Pivaloyl chloride

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Scoring system

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Pivaloyl chloride

EC Number:

221-921-6

EC Name:

Pivaloyl chloride

Cas Number:

3282-30-2

Molecular formula:

C5H9ClO

IUPAC Name:

2,2-dimethylpropanoyl chloride

Details on test material:

Purity of test material was not analytically confirmed. It was used as received from PPG Industries. Purity of that material is listed as > 99% on the MSDS.

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

21 days

Number of animals:

6 (3 per sex)

Details on study design:

Undiluted test material was placed on clipped skin under a gauze patch. Each patch was secured with a strip of non-irritating adhesive tape and the entire trunk of the animal was wrapped with a semi-permeable dressing.
The dressings were removed 4 hours later and the skin was gently wiped with a moist cloth to remove as much residual material as possible.

SCORING SYSTEM
The animals were scored for erythema and eschar formation, edema formation and any other dermal effects or irritation at 1, 24, 48, and 72 hours and 4, 7, 10, 14, 17 and 21 days after removal of the dressings. The maximum score for each endpoint was 4 for each observation. All of the erythema and edema scores for each observation point were added together, and the sum was divided by the number of animals observed to determine an irritation score. The maximum irritation score was selected from the observation time yielding the highest irritation score.

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Score:

6

Remarks on result:

other:

Remarks:

Erythema and edema were present at each observation time through Day 21.

Any other information on results incl. tables

Erythema and edema were present at each observation time through Day 21. The maximum irritation score was 7.0/8.0 on Day 7 (which would lead to a classification of severe irritant). Since necrosis was present on the test sites of all 6 animals, the test material was given a descriptive rating of corrosive.