Octan-3-ol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

data is from peer reviewed journals

Data source

Reference

Reference Type:

publication

Title:

Acute Toxicity of a Homologous Series of Branched-Chain Primary Alcohols

Author:

R. A. SCALA & E. G. BURTIS

Year:

1973

Bibliographic source:

American Industrial Hygiene Association Journal, (1973), 34:11, 493-499

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

An ocular irritation study of chemical 2-ethylhexyl alcohol was conducted on six rabbits to assess its eye irritation potential.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylhexan-1-ol

EC Number:

203-234-3

EC Name:

2-ethylhexan-1-ol

Cas Number:

104-76-7

Molecular formula:

C8H18O

IUPAC Name:

2 ethylhexan-1-ol

Test material form:

liquid

Details on test material:

- Name of test material: 2-Ethyl-1-hexanol
- IUPAC name: 1-Hexanol, 2-ethyl-
- Molecular formula: C8H18O
- Molecular weight: 130.2292 g//mol
- Substance type: Organic
- Physical State: Liquid

Specific details on test material used for the study:

- Name of test material: 2-Ethyl-1-hexanol
- IUPAC name: 1-Hexanol, 2-ethyl-
- Molecular formula: C8H18O
- Molecular weight: 130.2292 g//mol
- Substance type: Organic
- Physical State: Liquid

Test animals / tissue source

Species:

rabbit

Strain:

other: albino

Details on test animals or tissues and environmental conditions:

no data available

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 ml of undiluted alcohol

Duration of treatment / exposure:

Treated eye was closed for 30 seconds

Observation period (in vivo):

24, 72 hours and 7 days

Duration of post- treatment incubation (in vitro):

no data available

Number of animals or in vitro replicates:

Six

Details on study design:

TEST SITE
Area of exposure: conjunctival sac of left eye
% coverage: No data
Type of wrap if used: no wrap used

REMOVAL OF TEST SUBSTANCE
Washing (if done): no washing performed
Time after start of exposure: not applicable

SCORING SYSTEM: Grading scale is slight-moderate-marked and severe.
Signs of irritation exposure were graded and scored according to the method of Draize.


TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: Initially and at termination the eyes were examined following instillation of 2 % sodium fluorescein solution to detect any corneal lesions if not otherwise visible.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24 h

Score:

19

Reversibility:

not specified

Remarks on result:

probability of severe irritation

Results 2

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

72 h

Score:

20

Reversibility:

not specified

Remarks on result:

probability of severe irritation

Results 3

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

7 d

Score:

0

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

Persistent widespread corneal opacity was observed

Any other information on results incl. tables

Acute Eye Irritation from Oxo Alcohols                                  

Alcohol	Irritation*	Median score**
		24 hours	72 hours	7 days
2-ethylhexyl	Severe	19	20	0

*-Grading Scale is: Slight-moderate-severe

**- Based on the scoring system of Draize

 

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

The median scores were 19, 20 and 0 at 24 hours, 72 hours and day 7 respectively. Persistent widespread corneal opacity was observed till 7 days in the rabbits.
Hence, 2-ethylhexyl alcohol was considered to be severely irritating to rabbit eyes.

Executive summary:

An ocular irritation study of 2-ethylhexyl alcohol was conducted on six rabbits to assess its eye irritation potential.

A single application of 0.1 ml of undiluted alcohol was made into the conjunctival sac of the left eye of each of six rabbits. The untreated eye served as the control. The treated eye was closed for 30 seconds and eyes were not washed. Observations for irritancy and possible systemic toxicity were made at 1, 4, and 24 hours and at 2, 3, 4, and 7 days. Where positive effects persisted, observations were continued initially and at termination the eyes were examined following instillation of 2 % sodium fluorescein solution to detect any corneal lesions if not otherwise visible. Signs of irritation exposure were graded and scored according to the method of Draize.

 

Persistent widespread corneal opacity was observed till 7 days in the rabbits.

The median scores were 19, 20 and 0 at 24 hours, 72 hours and day 7 respectively.

Hence, 2-ethylhexyl alcohol was considered to be severely irritating to rabbit eyes.