3-methylbutanone

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24 hour exposure followed by a 14-day observation period

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study conducted according to acceptable scientific standards and reviewed by Quality Assurance. Additionally, the results of this study are valid for classification in that the conditions of exposure are more stringent than in current guidelines. Conduct of the study according to all aspects of GLP could not be confirmed.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

no guideline followed

Deviations:

no

Principles of method if other than guideline:

Five male guinea pigs (age not specified) were administered a single dose of 0.5 mL of the test substance to the depilated abdomen. An occlusive wrap was used to hold the substance against the skin for 24 hours. The skin was observed daily for irritant responses. The skin was observed for signs of erythema, edema, necrosis, eschar, scarring, staining, and erosion. Effects were graded as very slight, slight, moderate or strong. Body weights were recorded on a weekly basis. No gross pathology was performed at study termination.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

3-methyl-2-butanone

IUPAC Name:

3-methyl-2-butanone

Constituent 2

Reference substance name:

3-methylbutanone

EC Number:

209-264-3

EC Name:

3-methylbutanone

Cas Number:

563-80-4

Molecular formula:

C5H10O

IUPAC Name:

3-methylbutan-2-one

Constituent 3

Reference substance name:

methylbutanone; methyl isopropyl ketone; MIPK

IUPAC Name:

methylbutanone; methyl isopropyl ketone; MIPK

Details on test material:

-Test substance: Methyl isopropyl ketone
-Date of manufacture: October 1987
-Source: Tennessee Eastman Company

Test animals

Species:

guinea pig

Strain:

Hartley

Details on test animals or test system and environmental conditions:

Test animals:
-Sex: male
-Strain: Crl:(HA)BR Hartley
-Body weight (at study initiation): 502-582 g

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved, then depilated with a chemical depilatory

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

24 hours

Observation period:

14 days

Number of animals:

5 animals (male)

Details on study design:

Five guinea pigs (male) were administered a single dose of 0.5 mL of the test substance to the depilated abdomen. An occlusive wrap was used to hold the substance against the skin for 24 hours. After removal of the wrap, the skin was rinsed with water. The site of exposure was observed daily for irritant responses. Body weights were recorded on a weekly basis. No gross pathology was performed at study termination.

Results and discussion

In vivo

Results

Irritation parameter:

other: overall irritation – description

Basis:

animal: 1, 2, 3, 4, 5

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: Slight erythema was observed in all animals. All animals appeared clinically normal by 72 hours after termination of exposure to the test substance.

Irritant / corrosive response data:

Signs of irritation were restricted to slight erythema at the site of application. No numerical scores were provided in the study. Irritation was rated on a descriptive scale from very slight to strong.

Other effects:

All animals gained weight (99-128 g) over the course of the study. Additionally, all animals gained weight during both Week 1 and Week 2 of the study.

Applicant's summary and conclusion

Interpretation of results:

other: not classified

Remarks:

Criteria used for interpretation of results: OECD GHS

Conclusions:

Methyl isopropyl ketone was not acutely toxic, irritating, or corrosive after a 24 hour dermal exposure to Hartley guinea pigs under the occlusive conditions used in this study. There was no evidence of edema or eschar formation and erythema was, at most, slight at the site of application. All animals appeared clinically normal by 72 hours after termination of exposure and all animals gained weight normally over the course of the study.

Based on slight erythema that cleared by 72 hours post-exposure, methyl isopropyl ketone is not classifiable for Skin Irritation/Corrosion according to GHS.

Executive summary:

In a skin irritation/corrosion study, 5 Hartley guinea pigs were exposed to 0.5 mL of undiluted methyl isopropyl ketone under occlusion for 24 hours. After 24 hours, the test site was rinsed with running water. The site of application was then examined daily for irritant responses for 14 days. Signs of irritation were limited to slight erythema, with all animals appearing clinically normal at 72 hours after termination of exposure. Based on the results of this study, methyl isopropyl ketone presents a low toxicity hazard and is not considered an irritant or corrosive.