Dioctanoyl peroxide

Eye irritation

Administrative data

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.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: FDA

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Dioctanoyl peroxide

EC Number:

212-094-2

EC Name:

Dioctanoyl peroxide

Cas Number:

762-16-3

Molecular formula:

C16H30O4

IUPAC Name:

octanoyl octaneperoxoate

Test material form:

other: solid

Details on test material:

Perkadox SE-8: di-octanoyl peroxide
Stored at - 20 C until use

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

None provided

Test system

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.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24 h

Score:

0

Max. score:

3

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24 h

Score:

0.83

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24 h

Score:

0.83

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Applicant's summary and conclusion

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.