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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
Study period:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was performed pre-GLP and according to methods similar to OECD405.

Data source

Reference
Reference Type:
publication
Title:
Tissue Reactions to 2-Chloroethanol in Rabbits
Author:
Guess, W.L.
Year:
1970
Bibliographic source:
Toxicol. Appl. Pharamcol., 16, pp 382-390,

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
Draize
Principles of method if other than guideline:
- Individual scores are not reported, only the average for 6 animals per group.
GLP compliance:
no
Remarks:
pre-GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Anhydrous 2-chloroethanol was obtained from J. T. Baker Company.
Confirmation of purity was further accomplished by infrared analysis and index of refraction. These tests failed, however, to reveal traces of HCl
which altered the pH of the solutions of 2-chloroethanol in normal saline. This HCl was detected by silver nitrate test solution; on titration with 0.1 N NaOH solution, the hydrogen ion concentration was found to be 0.011 mole/liter. The HCl present in the 2- chloroethanol probably originates from hydrolysis of the compound in the presence of moisture. It was felt that chloroacetic acid was not the source of the acidic reaction since
the conditions necessary for the oxidation of the alcohol to the acid were not present.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
physiological saline
Controls:
no
Duration of treatment / exposure:
single instillation in the eye
Observation period (in vivo):
up to 1 week
Number of animals or in vitro replicates:
6 rabbits

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
6 animals
Time point:
other: 24-48-72 hours
Score:
1.39
Reversibility:
fully reversible within:
Remarks on result:
other: 7 days
Irritant / corrosive response data:
The average scores for the 6 animals per group are summarized in table 1. The average score for all animals for 24-48-72 hour is 0.27 for cornea, 1.9 for Iris, 1.9 for redness and 1.5 for chemosis.
Only the undiluted 2-chloroethanol caused a transient clouding of the cornea, and no further damage to this structure was noted even when checked with fluorescein sodium solution after 24 hours. There was irritation of the iris which was manifested primarily in the form of inflammation. It should be noted that 1: 5 dilution of 2-chloroethanol caused only a transient inflammation. There was excessive swelling and obvious reddening of the conjunctiva at the 24-hour observation period, and the condition worsened up to and including the 72-hour period. Recovery was complete in approximately 1 week.

Any other information on results incl. tables

Table 1.: Summary of ocular lesions mean of 6 animals per group

Dilution

Effect

Days after application

1

2

3

Undiluted

Cornea

Iris

Redness

Chemosis

0.8

1.8

2.1

1.1

0

2

2.3

2

0

1.8

1.3

1.5

1:2

Cornea

Iris

Redness

Chemosis

0

1.8

1.3

1.5

0

1.3

1

1.8

0

0.8

0.3

1

1:5

Cornea

Iris

Redness

Chemosis

0

0.8

0.8

1.3

0

0

0.3

1

0

0

0

0.3

1:10

Cornea

Iris

Redness

Chemosis

0

0

0

0.3

0

0

0

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
Category 2B (mildly irritating to eyes) based on GHS criteria
Remarks:
Migrated information
Conclusions:
Individual scores are not given however the avarage scores for all animals give sufficient information for C&L.. The average score for all animals for eye irritation for 24-48-72 hour is 0.27 for cornea, 1.9 for Iris, 1.9 for redness and 1.5 for chemosis. The effect are fully reversible in 7 days. The substance is therefore classified as mildly irritating to the eyes.
Executive summary:

This paper reports on the effect of pure 2-chloroethanol, and various dilutions of this material, on several of the tissue types with which a tracheotomy tube might come into contact in a patient. It was found that pure 2-chloroethanol is quite destructive to most of the tissues, including ophthalmic, mucosal, muscular, and subcutaneous tissues; however, on dilution, the toxicity potential decreased sharply. Dilutions of 1:10 were still toxic, but in most cases, dilutions of 1:100 were practically innocuous. A cell culture evaluation correlated almost perfectly with in vivo techniques.

The average score for all animals for eye irritation for 24-48-72 hour is 0.27 for cornea, 1.9 for Iris, 1.9 for redness and 1.5 for chemosis. Only the undiluted 2-chloroethanol caused a transient clouding of the cornea, and no further damage to this structure was noted even when checked with fluorescein sodium solution after 24 hours. There was irritation of the iris which was manifested primarily in the form of inflammation. It should be noted that 1: 5 dilution of 2-chloroethanol caused only a transient inflammation. There was excessive swelling and obvious reddening of the conjunctiva at the 24-hour observation period, and the condition worsened up to and including the 72-hour period. Recovery was complete in approximately 1 week.