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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:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: meets generally accepted scientific standards, well documented and acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
: exposure 24 hours instead of 4 hours; 12 animals were used
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Perkadox 16 (Bis(4-tert-butylcyclohexyl)peroxydicarbonate
- Substance type: organic peroxide
- Physical state: solid
- Storage condition of test material: -20°C

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: adults

Test system

Type of coverage:
occlusive
Preparation of test site:
other: abraded and intact skin
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
Duration of treatment / exposure:
24 h
Observation period:
observation 24 h and 72 h after exposure
Number of animals:
12
Details on study design:
TEST SITE
- Area of exposure: 1 inch x 1 inch
- % coverage: no data
- Type of wrap if used: surgical patch fixed by adhesive tape, wrapped with impervious material

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing
- Time after start of exposure: patch and material are removed after 24 h

SCORING SYSTEM: Draize (1944) and CIVO-grading system

Primary irritation to the skin is measured by a patch-test technique on the abraded and the intact skin of albino rabbits.
Twelve healthy adult New Zealand White albino rabbits were used for the test substance. 24 hours prior to applying the materials, the hair is removed from the backs of the animals with an electric clipper in such a way as to avoid abrasions.
An amount of 0.5 g of the test substance was brought into contact of the intact and the abraded skin under a surgical patch measuring 1 inch x 1 inch. The patches are fixed to the application site by means of adhesive tape and the entire trunk of the rabbits is wrapped with an impervious material to maintain the test patches in position and to retard evaporation of volatile substances.
Six rabbits are treated on the intact skin, the other six on the abraded skin. The abrasions are minor incisions through the stratum corneum, but not sufficiently deep to disturb the derma or to produce bleeding.
After an exposure period of 24 hours the patches and the material applied are removed and the resulting skin reactions are evaluated by the method of Draize (J. Pharmacol. 82 (1944) 377-). A second reading is made 48 hours later (72 hours after application).
In the case of surface active test substances the skin reactions after 72 hours usually consist of scaliness and/or necrosis. Since the Draize grading system does not comprise these abnormalities the second reading is carried out on the basis of the CIVO-grading system.

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 h; 72h
Score:
ca. 0
Max. score:
0
Reversibility:
other: no irritation
Remarks on result:
other: Intact and abraded skin
Other effects:
No other effects

Any other information on results incl. tables

Table 2: Individual and average skin irritation scores of Bis(4-tert-butylcyclohexyl) peroxydicarbonate

Rabbit number

Intact skin

 

Abraded skin

24 hours

72 hours

Rabbit number

24 hours

72 hours

A

B

A

B

 

A

B

A

B

5516

0

0

0

0

5510

0

0

0

0

5517

0

0

0

0

5511

0

0

0

0

5518

0

0

0

0

5512

0

0

0

0

5519

0

0

0

0

5513

0

0

0

0

5520

0

0

0

0

5514

0

0

0

0

5521

0

0

0

0

5515

0

0

0

0

average

0

0

average

0

0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Bis(4-tert-butylcyclohexyl) peroxydicarbonate did not cause any signs of skin irritation.
Executive summary:

In a primary dermal irritation study, 12 healthy adult New Zealand White albino rabbits were dermally exposed to 0.5 g of Perkadox 16 (Bis(4-tert-butylcyclohexyl) peroxydicarbonate) to an area of 1 inch² on abraded or intact skin of the back of 6 animals in each case. Test sites were covered with an occlusive dressing for 24 hours. Animals were then observed for 72 hours. Irritation was scored according the method of Draize et al. 1944 and the CIVO grading system. No reaction at all was observed. In this study Bis(4-tert-butylcyclohexyl) peroxydicarbonate is not a dermal irritant.