Registration Dossier

Administrative data

Description of key information

Based on the skin and eye irritation study performed in vivo the substance was not considered to be a skin or eye irritant.

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:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No GLP, no guideline was followed
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
, application time, scoring after 24 and 72 hours
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Kuiper´s Rabbit Ranch, Gary, Indiana
- Weight at study initiation: 2054 to 2377 gr.
- Housing: Individually housed in hanging wire-mesh cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 9 days

ENVIRONMENTAL CONDITIONS
- Temperature and humidity were controlled
Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
24 hours
Observation period:
24, 72 hours
Number of animals:
3 male and 3 female rabbits
Details on study design:
The hair was removed from the back of each rabbit (20 % - 30 % of the body surface) with an electric clipper. The skin of 3 of the rabbits was abraded with a scalpel blade. The abrasions penetrated the stratum corneum, but were not deep enough to cause bleeding. A volume of 0.5 mL of the test material was applied to the back of each rabbit under a one inch square gauze patch. The application sites were then 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. Following 24 hours of application, the bandages and collars were removed and the sites were washed with tap water and examined for skin irrittaion. The examinations were repeated at 72 hours.
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
male
Time point:
other: 24/72 hrs
Score:
1.5
Max. score:
4
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
male
Time point:
other: 24/72 hrs
Score:
1.5
Max. score:
4
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
male
Time point:
other: 24/72 hrs
Score:
1.5
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
male
Time point:
other: 24/72 hrs
Score:
1
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
male
Time point:
other: 24/72 hrs
Score:
0.5
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
male
Time point:
other: 24/72 hrs
Score:
0.5
Max. score:
4
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
female
Time point:
other: 24/72 hrs
Score:
1.5
Max. score:
4
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
female
Time point:
other: 24/72 hrs
Score:
2
Max. score:
4
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
female
Time point:
other: 24/72 hrs
Score:
0.5
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
female
Time point:
other: 24/72 hrs
Score:
1
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
female
Time point:
other: 24/72 hrs
Score:
1.5
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
female
Time point:
other: 24/27 hrs
Score:
0.5
Max. score:
4
Reversibility:
no data
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the study conditions and evaluation the test substance was not considered to be irritating.
Executive summary:

The study examined the skin irritation potential of 65 % 1,1-Di (t-butyl peroxy) cyclohexane, in phthalate plasticizer in New Zealand white rabbits. 0.5 mL of the test substance were applied to clipped rabbit skin. After 24 hours, the substance was washed off with tap water. The skin was examined for skin irritation 24 and 72 hours after application. Exposure to 1,1-Di (t-butyl peroxy) cyclohexane resulted in slight erythema and edema in the treated skin-areas of the three rabbits with mean erythema score of 1.5 and mean edema score of 0.8. Therefore, the substance is evaluated to be not irritating to the skin.

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:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No GLP, not a guideline study (although similar to present OECD guideline)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: H.A.R.E. Rabbits for Research, Hewitt, New Jersey
- Weight at study initiation: 2236 to 2903 grams
- Housing: The rabbits were individually housed in hanging wire-mesh cages in temperature and humidity controlled quarters.
- Diet: ad libitum
- Water: ad libitum
- acclimization period: 20 days

Vehicle:
unchanged (no vehicle)
Controls:
other: the left eye served as-the untreated control for each rabbit
Amount / concentration applied:
0.1 mL of the test material
Duration of treatment / exposure:
Single treatment
Observation period (in vivo):
1, 24, 48, 72 hours and 7 days after application
Number of animals or in vitro replicates:
6 rabbits (3 males and 3 females)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: not done

SCORING SYSTEM: Draize, J. H., Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, Assoc. Food and Drug Officials of the U.S., Austin, Texas, 1959, page 51, Modified according to revision of 1964. Edited"by A. J. Lehman. Further modified (inclusion of-0.5 scores) at International Research and Developmen.
Corporation.

TOOL USED TO ASSESS SCORE: fluorescein
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
4
Remarks on result:
other: males and females
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
other: males and females
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
other: male
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24/48/72 h
Score:
0.8
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: male
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
other: male
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: male
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24/48/72 h
Score:
0.17
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: male
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: male
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24/48/72 h
Score:
0.8
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: female
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24/48/72 h
Score:
0.17
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: female
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24/48/72 h
Score:
0.17
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: female
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24/48/72 h
Score:
0.17
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: female
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: female
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: female
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance examined in this study, 65 % 1,1-Di (t-butyl peroxy) cyclohexane, was considered not to be irritating to the eyes.
Executive summary:

The test substance, 65 % 1,1-Di (t-butyl peroxy) cyclohexane was examined for its eye irritation potential in 6 New Zealand White rabbits. The rabbits were administered with 0.1 mL of the test substance, placed into the cupped conjunctival sac of the right eye of each rabbit while the left eye served as-the untreated control for each rabbit. The eyes were not washed and observations/ scoring with sodium fluorescein solution were performed at 24, 48, 72 hours and 7 days after application. Results were scored by modified Draize scoring method (scoring with 0.5 intervals), showing according to the grading used in the study, regulations of the Federal Hazardous Substances Act., (and in accordance with present regulation, OECD GHS) that the test material is not be considered a primary eye-irritant.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation/corrosion:

The study examined the skin irritation potential of 65 % 1,1-Di (t-butyl peroxy) cyclohexane, in phthalate plasticizer in New Zealand white rabbits. 0.5 mL of the test substance were applied to clipped rabbit skin. After 24 hours, the substance was washed off with tap water.

The skin was examined for skin irritation 24 and 72 hours after application. Exposure to 1,1-Di (t-butyl peroxy) cyclohexane resulted in slight erythema and edema in the treated skin-areas of the three rabbits with mean erythema score of 1.5 and mean edema score of 0.8. Therefore, the substance is evaluated to be not irritating to the skin.

 

Eye irritation:

The test substance, 65 % 1,1-Di (t-butyl peroxy) cyclohexane was examined for its eye irritation potential in 6 New Zealand White rabbits. The rabbits were administered with 0.1 mL of the test substance, placed into the cupped conjunctival sac of the right eye of each rabbit while the left eye served as-the untreated control for each rabbit. The eyes were not washed and observations/ scoring with sodium fluorescein solution were performed at 24, 48, 72 hours and 7 days after application. Results were scored by modified Draize scoring method (scoring with 0.5 intervals). The mean cornea and iris score was 0, the mean conjuctivae score was 0.3 and the chemosis score was 0.05, fully reversible within 7 days. The test material is not considered to be an eye irritant according to regulations of the Federal Hazardous Substances Act. and EU present regulation.

Justification for selection of skin irritation / corrosion endpoint:
Only one study available.

Justification for selection of eye irritation endpoint:
Only one study available.

Justification for classification or non-classification

Based on the available data the test item is not classified for skin and eye irritation according to Regulation (EC) No 1272/2008 (CLP) .