Acetone

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Does not meet important criteria of today standard methods; data available from published compilation of eye irritation test results, limited documentation of test method and results, no guideline conditions: other dose tested, other scoring system, no post-observation for reversibility of effects; data acceptable as supporting information

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Chemical burns of the rabbit cornea

Author:

Carpenter CP, Smyth HF

Year:

1946

Bibliographic source:

Am J Ophthalmol 29: 1363-1372

Reference 2

Reference Type:

review article or handbook

Title:

Range-finding toxicity data: List VI

Author:

Smyth HF, Carpenter CP, Weil CS, Pozzani UC, Striegel JA

Year:

1962

Bibliographic source:

Am Ind Hyg Assoc J 23: 95-107

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Application of 0.005 mL, observation period 24 hrs, grading system with a range of 1 to 10

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Acetone

EC Number:

200-662-2

EC Name:

Acetone

Cas Number:

67-64-1

Molecular formula:

C3H6O

IUPAC Name:

propan-2-one

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.005 ml

Duration of treatment / exposure:

18 to 24 h

Observation period (in vivo):

24 h

Number of animals or in vitro replicates:

5

Details on study design:

Normal albino rabbit eyes are selected on the basis of absence of grossly visible staining by a 5% aqueous solution of fluorescein, flushed with distilled water 20 seconds after application. After a two-hour interval to allow the eye to return to normal, 0.005 ml or 0.020 ml acetone is applied to the center of the cornea while the lids are retracted. About one minute later the lids are released. 18 to 24 hours later, the eye is examined in strong diffuse daylight, then stained with fluorescein, and the injury is scored with a scoring system with a maximum of 20 points in total according to the degree of corneal opacity, iritis and necrosis..

Results and discussion

In vivo

Results

Irritation parameter:

other: grading system with a range of 1 to 10

Basis:

mean

Time point:

other: 24 hrs

Score:

5

Reversibility:

not specified

Irritant / corrosive response data:

Acetone was assigned to grade 5 (grading system with a range of 1 to 10): 0.005 ml acetone yielded a score not over 5.0 (scoring system with a maximal score of 20) and 0.02 ml yielded a score over 5.0 (no further details available).

Applicant's summary and conclusion

Interpretation of results:

other: minimum grade of severe eye irritant

Remarks:

Criteria used for interpretation of results: other: Grade 5 injury (scale 1 to 10)

Executive summary:

Undiluted acetone was instilled in rabbit eyes in volumes of 0.005 or 0.20 ml. After 24 hours exposure, acetone was assigned to grade 5 (grading system with a range of 1 to 10) corresponding to the minimum grade of severe eye irritant.