2,4-dimethylpentan-3-one

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Principles of method if other than guideline:

In rabbit eye irritation test 0.1 mL of the undiluted test substance was applied to the eye of 6 rabbits followed by a 14 day observation period. In three eyes a washing was performed one hour after dosing. The other three eyes remained unwashed. Effects were scored as slight, moderate, strong and severe. In addition fluorescein staining was performed. The test was performed according to internal method TA 150.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,4-dimethylpentan-3-one

EC Number:

209-294-7

EC Name:

2,4-dimethylpentan-3-one

Cas Number:

565-80-0

Molecular formula:

C7H14O

IUPAC Name:

2,4-dimethylpentan-3-one

Test material form:

liquid

Details on test material:

- Name of test material (as cited in report): 2,4-Dimethylpentanon-3 / Diisopropyl keton
- Physical state: liquid

Specific details on test material used for the study:

- Name of test substance( as cited in report): 2,4-Dimethyl-3-pentanone

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

- Weight at study initiation: not determined

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

Three out of six dosed eyes were washed after 1 hour.

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): In 3/6 eyes with distilled water
- Time after start of exposure: 1 hour

SCORING SYSTEM:
Eyes were scored for Initial, Conjunctiva, Lids, Nictating membrane, Cornea opacity, Iris score, Adnexal stain, Corneal stain and discharge.
Effects were rated Slight, Moderate or Strong.

Results and discussion

In vivo

Results

Irritation parameter:

other:

Remarks:

Overall result

Remarks on result:

other: See irritant/corrosive response data

Irritant / corrosive response data:

The test article mostly caused slight erythema and moderate edema of the adnexa in unwashed eyes one hour after administration. By 24 hours, two of three unwashed eyes appeared clinically normal, and signs of irritation were restricted to slight erythema in the third eye. Immediate washing was palliative. Signs of irritation in washed eyes one hour after dosing were restricted to slight edema and slight erythema of the adnexa, with the exception of moderate erythema of the conjunctiva in a single eye. All washed and unwashed eyes appeared normal by 48 hours after dosing.

Any other information on results incl. tables

Overview of results as reported in study report:

Results	3 unwashed eyes
	IMMED	1 HR	24 HR	48 HR	72 HR	DAY 7	DAY 14
Initial	Slt.
Conjuctiva		Mod.	Slt.
Lids
Nict. Membrane		Mod.	Slt.
Corneal Opacity
Iris
Adnexal Stain			0/3
Corneal Stain			0/3
Discharche		Slt.
Number Normal	0	0	2	3	3

Results	3 washed eyes
	IMMED	1 HR	24 HR	48 HR	72 HR	DAY 7	DAY 14
Initial	Slt.
Conjuctiva		Slt.	Slt.
Lids
Nict. Membrane		Slt.	Slt.
Corneal Opacity
Iris
Adnexal Stain			0/3
Corneal Stain			0/3
Discharche
Number Normal	0	0	2	3	3

Key: Slt. = Slight, Mod. = Moderate, Str. =Strong

No. Responding	Slight	Moderate	Strong	Severe	Fluorescein Stain
					Adnexa	Cornea
Unwashed eyes	3/3				0/3	0/3
Washed eyes	3/3				0/3	0/3

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met