Di-tert-butyl 1,1,4,4-tetramethyltetramethylene diperoxide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

29 September 1994 - 2 November 1994

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well-conducted and documented study performed under GLP; however, no CoA for the test material is included in the report.

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)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Di-tert-butyl 1,1,4,4-tetramethyltetramethylene diperoxide

EC Number:

201-128-1

EC Name:

Di-tert-butyl 1,1,4,4-tetramethyltetramethylene diperoxide

Cas Number:

78-63-7

Molecular formula:

C16H34O4

IUPAC Name:

2,5-bis(tert-butylperoxy)-2,5-dimethylhexane

Details on test material:

Chemical name: no data
Purity: no data
Lot No.: 0568422701
Receipt Date: September 9, 1994
Physical Description: Light yellow liquid
Storage Conditions: Room temperature
Expiration Date: February 15, 1995

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: adult
- Weight at study initiation:2.0 to 3.5 kg
- Housing: The animals were housed individually in suspended stainless steel cages. All housing and care were based on the standards recommended by the Guide for the Care and Use of Laboratory Animals
- Diet (e.g. ad libitum): Purina Certified Rabbit Chow #5322 was provided ad libitum to the animals throughout the study. The lot number and expiration date of each batch of diet used during the study were recorded. The feed was analyzed by the supplier for nutritional components and environmental contaminants. Dietary limitations for various environmental contaminants, including heavy metals, pesticides, polychlorinated biphenyls and total aflatoxin are set by the manufacturer. Within these limits, contaminants which may have been present were not expected to compromise the purpose of this study. Results of the dietary analyses (Certificates of Analysis) are provided by the manufacturer for each lot of diet. These are maintained by SLS.
- Water (e.g. ad libitum): Municipal tap water treated by reverse osmosis or deionization (back-up system) was available to the animals ad libitum throughout the study. The purified water was supplied by an automatic watering system. Monitoring of the drinking water for contaminants was conducted by SLS and the records are available for inspection. Within generally accepted limits, contaminants which may have been present were not expected to compromise the purpose of this study.
- Acclimation period: Upon receipt, animals were examined, identified with plastic ear tags and then quarantined for a minimum of five days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C):± 19-21
- Humidity (%): 46-64
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: 29 September 1994 - 2 November 1994

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml

Duration of treatment / exposure:

4 hours

Observation period:

Animals were examined for signs of erythema and edema and the responses scored at approximately 1, 24, 48 and 72 hours and up to 14 days after patch removal

Number of animals:

3 males and 3 females

Details on study design:

TEST SITE
- Area of exposure: 1" X 1" square 4 ply gauze patch
- % coverage:-
- Type of wrap if used: The test article was administered under the gauze patch. The gauze patch was held in contact with the skin at the cut edges with a non-irritating tape. Removal and ingestion of the test article was prevented by placing an elastic wrap over the trunk and test area (semi-occlusive binding). The elastic wrap was then further secured with adhesive tape around the trunk at the cranial and caudal ends.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test article was removed using gauze moistened with distilled water.
- Time after start of exposure: immediatly after the 4 hour exposure.

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

all

Time point:

other: 24-48-72 hours

Score:

1.22

Max. score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: in 5/6 animals desquamation was observed

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

all

Time point:

other: 24-48-72 hours

Score:

0.94

Max. score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: in 5/6 animals desquamation was observed

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 resolved completely in all animals by study day 14. Additional dermal findings noted during the period included desquamation, which was noted on 5/6 test sites.

Any other information on results incl. tables

Summary of dermal lesions

 

no.	Effect	Hour	Days after application						Mean score erythema 24/48/72 h *	Mean score oedema 24/48/72 h *
		1	1	2	3	7	10	14
51403/M	Erythema/ eschar Oedema	1 1	1 1	1 1	1 0	1** 0	2 1	0** 0	1	0.66
51411/F	Erythema/ eschar Oedema	1 1	2 1	1 1	1 0	0 0	- -	- -	1.33	0.66
51387/M	Erythema/ eschar Oedema	2 1	2 1	1 1	0 1	0** 0	- -	- -	1	1
51388/M	Erythema/ eschar Oedema	2 2	2 1	1 1	1 1	1 0	1** 0	0** 0	1.33	1
51427/F	Erythema/ eschar Oedema	2 1	2 1	1 1	1 1	1** 1	2 1	0** 0	1.33	1
51430/F	Erythema/ eschar Oedema	2 2	2 2	2 1	1 1	1 1	2 1	0** 0	1.66	1.33
Mean Group									1.22	0.94

* Mean score based on 24, 48 and 72 h after application

**desquamation

 

Applicant's summary and conclusion

Executive summary:

The potential irritant and/or corrosive effects of the substance 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 resolved completely in all animals by study day 14. Additional dermal findings noted during the period included desquamation, which was noted on 5/6 test sites. Under the conditions of this test the substance is considered to be an irritant to the skin of the rabbit.