Dioctanoyl peroxide

Endpoint summary

Description of key information

Dioctanoyl peroxide is severly irritating to intact and abraded rabbit skin following a 24-hour exposure. Dioctanoyl peroxide was not irritating to rabbit eyes.

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:

1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP study with adequate details. No COA but the test article was identified as dicotanoyl peroxide.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

No data

Type of coverage:

occlusive

Preparation of test site:

other: intact and abraded

Vehicle:

not specified

Controls:

no

Amount / concentration applied:

0.5 grams

Duration of treatment / exposure:

24 hours

Observation period:

24 and 72 hours after application

Number of animals:

Six intact and six abraded.

Details on study design:

Primary irritation to the skin is measured by patch test technique
on the abraded and intact skin of albino rabbits.
Twelve healthy adult New Zealand White albino rabbits were used.
Twenty four hours prior to applying the material
the hair is removed from the backs of the animals with an electric clipper
in such away as to avoid abrasion.
An amount of 0.5 ml (in case of liquids) or 0.5 g (in case of solids
or semi-solids) of the test substance is brought on the intact or abraded
skin under a surgical patch measuring 1 inch x 1 inch; The patches are
fixed to the application site by means of adhesive tape and the entire
trunk of the rabbits is wrapped with an impervious material to maintain
the test patches in position and to retard evaporation of volatile substances.

Six rabbits are treated on the intact skin, the other six on the
abraded skin. The abrasions are are minor incisions through the stratum
corneum but not sufficiently deep to disturb the derma or to produce
bleeding.
After an exposure period of 24 hours the patches and the material
applied are removed and the resulting skin reactions are evaluated by the
method of Draize (J. Pharmacol. 82 (1944) 377 - 390). A second reading is
made 48 hours later (72 hour after application).
In the case of surface active test substances the skin reactions after
72 hours usually consist of scaliness and/or necrosis. Since the Draize
grading system does not comprise these abnormalities the second reading
is carried out on the basis of the ClVO-grading system.

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

2.66

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

positive indication of irritation

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

positive indication of irritation

Irritation parameter:

edema score

Basis:

mean

Time point:

24 h

Score:

2.16

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

positive indication of irritation

Irritation parameter:

edema score

Basis:

mean

Time point:

72 h

Score:

1.16

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

positive indication of irritation

intact skin abraded skin

rabbit 24 hours 72 hours rabbit 24 hours 72 hours

no A B A B no A B A B

5516 3 -2 3 -1 5510 3 -2 3-1

5517 2 -2 3 -2 5511 4- 3 3 -2

5518 2 -3 3 -1 5512 3 -2 3 -1

5519 3 -2 3 -1 5513 2 -2 0 -0

5520 3 -2 3 -1 5514 3 -2 3 -1

5521 3 -2 3 -1 5515 2 -2 3 -1

aver.: 4.8 4.2 5.0 3.5

A = erythema; B = edema

Interpretation of results:

Category 2 (irritant)

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Dioctanoyl peroxide was severly irritating to rabbit skin following a 24-hour exposure.

Executive summary:

Dioctanoyl peroxide was evaluated for skin reactions following a 24 -hour exposure on intact and abraded skin. Evaluations were made following the 24 -hour expousre and 48 hours later (72 -hours post exposure). Evaluations were based on the Draize method.

Diotanoyl peroxided was severely irritating to rabbit skin following a 24 -hour exposure.

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:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

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

Reference 2

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: Non-GLP study but adequate details. While a COA was not included, the test article was identified as dioctanoyl peroxide.

Qualifier:

according to guideline

Guideline:

other: FDA

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

None provided

Vehicle:

not specified

Amount / concentration applied:

As received.

Duration of treatment / exposure:

One time instillation in one eye of each rabbit.

Observation period (in vivo):

24 and 48 hours

Number of animals or in vitro replicates:

Six

Details on study design:

In general the techniques of tests as published by the FDA of
the United States (Fed, Reg, 28 (119), 5582, 1963) and Draize and
Kelley (Drug Cosmet. Industr. 11 (1952) 36) are followed,
Six New Zealand White albino rabbits are used for each test
substance. The animals are caged individually and receive no hay or
other extraneous material that might enter the eyes.
The eyes of the animals are examined before testing and only
those animals without observable eye defects are used . One tenth of
a milliliter of the test substance, or in case of solids or semisolids,
100 milligrams of the test substance, is allowed to fall on
the everted lower lid of one eye of each rabbit; the upper and lower
eye lid are then carefully closed and subsequently held together
for at least one second before releasing, to prevent loss of material.
The other eye, remaining untreated, serves as a control.
The eyes are not washed following instillation and the animals
are released immediately.
The eyes are examined at 24, 48, 72 hours and 7 days after
instillation of the test material.
An animal is considered as giving a positive reaction if there
is, at any of the readings, discernible opacity of the cornea
(other than a slight dulling of the normal lustre), or ulceration
of the cornea, or inflammation of the iris (other than a slight
deepening of the folds (rugae) or a slight circumcorneal injection),
or if such substances produce in the conjunctivae (palpebral and
bulbar, excluding the cornea and iris) an obvious swelling with
partial eversion of the lids, or a diffuse deep-crimson red with
individual vessels not easily discernible. The FDA-scoring scale is
used.
The test is considered positive if four or more of the animals
in the test group of six rabbits exhibit a positive reaction . If
one animal exhibits a positive reaction , the test is regarded as
negative.
If two or three animals exhibit a positive reaction, the test
is repeated, using a different group of six animals. The second
test is considered as positive if three or more of the animals
exhibit a positive reaction. If only one or two animals in the
second test exhibit a positive reaction, the test is again repeated
with a different group of six animals. Should a third test be needed
the substance will be regarded as an irritant if two or more animals
exhibit a positive response.
A substance which has elicited corneal and/or iris lesions which have
not cleared by the seventh day reading, is considered a severe eye irritant.

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24 h

Score:

0

Max. score:

3

Irritation parameter:

iris score

Basis:

mean

Time point:

24 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24 h

Score:

0.83

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24 h

Score:

0.83

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Interpretation of results:

not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Dioctanoyl peroxide is not classified as an eye irritant in accordance with EU criteria.

Executive summary:

Dioctanoyl peroxide was evaluated for eye irritation in rabbits in accordance with the FDA and Draize methods. 100 mg of the test substance was instilled into one eye of six rabbits. Eyes were evaluated 24 hours following instillation. There was no effect on the cornea or iris of any of the animals. Scores of 1 were reported for conjucntival redness and chemosis at the 24 hour evaluation. All scores were zero at the 48 hour reading.

Dioctanoyl peroxide was not irritating to rabbit eyes.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the availble information the substance is classified as irritating to skin, category 2.