Reaction mass of 2-methylbutyl acetate and pentyl acetate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

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)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 2-methylbutyl acetate and pentyl acetate

EC Number:

908-918-1

Molecular formula:

Unspecified

IUPAC Name:

Reaction mass of 2-methylbutyl acetate and pentyl acetate

Details on test material:

Primary Amyl Acetate (mixture of n-pentyl acetate and 2-methylbutyl acetate)
Clear, non-viscous liquid. No additional information available.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

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

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:

other: 24, 48 and 72 hours

Score:

1.7

Max. score:

2

Reversibility:

fully reversible within: 10 days

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0.6

Max. score:

1

Reversibility:

fully reversible within: 7 days

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 day 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:

Category 3 (mild irritant) based on GHS criteria

Conclusions:

Application of the sample to covered skin resulted in minor irritation, not meeting the EU criteria for classification.

Executive summary:

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