tert-pentyl 2-ethylperoxyhexanoate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: 2a Guideline study without detailed documentations (no certificat of analysis for example)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: 16 CFR 1500.4l.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

tert-pentyl 2-ethylperoxyhexanoate

EC Number:

211-687-3

EC Name:

tert-pentyl 2-ethylperoxyhexanoate

Cas Number:

686-31-7

Molecular formula:

C13H26O3

IUPAC Name:

2-methylbutan-2-yl 2-ethylhexaneperoxoate

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): tert-amyl peroxyoctoate

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: purchased from H.A.R.E. - Rabbits for Research, Hewitt, N.J. for use in this study.
- Age at study initiation: no data
- Weight at study initiation: 2-4 kg
- Housing :individually in wire mesh bottom cages in an environment-controlled room.
- Diet and water : ad libitum
- Acclimation period: quarantined for a minimum of 5 day

ENVIRONMENTAL CONDITIONS
All housing and care conformed to the sta'ndards established in "Guide for the Care and use of Laboratory Animals" DHEW publication
No. (NIH) 78-23.

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved or abraded

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

24 hours

Observation period:

24 or 72 hours

Number of animals:

6

Details on study design:

Shortly before dosing, the dorsal surface of each rabbit was clipped free of fur with electric clippers.
During this procedure, care was taken to avoid accidential abrasion to the skin.
Just prior to test article application, the test site on the right dorsal side was abraded with the tip of a 22 gauge hypodermic needle. The abrasions were 4 incisions made in cross hatch which penetrated the stratum corneum but did not disturb the derma and/or produce bleeding.

Results and discussion

In vivo

Results

Irritation parameter:

other: erythema and edema scores

Basis:

mean

Time point:

other: 24 and 72 hours

Max. score:

0

Remarks on result:

other: shaved skin

Any other information on results incl. tables

Scores:

	Exposure time (h)	Skin	Rabbit 1	Rabbit 2	Rabbit 3	Rabbit 4	Rabbit 5	Rabbit 6
Erythema and eschar formation	24	intact	2	2	2	1	1	1
	72	intact	0	0	0	0	0	0
	24	abraded	2	2	2	1	1	1
	72	abraded	0	0	0	0	0	0
Edema formation	24	intact	0	1	1	0	0	1
	72	intact	0	0	0	0	0	0
	24	abraded	0	1	1	0	0	1
	72	abraded	0	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

After a 24-hour exposure period under occlusive conditions, tert-amyl peroctoacte is not irritating for rabbit skin.

Executive summary:

The acute dermal irritation of tert-amylperoctoate was evaluated in rabbits according to 16 CFR 1500.4l. guideline and in compliance with GLP. The test item was applied undiluted to the skin of 3 New Zealand White rabbits (shave skin or abraded skin) and held in contact for 24 hours by means of an occlusive dressing.

Mean scores over 24, and 72 hours for each animal were for erythema and eschar foramation, and for edema.

On shaved skin, no irritation was observed (all scores were 0). On abraded skin, slight to moderate signs of irritation were observed but only at 24 hours, not at 72 hours.

Under the experimental conditions, after a 24-hour exposure period under occlusive conditions, tert-amyl peroctoacte is not irritating for rabbit skin.