2-chloroethanol

Eye irritation

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

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

Test material information

Constituent 1

Reference substance name:

2-chloroethanol

EC Number:

203-459-7

EC Name:

2-chloroethanol

Cas Number:

107-07-3

Molecular formula:

C2H5ClO

IUPAC Name:

2-chloroethan-1-ol

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.