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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

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:
comparable to guideline study with acceptable restrictions

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:
, application time, scoring after 24 and 72 hours
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Cyclohexylidenebis[tert-butyl] peroxide
EC Number:
221-111-2
EC Name:
Cyclohexylidenebis[tert-butyl] peroxide
Cas Number:
3006-86-8
Molecular formula:
C14H28O4
IUPAC Name:
1,1-bis(tert-butylperoxy)cyclohexane

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: 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

Test system

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.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
male
Time point:
24/48/72 h
Score:
1.5
Max. score:
4
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
male
Time point:
24/48/72 h
Score:
1.5
Max. score:
4
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
male
Time point:
24/48/72 h
Score:
1.5
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
male
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
male
Time point:
24/48/72 h
Score:
0.5
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
male
Time point:
24/48/72 h
Score:
0.5
Max. score:
4
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
female
Time point:
24/48/72 h
Score:
1.5
Max. score:
4
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
female
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
female
Time point:
24/48/72 h
Score:
0.5
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
female
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
female
Time point:
24/48/72 h
Score:
1.5
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
female
Time point:
24/48/72 h
Score:
0.5
Max. score:
4
Reversibility:
no data

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
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.