Cyclohexylidenebis[tert-amyl] peroxide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Cyclohexylidenebis[tert-amyl] peroxide

EC Number:

239-741-1

EC Name:

Cyclohexylidenebis[tert-amyl] peroxide

Cas Number:

15667-10-4

Molecular formula:

C16H32O4

IUPAC Name:

1,1-bis[(2-methylbutan-2-yl)peroxy]cyclohexane

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Myrtle's Rabbitry, Thompson Station, TN
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: individually in suspended stainless steel cages
- Diet: PMI Certified Rabbit Chow #5322 (Purina Mi lis, lnc.) was provided ad libitum
- Water: Municipal tap water treated by reverse osmosis was available ad libitum
- Acclimation period: a minimum of five days

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 69-71
- Humidity (%): 44-56
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 ml

Duration of treatment / exposure:

4 hours

Observation period:

at approximately 1, 24, 48 and 72 hours and up to 14 days

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure:
- % coverage: 1" x 1" square 4 ply gauze patch
- Type of wrap if used: semi-occlusive binding

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gauze moistened with distilled water followed by dry gauze
- Time after start of exposure: 4 h

SCORING SYSTEM:
- Method of calculation: Draize score

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1 and 5

Time point:

24/48/72 h

Score:

3.3

Max. score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

positive indication of irritation

Results 2

Irritation parameter:

erythema score

Basis:

animal: #2, 3 and 6

Time point:

24/48/72 h

Score:

3.3

Max. score:

4

Reversibility:

fully reversible within: 10 days

Remarks on result:

positive indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

positive indication of irritation

Results 4

Irritation parameter:

edema score

Basis:

animal: #1, 2, 3, 4 and 6

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 5

Irritation parameter:

edema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

1.7

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritant / corrosive response data:

Exposure to the test article produced very slight to well-defined erythema and very slight to slight edema on 6/6 test sites at the 1 hour scoring interval. The dermal irritation progressed to mild to severe blanching on all test sites by the 24 hour scoring interval. The dermal irritation resolved completely in all animals by study day 14. Additional dermal findings noted during the period included focal/pinpoint to mild eschar, eschar exfoliation and desquamation, which were noted on 2/6, 2/6 and 6/6 test sites, respectively.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

Lupersol 531-80M is considered to be an irritant to the skin of the rabbit. However, due to the lack of any in-depth injury, the test article is not considered to be corrosive

Executive summary:

The potential irritant and/or corrosive effects of Lupersol 531-80M were evaluated on the skin of New Zealand White rabbits. Each of six rabbits received a 0.5 ml dose of the test article as a single dermal application. The dose was held in contact with the skin under a semi-occlusive binder for an exposure period of four hours. Following the exposure period, the binder was removed and the remaining test article was wiped from the skin using gauze moistened with distilled water. Test sites were subsequently examined and scored for dermal irritation for up to 14 days following patch removal. Exposure to the test article produced very slight to well-defined erythema and very slight to slight edema on 6/6 test sites at the 1 hour scoring interval. The dermal irritation progressed to mild to severe blanching on all test sites by the 24 hour scoring interval. The dermal irritation resolved completely in all animals by study day 14. Additional dermal findings noted during the period included focal/pinpoint to mild eschar, eschar exfoliation and desquamation, which were noted on 2/6, 2/6 and 6/6 test sites, respectively. Under the conditions of this test, Lupersol 531-80M is considered to be an irritant to the skin of the rabbit.