Farnesol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1992

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

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:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Housing: Individual housing (50 x 45 x 40 cm) in a battery of cages, each equipped with a paper roll disposal system
- Diet (e.g. ad libitum): Pellets with added vitamins, ad libitum
- Water (e.g. ad libitum): Drinking water for human consumption, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3 C
- Humidity (%): 30 to 70 %
- Photoperiod (hrs dark / hrs light): 12 hour photoperiod with artificial lighting (120 lux)

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

15 days post application

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: Clipped area (approximately 6 cm2) on the back of each test animal
- Type of wrap if used: Ypsiplast® (Holthaus Medical, Remscheid-Lüttringhausen), held in place by non-irritating tape (Elastoplast®, Beiersdorf AG, Hamburg) and Stuelpa® (P. Hartmann AG, Heidenheim-Brenz)

SCORING SYSTEM:
As per OECD Test Guideline 404
Erytrhema and eschar 0 -4 scale
Oedema 0-4 scale

Animals were examined for signs of erythema and oedema at 60 minutes and 24, 48 and 72 hours after patch removal and once daily thereafter up to 15 days post-application.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.67

Max. score:

3

Reversibility:

fully reversible within: 9 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2.67

Max. score:

3

Reversibility:

not fully reversible within: 15 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 8 days

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.33

Max. score:

2

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: Scale formation after 6 days

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

not fully reversible within: 15 days

Remarks on result:

other: Induration after 72 hours, scabbing after 6 days

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2.33

Max. score:

3

Reversibility:

fully reversible within: 12 days

Remarks on result:

other: Scale formation after 7 days

Irritant / corrosive response data:

Erythema (very slight to severe) was observed in all animals between 1 h after patch removal and day 7 post application (p.a.). It was still apparent in two animals on day 8 p.a. and in one animal up to the end of the observation period (day 15 p.a.). Oedema (very slight to severe) was observed in all animals up to day 6 p.a., and was still apparent in two animals up to day 11 p.a. and in one animal up to day 15 p.a.

Scale formation was seen from day 6 and day 7 p.a. up to the end of the observation period (day 15 p.a.) in animals no. 1 and 3, respectively.

Additionally, in one animal (no. 2) the treated skin area became indurated from 72 h and up to day 13 p.a. This induration was associated with fissures which were first bloody and then covered with scab. At the days 14 and 15 after patch removal the healing process caused an incipient desquamation of the indurated skin area .

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

Mean individual values of 2.67, 2.67 and 2.0 were observed for erythema and mean individual values of 1.33, 3.0 and 2.33 were observed for oedema.

Executive summary:

The test item was assessed in an acute dermal irritation/corrosion test in 3 albino rabbits. Shaved skin was exposed to 0.5 mL of the test article for 4 hours under a semi-occulsive dressing. Animals were examined for signs of erythema and oedema at 60 min, 24, 48 and 72 h after patch removal and thereafter once daily up to day 15 post application. Mean individual values of 2.67, 2.67 and 2.0 were observed for erythema and mean individual values of 1.33, 3.0 and 2.33 were observed for oedema. Very slight to severe erythema and oedema were observed in all animals. Additionally, scale formation was observed in two animals and in duration of the treated skin area with bloody fissures was seen in one animal. The effects in one animal were not fully reversible within 15 days after patch removal. This study is reliable without restrictions (Klimisch 1) as it was conducted according to relevant guidelines and GLP.

As mean values of ≥ 2.3 to ≤ 4.0 for erythema/eschar and oedema were observed in at least 2 of 3 tested animals, the test item is classified a Skin Irritant, Category 2.