Registration Dossier

Administrative data

Endpoint:
eye irritation
Remarks:
other: Study conducted according to an internal Eastman Kodak Company laboratory method.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Single ocular exposure followed by a 14 day observation period
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted prior to introduction of Good Laboratory Practices; data from a summary report; actual test data not available for review. Study was conducted by an internal Eastman Kodak Company method, developed prior to established guidelines. The results of this study are valid for classification insofar as the conditions of exposure are at least as stringent as modern guidelines.

Data source

Reference
Reference Type:
other: Eastman Kodak Company Basic Toxicity Summary Report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
no guideline available
Deviations:
not specified
Principles of method if other than guideline:
Method is an in vivo study using six rabbits. One drop of the test substance was administered into the conjunctival sac of one eye of each of the rabbits. Three of the treated eyes were immediately washed with running distilled water; the other three eyes were not irrigated. The treated eyes of the rabbits were examined for signs of irritation. Over a 14-day observation period, ocular reactions and signs of irritation were recorded and graded.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
-Name of test material as cited in study report: Methyl isoamyl ketone
-Appearance: liquid
-Melting Point: -74 °C
-Boiling Point: 145 °C at 760 mm Hg
-Solubility: 0.5% in water at 20 °C
-Purity: 98%
-Impurities: 2% MIBK, 10-20 ppm HOMME
-Shipped to testing laboratory: May 16, 1978
-Source of test material: Tennesse Eastman Company (Eastman Chemical Company)
-Storage conditions: room temperature and humidity

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
1 drop administered to one eye
Duration of treatment / exposure:
single application
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
6
Details on study design:
Method is an in vivo study using rabbits. One drop of undiluted methyl isoamyl ketone was administered into the conjunctival sac of one eye of each of six rabbits. After instillation, the lids were held together briefly to insure adequate distribution of the test material. The untreated eye of each rabbit served as a control. Three of the treated eyes were immediately washed with running distilled water; the other three eyes were not irrigated. The treated eyes of the rabbits were examined for signs of irritation immediately after test material administration, at 24 hours post dose, and at termination of the study. In addition, the treated eyes of all rabbits were examined with sodium fluorescein at 24 hours post-dose. Additional examinations of the eye, if any, were not defined in the study report. Ocular reactions were recorded at each examination and graded as slight, moderate, or strong. The general health of the rabbits was monitored at each observation time.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Ocular reactions were graded as slight, moderate, or strong. No numerical scores were reported in the study report.
Basis:
other: unwashed treated eyes
Time point:
other: Initial, 24, and 14 days
Score:
> 1 000
Max. score:
1 000
Reversibility:
not specified
Remarks on result:
other: For the three unwashed eyes, signs of irritation noted during the observation were described as, at most, slight. Fluorescein staining of the adnexa was evident for two of three unwashed eyes at the 24-hour examinations.
Irritation parameter:
other: Ocular reactions were graded as slight, moderate, or strong. No numerical scores were reported in the study report.
Basis:
other: washed treated eyes
Time point:
other: Initial, 24, and 14 days
Score:
> 1 000
Max. score:
1 000
Reversibility:
not specified
Remarks on result:
other: For the three washed eyes, signs of irritation noted during the observation were described as, at most, slight. Fluorescein staining was not evident for the three washed eyes at the 24-hour examinations.
Irritant / corrosive response data:
For unwashed eyes, signs of irritation were reported as, at most, slight. Fluorescein staining of the adnexa was evident for two of the three unwashed eyes. For washed eyes, signs of irritation noted during the observation were described as, at most, slight. No fluorescein staining was evident for the washed eyes. Based on the lack of staining in washed eyes, irrigation of the eyes was palliative.

Any other information on results incl. tables

Note that no irritation scores were used in this study. The values of 1000 were used only as a placeholder, as numerical values are required to pass the completeness check

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Methyl isoamyl ketone was, at most, a slight irritant by the ocular route under conditions used in this study. Prompt washing of the eyes was palliative. This is consistent with minimal effects observed following single and repeated application to the clipped skin of guinea pigs. Based on minimal signs of eye irritation with no signs of corrosion, methyl isoamyl ketone is not classified for eye irritation/corrosion under GHS.
Executive summary:

In a primary eye irritation study, one drop of undiluted methyl isoamyl ketone was instilled into the conjunctival sac of one eye of each of 6 New Zealand albino rabbits. Of these, three had their eyes washed immediately after treatment and three were unwashed. Animals were then observed for 14 days. Ocular reactions were recorded and descriptors (slight, moderate, strong, severe) were assigned for grading severity of ocular lesions. The eyes of all rabbits were examined with fluorescein dye at 24 hours. Methyl isoamyl ketone was reported to cause, at most, slight irritation in unwashed and washed eyes. Immediate washing of the eyes was palliative. Based on the results of this study, methyl isoamyl ketone is, at most, a slight ocular irritant.