1-(1,1-dimethylpropylperoxy)-1-methoxycyclohexane

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:

2005

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-methoxy-1-[(2-methylbutan-2-yl)peroxy]cyclohexane

EC Number:

700-446-2

Cas Number:

125768-93-6

Molecular formula:

C12H24O3

IUPAC Name:

1-methoxy-1-[(2-methylbutan-2-yl)peroxy]cyclohexane

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Millbrook Breeding Labs, Amherst, MA
- Age at study initiation: . ca. 5 months
- Weight at study initiation: 3.3 - 3.8 kg
- Housing: 1 /cage in suspended wire cages
- Diet: Fresh PMI Rabbit Chow (Diet #5321), ad libitum
- Water: ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- 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:

14 days

Number of animals:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1 and #2

Time point:

other: 24, 48 and 72 hours

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24, 48 and 72 hours

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 3

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24, 48 and 72 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24, 48 and 72 hours

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Irritant / corrosive response data:

Erythema was absent to barely perceptible at 60 minutes following patch removal, barely perceptible to well defined at 24 and 48 hours, well defined at 72 hours, barely perceptible to well defined on day 7 and absent by day 14.
Edema was barely perceptible to moderate at 60 minutes following patch removal, barely perceptible to well defined at 24 hours, absent to well defined at 48 and 72 hours, absent to barely perceptible on day 7 and absent by day 14.

Other effects:

There were no abnormal physical signs noted during the observation period.
One animal lest weight on day 7. Ali other body weight changes were normal.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Luperox XPS-TP is slightly irritant for the skin.

Executive summary:

The irritant or corrosive effects, if any, of Luperox XPS-TP when applied dermally was evaluated following OECD guideline no. 404. Three healthy New Zealand White rabbits (1 male - 2 females) were dosed dermally with Luperox XPS-TP. The test article (0.5 ml) was applied dermally to one intact site/rabbit. The test article was kept in contact with the skin for 4 hours at which time the wrappings were removed. Dermal reactions were scored at 60 minutes following patch removal. Reactions were scored again at 24, 48 and 72 hours and on days 7 and 14 following patch removal. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction at these time periods. Body weights were recorded pretest, 72 hours, day 7 and at termination. Erythema was absent to barely perceptible at 60 minutes following patch removal, barely perceptible to well defined at 24 and 48 hours, well defined at 72 hours, barely perceptible to well defined on day 7 and absent by day 14. Edema was barely perceptible to moderate at 60 minutes following patch removal, barely perceptible to well defined at 24 hours, absent to well defined at 48 and 72 hours, absent to barely perceptible on day 7 and absent by day 14. There were no abnormal physical signs noted during the observation period. One animal lost weight on day 7. All other body weight changes were normal. Luperox XPS-TP is slightly irritant for the skin.