Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

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

Referenceopen allclose all

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 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

Constituent 1
Chemical structure
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.