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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:
1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Was not conducted under GLP but has sufficient data for interpretation of results.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
N-butyl acetate
EC Number:
204-658-1
EC Name:
N-butyl acetate
Cas Number:
123-86-4
Molecular formula:
C6H12O2
IUPAC Name:
butyl acetate
Details on test material:
- Name of test material (as cited in study report): N-Butyl Acetate
- Physical state: liquid
- Analytical purity: as n-butyl acetate is usually available as high quality / purity, it can probably be assumed that test item purity was high

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Diet: commercial available diet, ad libitum
- Water: municipal water, ad libitum

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL
Duration of treatment / exposure:
4-hour contact
Observation period:
up to 10 days after 4 hour contact period.
Number of animals:
6 (3 males and 3 females)
Details on study design:
READING TIMES: 1 hour, 24 hour, and 2, 3, 7 and 10 days after 4 hour contact period.

SCORING SYSTEM: Method of Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable as no effect has been observed
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable as no effect has been observed
Irritant / corrosive response data:
none.
Other effects:
One animal was found dead at 10 days from unknown causes, but most probably not treatment-related.

Any other information on results incl. tables

None.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study n-butyl acetate was not irritating to the skin of rabbits.
Executive summary:

A 4 -hour occlusive treatment of 6 rabbits (3 males and 3 females) with 0.5 mL of the test item similar to OECD TG 404 did not induce any erythema nor edema, therefore the test item does not reveal any irritating potential under the conditions tested (Myers et al., 1987).

This study was judged to be reliable (RL2) and therefore was selected as key study.