1,1,1,3,3,3-hexafluoropropan-2-ol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1966, no further information.

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

significant methodological deficiencies

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1966

Report date:

1966

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

- Principle of test:
Instilled neat (undiluted) test substance into one conjunctival sac of rabbits. Observations of the exposed eye reactions and the surrounding tissues were made for 29 days.
- Short description of test conditions:
The test substance was instilled undiluted into one conjunctival sac of each of two albino rabbits. Twenty seconds after contact, one of the treated eyes was flushed with tap water for a one-minute interval; the other treated eye was not washed. Observations of the treated eyes were made in bright artificial light, and with the aid of a hand-slit lamp on the day of exposure, and at 1, 2, 3, 4, 7, and 29 days following instillation. Examinations with 5% fluorescein stain and a biomicroscope were done when indicated.
- Parameters analysed / observed:
The cornea, iris, and conjunctiva of the treated eye of each rabbit were thoroughly examined, and separate observations were recorded for each ocular tissue.

GLP compliance:

no

Remarks:

pre-GLP

Test material

Test material information

Constituent 1

Reference substance name:

1,1,1,3,3,3-hexafluoropropan-2-ol

EC Number:

213-059-4

EC Name:

1,1,1,3,3,3-hexafluoropropan-2-ol

Cas Number:

920-66-1

Molecular formula:

C3H2F6O

IUPAC Name:

1,1,1,3,3,3-hexafluoropropan-2-ol

Test material form:

liquid

Test animals / tissue source

Species:

rabbit

Strain:

other: Albino rabbit, not further specified

Details on test animals or tissues and environmental conditions:

None specified

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.05 mL

Duration of treatment / exposure:

One treated eye was unwashed, the other was flushed with tap water for one minute at 20 seconds after instillation of the test substance.

Observation period (in vivo):

29 days
Reading time points: Day of treatment, and Day 1, 2, 3, 4, 7, 29

Number of animals or in vitro replicates:

2

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): 1 of 2 treated eyes was flushed with tap water for one minute
- Time after start of exposure: twenty seconds after instillation of the test substance

SCORING SYSTEM:
- observations of cornea, iris, and conjunctiva

TOOL USED TO ASSESS SCORE:
- hand-slit lamp / biomicroscope / fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

Washed eye

Basis:

animal #1

Time point:

other: Almost immediately

Reversibility:

not reversible

Remarks:

At Day 29

Remarks on result:

other: grayish-white colour change

Results 2

Irritation parameter:

cornea opacity score

Remarks:

Unwashed eye

Basis:

animal #2

Time point:

other: Less than 30 seconds

Reversibility:

not reversible

Remarks:

At Day 29

Remarks on result:

other: cloudy opacity

Results 3

Irritation parameter:

iris score

Remarks:

Washed eye

Basis:

animal #1

Time point:

other: Within 7 days

Reversibility:

not fully reversible within: 29 days

Remarks on result:

other: marked iritis

Results 4

Irritation parameter:

iris score

Remarks:

Unwashed eye

Basis:

animal #2

Time point:

other: Within 7 days

Reversibility:

not reversible

Remarks:

At Day 29

Remarks on result:

other: severe iritis

Results 5

Irritation parameter:

conjunctivae score

Remarks:

Washed eye

Basis:

animal #1

Time point:

other: Within 1 h

Reversibility:

not reversible

Remarks:

At Day 29

Remarks on result:

other: bloody discharge

Results 6

Irritation parameter:

conjunctivae score

Remarks:

Unwashed eye

Basis:

animal #2

Time point:

other: Within 1 h

Reversibility:

not reversible

Remarks:

At Day 29

Remarks on result:

other: bloody discharge

Results 7

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks on result:

not determinable because of methodological limitations

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks on result:

not determinable because of methodological limitations

Irritant / corrosive response data:

Washed eye:
Cornea -- Grayish-white colour change almost immediately; at 1-7 days, penetrating, progressive injury with developing opaque areas. At 29 days opacity with deep vascularization; considerable area was opaque with heavily vascularized protrusion.
Iris -- Photophobia, then decreased reaction to light at 3-4 days; marked iritis (prominent flare caused by infiltration of iris debris into the anterior chamber) with non-symetric pupillary constriction during first 7 days. At 29 days, iris had normal colour where visible, but was still photophobic.
Conjunctiva -- Bloody discharge within 1 hour; severe irritation with fibrinopurulent discharge through 7 days. At 29 days, decreased purulent discharge with mild redness and swelling.

Unwashed eye:
Cornea -- Cloudy opacity in less than 30 seconds; grossly eroded with dry precipitated appearance at 4 hours following instillation of the test substance; at 1-7 days, marked progressive injury through the depth of the cornea; developing opaque areas. At 29 days, cornea almost completely covered and unrecognizable under scar tissue and mass of fibrin mixed with pus.
Iris -- Often obscured; severe iritis (marked flare), with edema and decreased reaction to light during the initial 7 days. At 29 days, iris was not visible; no obvious perception of light.
Conjunctiva -- Bloody discharge within 1 hour; severe irritation with fibrinopurulent discharge through 7, and at 29 days.

Other effects:

- Other observations: Instillation of the test substance caused immediate apparent pain. Prompt flushing did not result in marked reduction of injury.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS Category 1 (H318) according to Regulation (EC) No 1272/2008

Conclusions:

Although the in vivo data is old and study reliability may be that of reliability 3, results of ocular exposure to the test substance clearly shows profound and irreversible eye damage at Day 29 following exposure, and corrosive effects on the surrounding conjunctival tissues. The study was conducted prior to publication (1981) of the OECD Test Guideline requirements for Eye Irritation / Corrosion studies. This data is sufficient to cover the eye irritation / corrosion endpoint, and classify the test substance as causing Serious Eye Damage / Irritation: 1.