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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion
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:
24-hour application followed by 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; no information on number of animals used; 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 guinea pigs. Following depilation of the abdomen of each animal, a single dose of the undiluted test material was applied under an occlusive cuff. Animals were exposed to test material for 24 hours, then cuffs were removed; animals were observed following removal of the cuff, and on Days 7 and 14. In addition to observations for mortality, dermal reactions were also recorded.
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

Species:
guinea pig
Strain:
Hartley
Details on test animals and environmental conditions:
no data

Test system

Type of coverage:
occlusive
Preparation of test site:
other: The abdomen of each animal was depilated.
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
no data
Duration of treatment / exposure:
24 hours
Observation period:
14 days
Number of animals:
no data
Details on study design:
Following depilation of the abdomen of each animal, a single dose of the undiluted test material (doses not reported) was applied under an occlusive wrap prepared from a pad of gauze held in place with an impervious cuff made of rubber dental dam. The cuff was wrapped securely around the torso and held in place using non-irritating tape. After an exposure period of 24 hours, the cuffs and wrappings were removed. Animals were observed following removal of the cuff, and on Days 7 and 14. Observations for mortality and dermal reactions were recorded.

Results and discussion

In vivo

Results
Irritation parameter:
other: Numerical grading was not used. Skin irritation was graded as slight, moderate, or severe. Signs of absorption were recorded as either evident or not evident based on observations of systemic effects.
Basis:
other: overall
Reversibility:
no data
Remarks on result:
other: Numerical grades of irritation (erythema and edema) were not provided in the study report. Overall irritation was reported as slight on a scale of slight to strong.
Irritant / corrosive response data:
The test material was considered to cause slight irritation with some signs of desquamation.
Other effects:
Signs of skin absorption were not evident.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Following 24-hour occlusive exposure of the test material to the depilated abdominal skin of the guinea pig, methyl isoamyl ketone was slightly irritating, but not corrosive. Methyl isoamyl ketone is not a primary skin irritant. Only minimal irritation and some signs of desquamation were noted during the study. Skin absorption was not evident. The conditions of exposure in this non-guideline study were significantly more stringent than those used in present day guideline skin irritation studies, i.e., 24-hr exposure versus 4-hr exposure currently used. Based on the results of this study, the degree of irritation was insufficient to classify methyl isoamyl ketone as a skin irritant according to GHS guidelines.
Executive summary:

In a primary dermal irritation study, guinea pigs were exposed to methyl isoamyl ketone under an occlusive wrap for 24 hours. Animals were then observed for signs of irritation. Signs of irritation were scored as slight, moderate, or severe. Methyl isoamyl ketone caused minimal irritation with some signs of desquamation, but no signs of corrosion. Signs of skin absorption were not evident. Methyl isoamyl ketone is not considered a dermal irritant under conditions used in this study.