Isopentyl acetate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: information on methodology and results is acceptable in quality and extent; study was conducted prior to GLP and test guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

Irritation following administration of 0.5 ml to the skin of rabbits was examined.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Primary Amyl Acetate (mixture of n-pentyl acetate and 2-methylbutyl acetate)

IUPAC Name:

Primary Amyl Acetate (mixture of n-pentyl acetate and 2-methylbutyl acetate)

Details on test material:

Clear, non-viscous liquid. Charge No: 475010-135-500564.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

The animals were maintained on appropriate commercial diet and municipal water. Both were available ad libitum except when animals were restrained.

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

Skin reaction is scored, by the method of Draize (given below), at one hour, one day, 2 days, 3 days and possibly 7 days after dosing.

Number of animals:

6 (3 males, 3 females)

Details on study design:

Male or female New Zealand White rabbits are dosed with 0.5 ml. The dose is applied to the clipped, intact skin under a gauze patch and is loosely covered with impervious sheeting. The test material is applied to each of 6 rabbits, which are restrained for the 4-hr contact period. Excess sample is removed after contact. Skin reaction is scored, by the method of Draize, at one hour, one day, 2 days, 3 days and possibly 7 days after dosing.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

1.7

Max. score:

2

Reversibility:

fully reversible within: 10 d

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.6

Max. score:

1

Reversibility:

fully reversible within: 7 d

Irritant / corrosive response data:

Application of 0.5 ml of primary amyl acetate to covered rabbit skin resulted in well-defined erythema on 6 of 6 animals (Table 1). Slight edema was evident on 5. By 7 days only 2 rabbits had erythema (slight), none had edema, but all 6 had desquamation. Minor desquamation persisted on 5 rabbits through 14 days.

Other effects:

No additional information available.

Any other information on results incl. tables

Table 1 Results of skin irritation test

Time	Mean score
	Erythema and Eschar Formation	Edema
5 hours	0.2	0.2
1 day	2.0	0.5
2 days	1.8	0.8
3 days	1.2	0.3
7 days	0.3	0.0
10 days	0.0	0.0
14 days	0.0	0.0

Minor desquamation was observed on days 7 - 14. It became less evident at 10 and 14 days.

Scoring was by the Draize method

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Application of primary amyl acetate (a mixture of n-pentyl acetate and 2-methylbutyl acetate) to covered skin resulted in minor irritation, not meeting the EU criteria for classification. N-pentyl acetate and 2-methylbutyl acetate are structural isomers of isopentyl acetate. Based on this molecular similarity it is assumed that isopentyl acetate exhibits an equal or similar skin irritation potential and will accordingly not be classified as irritating to the skin.

Executive summary:

The skin irritation potential of primary amyl acetate was examined. Application of the sample to covered skin resulted in minor irritation.