tert-pentyl 2-ethylperoxyhexanoate

Endpoint summary

Description of key information

Tert-amyl peroxy-2-ethylhexanoate is not irritating for rabbit eye and skin (Reagan, 1981).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

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)

Qualifier:

according to guideline

Guideline:

other: 16 CFR 1500.4l.

GLP compliance:

yes (incl. QA statement)

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.

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.

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

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

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.

Reference 2

Endpoint:

skin irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

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

Qualifier:

according to guideline

Guideline:

other: CFR 1500

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues 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.

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

24, 48 and 72 hours

Number of animals or in vitro replicates:

6

Details on study design:

Prior to the test, the eyes were examined with sodium fluorescein and an ultraviolet lamp. only animals without any lesion were used for the test.

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

0

Interpretation of results:

GHS criteria not met

Conclusions:

Under these experimental conditions, tert-amyl peroxyoctoacte is not irritating for rabbit eye.

Executive summary:

The potential of tert-amyl peroxyoctoacte to induce ocular irritation was evaluated in rabbits according to CFR 1500 guideline and in compliance with GLP.

A single dose of 0.1mL of the undiluted test item was administered to one eye of six New Zealand White Rabbits.

. The other eye was not treated and served as control.

Ocular reactions were observed approximately 1 hour, 24, 48 and 72 hours after the administration and then daily until reversibility of the ocular reactions. The mean values of the scores for chemosis, redness of the conjunctiva, iris lesions and corneal opacity were calculated for each animal.

Mean scores for all animals over 24, 48 and 72 hours were 0 for chemosis, redness of the conjunctiva, iris lesions and for corneal opacity.

Under these experimental conditions, tert-amyl peroxyoctoacte is not irritating for rabbit eye.

Reference 2

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Two well conducted study are avaible. Both were Klimisch 2, GLP compliant.

The acute dermal irritation of tert-amylperoctoate was evaluated in rabbits according to 16 CFR 1500.4 guideline and in compliance with GLP (Reagan, 1981). 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 formation, and for edema. No irritation was observed on shaved skin (all scores were 0).

The eye irritation potential was evaluated in rabbits according to CFR 1500 guideline and in compliance with GLP. A single dose of 0.1mL of the undiluted test item was administered to one eye of six New Zealand White Rabbits. The other eye was not treated and served as control. Ocular reactions were observed approximately 1 hour, 24, 48 and 72 hours after the administration and then daily until reversibility of the ocular reactions. Mean scores for all animals over 24, 48 and 72 hours were 0 for chemosis, redness of the conjunctiva, iris lesions and for corneal opacity. Therefore tert-amyl peroxy-2-ethylhexanoate is not irritating for rabbit eye.

Justification for selection of skin irritation / corrosion endpoint:
Key study, Klimisch 2.

Justification for selection of eye irritation endpoint:
Key study, Klimisch 2.

Justification for classification or non-classification

According to the directive 67/548/EEC and according to EU Regulation (EC) N0. 1272/2008 (CLP), tert-amyl peroxy-2 -ethylhexanoate is not a skin or an eye irritant.