Crotonaldehyde

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion

Remarks:

other: US Department of Transportation (DOT), hazardous materials regulations

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Pre-GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1972

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: DOT

Principles of method if other than guideline:

none

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Crotonaldehyde

EC Number:

224-030-0

EC Name:

Crotonaldehyde

Cas Number:

4170-30-3

Molecular formula:

C4H6O

IUPAC Name:

but-2-enal

Details on test material:

none

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

occlusive

Preparation of test site:

other: abraded and unabraded sites

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 ml

Duration of treatment / exposure:

4 hours

Observation period:

4, 24, and 72 hours

Number of animals:

6

Details on study design:

Prior to the application of the test material, the hair was clipped from the back and flanks of each rabbit. Two test sites located lateral to the midline of the back approximately 10 centimeters apart were selected. one of the two sites was abraded by making four epidermal incisions, two perpendicular to the other two, which the other test site remained intact.
Exactly 0.5 ml of the undilted liquid was applied to each test site on each rabbit. The test sites were immediately covered with two inch square gauze patches. The patches were placed directly over the test sites and secured with masking tape. The trunk of each animal was then wrapped with plastic sheeting. The wrap held the patches in position and retarded evaporation of the test material during the four hour exposure period.
At the end of four hours, the plastic wrapping and patches were removed. The intact and abraded sites were examined and scored separately for erythema and edema on a graded scale of 0-4. After 24 and 72 hours, the sites were scored again.

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Score:

8

Max. score:

8

Other effects:

none

Any other information on results incl. tables

none

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Corrosive to the skin of rabbits

Executive summary:

Young albino rabbits of the New Zealand strain were used in the evaluation of the primary skin irritating properties of crotonaldehyde. The test prodcedure was modeled after the Department of Transportation, Hazardous Materials Regulation (US). 0.5 ml of Crotonaldehyde was applied undiluted to abraded and unabraded sites on the same animals which were then covered with gauze and plastic wrap. Exposure time was 4 hours and irritation observations were recorded at 4, 24 and 72 hours after exposure. Crotonaldehyde was corrosive to rabbit skin at all time points to all animals.