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Toxicological information

Eye irritation

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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

Constituent 1
Chemical structure
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

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
4
Reversibility:
not specified
Remarks on result:
positive indication of irritation
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.
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.
Irritant / corrosive response data:
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.