin alterations and gross pathology were observed for 14 days following application. No mortalities were observed and the dermal LD50 was determined to be > 15 g/kg bodyweight. This study is reliable with restrictions (Klimisch 2) as it was well-designed and well-reported, however was not performed according to any specific guideline or to GLP.