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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:
1978-08-23 and 1978-12-15
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
no 48-hour-observation; further time points necessary to evaluate fully reversibility
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
tert-butyl peracetate
EC Number:
203-514-5
EC Name:
tert-butyl peracetate
Cas Number:
107-71-1
Molecular formula:
C6H12O3
IUPAC Name:
tert-butyl peracetate

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Kuiper's Rabbit Ranch, Gary, Indiana
- Weight at study initiation: 2295 to 2933 grams
- Housing: individually housed in hanging wire-mesh cages
- Diet: Purina® Rabbit Chow®, ad libitum
- Water: ad libitum
- Acclimation period: 14 days

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped and abraded
Vehicle:
not specified
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL
Duration of treatment / exposure:
24 hours
Observation period:
24 and 72 hours
Number of animals:
3 males
3 females
Details on study design:
TEST SITE
- Area of exposure: back of each rabbit under a one inch square gauze patch
- % coverage: 20 -30% of the body surface
- Type of wrap: the application sites were covered with gauze bandaging and overwrapped with Saran Wrap. The entire application area was then wrapped with several layers of 75 mm Elastoplast tape. A collar was also applied.

REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 24 hours

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24 h/ 72 h
Score:
0.75
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: individual scores for intact skin
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24 h/ 72 h
Score:
0.25
Max. score:
4
Reversibility:
fully reversible within:
Remarks on result:
other: individual scores for intact skin
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24 h/ 72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: individual scores for intact skin
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24 h/72 h
Score:
0
Max. score:
4
Remarks on result:
other: individual score for intact skin
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24 h/ 72 h
Score:
0.75
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: individual score for intact skin
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24 h/ 72 h
Score:
0
Max. score:
4
Remarks on result:
other: individual score for intact skin
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24 h/ 72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: individual score for abraded skin
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24 h/ 72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: individual score for abraded skin; blanching after 24 h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24 h/ 72 h
Score:
0
Max. score:
4
Remarks on result:
other: individual score for abraded skin
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24 h/ 72 h
Score:
0.75
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: individual score for abraded skin
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24 h/ 72 h
Score:
0
Max. score:
4
Remarks on result:
other: individual score for abraded skin
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24 h/ 72 h
Score:
0.75
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: individual score for abraded skin
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
not determinable
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
not determinable
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Remarks on result:
not determinable
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Remarks on result:
not determinable
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Remarks on result:
not determinable
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Remarks on result:
not determinable
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Remarks on result:
not determinable
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Remarks on result:
not determinable
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Remarks on result:
not determinable
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Remarks on result:
not determinable
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Remarks on result:
not determinable
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Remarks on result:
not determinable

Applicant's summary and conclusion

Interpretation of results:
not irritating
Conclusions:
The results obtained from the study show, that the mean values of the recordings 24 and 72 hours after treatment for both erythema and edema were in the range of 0 to 1 for all individual animals.
Executive summary:

In a primary dermal irritation study (International Research and Development Corporation, 1978), three male and three female New Zealand White rabbits were dermally exposed to 0.5 mL of tert-butyl peracetate (75% (w/w) in mineral spirit) for 24 hours. The skin of three of the rabbits was abraded with a scalpel blade. Animals then were observed 24 and 72 hours after test item application. Irritation was scored by a modified method of Skin Reaction Code (National Academy of Sciences, 1977). The mean erythema score (24/72h) was 0.6 for intact skin and 0.5 for abraded skin and the mean edema score (24/72h) was 0.25 for intact and 0.5 for abraded skin. Based on the results tert-butyl peracetate (75 % (w/w) in mineral spirit) is not considered a dermal irritant.