Cyclohexylidenebis[tert-amyl] peroxide

Eye irritation

Administrative data

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

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 405 (Acute Eye 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 / tissue source

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

Test system

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

Results and discussion

In vivo

Results

Results 1

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

Results 2

Irritation parameter:

iris score

Basis:

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

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

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

Results 4

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

Results 5

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

Results 6

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

Results 7

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.

Applicant's summary and conclusion

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.