Dioctanoyl peroxide

Skin irritation / corrosion

Administrative data

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.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

No data

Test system

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.

Results and discussion

In vivo

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.