Farnesol

Eye irritation

Administrative data

Endpoint:

eye 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 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye 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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

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

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

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0. 1mL
- Concentration (if solution): undiluted

Duration of treatment / exposure:

Ocular reactions were assessed 1, 24, 48 and 72 h after treatment and thereafter once daily up to day 5 post application.

Observation period (in vivo):

5 days

Number of animals or in vitro replicates:

3

Details on study design:

The test item was introduced into the conjunctival sac of the left eye and the untreated right eye served as control. There was no removal of the test item.

SCORING SYSTEM:
Grading of ocular lessions as per EEC directive 93/21/EEC of April 27, 1993:
Corneal Opacity (0-4 scale)
Irititis (0-2 scale)
Conjunctival redness (0-3 score)
Chemosis (0-4 scale)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 2 days

Remarks on result:

other: Hyperemia of the iris observed

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.67

Max. score:

1

Reversibility:

fully reversible within: 3 days

Remarks on result:

other: Hyperemia of the iris observed

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 5 days

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 3 days

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 3 days

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 3 days

Remarks on result:

other: Secretion observed with chemosis

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.67

Max. score:

2

Reversibility:

fully reversible within: 2 days

Remarks on result:

other: Secretion observed with chemosis

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 2 days

Remarks on result:

other: Secretion observed with chemosis

Irritant / corrosive response data:

Hyperemia of the iris was observed at 1 and 24 hours post application (p.a.) in animal no. 1 as well as at 24 and 48 hours p.a. in animal no. 2. Moderate redness of the conjunctivae was seen 1 hour p.a. in all animals. Redness was still apparent up to day 4 p.a. in animal no. 1 and up to 48 hours p.a. in animals no. 2 and 3. Swelling of the conjunctivae (slight to moderate) was observed in all animals 1 and 24 hours p.a. and was still apparent in animal no. 1 up to day 4 p.a. and in animal no 3 at 48 hours p.a. Additionally, slight to moderate ocular secretion was seen between 1 and 48 hours p.a. in all animals. The observed findings were reversible within 5 days p.a.

Other effects:

No other toxic effects were observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The mean individual grades of ocular reactions at 24, 48 and 72 hr post-application were 0.0, 0.0 and 0.0 for corneal opacity, 0.33, 0.67 and 0.0 for iritis, 2.0, 1.0 and 1.0 for conjunctival redness, and 1.0, 0.67 and 0.33 for chemosis. All effects were fully reversible within 5 days.

Executive summary:

The eye irritation/corrosion potential of the test item was tested on 3 albino rabbits. In each animal, 0.1 mL of the test article was introduced into the conjunctival sac of one eye and the untreated eye served as control. Both eyes were examined at 24, 48 and 72 h post application (p.a.) and thereafter once daily up to day 5 p.a. Hyperermia of the iris was observed in two animals. Slight to moderate redness and swelling of the conjunctivae as well as slight to moderate ocular secretion were seen in all animals. The mean individual grades of ocular reactions at 24, 48 and 72 hr post-application were 0.0, 0.0 and 0.0 for corneal opacity, 0.33, 0.67 and 0.0 for iritis, 2.0, 1.0 and 1.0 for conjunctival redness, and 1.0, 0.67 and 0.33 for chemosis. All effects were fully reversible within 5 days. No other toxic effects were observed. The test substance is therefore not classified as an eye irritant according to CLP Regulation (EC) No 1272/2008 (8th Adaptation to Technical Progress). This study is reliable without restriction (Klimisch 1) as it was conducted according to guideline and GLP.