2,2-dichloro-1,1,1-trifluoroethane

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:

other: Acceptable method not GLP, no OECD TG followed

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,2-dichloro-1,1,1-trifluoroethane

EC Number:

206-190-3

EC Name:

2,2-dichloro-1,1,1-trifluoroethane

Cas Number:

306-83-2

Molecular formula:

C2HCl2F3

IUPAC Name:

2,2-dichloro-1,1,1-trifluoroethane

Constituent 2

Reference substance name:

Ethane, 2,2-dichloro-1,1,1-trifluoro- -

IUPAC Name:

Ethane, 2,2-dichloro-1,1,1-trifluoro- -

Details on test material:

- Name of test material (as cited in study report): Ethane, 1,1-dichloro-2,2,2-trifluoro (FC-123)
- Other: OCNB-173-17

Test animals / tissue source

Species:

rabbit

Strain:

other: albino

Details on test animals or tissues and environmental conditions:

no data

Test system

Vehicle:

other: propylene glycol

Controls:

yes, concurrent vehicle

Amount / concentration applied:

Group 1: 0.1 mL undiluted test substance
Group 2: 0.2 mL 50:50 mixture of test substance and propylene glycol
Group 3: 0.1 mL propylene glycol

Duration of treatment / exposure:

20 seconds (washed eye) to 14 days (unwashed eye)

Observation period (in vivo):

14 days

Number of animals or in vitro replicates:

- Two animals per group.

Details on study design:

The appropriate dose of material was placed in the right conjunctival sac of each of two albino rabbits. In all groups, after 20 seconds, one treated eye was washed with tap water for one minute. The treated eye of the other rabbit was not washed. Observations of the cornea, iris, and conjunctiva were made with a hand-slit lamp at one and four hours, and at one, two, three, seven, and fourteen days. Fluorescein stain and a biomicroscope were used at examinations after the day of treatment.

The test chemical, the 50:50 mixture, and propylene glycol were chilled in a refrigerator and administered with a cold glass syringe.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

other: See attached Table

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

other: See attached Table

Irritant / corrosive response data:

See attached Table 1.

Undiluted Ethane, 1,1-dichloro-2,2,2-trifluoro produced mild to moderate conjuctival irritation with no corneal or iritic involvement in an unwashed rabbit eye. An eye dosed with the test substance and promptly washed had mild to slight transient corneal opacity and mild to moderate conjunctival irritation with no iritic involvement. Both eyes were normal within 3-7 days.

Any other information on results incl. tables

Eyes dosed with the 50:50 mixture had slight to moderate corneal opacity with partial circumcorneal vascularization, mild iritic congestion, and mild to severe conjunctival irritation. The washed eye had slight to moderate corneal opacity, slight iritic congestion, and mild to moderate conjunctival irritation. Both eyes were normal within 14 days.

Eyes dosed with propylene glycol produced mild to moderate conjunctival irritation. Both eyes were normal within 3 days.

The eyes dosed with the 50:50 mixture were much more irritated than those dosed with the neat material. The reason was probably because the mixture allowed HCFC-123 to be in intimate contact with the eye longer than the neat HCFC-123 which boiled out.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study, ethane, 1,1-dichloro-2,2,2-trifluoro produced mild to moderate conjuctival irritation with no corneal or iritic involvement in an unwashed rabbit eye. An eye dosed with the test substance and promptly washed had mild to slight transient corneal opacity and mild to moderate conjunctival irritation with no iritic involvment. Both eyes were normal within 3-7 days.