Cyclohexylidenebis[tert-amyl] peroxide

Endpoint summary

Description of key information

Skin irritation

The potential irritant and/or corrosive effects of Lupersol 531-80M were evaluated on the skin of New Zealand White rabbits (Douds, 1995c). 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.

Eye irritation

The potential eye irritant and/or corrosive effects of Lupersol 531-80M were evaluated on New Zealand White rabbits (Douds, 1995d). Each of six rabbits received a 0.1 ml dose of the test article in the conjunctival sac of the right eye. The contralateral eye of each animal remained untreated and served as a control. Test and control eyes were examined for signs of irritation for up to 7 days following dosing. Exposure to the test article produced iritis in 2/6 test eyes at the 1 hour scoring interval. The iridal irritation resolved completely in the affected animals by the 24 hour scoring interval. Conjunctivitis (redness, swelling and discharge) was noted in 6/6 test eyes at the 1 hour scoring interval. The conjunctival irritation resolved completely in ail animals by the day 7 scoring interval. Under the conditions of this test, Lupersol 531 -80M is considered to be a slight irritant to the ocular tissue of the rabbit.

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

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

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

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

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

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

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye 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

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues 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): 71
- Humidity (%): 57-67
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

0.1 ml

Duration of treatment / exposure:

24 h

Observation period (in vivo):

1, 24, 48 and 72 hours and up to 21 days after dosing

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): physiological saline
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize scores

TOOL USED TO ASSESS SCORE: fluorescein

Irritation parameter:

cornea opacity score

Basis:

animal: #1, 2, 3, 4, 5 and 6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

animal: #1, 2, 3, 4, 5 and 6

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

animal: #1, 2, 3 and 4

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

conjunctivae score

Basis:

animal: #5 and 6

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

chemosis score

Basis:

animal: #1 and 2

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 days

Irritation parameter:

chemosis score

Basis:

animal: #3, 5 and 6

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0.7

Max. score:

3

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

Exposure to the test article produced iritis in 2/6 test eyes at the 1 hour scoring interval. The iridal irritation resolved completely in the affected animals by the 24 hour scoring interval. Conjunctivitis (redness, swelling and discharge) was noted in 6/6 test eyes at the 1 hour scoring interval. The conjunctival irritation resolved completely in all animals by the day 7 scoring interval. No corneal opacity, iritis or conjunctivitis was observed in the control eyes.

Interpretation of results:

GHS criteria not met

Conclusions:

Luperso 531-M80 is considered to be a slight irritant to the ocular tissue of the rabbit

Executive summary:

The potential eye irritant and/or corrosive effects of Lupersol 531-80M were evaluated on New Zealand White rabbits. Each of six rabbits received a 0.1 ml dose of the test article in the conjunctival sac of the right eye. The contralateral eye of each animal remained untreated and served as a control. Test and control eyes were examined for signs of irritation for up to 7 days following dosing. Exposure to the test article produced iritis in 2/6 test eyes at the 1 hour scoring interval. The iridal irritation resolved completely in the affected animals by the 24 hour scoring interval. Conjunctivitis (redness, swelling and discharge) was noted in 6/6 test eyes at the 1 hour scoring interval. The conjunctival irritation resolved completely in all animals by the day 7 scoring interval. The mean scores over 24, 48 and 72 hours were 0, 0, 1.2 a,d 0.6 for corneal opacity, iritis and conjunctival and chemosis effects, respectively. Under the conditions of this test, Lupersol 531-80M is considered to be a slight irritant to the ocular tissue of the rabbit.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

According to CLP and GHS criteria:

Skin irritation cat. 2, H315: Causes skin irritation