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Toxicological information

Skin irritation / corrosion

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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

Constituent 1
Chemical structure
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

Resultsopen allclose all
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
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.