Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
07/22/1987 - 07/25/1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP run study following EPA Guideline OPP 81-5

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
GLP compliance:
yes
Remarks:
40 CFR 792

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
clear, colorless liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Young adult rabbits of the New Zealand were procured, maintained individually in screen-bottom cages in temperature and humidity controlled quarters, provided access to water ad libitum and a measured amount of Purina High fiber Rabbit Chow and held for an acclimation period of at least 7 days. Animal husbandry and housing at HLA comply with standards outlined in the "Guide for the Care and Use of Laboratory Animals."

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
The test material was applied to the intact skin of each rabbit in the amount of 0.5 mL.
Duration of treatment / exposure:
4 hours
Observation period:
30 minutes following the removal of the test material, with subsequent examinations made at 24, 48, 72 and 96 hours.
Number of animals:
six, 3 males and 3 females
Details on study design:
The test material was applied to the intact skin of each rabbit in the amount of 0.5mL. The treated area was covered with a 2.5x2.5 cm gauze patch secured with paper tape, loosely overwrapped with Saran Wrap and secured with Elastoplast tape to provide a semi-occlusive dressing. Collars were applied to restrain the test animals for the 4-hour exposure period.
After the exposure period, the patches were removed. The test sites were washed using lukewarm tap water and disposable paper towels. The test material was removed for the test sites as thoroughly as possible without irritating the skin. Thirty minutes following removal of the test material, the degree of erythema and edema were read according to the Draize technique. Subsequent examinations were made at 24, 48, 72 and 96 hours after patch removal.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 H
Score:
0.3
Reversibility:
not fully reversible within: 4 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 H
Score:
0.5
Reversibility:
not fully reversible within: 4 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 H
Score:
0.5
Reversibility:
not fully reversible within: 4 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 - 48 H
Score:
0.43
Reversibility:
not fully reversible within: 4 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 H
Score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 H
Score:
0.5
Reversibility:
not fully reversible within: 4 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 H
Score:
0.5
Reversibility:
not fully reversible within: 4 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 - 48H
Score:
0.33
Reversibility:
not fully reversible within: 4 days
Irritant / corrosive response data:
The test material produced slight to moderate erythema and edema reactions during the study.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
The test material Isodecyl Benzoate was evaluated for its primary skin irritation potential in male and female rabbits. The test material produced reversible slight to moderate erythema and edema reactions during the study.
Executive summary:

Isodecyl Benzoate was evaluated for its primary skin irritation potential in male and female rabbits. Young adult the New Zealand White rabbits (2007-2580 g) were procured, maintained individually in screen-bottom cages in temperature and humidity controlled quarters (24-26ºC and 54-58% RH), provided access to water ad libitum and a measured amount of Purina High fiber Rabbit Chow, and held for an acclimation period of at least 7 days. Each animal was assigned a unique identification number and was identified with a metal ear tag. Animal husbandry and housing complied with standards outlined in the "Guide for the Care and Use of Laboratory Animals." Twenty-four hours prior to test material administration, hair was clipped from the back and flanks of each animal and inspected for interfering lesions, irritation, or defects that would preclude the use of any animal in the study. The test material was applied to the intact skin of each rabbit in the amount of 0.5 mL. The treated area was covered with a 2.5 x 2.5 cm gauze patch secured with paper tape, loosely over wrapped with Saran Wrap, and secured with Elastoplast tape to provide a semi-occlusive dressing. Collars were applied to restrain the test animals for the 4-hour exposure period.

After the exposure period, the patches were removed and the test sites were washed using lukewarm tap water and disposable paper towels. The test material was removed for the test sites as thoroughly as possible without irritating the skin. Thirty minutes following removal of the test material, the degree of erythema and edema were read according to the Draize technique. Subsequent examinations were made at 24, 48, 72 and 96 hours after patch removal.

The test material produced reversible slight to moderate erythema and edema reactions during the study.