Oct-1-ene-3-ol

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:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Oct-1-ene-3-ol

EC Number:

222-226-0

EC Name:

Oct-1-ene-3-ol

Cas Number:

3391-86-4

Molecular formula:

C8H16O

IUPAC Name:

oct-1-en-3-ol

Test material form:

liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Bedoukian Research Inc.; 2005005-0019
- Expiration date of the lot/batch: 12/2005
- Purity test date: Jan. 5, 2005

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Tightly sealed under inert gas in a cool, well ventilated area.
- Stability under test conditions: Stable

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Millbrook Breeding Labs, Amherst, Massachusetts, USA
- Age at study initiation: at least 10 weeks old
- Weight at study initiation: 2.00-2.46 kg
- Housing: individually in suspended stainless steel cages
- Diet (e.g. ad libitum): TEK 8630 Rabbit Food
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 68 +/- 5 degrees F
- Humidity (%): 30-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: April 21-28, 2005

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 100%

Duration of treatment / exposure:

24 hrs

Observation period (in vivo):

Until no signs of irritation were observed (6-7 days)

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hrs

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 4 days

Results 2

Irritation parameter:

iris score

Basis:

animal #2

Time point:

72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 4 days

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 4 days

Irritant / corrosive response data:

One animal showed mild corneal opacity starting at the 24 hr observation which resolved by the day 4 observation. One animal showed iris irritation (score of 1) at the 72 hr observation only. All three animals showed redness of the conjunctiva beginning at the 1 hr observation. In all animals this was resolved by day 7. Chemosis was also seen in all animals starting at the 1 hr observation, and was resolved in all animals by day 4. Discharge was also noted in all animals at the one hr observation, and was resolved in all animals by the 48 hr observation. Untreated eyes showed no signs of irritation.

Results of the examination with fluorescein showed all animals had mild to moderate fluorescein staining by the 48 hr observation. This was resolved in all animals by the day 7 observation.

Other effects:

- Lesions and clinical observations: All animals gained weight during the study, and no animals showed signs of toxicity.

Any other information on results incl. tables

Eye Irritation Scores – Average of 24/48/72 hr Readings

	Animal 1	Animal 2	Animal 3
Cornea Opacity	0	1.33	0
Cornea Area	0	3.66	0
Iris	0	0.33	0
Conjunctival Redness	1.33	2	1
Chemosis	0	0.66	0.33
Discharge	0	0.33	0
Intensity of Staining with Fluoroscein	2	0.66	1
Area of Staining with Fluoroscein	2	1	2
Day All Symptoms Fully Reversed	6	7	6

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance is not classified as irritating to eyes according to the Regulation EC No. 1272/2008 (CLP) criteria.

Executive summary:

The eye irritant potential of 1-octen-3-ol was tested in an OECD guideline 405 study. 0.1 mL of test substance was placed in the conjunctival sac of three rabbits. The other eye was left untreated as a control. The animals were observed at 1, 24, 48, and 72 hrs after installing the test substance, and daily thereafter until no signs of irritation remained. The test substance is moderately irritating to eyes.