Dihexadecyl peroxodicarbonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study was performed pre-GLP and pre-guideline. The report is very concise. No data on test item composition or purity. The exposure was for a period of 24-hours and under occlusion. The test substance was not moistened to ensure optimal contact with the skin. However in 6 animals the skin was abraded and no reaction occured. Therefor the negative outcome of this test is acceptable.

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

Remarks:

pre-GLP

Test material

Test material information

Constituent 1

Reference substance name:

Dihexadecyl peroxodicarbonate

EC Number:

247-611-0

EC Name:

Dihexadecyl peroxodicarbonate

Cas Number:

26322-14-5

Molecular formula:

C34H66O6

IUPAC Name:

1-[({[(hexadecyloxy)carbonyl]peroxy}carbonyl)oxy]hexadecane

Details on test material:

Perkadox 24
di-cetyl peroxydicarbonate
solid
storage at -20°C

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: No data
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data

IN-LIFE DATES: No data

Test system

Type of coverage:

occlusive

Preparation of test site:

other: intact and abraded, both clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

24 hours

Observation period:

24 and 72 hours after application the skin reaction is scored.

Number of animals:

12, 6 with intact skin and 6 with abraded skin

Details on study design:

TEST SITE
- Area of exposure: back
- % coverage: 1x1 inch
- Type of wrap if used: 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

REMOVAL OF TEST SUBSTANCE: the test substance is removed, no further details.
- Washing (if done):
- Time after start of exposure:

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Remarks:

all animals

Time point:

other: 24-72 hours after application

Score:

0

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

animal: all animals

Time point:

24/48/72 h

Remarks on result:

other: not reported

Results 3

Irritation parameter:

edema score

Basis:

animal: all animals

Time point:

24/48/72 h

Remarks on result:

other: not reported

Irritant / corrosive response data:

No skin reaction observed

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

No effects on the skin were observed.

Executive summary:

12 new zealand white rabbits were exposed to the test substance for 24 hours under occulsion on their backs. 6 animals had abraded skin and 6 animals had intact skin. 24 and 72 hours after application no effects on the skin were observed.