Tridecan-1-ol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data from peer review journals

Data source

Reference

Reference Type:

publication

Title:

Acute Toxicity to the rat

Author:

SCALA et al.

Year:

1973

Bibliographic source:

American Industrial Hygiene Association Journal

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 the test chemical was condcuted on six rabbits to assess its eye irritation potential.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Tridecan-1-ol

EC Number:

203-998-8

EC Name:

Tridecan-1-ol

Cas Number:

112-70-9

Molecular formula:

C13H28O

IUPAC Name:

tridecan-1-ol

Test material form:

solid

Details on test material:

- Name of test material (as cited in study report):Tridecanol (C-13)
- Molecular formula :C13H28O
- Molecular weight :200.37 g/mole
- Substance type:Solid
- Physical state:Organic

Specific details on test material used for the study:

- Name of test material: tridecan-1-ol
- Molecular formula: C13H28 O
- Molecular weight: 200.37 g/mole
- Substance type: Solid
- Physical state: Organic

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

No data

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

0.1 ml of undiluted alcohol

Duration of treatment / exposure:

7 days

Observation period (in vivo):

at 1, 4, and 24 hours and at 2, 3, 4, and 7 days

Number of animals or in vitro replicates:

Six

Details on study design:

TEST SITE
Area of exposure: conjuctival 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.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24 h

Score:

4

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Results 2

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

72 h

Score:

0

Reversibility:

not specified

Remarks on result:

other: Little irritation and persistent corneal opacity was observed.

Results 3

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

7 d

Score:

0

Reversibility:

not specified

Remarks on result:

other: Little irritation and persistent corneal opacity was observed.

Other effects:

Little irritation and persistent corneal opacity was observed.

Any other information on results incl. tables

Score:

Alcohol	Irritation	Median Score
		24 hr	72 hr	7 days
Tridecyl alcohol	Moderate	4	0	0

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

The median score was 4, 0 and 0 at 24 hours, 27 hours and day 7 respectively. Also the chemical caused little irritation in most of the animals, but persistent corneal opacity in one rabbit. Thus on the basis of scores and observed effects the test chemical was considered as moderately irritating to the rabbits’ eye.

Executive summary:

An ocular irritation study of the test chemical 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. The median score was 4, 0 and 0 at 24 hours, 27 hours and day 7 respectively. Also the chemical caused little irritation in most of the animals, but persistent corneal opacity in one rabbit. Thus on the basis of scores and observed effects the test chemical was considered as moderately irritating to the rabbits’ eye.