Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
Qualifier:
according to guideline
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
GLP compliance:
yes
Remarks:
40 CFR 792
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system 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."
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, and 72 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, and 72 hours after patch removal.
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #6
Time point:
other: 4h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: 4h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: 4h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: 4h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: 4h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 4h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 4h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 4h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 72h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 72h
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 72h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 72h
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
not fully reversible within: 72h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
0
Reversibility:
not fully reversible within: 72h
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 4h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 4h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 4h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 4h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritant / corrosive response data:
The test material produced slight to moderate erythema and edema reactions during the study.
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, and 72 hours after patch removal.


 


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

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
06/08/1987 - 06/28/1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP run study according to EPA Guideline OPP 81-4
Qualifier:
according to guideline
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
GLP compliance:
yes
Remarks:
40 CFR 792.35 (b) (6) (7)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Young adult New Zealand White rabbits (4M and 2F; 2229- 2404 g B Wt M and 2255 & 2455g B Wt F) were procured, maintained individually in screen-bottom cages in temperature and humidity controlled quarters (19-21ºC and 39-61% 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. Animal husbandry and housing at HLA comply with standards outlined in the "Guide for the Care and Use of Laboratory Animals."
Vehicle:
unchanged (no vehicle)
Controls:
other: contralateral eye used as control
Amount / concentration applied:
0.1mL placed on the everted lower lid of one eye.
Duration of treatment / exposure:
The eyes of the rabbits remained unflushed.
Observation period (in vivo):
The treated eyes were observed for ocular irritation at 24, 48, and 72 hours after treatment.
Number of animals or in vitro replicates:
6 rabbits
Details on study design:
Each rabbit received 0.1mL of the test material placed on the everted lower lid of one eye, with the contralateral eye serving as the untreated control. The upper and lower lid were gently held together for one second to prevent loss of material and then released. The eyes of the rabbits remained unflushed. The treated eyes were observed for ocular irritation at 24, 48 and 72 hours after treatment. At the 72 hour reading, sodium fluorescein was used to aid in revealing corneal injury. Irritation was graded and scored according to the Draize technique. Animals were weighed just prior to the test material administration.
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
48 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
72 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
48 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
72 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
48 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
72 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
48 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
72 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
48 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
72 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
not reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
48 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
72 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.44
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The test material produced reversible slight to moderate conjuctival irritation during the study.

No pain response was elicited from any animal following instillation of the test material.

Blanching of the conjunctiva was seen in 2 of the 6 animals at 1 hour.

No corneal or iridal irritation was observed in any animal during the study period.

Interpretation of results:
slightly irritating
Remarks:
Migrated information reversible Criteria used for interpretation of results: OECD GHS
Conclusions:
The test material produced reversible slight to moderate conjuctival irritation during the study.
Executive summary:

Isodecyl Benzoate was evaluated for its primary eye irritation potential in male and female rabbits. Young adult New Zealand White rabbits (4M and 2F; 2229- 2404 g B Wt M and 2255 & 2455g B Wt F) were procured, maintained individually in screen-bottom cages in temperature and humidity controlled quarters (19-21ºC and 39-61% 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." Animals were weighed just prior to the test material administration. Each rabbit received 0.1mL of the test material placed on the everted lower lid of one eye, with the contralateral eye serving as the untreated control. The upper and lower lid were gently held together for one second to prevent loss of material and then released. The eyes of the rabbits remained unflushed. The treated eyes were observed for ocular irritation at 24, 48 and 72 hours after treatment. At the 72 hour reading, sodium fluorescein was used to aid in revealing corneal injury. Irritation was graded and scored according to the Draize technique.


 


The test material produced reversible slight to moderate conjunctival irritation during the study that was fully reversable by the 48h observation time point.


 

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Primary Dermal Irritation Study of Isodecyl Benzoate in Rabbits; GLP run according to EPA OPP 81-5 (Acute Dermal Irritation)(1987).

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

Primary Eye Irritation Study of Isodecyl Benzoate in Rabbits; GLP run study according to EPA Guideline OPP 81-4 (1987).

The test material produced reversible slight to moderate conjuctival irritation during the study.

Justification for classification or non-classification

No classification for acute irritation is indicated according to the general classification and labeling requirements for dangerous substances and preparations (Directive 67-548-EEC) or the classification, labeling and packaging (CLP) regulation (EC) No 1272/2008.